The German health technology assessment institute, IQWiG, plans to begin testing the
latest version of its cost-benefit assessment methodology for medicines towards the end of September. The results of the testing, which will last for about four months, will be keenly awaited by pharmaceutical companies because IQWiG's assessments will be used to set ceiling reimbursement prices for new drugs reimbursed by the health insurance bodies. Previously, IQWiG (the Institute for Quality and Efficiency in Healthcare) assessed only the clinical benefits of medicines, but under last year's healthcare competition reform law it now also has to consider the costs of therapies in relation to their benefits. To do this it has had to draft a cost-benefit methodology. A first version was put out for public consultation earlier this year, and drew many comments from stakeholders. Some were critical of the proposed methodology, particularly the "efficiency frontier analysis" that IQWiG plans to use as the basis of cost-benefit assessments (Scrip Online, April 8th,
2008). The US industry body, PhRMA, for example, said that while the efficiency
frontier was "a theoretically sound concept", it was not clear whether it would work in practice.
IQWiG claims that efficiency frontier analysis can be "used in a very flexible manner to compare the cost-benefit relation of any number of therapy alternatives". The graph produced using this analysis shows clearly which existing therapies are efficient and those that are not, it said. For drugs that are more beneficial but more expensive than those already in use, it will be possible to determine where their price would have to lie so that the cost-benefit relationship falls within the accepted efficiency range, it added.
Pricing and cost assessment
IQWiG's new methodology will help the central federal association of health insurance
funds to determine an appropriate ceiling price for drugs that are reimbursed by the
statutory health insurers but cannot be included in a reference price group, according to the institute.
If the price suggested by the manufacturer was higher than this ceiling, the manufacturer could choose whether or not to lower its price. If it did not, the patient would have to pay the difference or opt for another product. The institute's assessment will also include a budget impact analysis that can be used in estimating how a decision may affect expenditure in the healthcare system as a whole.
Timetable
IQWiG said it expects to publish the next version (1.1) of the methodology at the end of September. This version will not specifically take into account the comments received, but will "clarify aspects that were misunderstood in version 1.0".
Simultaneously, the institute plans to publish a "scientific reply" to the comments, as well as the comments themselves and three additional technical documents. The
comments will be incorporated into version 2.0, which is expected to be published in
March 2009, again for public consultation. Once this consultation is complete, version 3.0 will be published, although the institute could not say at this stage when this might be.
VFA uploads comments
In the meantime, the R&D-based industry body, the VFA, has published on its own
website some of the comments sent to IQWiG on the proposed cost-benefit methodology. The VFA decided to do this in the interests of "transparency" and to allow interested parties to "play a role in the development of a future cost-benefit evaluation of medicines", said its director, Cornelia Yzer.
SCRIP - World Pharmaceutical News -
www.scrippharma.com FILED 27 August 2008 COPYRIGHT Informa UK Ltd 2008
COPYRIGHT BY T&F Informa UK Ltd
8.28.2008
Health Economics Position in Europe: Director of Market Access, Pricing and Reimbursement in Belgium
Dear Readers,
please find below job posting that just came in. Interested individuals please contact Michael Lister (contact details below).
Cheers
Ulf
Location: Belgium
The Client is a late-stage biomedical company and operates at the cutting edge of regenerative medicine and focuses on the development of innovative local treatments for damaged and osteoarthritic joints.
Major Accountabilities:
• To set up and maintain lead contacts and relationships at government authority level and develop plans to gain support and market access for company products
• To develop pricing and reimbursement strategies to ensure a premium price and favorable reimbursement on an on-going basis
• To provide tools to facilitate the negotiation process with payers.
• To respond to inquiries and to ensure implementation of specific access and reimbursement programs and their proper resolution
• To coordinate and manage external pricing & reimbursement consulting projects
Requirements for the Job:
• Experience in pharmaceutical and/or healthcare industry with experience in reimbursement, health economics, public policy, strategy development.
• Ideally direct in-depth experience of at least 1 EU reimbursement environment. General familiarity with the European reimbursement environment is essential.
• Past involvement in producing P&R tools (Core Value Dossier)
• Languages: Fluent English a must, Dutch and/or French useful, any other major European language a plus.
Michael Lister
VirdisPharma
Virdis House
Bishops Mews
Transport Way
Oxford, OX4 6HD, UK
Mobile: +44 (0) 7825 541499
Tel: +44 (0) 1865 770033
Fax: +44 (0) 1865 711776
http://www.virdispharma.com
please find below job posting that just came in. Interested individuals please contact Michael Lister (contact details below).
Cheers
Ulf
Location: Belgium
The Client is a late-stage biomedical company and operates at the cutting edge of regenerative medicine and focuses on the development of innovative local treatments for damaged and osteoarthritic joints.
Major Accountabilities:
• To set up and maintain lead contacts and relationships at government authority level and develop plans to gain support and market access for company products
• To develop pricing and reimbursement strategies to ensure a premium price and favorable reimbursement on an on-going basis
• To provide tools to facilitate the negotiation process with payers.
• To respond to inquiries and to ensure implementation of specific access and reimbursement programs and their proper resolution
• To coordinate and manage external pricing & reimbursement consulting projects
Requirements for the Job:
• Experience in pharmaceutical and/or healthcare industry with experience in reimbursement, health economics, public policy, strategy development.
• Ideally direct in-depth experience of at least 1 EU reimbursement environment. General familiarity with the European reimbursement environment is essential.
• Past involvement in producing P&R tools (Core Value Dossier)
• Languages: Fluent English a must, Dutch and/or French useful, any other major European language a plus.
Michael Lister
VirdisPharma
Virdis House
Bishops Mews
Transport Way
Oxford, OX4 6HD, UK
Mobile: +44 (0) 7825 541499
Tel: +44 (0) 1865 770033
Fax: +44 (0) 1865 711776
http://www.virdispharma.com
8.15.2008
Senators Propose Nonprofit Institute to Study Comparative Effectiveness
published in "Quality"
Democratic Senate leaders July 31 introduced legislation that would create a comparative effectiveness institute dedicated to researching and disseminating information about which health care treatments work best, without evaluating cost or health plan design factors.
The proposed Comparative Effectiveness Research Act of 2008 (S. 3408) would establish the Health Care Comparative Effectiveness Research Institute, a private nonprofit corporation that would study which medical treatments--including surgeries, pharmaceuticals, and medical devices--have the best clinical outcomes.
"Doctors and patients need reliable, unbiased information about the effectiveness of treatments to determine the best care possible, but right now that data is scarce and unorganized," Sen. Max Baucus (D-Mont.), chairman of the Senate Finance Committee, said in a statement. "This bill will advance the process of reviewing and producing valuable information and making it available to health care providers, and to all Americans."
Baucus introduced the bill, along with Sen. Kent Conrad (D-N.D.), chairman of the Senate Budget Committee. Conrad said that with the research generated by the institute "patients and their doctors can make better decisions on treatment--meaning we could lower costs and improve health care outcomes."
The institute would be funded by both private and public entities through the creation of a Comparative Effectiveness Research Trust Fund (CERTF). If the legislation is enacted, total funding for the institute would exceed $300 million after five years, according to a Finance Committee summary of the bill.
Insurers and industry groups Aug. 1 weighed in with support for the proposed legislation, saying it is a needed first step in improving the heath care system.
Institute Structure, Responsibilities
The institute would be responsible for establishing research priorities based on the need for better evidence, the burdens of a particular disease, practice variations, the potential for improved care, and the expenses associated with a given condition or care strategy, according to the summary.
The research itself would be conducted by both public and private entities, which would be approved by the institute's board of governors. The research would be peer-reviewed and include systematic reviews, observational studies, clinical trials, and randomized controlled trials.
The board of governors would include 18 public and private stakeholders, as well as the secretary of the Department of Health and Human Services, and the directors of the Agency for Healthcare Research and Quality and the National Institutes of Health.
The institute also would establish an expert methodology committee responsible for developing standards for any research the institute uses. The committee would also be responsible for studying whether cost and health plan design could eventually be incorporated into comparative effectiveness research.
Although the institute would not take costs and health plan design into consideration, a future Congress could incorporate those factors into the research, according to the Finance Committee's summary.
The institute would be required to establish public comment periods, allowed to establish additional advisory committees, and encouraged to study the differences in clinical outcomes for patient subgroups, such as racial and ethnic minorities, according to the committee summary.
Funding for the institute would come from general revenues, the Medicare Trust Funds, and from fees assessed on health plans. The Medicare Trust Funds would contribute $1 per beneficiary annually and health plans would be assessed $1 per-covered-life annually, according to the committee summary.
Industry Reactions
Insurers and other industry groups applauded the intent of the legislation, with some emphasizing the importance of excluding cost-effectiveness analyses from the research.
The Advanced Medical Technology Association (AdvaMed), device industry group, said it is pleased that, although the bill does allow for the study of cost-effectiveness, it does not authorize such study as a part of the institute's research.
"As Congress considers comparative effectiveness legislation, we believe safeguards should be included to ensure that the final determination of what treatment option works best for each patient should be made by individuals and their physicians," Stephen J. Ubl, president and chief executive officer of AdvaMed, said in a statement. "It is also essential that research recognize the unique iterative nature of device innovation when establishing research priorities and conducting studies."
The Pharmaceutical Care Management Association--which represents pharmacy benefit managers--and the Pharmaceutical Research and Manufacturers of America (PhRMA)--which represents drug manufacturers--also voiced their support for the bill, as did the Blue Cross and Blue Shield Association.
In an Aug. 1 statement, PhRMA Senior Vice President Ken Johnson said the drug industry group "supports the development and use of high-quality evidence, including comparative clinical effectiveness evidence, for healthcare decision-making. Proposals to expand government-supported comparative clinical effectiveness research should be structured to promote better patient health and timely patient access to needed therapies, and avoid denying or delaying patients' access to beneficial care, as what often occurs in Europe and Australia."
Scott P. Serota, president and chief executive officer of the Blue Cross and Blue Shield Association (BCBSA), said in a statement, "To improve tomorrow's healthcare coverage we need to change the incentives in today's healthcare system." Serota added that comparative effectiveness research "will empower patients and providers by providing information on quality and value, and improve safety and affordability of healthcare for everyone."
America's Health Insurance Plans also issued a statement commending the bill's introduction. The organization has previously indicated its support for including cost considerations in comparative effectiveness research (96 HCDR, 5/19/08 ).
"Senators Baucus and Conrad took an important step by introducing legislation to create an independent entity to give patients and their doctors the information they need to make health care decisions based on safety, effectiveness, and value. We believe this is the right time for this proposal and pledge to work with the Senators to advance comparative effectiveness legislation," Karen Ignagni, president and chief executive officer of AHIP.
The bill was referred to the Senate Finance Committee.
The text of the bill is available at http://finance.senate.gov/sitepages/leg/LEG%202008/080108%20Comparative%20Effectiveness%20Leg%20text.pdf.
A section-by-section summary of the bill is available at http://finance.senate.gov/sitepages/leg/LEG%202008/080108%20CE%20Section-by-Section.pdf.
Democratic Senate leaders July 31 introduced legislation that would create a comparative effectiveness institute dedicated to researching and disseminating information about which health care treatments work best, without evaluating cost or health plan design factors.
The proposed Comparative Effectiveness Research Act of 2008 (S. 3408) would establish the Health Care Comparative Effectiveness Research Institute, a private nonprofit corporation that would study which medical treatments--including surgeries, pharmaceuticals, and medical devices--have the best clinical outcomes.
"Doctors and patients need reliable, unbiased information about the effectiveness of treatments to determine the best care possible, but right now that data is scarce and unorganized," Sen. Max Baucus (D-Mont.), chairman of the Senate Finance Committee, said in a statement. "This bill will advance the process of reviewing and producing valuable information and making it available to health care providers, and to all Americans."
Baucus introduced the bill, along with Sen. Kent Conrad (D-N.D.), chairman of the Senate Budget Committee. Conrad said that with the research generated by the institute "patients and their doctors can make better decisions on treatment--meaning we could lower costs and improve health care outcomes."
The institute would be funded by both private and public entities through the creation of a Comparative Effectiveness Research Trust Fund (CERTF). If the legislation is enacted, total funding for the institute would exceed $300 million after five years, according to a Finance Committee summary of the bill.
Insurers and industry groups Aug. 1 weighed in with support for the proposed legislation, saying it is a needed first step in improving the heath care system.
Institute Structure, Responsibilities
The institute would be responsible for establishing research priorities based on the need for better evidence, the burdens of a particular disease, practice variations, the potential for improved care, and the expenses associated with a given condition or care strategy, according to the summary.
The research itself would be conducted by both public and private entities, which would be approved by the institute's board of governors. The research would be peer-reviewed and include systematic reviews, observational studies, clinical trials, and randomized controlled trials.
The board of governors would include 18 public and private stakeholders, as well as the secretary of the Department of Health and Human Services, and the directors of the Agency for Healthcare Research and Quality and the National Institutes of Health.
The institute also would establish an expert methodology committee responsible for developing standards for any research the institute uses. The committee would also be responsible for studying whether cost and health plan design could eventually be incorporated into comparative effectiveness research.
Although the institute would not take costs and health plan design into consideration, a future Congress could incorporate those factors into the research, according to the Finance Committee's summary.
The institute would be required to establish public comment periods, allowed to establish additional advisory committees, and encouraged to study the differences in clinical outcomes for patient subgroups, such as racial and ethnic minorities, according to the committee summary.
Funding for the institute would come from general revenues, the Medicare Trust Funds, and from fees assessed on health plans. The Medicare Trust Funds would contribute $1 per beneficiary annually and health plans would be assessed $1 per-covered-life annually, according to the committee summary.
Industry Reactions
Insurers and other industry groups applauded the intent of the legislation, with some emphasizing the importance of excluding cost-effectiveness analyses from the research.
The Advanced Medical Technology Association (AdvaMed), device industry group, said it is pleased that, although the bill does allow for the study of cost-effectiveness, it does not authorize such study as a part of the institute's research.
"As Congress considers comparative effectiveness legislation, we believe safeguards should be included to ensure that the final determination of what treatment option works best for each patient should be made by individuals and their physicians," Stephen J. Ubl, president and chief executive officer of AdvaMed, said in a statement. "It is also essential that research recognize the unique iterative nature of device innovation when establishing research priorities and conducting studies."
The Pharmaceutical Care Management Association--which represents pharmacy benefit managers--and the Pharmaceutical Research and Manufacturers of America (PhRMA)--which represents drug manufacturers--also voiced their support for the bill, as did the Blue Cross and Blue Shield Association.
In an Aug. 1 statement, PhRMA Senior Vice President Ken Johnson said the drug industry group "supports the development and use of high-quality evidence, including comparative clinical effectiveness evidence, for healthcare decision-making. Proposals to expand government-supported comparative clinical effectiveness research should be structured to promote better patient health and timely patient access to needed therapies, and avoid denying or delaying patients' access to beneficial care, as what often occurs in Europe and Australia."
Scott P. Serota, president and chief executive officer of the Blue Cross and Blue Shield Association (BCBSA), said in a statement, "To improve tomorrow's healthcare coverage we need to change the incentives in today's healthcare system." Serota added that comparative effectiveness research "will empower patients and providers by providing information on quality and value, and improve safety and affordability of healthcare for everyone."
America's Health Insurance Plans also issued a statement commending the bill's introduction. The organization has previously indicated its support for including cost considerations in comparative effectiveness research (96 HCDR, 5/19/08 ).
"Senators Baucus and Conrad took an important step by introducing legislation to create an independent entity to give patients and their doctors the information they need to make health care decisions based on safety, effectiveness, and value. We believe this is the right time for this proposal and pledge to work with the Senators to advance comparative effectiveness legislation," Karen Ignagni, president and chief executive officer of AHIP.
The bill was referred to the Senate Finance Committee.
The text of the bill is available at http://finance.senate.gov/sitepages/leg/LEG%202008/080108%20Comparative%20Effectiveness%20Leg%20text.pdf.
A section-by-section summary of the bill is available at http://finance.senate.gov/sitepages/leg/LEG%202008/080108%20CE%20Section-by-Section.pdf.
7.24.2008
NICE restricts rheumatoid arthritis treatment options
Scrip
Patients with refractory rheumatoid arthritis in the UK who previously had the option of
three treatments will now have the option of just one, a draft appraisal from NICE has
recommended.
Patient groups and charities have reacted strongly to the final appraisal determination,
considering it tantamount to greater suffering for patients, a diminishment of treatment
options and "a lack of interest in patient quality of life".
Treatment for RA is currently spread across three main anti-tumour necrosis factor (anti-
TNF) products available on the NHS: Wyeth's Enbrel (etanercept), Abbott's Humira
(adalimumab) and Schering-Plough's Remicade (infliximab). These can be used
sequentially to treat RA, replacing initial or second anti-TNF treatment if they are found
to be, or become, ineffective.
However, the NICE draft will limit this to one anti-TNF, with only one additional
treatment, Roche's B-cell targeting therapy MabThera (rituximab). Rituximab was
previously offered alongside Bristol-Myers Squibb's Orencia (abatacept) after the initial
three RA treatments proved ineffective. Abatacept was not recommended for NHS use in
April after NICE decided that it was not cost-effective, despite an appeal against the
decision (Scrip Online, April 24th, 2008).
The NICE draft examined data available on clinical effectiveness of the three anti-TNFs,
the nature of rheumatoid arthritis, and the value placed on the benefits of treatments by
people with RA, those who represent them and clinical specialists. It also examined
"effective use" of NHS resources and cost-effectiveness of the drugs, with their cost
estimated in some cases by use of figures in the British National Formulary to reach net
annual totals of £9,295 for adalimumab, £9,295 for etanercept and £8,812 for infliximab
per patient.
In a letter of response to the committee's decision, The National Rheumatoid Arthritis
Society has argued that successful treatment with anti-TNFs cannot be predicted in
individual patients, resulting in it being "vital" to provide a number of treatment options
for the disease.
Arthritis Care agreed, arguing RA patients were "step by step having their choices
limited and will be missing out on therapies which could have a profound effect on their
quality and length of life." They also pointed to the continued sequential use of anti-
TNFs in other EU nations, arguing the NICE decision would "[go] against the grain of
policy in Europe", rendering England the "poor man" of Europe for RA treatment.
Final guidance is expected in September. SCRIP - World Pharmaceutical News -
www.scrippharma.com FILED 23 July 2008 COPYRIGHT Informa UK Ltd 2008
Patients with refractory rheumatoid arthritis in the UK who previously had the option of
three treatments will now have the option of just one, a draft appraisal from NICE has
recommended.
Patient groups and charities have reacted strongly to the final appraisal determination,
considering it tantamount to greater suffering for patients, a diminishment of treatment
options and "a lack of interest in patient quality of life".
Treatment for RA is currently spread across three main anti-tumour necrosis factor (anti-
TNF) products available on the NHS: Wyeth's Enbrel (etanercept), Abbott's Humira
(adalimumab) and Schering-Plough's Remicade (infliximab). These can be used
sequentially to treat RA, replacing initial or second anti-TNF treatment if they are found
to be, or become, ineffective.
However, the NICE draft will limit this to one anti-TNF, with only one additional
treatment, Roche's B-cell targeting therapy MabThera (rituximab). Rituximab was
previously offered alongside Bristol-Myers Squibb's Orencia (abatacept) after the initial
three RA treatments proved ineffective. Abatacept was not recommended for NHS use in
April after NICE decided that it was not cost-effective, despite an appeal against the
decision (Scrip Online, April 24th, 2008).
The NICE draft examined data available on clinical effectiveness of the three anti-TNFs,
the nature of rheumatoid arthritis, and the value placed on the benefits of treatments by
people with RA, those who represent them and clinical specialists. It also examined
"effective use" of NHS resources and cost-effectiveness of the drugs, with their cost
estimated in some cases by use of figures in the British National Formulary to reach net
annual totals of £9,295 for adalimumab, £9,295 for etanercept and £8,812 for infliximab
per patient.
In a letter of response to the committee's decision, The National Rheumatoid Arthritis
Society has argued that successful treatment with anti-TNFs cannot be predicted in
individual patients, resulting in it being "vital" to provide a number of treatment options
for the disease.
Arthritis Care agreed, arguing RA patients were "step by step having their choices
limited and will be missing out on therapies which could have a profound effect on their
quality and length of life." They also pointed to the continued sequential use of anti-
TNFs in other EU nations, arguing the NICE decision would "[go] against the grain of
policy in Europe", rendering England the "poor man" of Europe for RA treatment.
Final guidance is expected in September. SCRIP - World Pharmaceutical News -
www.scrippharma.com FILED 23 July 2008 COPYRIGHT Informa UK Ltd 2008
7.10.2008
New Health Economics Job Opportunities
I am posting several new positions in EU and the US both industry as well as consultancy on behalf of Simon Rose, please see his contact details below.
best wishes
Ulf
Associate Director Market Access and Pricing Europe - Switzerland
This is an excellent opportunity to join a leading, niche Biopharma based at their European HQ. My client is a rapidly expanding and developing their Market Access and Pricing department. This purpose of the role is to focus on all market access issues related to in line brands.
Core Responsibilities:
Identification of payer needs.
Conduct of a gap analysis between payer expectations and what the product can deliver.
Development of a commercial policy for all in line brands at launch & the active management of these policies once products are launched
Collaborate with business planning to monitor pricing and impact across Europe
Collaborate with operational marketing to conduct market research
Skills/Knowledge Required:
Has an established network of KOLs.
Has a solid scientific background allowing to understand the impact of trial design on payer strategies and to challenge clinical development or medical affairs.
Previous Pharma or consultancy experience
Postgraduate degree
Excellent Communication and negotiation skills
Associate Director – Consulting Any EU Location
My client is a large, well respected Global consultancy who are rapidly expanding. As my client is interested in the best talent there is flexibility on location. The ideal candidate will need to have in-depth knowledge in Economic Modelling, Pricing and Reimbursement and Health Economic Evaluation. This role would be good for a manager looking for line management responsibility.
As this is deemed as a Strategic role within the organisation their will be a number of other key responsibilities such as:
Maintain proficiency of skills and knowledge and remain current with industry trends based current literature, application of new technology.
Participate in client engagements and manage project deliverables
Present research findings to industry clients and at professional conferences. Publish research in-peer reviewed literature
Participate in Business Development, Marketing and Sales activities
Qualifications
Knowledge of Clinical Trials
Strong negotiation skills
Excellent Communication and Computer Skills
Ability to lead by example
Previously working in a Matrix structure
European Pricing and Reimbursement Manager for a new start-up company
UK based
My client is one of the fastest growing US pharmaceutical companies with ambitious plans for expansion in to Europe. With an exciting potential blockbuster in the pipeline it is exciting times for this organisation. With being a forward thinking company and knowing there will be Market Access issues this position is on of the first to be created.
The job-holder in this role will drive, manage and support the multiple elements that will need to be constructed and integrated to achieve successful reimbursement in Europe. The over arching objective of this role is to minimize, as far as possible, the delay between obtaining regulatory approval and subsequently ensuring rapid market access to both patients and physicians.
Core responsibilities
Assist in internal pricing discussions and in developing a global pricing strategy
Set up and manage external pricing partnerships and third parties
In partnership with Health Outcomes team, lead development of value messages and value communication tools for payors and reimbursement agencies
Identify key stakeholders for P&R and market access in major EU markets
Determine their specific information needs and requirements to tailor health outcomes data appropriately
Within markets determine the sequence to engage with stakeholders and optimum timings
Produce “master” reimbursement strategy plan for key EU markets
Work with affiliates and country managers to action this plan to deliver success at the local level
Manage external partners to assist in facilitating access and with all “non-technical” P&R needs.
Technical Skills, Competencies & Qualifications
Looking for someone to rise to a unique challenge
Previous experience in healthcare industry with ideally a hospital / orphan / specialised product
Experience in global / regional (EU) market access role or possible local market / affiliate experience and interaction with P&R stakeholders (national, regional, hospital).
Familiar with needs of P&R stakeholders in major EU markets
Strong strategic and analytical thinking - to be able to pull together a pan-European reimbursement plan.
Excellent influencing and relationship building skills.
Fluency in English. Foreign language skills are a plus.
Head of Health Economics and Senior Manager - Home Counties, UK
Our client, the world's largest biotechnology company, discovers and develops important therapeutics which bring meaningful improvement to the lives of people all over the world. Science-based and patient-driven, they aspire to be the best human therapeutics company, building their success on innovation, team work, risk-taking and the pursuit of excellence.
Head of Health Economics
Responsibilities
Review of Affiliate’s health economics priorities, allocation of HE resources in line with business strategy
Planning and delivery of health economics policies and activities for the UK and Ireland Affiliate
Act as strong local partner in shaping the expression of product value on global and international matrix teams
Management and continuous improvement of the UK Affiliate health economics processes, aligned with the matrix
Direct and manage HTA submissions to NICE, SMC and AWMSG, and coordination of delivery of constituent components
Senior Manager Health Economics
Responsibilities
Design and delivery of HTA models for current and future products
Delivery of NICE, SMC and AWMSG submissions
Training of staff on value proposition elements
Supporting the Affiliate Business Units in the use of HTA data with customers
Management and coordination of external consultants and business partners
Execution of data generation and analysis projects
Head of Health Economics (Europe)
Location: South East England
My Clients is a research-based global pharmaceutical company and one of the global leaders of the industry. They have ambitious growth plans in Europe. Currently they are covering around 60% of the European Healthcare systems and in the next few years expanding to around 85%. This position is based in their European Headquarters
Position Overview
Cost effectiveness of drugs is becoming increasingly important in an environment where healthcare costs are increasing beyond means and an increasing number of drugs in marketed for a limited number of indications. Due to local laws and pricing policies, cost effectiveness analyses are often nationally based, sometimes regionally. As a central coordinating and services department for Europe, this role will be responsible for drafting models for Outcomes Analyses, applying the appropriate disutilities and ensuring sufficient flexibility in the model so that it can be adapted to fit the needs of European Affiliates. The position also supposed to act as an advocate for Health Economics, raising the awareness of (the need for) Health Economics in the organisation,
Competencies (skills, abilities, aptitudes)
Create a compelling vision of Health Economics Function and communicate this sense of purpose effectively internally and external to my clients an ambassador for the function and an educator to organisation.
Plan ahead to support growth and priorities by defining superior competitive strategies for pipeline by positively influencing the life cycle of pipeline and newly marketed products and filling product gaps.
Demonstrate knowledge of European marketplace including the Pharma industry, competitors, customers, HTA and reimbursement agencies together with regulatory agencies.
Appropriately share viewpoints, opinions and advice even when these may be negative or unpopular but in the interest of cost effective management of company assests.
Technical Skills & Qualifications
Advance degree in either - Health Economics, Public Health, Epidemiology, Pharmacy, Medical or Statistics. Experience in Clinical research is beneficial.
Experience of interfacing between clinical, regulatory and business groups in the Pharma industry
Accomplishments to include publications in the economic field, acknowledged clinical activities and successful submissions to reimbursement/HTA groups.
Understand how Health Economics can be successfully applied throughout the drug development cycle for a winning pricing and reimbursement strategy.
In depth experience analysing and demonstrating the value of pharmaceutical products using appropriate economic tools and modelling.
Strong technical and scientific knowledge in economics research methodology applied to healthcare.
Operational excellence and exceptional business and financial acumen.
Head of Health Economics for a large European Consultancy
Location – USA or Canada
My client is well reputed, independently owned consultancy looking to expand its business to North America. They are a one stop shop offering a wide range of services and currently working with the majority of the leading Pharmaceutical and Medical Devices Company.
This rare opportunity In will support the General Manager in developing a technical department with sufficient skills in decision analytic modelling, health technology appraisals, value dossiers and publishing health economic studies.
Core Responsibilities:
Build, lead and mentor a brand new team
Build relationships with internal and external stakeholders
Have a strong technical background
Experience / Qualifications:
Relevant postgraduate degree
Previous line responsibilities
Excellent communication both written and verbal
A strong understanding in the US healthcare system
Associate Director or Director of Health Outcomes UK - Berkshire
My client supplies thousands of medical products and services to almost every hospital and Trust in Great Britain. It is diverse company which covers Pharma, Devices and Delivery mostly dealing with critical care.
The position that I am recruiting for is new to the organisation with the objective to develop and implement the Health Economics and Quality of Life strategy for the UK and by:
Making best of the data that they have today through assisting the business to build financial models and business cases that position our current offerings as being of economic benefit as well as clinical benefit.
Working with Government Affairs and Public Policy team and the business to influence Governments, Key Opinion Leaders and Patient associations through the macro-economics advantages of our product and services.
Influencing my Clients Global and Europe to produce UK required data to support the introduction of new and developing technologies and services.
Developing UK pricing and reimbursement strategies for new and developing technologies and services.
Skills and qualifactions
English to business standard – written and spoken
Understanding of Reimbursement Systems in key UK Markets.
Experience in the practice, design and implementation of health economic studies including cost-minimisation, cost-effectiveness, cost utility, cost-benefit and cost-consequence analysis, as well as a solid foundation in the design and application of quality-of-life research and standards of care to pharmaceutical and device reimbursement.
Effective written and oral communication skills.
Ability to negotiate and influence senior level Country leadership teams.
The ability to make effective independent decisions within a matrix environment under minimal supervision.
Proficiency with Internet and multiple software applications including Microsoft Office, statistical and decision analysis software.
Demonstrable record of collaborative working, and personal delivery to agreed timelines
Experience of managing external suppliers.
Advance degree in either - Health Economics, Public Health, Epidemiology, Pharmacy, Medical or Statistics.
Prior experience with working in or with consultancy agencies, Pharma or Academia.
Clear, decisive and strategic thinker, with the ability to translate strategy into commercial outcomes and actions
Health economist Romania
This is an excellent position for someone looking for career opportunities. You would join a leading pharmaceutical company taking leadership in demonstrating value for our client’s products with a great opportunity to make a significant difference to the life of patients.
Responsibilities
-Develop cost-effectiveness and budget impact models
-Design and implement non-interventional retrospective or prospective outcomes studies
-Provide input to medical/clinical study plans to support and optimize HE value propositions
-Develop HE communication in terms of value dossiers, presentations and publications to support market access with key health care decision makers and stake holders
-Liais and coordinate activities with Public Affairs, Medical, Sales and Marketing colleagues in cross-functional brand and value teams
-Reporting to Director
Required Skills
-An academic degree in economics, statistics, epidemiology or related quantitative discipline. Preferrably complemented with a MSc in Health Economics
-1-2 years experience in HE from pharmaceutical industry or consulting
- Project management experience in implementation of HE project and studies with delivery on tight time lines -Strong business orientation and analytical skills with good communication and interpersonal skills and a high level of self-organization and self-motivation
-Fluency in English
Feel free to contact Simon Rose on +44 (0) 207 922 7155 (Direct Line) or email simon.rose@hayspharma.com for more information. If this role does not suit you but you are interested in hearing about other positions Simon has positions across Europe at different levels.
Kind regards,
Simon Rose
Consultant, Health Economics and Outcomes Research - Hays Pharma
t. +44 (0) 20 7922 7155 f. +44 (0) 20 7922 7101 m.+44 (0) 7818 294633
Please join my network at http://www.linkedin.com/in/simonroseheor
best wishes
Ulf
Associate Director Market Access and Pricing Europe - Switzerland
This is an excellent opportunity to join a leading, niche Biopharma based at their European HQ. My client is a rapidly expanding and developing their Market Access and Pricing department. This purpose of the role is to focus on all market access issues related to in line brands.
Core Responsibilities:
Identification of payer needs.
Conduct of a gap analysis between payer expectations and what the product can deliver.
Development of a commercial policy for all in line brands at launch & the active management of these policies once products are launched
Collaborate with business planning to monitor pricing and impact across Europe
Collaborate with operational marketing to conduct market research
Skills/Knowledge Required:
Has an established network of KOLs.
Has a solid scientific background allowing to understand the impact of trial design on payer strategies and to challenge clinical development or medical affairs.
Previous Pharma or consultancy experience
Postgraduate degree
Excellent Communication and negotiation skills
Associate Director – Consulting Any EU Location
My client is a large, well respected Global consultancy who are rapidly expanding. As my client is interested in the best talent there is flexibility on location. The ideal candidate will need to have in-depth knowledge in Economic Modelling, Pricing and Reimbursement and Health Economic Evaluation. This role would be good for a manager looking for line management responsibility.
As this is deemed as a Strategic role within the organisation their will be a number of other key responsibilities such as:
Maintain proficiency of skills and knowledge and remain current with industry trends based current literature, application of new technology.
Participate in client engagements and manage project deliverables
Present research findings to industry clients and at professional conferences. Publish research in-peer reviewed literature
Participate in Business Development, Marketing and Sales activities
Qualifications
Knowledge of Clinical Trials
Strong negotiation skills
Excellent Communication and Computer Skills
Ability to lead by example
Previously working in a Matrix structure
European Pricing and Reimbursement Manager for a new start-up company
UK based
My client is one of the fastest growing US pharmaceutical companies with ambitious plans for expansion in to Europe. With an exciting potential blockbuster in the pipeline it is exciting times for this organisation. With being a forward thinking company and knowing there will be Market Access issues this position is on of the first to be created.
The job-holder in this role will drive, manage and support the multiple elements that will need to be constructed and integrated to achieve successful reimbursement in Europe. The over arching objective of this role is to minimize, as far as possible, the delay between obtaining regulatory approval and subsequently ensuring rapid market access to both patients and physicians.
Core responsibilities
Assist in internal pricing discussions and in developing a global pricing strategy
Set up and manage external pricing partnerships and third parties
In partnership with Health Outcomes team, lead development of value messages and value communication tools for payors and reimbursement agencies
Identify key stakeholders for P&R and market access in major EU markets
Determine their specific information needs and requirements to tailor health outcomes data appropriately
Within markets determine the sequence to engage with stakeholders and optimum timings
Produce “master” reimbursement strategy plan for key EU markets
Work with affiliates and country managers to action this plan to deliver success at the local level
Manage external partners to assist in facilitating access and with all “non-technical” P&R needs.
Technical Skills, Competencies & Qualifications
Looking for someone to rise to a unique challenge
Previous experience in healthcare industry with ideally a hospital / orphan / specialised product
Experience in global / regional (EU) market access role or possible local market / affiliate experience and interaction with P&R stakeholders (national, regional, hospital).
Familiar with needs of P&R stakeholders in major EU markets
Strong strategic and analytical thinking - to be able to pull together a pan-European reimbursement plan.
Excellent influencing and relationship building skills.
Fluency in English. Foreign language skills are a plus.
Head of Health Economics and Senior Manager - Home Counties, UK
Our client, the world's largest biotechnology company, discovers and develops important therapeutics which bring meaningful improvement to the lives of people all over the world. Science-based and patient-driven, they aspire to be the best human therapeutics company, building their success on innovation, team work, risk-taking and the pursuit of excellence.
Head of Health Economics
Responsibilities
Review of Affiliate’s health economics priorities, allocation of HE resources in line with business strategy
Planning and delivery of health economics policies and activities for the UK and Ireland Affiliate
Act as strong local partner in shaping the expression of product value on global and international matrix teams
Management and continuous improvement of the UK Affiliate health economics processes, aligned with the matrix
Direct and manage HTA submissions to NICE, SMC and AWMSG, and coordination of delivery of constituent components
Senior Manager Health Economics
Responsibilities
Design and delivery of HTA models for current and future products
Delivery of NICE, SMC and AWMSG submissions
Training of staff on value proposition elements
Supporting the Affiliate Business Units in the use of HTA data with customers
Management and coordination of external consultants and business partners
Execution of data generation and analysis projects
Head of Health Economics (Europe)
Location: South East England
My Clients is a research-based global pharmaceutical company and one of the global leaders of the industry. They have ambitious growth plans in Europe. Currently they are covering around 60% of the European Healthcare systems and in the next few years expanding to around 85%. This position is based in their European Headquarters
Position Overview
Cost effectiveness of drugs is becoming increasingly important in an environment where healthcare costs are increasing beyond means and an increasing number of drugs in marketed for a limited number of indications. Due to local laws and pricing policies, cost effectiveness analyses are often nationally based, sometimes regionally. As a central coordinating and services department for Europe, this role will be responsible for drafting models for Outcomes Analyses, applying the appropriate disutilities and ensuring sufficient flexibility in the model so that it can be adapted to fit the needs of European Affiliates. The position also supposed to act as an advocate for Health Economics, raising the awareness of (the need for) Health Economics in the organisation,
Competencies (skills, abilities, aptitudes)
Create a compelling vision of Health Economics Function and communicate this sense of purpose effectively internally and external to my clients an ambassador for the function and an educator to organisation.
Plan ahead to support growth and priorities by defining superior competitive strategies for pipeline by positively influencing the life cycle of pipeline and newly marketed products and filling product gaps.
Demonstrate knowledge of European marketplace including the Pharma industry, competitors, customers, HTA and reimbursement agencies together with regulatory agencies.
Appropriately share viewpoints, opinions and advice even when these may be negative or unpopular but in the interest of cost effective management of company assests.
Technical Skills & Qualifications
Advance degree in either - Health Economics, Public Health, Epidemiology, Pharmacy, Medical or Statistics. Experience in Clinical research is beneficial.
Experience of interfacing between clinical, regulatory and business groups in the Pharma industry
Accomplishments to include publications in the economic field, acknowledged clinical activities and successful submissions to reimbursement/HTA groups.
Understand how Health Economics can be successfully applied throughout the drug development cycle for a winning pricing and reimbursement strategy.
In depth experience analysing and demonstrating the value of pharmaceutical products using appropriate economic tools and modelling.
Strong technical and scientific knowledge in economics research methodology applied to healthcare.
Operational excellence and exceptional business and financial acumen.
Head of Health Economics for a large European Consultancy
Location – USA or Canada
My client is well reputed, independently owned consultancy looking to expand its business to North America. They are a one stop shop offering a wide range of services and currently working with the majority of the leading Pharmaceutical and Medical Devices Company.
This rare opportunity In will support the General Manager in developing a technical department with sufficient skills in decision analytic modelling, health technology appraisals, value dossiers and publishing health economic studies.
Core Responsibilities:
Build, lead and mentor a brand new team
Build relationships with internal and external stakeholders
Have a strong technical background
Experience / Qualifications:
Relevant postgraduate degree
Previous line responsibilities
Excellent communication both written and verbal
A strong understanding in the US healthcare system
Associate Director or Director of Health Outcomes UK - Berkshire
My client supplies thousands of medical products and services to almost every hospital and Trust in Great Britain. It is diverse company which covers Pharma, Devices and Delivery mostly dealing with critical care.
The position that I am recruiting for is new to the organisation with the objective to develop and implement the Health Economics and Quality of Life strategy for the UK and by:
Making best of the data that they have today through assisting the business to build financial models and business cases that position our current offerings as being of economic benefit as well as clinical benefit.
Working with Government Affairs and Public Policy team and the business to influence Governments, Key Opinion Leaders and Patient associations through the macro-economics advantages of our product and services.
Influencing my Clients Global and Europe to produce UK required data to support the introduction of new and developing technologies and services.
Developing UK pricing and reimbursement strategies for new and developing technologies and services.
Skills and qualifactions
English to business standard – written and spoken
Understanding of Reimbursement Systems in key UK Markets.
Experience in the practice, design and implementation of health economic studies including cost-minimisation, cost-effectiveness, cost utility, cost-benefit and cost-consequence analysis, as well as a solid foundation in the design and application of quality-of-life research and standards of care to pharmaceutical and device reimbursement.
Effective written and oral communication skills.
Ability to negotiate and influence senior level Country leadership teams.
The ability to make effective independent decisions within a matrix environment under minimal supervision.
Proficiency with Internet and multiple software applications including Microsoft Office, statistical and decision analysis software.
Demonstrable record of collaborative working, and personal delivery to agreed timelines
Experience of managing external suppliers.
Advance degree in either - Health Economics, Public Health, Epidemiology, Pharmacy, Medical or Statistics.
Prior experience with working in or with consultancy agencies, Pharma or Academia.
Clear, decisive and strategic thinker, with the ability to translate strategy into commercial outcomes and actions
Health economist Romania
This is an excellent position for someone looking for career opportunities. You would join a leading pharmaceutical company taking leadership in demonstrating value for our client’s products with a great opportunity to make a significant difference to the life of patients.
Responsibilities
-Develop cost-effectiveness and budget impact models
-Design and implement non-interventional retrospective or prospective outcomes studies
-Provide input to medical/clinical study plans to support and optimize HE value propositions
-Develop HE communication in terms of value dossiers, presentations and publications to support market access with key health care decision makers and stake holders
-Liais and coordinate activities with Public Affairs, Medical, Sales and Marketing colleagues in cross-functional brand and value teams
-Reporting to Director
Required Skills
-An academic degree in economics, statistics, epidemiology or related quantitative discipline. Preferrably complemented with a MSc in Health Economics
-1-2 years experience in HE from pharmaceutical industry or consulting
- Project management experience in implementation of HE project and studies with delivery on tight time lines -Strong business orientation and analytical skills with good communication and interpersonal skills and a high level of self-organization and self-motivation
-Fluency in English
Feel free to contact Simon Rose on +44 (0) 207 922 7155 (Direct Line) or email simon.rose@hayspharma.com for more information. If this role does not suit you but you are interested in hearing about other positions Simon has positions across Europe at different levels.
Kind regards,
Simon Rose
Consultant, Health Economics and Outcomes Research - Hays Pharma
t. +44 (0) 20 7922 7155 f. +44 (0) 20 7922 7101 m.+44 (0) 7818 294633
Please join my network at http://www.linkedin.com/in/simonroseheor
Commentary: Pharma's future is virtual, say Kate Moss and Dr Steve Arlington of PricewaterhouseCoopers
As pharma switches from developing palliatives to cures, its productivity in the lab is
plummeting. The number of innovative new medicines reaching the market is falling,
while the time and money required to research and develop them continue to soar, with
major strategic implications for the industry as a whole, says PricewaterhouseCoopers.
In its latest Pharma 2020: Virtual R&D report on the future of the sector,
PricewaterhouseCoopers argues that incremental changes are no longer enough.
Companies will need to decide what they want to focus on - whether, for example, to
continue playing in a mass market or concentrate on developing speciality treatments.
And whatever route they choose, they will have to make fundamental changes in the way
they work.
virtual humans
It is now widely recognised that, if pharma is to produce therapies which deliver the
value patients, payers and providers seek, it must acquire a much better grasp of how
human beings operate at the molecular level and the functional changes associated with,
or arising from, disease.
This knowledge can then be used to create predictive computer models for simulating the
physiological effects of interacting with specific targets, identifying which targets are
involved in a given disease and determining what sort of intervention is required.
This is a huge task. Numerous organisations are already building discrete models of
different organs and cells, but these models must ultimately be integrated into a single
validated model in order to predict the effects of modulating a biological target on the
whole system. That model must also be capable of reflecting common genetic and
phenotypic variations, so the computing power required to support it will be enormous.
Nevertheless, various efforts to create a digital representation of the human body are
already underway. The Step Consortium is developing a technological structure for
investigating the human body as a single system. The Living Human Project is building a
model of the musculoskeletal apparatus; and the Physiome Project is creating a
computational framework for understanding the integrative function of cells, organs and
organisms.
It is unlikely that "virtual man" will be available by 2020, but virtual cells, organs and
animals will certainly play a much bigger role in pharmaceutical R&D. Several other
technologies will also make a major contribution to the process. Semantic technologies
will, for example, enable scientists to connect disparate data sets and query the data
using "natural language". This will make it much easier to identify previously
unobservable links between a particular disease or molecule and the pathways it affects.
Similarly, advances in nanotechnology and genetic engineering will enable the industry
to develop totally new forms of treatment which improve compliance and hence
outcomes.
Once virtual man has been built, it will also be possible to screen candidate medicines in
a digital representation of the human body which can be adjusted to reflect common
genetic variations and disease traits. This will show whether a molecule interacts with
any unwanted targets and produces any side effects, and in what circumstances it does
so. Predictive analysis will then enable researchers to assess how the molecule is likely
to be absorbed, distributed, metabolised and excreted; what long-term side effects it
might have; what free plasma concentration is needed to provide the optimal balance
between efficacy and safety; and what formulation and dosing levels might work best.
one phase for clinical development
Of course, even the most robustly modelled molecules will still have to be tested in real
people. However, the development process will also change dramatically. Clinical trials
are currently cumbersome, time-consuming, require the participation of numerous
patients and often yield unclear results. Much of this inefficiency stems from the fact
that patient data resides in different formats in multiple databases, which cannot
communicate. Without easy access to information that is recorded consistently, the
process of designing trials and monitoring patients remains much as it was 20 years ago.
But common data standards are now being developed and many countries will introduce
electronic health records within the next decade. Semantic technologies will also enable
pharma to link trial data with epidemiological and early research data, and identify any
significant patterns, while pervasive monitoring will let it track patients on a real-time
basis wherever they are. The new European Centre for Connected Health is one of
several organisations already testing various remote monitoring systems, and new
technologies will facilitate the creation of embedded devices, such as electronic circuits
which can be "printed" on the skin to track a patient's blood capillaries and nerve
endings.
These advances will ultimately render the current model of development, with its four
distinct phases, obsolete. The process will start with the administration of a treatment to
a single patient, who has been screened to ensure that he or she has the relevant medical
profile. Once there is evidence that the treatment does not cause any immediate adverse
reaction, it will be sequentially administered to between 20-100 more patients, all of
whom have also been screened. The data they generate will then be compared with data
from the modelling that preceded the study and subjected to techniques like Bayesian
analysis. These findings will determine how the study is adapted, but the study itself will
be conducted in a single, continuous phase.
The needs of patients, payers, providers and the regulators will also play a much more
prominent part in shaping how trials are designed. Many companies submit products
which, although they secure regulatory approval, have limited therapeutic value and fail
to generate a commercial return. But, by 2020, pharma will collaborate with payers
when they develop their trial protocols to assess the value of new treatments.
automated approvals
Pervasive monitoring and electronic health records will transform the approval process,
too. At present, a regulator reviews the data on a molecule at the end of development,
when the sponsoring company submits the supporting dossier. By 2020, this all-ornothing
system will be replaced by a cumulative approach.
The sponsoring company will collaborate with the regulator to establish the evidence
that is required and then submit it electronically, in line with a predetermined schedule.
Once sufficient data have been collected to show that a medicine is safe, efficacious and
cost-effective in the initial study population, the regulator will issue a "live licence"
allowing the company to market the treatment on a restricted basis, subject to the
collection of further data on how it performs. With each incremental increase in evidence
of safety, efficacy and value, the regulator will extend the licence to cover more
patients, different indications or different formulations.
A precedent for contingent licensing has already been established with orphan drugs, and
by 2020 sophisticated monitoring devices will produce a day-to-day environment that
equates with the controlled environment in which trials are conducted today. This
process also has several practical benefits. It will enable companies to begin recouping
their costs more quickly, thereby helping to fund further testing of new products in larger
populations and the development of new therapies for different subtypes of the same
disease. It will also enable the regulators to manage their resources more effectively,
since they will be able to forecast their workload much more accurately.
conclusions
The changes we have outlined above represent a seismic shift in the way pharma
operates. The industry leaders will have to begin by deciding what sort of companies
they want to be and aligning their business models accordingly, to ensure that they have
the right corporate culture and skills to realise that vision.
They will also have to collaborate much more extensively - with each other, with
technology providers and with everyone in the healthcare value chain. But those that
succeed should get a fair return for their efforts. If society stifles pharmaceutical
investment in R&D by refusing to pay for real innovation, who will produce the new
medicines we need?
Kate Moss is a director in the firm's Pharmaceutical and Life Sciences Industry Practice.
Dr Steve Arlington is the Global Pharmaceutical and Life Sciences Industry Advisory
Leader of PricewaterhouseCoopers. SCRIP - World Pharmaceutical News -
www.scrippharma.com FILED 09 July 2008 COPYRIGHT Informa UK Ltd 2008
plummeting. The number of innovative new medicines reaching the market is falling,
while the time and money required to research and develop them continue to soar, with
major strategic implications for the industry as a whole, says PricewaterhouseCoopers.
In its latest Pharma 2020: Virtual R&D report on the future of the sector,
PricewaterhouseCoopers argues that incremental changes are no longer enough.
Companies will need to decide what they want to focus on - whether, for example, to
continue playing in a mass market or concentrate on developing speciality treatments.
And whatever route they choose, they will have to make fundamental changes in the way
they work.
virtual humans
It is now widely recognised that, if pharma is to produce therapies which deliver the
value patients, payers and providers seek, it must acquire a much better grasp of how
human beings operate at the molecular level and the functional changes associated with,
or arising from, disease.
This knowledge can then be used to create predictive computer models for simulating the
physiological effects of interacting with specific targets, identifying which targets are
involved in a given disease and determining what sort of intervention is required.
This is a huge task. Numerous organisations are already building discrete models of
different organs and cells, but these models must ultimately be integrated into a single
validated model in order to predict the effects of modulating a biological target on the
whole system. That model must also be capable of reflecting common genetic and
phenotypic variations, so the computing power required to support it will be enormous.
Nevertheless, various efforts to create a digital representation of the human body are
already underway. The Step Consortium is developing a technological structure for
investigating the human body as a single system. The Living Human Project is building a
model of the musculoskeletal apparatus; and the Physiome Project is creating a
computational framework for understanding the integrative function of cells, organs and
organisms.
It is unlikely that "virtual man" will be available by 2020, but virtual cells, organs and
animals will certainly play a much bigger role in pharmaceutical R&D. Several other
technologies will also make a major contribution to the process. Semantic technologies
will, for example, enable scientists to connect disparate data sets and query the data
using "natural language". This will make it much easier to identify previously
unobservable links between a particular disease or molecule and the pathways it affects.
Similarly, advances in nanotechnology and genetic engineering will enable the industry
to develop totally new forms of treatment which improve compliance and hence
outcomes.
Once virtual man has been built, it will also be possible to screen candidate medicines in
a digital representation of the human body which can be adjusted to reflect common
genetic variations and disease traits. This will show whether a molecule interacts with
any unwanted targets and produces any side effects, and in what circumstances it does
so. Predictive analysis will then enable researchers to assess how the molecule is likely
to be absorbed, distributed, metabolised and excreted; what long-term side effects it
might have; what free plasma concentration is needed to provide the optimal balance
between efficacy and safety; and what formulation and dosing levels might work best.
one phase for clinical development
Of course, even the most robustly modelled molecules will still have to be tested in real
people. However, the development process will also change dramatically. Clinical trials
are currently cumbersome, time-consuming, require the participation of numerous
patients and often yield unclear results. Much of this inefficiency stems from the fact
that patient data resides in different formats in multiple databases, which cannot
communicate. Without easy access to information that is recorded consistently, the
process of designing trials and monitoring patients remains much as it was 20 years ago.
But common data standards are now being developed and many countries will introduce
electronic health records within the next decade. Semantic technologies will also enable
pharma to link trial data with epidemiological and early research data, and identify any
significant patterns, while pervasive monitoring will let it track patients on a real-time
basis wherever they are. The new European Centre for Connected Health is one of
several organisations already testing various remote monitoring systems, and new
technologies will facilitate the creation of embedded devices, such as electronic circuits
which can be "printed" on the skin to track a patient's blood capillaries and nerve
endings.
These advances will ultimately render the current model of development, with its four
distinct phases, obsolete. The process will start with the administration of a treatment to
a single patient, who has been screened to ensure that he or she has the relevant medical
profile. Once there is evidence that the treatment does not cause any immediate adverse
reaction, it will be sequentially administered to between 20-100 more patients, all of
whom have also been screened. The data they generate will then be compared with data
from the modelling that preceded the study and subjected to techniques like Bayesian
analysis. These findings will determine how the study is adapted, but the study itself will
be conducted in a single, continuous phase.
The needs of patients, payers, providers and the regulators will also play a much more
prominent part in shaping how trials are designed. Many companies submit products
which, although they secure regulatory approval, have limited therapeutic value and fail
to generate a commercial return. But, by 2020, pharma will collaborate with payers
when they develop their trial protocols to assess the value of new treatments.
automated approvals
Pervasive monitoring and electronic health records will transform the approval process,
too. At present, a regulator reviews the data on a molecule at the end of development,
when the sponsoring company submits the supporting dossier. By 2020, this all-ornothing
system will be replaced by a cumulative approach.
The sponsoring company will collaborate with the regulator to establish the evidence
that is required and then submit it electronically, in line with a predetermined schedule.
Once sufficient data have been collected to show that a medicine is safe, efficacious and
cost-effective in the initial study population, the regulator will issue a "live licence"
allowing the company to market the treatment on a restricted basis, subject to the
collection of further data on how it performs. With each incremental increase in evidence
of safety, efficacy and value, the regulator will extend the licence to cover more
patients, different indications or different formulations.
A precedent for contingent licensing has already been established with orphan drugs, and
by 2020 sophisticated monitoring devices will produce a day-to-day environment that
equates with the controlled environment in which trials are conducted today. This
process also has several practical benefits. It will enable companies to begin recouping
their costs more quickly, thereby helping to fund further testing of new products in larger
populations and the development of new therapies for different subtypes of the same
disease. It will also enable the regulators to manage their resources more effectively,
since they will be able to forecast their workload much more accurately.
conclusions
The changes we have outlined above represent a seismic shift in the way pharma
operates. The industry leaders will have to begin by deciding what sort of companies
they want to be and aligning their business models accordingly, to ensure that they have
the right corporate culture and skills to realise that vision.
They will also have to collaborate much more extensively - with each other, with
technology providers and with everyone in the healthcare value chain. But those that
succeed should get a fair return for their efforts. If society stifles pharmaceutical
investment in R&D by refusing to pay for real innovation, who will produce the new
medicines we need?
Kate Moss is a director in the firm's Pharmaceutical and Life Sciences Industry Practice.
Dr Steve Arlington is the Global Pharmaceutical and Life Sciences Industry Advisory
Leader of PricewaterhouseCoopers. SCRIP - World Pharmaceutical News -
www.scrippharma.com FILED 09 July 2008 COPYRIGHT Informa UK Ltd 2008
7.09.2008
Reduced Cancer Drug Reimbursements Don’t Impede Access – JAMA Study
July 8, 2008
A review of Medicare claims data from 2003 through 2006 found no evidence that lowering payments to physicians for cancer drugs has adversely affected access to care.
The review by Alisa Shea and colleagues at the Duke University School of Medicine addresses concerns that the reduction in physician reimbursement mandated by the 2003 Medicare Modernization Act - and beginning in 2004 - would lead some private oncology practices to close, requiring the 80 percent of cancer patients who receive treatment in community settings to travel farther from their homes to local hospitals.
"As measured by travel distance and time to chemotherapy, our findings do not support anecdotal reports that the enactment of the MMA has changed access to chemotherapy in a meaningful way," the authors state. The study appears in the July 9 Journal of the American Medical Association.
The study found the median wait time for treatment was about 28 days and that the wait in 2006 was not significantly different from 2003 in any treatment setting analyzed. The median travel distance was approximately eight miles, only about 1.3 miles further in 2006 than in 2003.
Under MMA, Medicare payments to physicians for chemotherapy were reduced from 95 percent of average wholesale prices in 2003 to 85 percent in 2004. In 2006, payments were further reduced to 106 percent of manufacturer-reported average sales prices.
Based on a nationally representative 5 percent sample of Medicare inpatient, outpatient and carrier claims, the study supports the conclusions of earlier studies that used some Medicare claims data, as well as patient and physician surveys, site visits and focus groups.
Studies released in 2007 by the Medicare Payment Advisory Commission and the National Payment Advocate Foundation found patients did not perceive changes in treatment following MMA enactment. However, the Duke researchers point out there has been "limited" empirical evidence on whether changes in reimbursement policy influenced the location or timeliness of chemotherapy.
The authors caution that the "slow transition to full implementation of the reimbursement changes mandated by MMA" may account for the lack of impact. In the short term, oncology practices may have been able to absorb financial losses or compensate for those losses by providing other services, the authors suggest.
They also note that CMS demonstration projects may have offset reductions in reimbursement by providing additional compensation for certain services. CMS sponsored a "quality of care" demonstration in 2006 that drew broad participation by oncologists .
-Cathy Kelly (c.kelly@elsevier.com)
A review of Medicare claims data from 2003 through 2006 found no evidence that lowering payments to physicians for cancer drugs has adversely affected access to care.
The review by Alisa Shea and colleagues at the Duke University School of Medicine addresses concerns that the reduction in physician reimbursement mandated by the 2003 Medicare Modernization Act - and beginning in 2004 - would lead some private oncology practices to close, requiring the 80 percent of cancer patients who receive treatment in community settings to travel farther from their homes to local hospitals.
"As measured by travel distance and time to chemotherapy, our findings do not support anecdotal reports that the enactment of the MMA has changed access to chemotherapy in a meaningful way," the authors state. The study appears in the July 9 Journal of the American Medical Association.
The study found the median wait time for treatment was about 28 days and that the wait in 2006 was not significantly different from 2003 in any treatment setting analyzed. The median travel distance was approximately eight miles, only about 1.3 miles further in 2006 than in 2003.
Under MMA, Medicare payments to physicians for chemotherapy were reduced from 95 percent of average wholesale prices in 2003 to 85 percent in 2004. In 2006, payments were further reduced to 106 percent of manufacturer-reported average sales prices.
Based on a nationally representative 5 percent sample of Medicare inpatient, outpatient and carrier claims, the study supports the conclusions of earlier studies that used some Medicare claims data, as well as patient and physician surveys, site visits and focus groups.
Studies released in 2007 by the Medicare Payment Advisory Commission and the National Payment Advocate Foundation found patients did not perceive changes in treatment following MMA enactment. However, the Duke researchers point out there has been "limited" empirical evidence on whether changes in reimbursement policy influenced the location or timeliness of chemotherapy.
The authors caution that the "slow transition to full implementation of the reimbursement changes mandated by MMA" may account for the lack of impact. In the short term, oncology practices may have been able to absorb financial losses or compensate for those losses by providing other services, the authors suggest.
They also note that CMS demonstration projects may have offset reductions in reimbursement by providing additional compensation for certain services. CMS sponsored a "quality of care" demonstration in 2006 that drew broad participation by oncologists .
-Cathy Kelly (c.kelly@elsevier.com)
7.08.2008
The end of the industry as we know it?
Scrip
The future does not look bright, at least for those big pharma companies unable to adapt
to its new realities. The expiry of blockbuster drug patents, rising research costs and
falling product approval rates are some of the familiar woes facing the sector, but
speakers at a recent conference in Japan were in no doubt that a diagnostics-led
revolution in disease management would place further pressure on traditional business
models.
"The next 10 years will be revolutionary for the practice of medicine, with more change
in this period than in the last 50 years," predicted Dr Michael Ramsay, president of the
Baylor Research Institute in the US. Reactive "sick care" will be replaced by proactive,
preventative health care, driven by fundamental changes to the way diseases are
diagnosed and treated, he said in a keynote address to the BioExpo/Interphex Japan
meeting in Tokyo.
In remarks echoed closely by another keynote speaker, Dr Lee Hood of the Institute for
Systems Biology in Seattle, Dr Ramsay foresaw a much closer melding of diagnostic and
therapeutic technologies, with a focus on early detection before symptoms appear. This
would be accompanied by personalised, tailored treatments aided by low-cost,
individual genomic profiling, he suggested.
The convergence would lead to a seismic shift in how diseases are tackled, with key new
technologies such as DNA sequencing and blood-based molecular disease fingerprinting
at the forefront, the speakers posited. Dr Hood put forward the view that improved
knowledge of complex biological systems, along with procedures which could generate
"billions of data points on each individual patient", would lead to the "P4" medicine
model - predictive, personalised, preventive and participatory.
While healthcare is already beginning to see the emergence of effective, molecular-
PHIND: Pharma & Healthcare Ind News - today only (PHID)
Page 16
targeted biologic therapies, particularly in oncology, the new technologies would
dramatically improve outcomes and cut healthcare costs by ensuring the optimal
treatment of responsive patients, the speakers said. The ability to determine disease
states from small quantities of blood, and the digitisation of such data, would also trickle
down to benefits for the developing world, Dr Hood proposed.
Both he and Dr Ramsay saw these changes, should they indeed come to pass, as spelling
dramatic changes for the pharma industry. There would be a demise of the "one size fits
all" blockbuster drug, which in reality is often truly effective in only a relatively small
proportion of patients, they noted. Put simply, "many drugs don't work for specific
patients because they are all genetically different", Dr Ramsay explained.
Dr Hood put it to delegates that, in such an environment, some conventional drug
companies would not survive, while others "would have a very hard time". But the
technical challenges of this vision of healthcare should not be underestimated, he
warned, pointing to the need to validate biomarkers, properly correlate disease
fingerprints with actual disease states and ensure the security of personal data, for
example. The effective integration of disparate disciplines will also necessitate extensive
international partnerships, he said.
Speaking in another keynote address to the meeting, former Teva Pharmaceutical
Industries president and CEO Israel Makov (now chairman of Given Imaging) said he
was in broad agreement with these views. "The successful CEO of the future will be able
to juggle many balls," and bring together a range of different disciplines. Successful new
companies would be smaller and more agile and big pharma risks being "a prisoner of
its history", he cautioned.
He also pointed to the important role that the generic, rather than innovative, industry is
already playing in terms of the provision of healthcare today. Generics now account for
around half of the world's prescriptions but at around one-tenth of the cost of the $433
billion a year branded sector. Based on 2004 data, generics save the global society $330
billion a year, he said.
To help companies address some of their more immediate R&D challenges, Dr Arun
Chandavarkar, chief operating officer at the Indian company Biocon, advocated the path
of "affordable innovation". Firms should be looking for a return on innovation rather
than a return on investment, measured in terms of reduced risk, cost and speed, he said,
adding that more research needs to be directed towards emerging markets where drug
access and affordability are key issues.
The emergence of targeted drugs for smaller patient populations is also driving the need
to lower the cost of innovation, he told the meeting. SCRIP - World Pharmaceutical
News - www.scrippharma.com FILED 04 July 2008 COPYRIGHT Informa UK Ltd
2008
COPYRIGHT BY T&F Informa UK Ltd
The future does not look bright, at least for those big pharma companies unable to adapt
to its new realities. The expiry of blockbuster drug patents, rising research costs and
falling product approval rates are some of the familiar woes facing the sector, but
speakers at a recent conference in Japan were in no doubt that a diagnostics-led
revolution in disease management would place further pressure on traditional business
models.
"The next 10 years will be revolutionary for the practice of medicine, with more change
in this period than in the last 50 years," predicted Dr Michael Ramsay, president of the
Baylor Research Institute in the US. Reactive "sick care" will be replaced by proactive,
preventative health care, driven by fundamental changes to the way diseases are
diagnosed and treated, he said in a keynote address to the BioExpo/Interphex Japan
meeting in Tokyo.
In remarks echoed closely by another keynote speaker, Dr Lee Hood of the Institute for
Systems Biology in Seattle, Dr Ramsay foresaw a much closer melding of diagnostic and
therapeutic technologies, with a focus on early detection before symptoms appear. This
would be accompanied by personalised, tailored treatments aided by low-cost,
individual genomic profiling, he suggested.
The convergence would lead to a seismic shift in how diseases are tackled, with key new
technologies such as DNA sequencing and blood-based molecular disease fingerprinting
at the forefront, the speakers posited. Dr Hood put forward the view that improved
knowledge of complex biological systems, along with procedures which could generate
"billions of data points on each individual patient", would lead to the "P4" medicine
model - predictive, personalised, preventive and participatory.
While healthcare is already beginning to see the emergence of effective, molecular-
PHIND: Pharma & Healthcare Ind News - today only (PHID)
Page 16
targeted biologic therapies, particularly in oncology, the new technologies would
dramatically improve outcomes and cut healthcare costs by ensuring the optimal
treatment of responsive patients, the speakers said. The ability to determine disease
states from small quantities of blood, and the digitisation of such data, would also trickle
down to benefits for the developing world, Dr Hood proposed.
Both he and Dr Ramsay saw these changes, should they indeed come to pass, as spelling
dramatic changes for the pharma industry. There would be a demise of the "one size fits
all" blockbuster drug, which in reality is often truly effective in only a relatively small
proportion of patients, they noted. Put simply, "many drugs don't work for specific
patients because they are all genetically different", Dr Ramsay explained.
Dr Hood put it to delegates that, in such an environment, some conventional drug
companies would not survive, while others "would have a very hard time". But the
technical challenges of this vision of healthcare should not be underestimated, he
warned, pointing to the need to validate biomarkers, properly correlate disease
fingerprints with actual disease states and ensure the security of personal data, for
example. The effective integration of disparate disciplines will also necessitate extensive
international partnerships, he said.
Speaking in another keynote address to the meeting, former Teva Pharmaceutical
Industries president and CEO Israel Makov (now chairman of Given Imaging) said he
was in broad agreement with these views. "The successful CEO of the future will be able
to juggle many balls," and bring together a range of different disciplines. Successful new
companies would be smaller and more agile and big pharma risks being "a prisoner of
its history", he cautioned.
He also pointed to the important role that the generic, rather than innovative, industry is
already playing in terms of the provision of healthcare today. Generics now account for
around half of the world's prescriptions but at around one-tenth of the cost of the $433
billion a year branded sector. Based on 2004 data, generics save the global society $330
billion a year, he said.
To help companies address some of their more immediate R&D challenges, Dr Arun
Chandavarkar, chief operating officer at the Indian company Biocon, advocated the path
of "affordable innovation". Firms should be looking for a return on innovation rather
than a return on investment, measured in terms of reduced risk, cost and speed, he said,
adding that more research needs to be directed towards emerging markets where drug
access and affordability are key issues.
The emergence of targeted drugs for smaller patient populations is also driving the need
to lower the cost of innovation, he told the meeting. SCRIP - World Pharmaceutical
News - www.scrippharma.com FILED 04 July 2008 COPYRIGHT Informa UK Ltd
2008
COPYRIGHT BY T&F Informa UK Ltd
7.03.2008
European Union on the verge of a new legislation to ease cross border medical care
from the The Wall Street Journal
European Union citizens would be able to seek medical acre anywhere in the 27-nation bloc without prior authorization and get reimbursement for the treatment by their insurer under draft rules presented by the EU executive. The guidelines are meant to ease congestion in countries with long waiting lists for certain kinds of operations and allow people greater freedom to choose where they want to be treated.
European Union citizens would be able to seek medical acre anywhere in the 27-nation bloc without prior authorization and get reimbursement for the treatment by their insurer under draft rules presented by the EU executive. The guidelines are meant to ease congestion in countries with long waiting lists for certain kinds of operations and allow people greater freedom to choose where they want to be treated.
However, the Bristish government said its National Health Service wouldn't fund any care abroad that wouldn't be provided in Britain.
- Associated Press
- Associated Press
7.01.2008
NICE launches revised guide to appraisals methodologies
The National Institute for Health and Clinical Excellence has launched a revised version of its guide to methods of appraisal.The new Guide to the Methods of Technology Appraisal replaces the previous document published in May 2004, and provides an overview of the principles and methods used by NICE to assess health technologies, including both drugs and other treatments. It is intended for use by the independent advisory committees which prepare the Institute's guidance and also for the organisations representing patient groups, health professionals and manufacturers that submit evidence and comment on draft recommendations."NICE is the global leader in evaluating the benefits of new drugs and treatments. Our methods guide underpins the development of all of our appraisal guidance and so it is very important that we regularly review it to take into account the latest research and to reflect changes in the field of healthcare economics," commented Professor Peter Littlejohns, clinical and public health director at NICE. "This review has been a valuable process which has enabled us to incorporate the views of stakeholders and the public. The new guide will help keep NICE at the cutting edge of this important work," he added.The new Guide is to be used in conjunction with the Institute's Guide to the Technology Appraisal Process and its Guide to the Single Technology Appraisal Process, which describe the steps the Institute goes through in developing its guidance.
6.18.2008
Webinar: How To Maximize Your Reimbursement Value Through Pharmacoeconomic And Outcomes Research
-D-C Reports, Windhover Information and Boston Healthcare Associates proudly present:
Adapting to the Changing Dossier Environment: Creating Pharmacoeconomic and Health Outcomes Data That Will Impact Coverage and Formulary Decisions
WEBINAR: Thursday, June 26, 2008
12:00 pm ET / 9 am PT / 90 minutes
FEATURING:
Gina Ford, Executive Director Boston Healthcare
Phil Cyr, Director Boston Healthcare
For more speaker information
---------------------------
EARLY BIRD PRICE
Now through June 19
- Webinar: $299
- Live webinar plus complete audio recording: $399
- Audio recording only: $399
---------------------------
ABOUT THE WEBINAR:
A recent survey of health plan pharmacy directors indicated that they felt that more than half of the economic models submitted as part of the AMCP were inadequate. In addition, WellPoint's Outcomes-based FormularySM Guidelines, which were heavily influenced by international health technology assessment organizations such as NICE and the Australian Technology Assessment Agencies, have drastically increased health economic and outcomes evidentiary requirements for new drug submissions.
Recently, US health care payers have increased their efforts to incorporate pharmacoeconomic and health outcomes data into their coverage and formulary decisions. Changes in the AMCP dossier now require budget-impact,
quality-of-life, and cost-of-illness information for your new products. Furthermore, you now have to emphasize the need for greater transparency of health economic and outcomes data submitted, especially cost-effectiveness models.
But what are the health economics and outcomes research changes to the AMCP dossier? And do you know all the key evidentiary requirements of WellPoint's Outcomes-based FormularySM Guidelines? Find out exactly what you need to know about these changes BEFORE it's time to submit your next drug for approval.
So join us, in the convenience of your own office, for a thought-provoking analysis. Grab your team (or several teams), a conference room at your office, a phone and a computer with Web access (that last one's optional). No travel required.
Walk away with valuable answers to the following questions:
- How do you conduct the right pharmacoeconomic and health outcomes analyses for your new products?
- What are the evidentiary requirements of the AMCP and WellPoint Dossiers related to health economics and outcomes research?
- What are some "real-world" examples of the impact pharmacoeconomic information will have on payers' decisions?
- How are U.S. pharmacy and medical directors use pharmacoeconomic and outcomes research in their
decision-making process?
- How do you maximize your reimbursement value through pharmacoeconomic and outcomes research?
- How are U.S. payers will use pharmacoeconomic and outcomes research in the coming years?
- Which pharmacoeconomic studies are most commonly used for payer coverage and formulary decisions, and what you should know about them?
- How are private health plans are using pharmacoeconomic information?
- What role will pharmacoeconomics and outcomes research will play in the public payer sector?
... and much more!
---------------------------
More webinar information
For more information on Windhover products and conferences, visit us at or send an email to
Windhover Information
10 Hoyt St., Norwalk, CT 06851
* Tel: +1 (203) 838-4401 x 113
* Fax: +1 (203) 838-3214
Adapting to the Changing Dossier Environment: Creating Pharmacoeconomic and Health Outcomes Data That Will Impact Coverage and Formulary Decisions
WEBINAR: Thursday, June 26, 2008
12:00 pm ET / 9 am PT / 90 minutes
FEATURING:
Gina Ford, Executive Director Boston Healthcare
Phil Cyr, Director Boston Healthcare
For more speaker information
---------------------------
EARLY BIRD PRICE
Now through June 19
- Webinar: $299
- Live webinar plus complete audio recording: $399
- Audio recording only: $399
---------------------------
ABOUT THE WEBINAR:
A recent survey of health plan pharmacy directors indicated that they felt that more than half of the economic models submitted as part of the AMCP were inadequate. In addition, WellPoint's Outcomes-based FormularySM Guidelines, which were heavily influenced by international health technology assessment organizations such as NICE and the Australian Technology Assessment Agencies, have drastically increased health economic and outcomes evidentiary requirements for new drug submissions.
Recently, US health care payers have increased their efforts to incorporate pharmacoeconomic and health outcomes data into their coverage and formulary decisions. Changes in the AMCP dossier now require budget-impact,
quality-of-life, and cost-of-illness information for your new products. Furthermore, you now have to emphasize the need for greater transparency of health economic and outcomes data submitted, especially cost-effectiveness models.
But what are the health economics and outcomes research changes to the AMCP dossier? And do you know all the key evidentiary requirements of WellPoint's Outcomes-based FormularySM Guidelines? Find out exactly what you need to know about these changes BEFORE it's time to submit your next drug for approval.
So join us, in the convenience of your own office, for a thought-provoking analysis. Grab your team (or several teams), a conference room at your office, a phone and a computer with Web access (that last one's optional). No travel required.
Walk away with valuable answers to the following questions:
- How do you conduct the right pharmacoeconomic and health outcomes analyses for your new products?
- What are the evidentiary requirements of the AMCP and WellPoint Dossiers related to health economics and outcomes research?
- What are some "real-world" examples of the impact pharmacoeconomic information will have on payers' decisions?
- How are U.S. pharmacy and medical directors use pharmacoeconomic and outcomes research in their
decision-making process?
- How do you maximize your reimbursement value through pharmacoeconomic and outcomes research?
- How are U.S. payers will use pharmacoeconomic and outcomes research in the coming years?
- Which pharmacoeconomic studies are most commonly used for payer coverage and formulary decisions, and what you should know about them?
- How are private health plans are using pharmacoeconomic information?
- What role will pharmacoeconomics and outcomes research will play in the public payer sector?
... and much more!
---------------------------
More webinar information
For more information on Windhover products and conferences, visit us at or send an email to
Windhover Information
10 Hoyt St., Norwalk, CT 06851
* Tel: +1 (203) 838-4401 x 113
* Fax: +1 (203) 838-3214
Job prospects for health economists
Over the last couple of weeks I have received quite a few of inquiries about the job prospects in health economics, the type of training required and of course also about the earnings potential both from US and European young professionals / students who came across my blog and therefore I thought that warrants a separate post on the blog. Needless to say that I am very delighted that the readership is growing rapidly and that people find the information useful - especially professionals becoming interested in this field. Indeed the area is expanding rapidly due to health policy developments across the globe. I found an interesting career information sheet from Australia but I think the comments made on job prospects etc. are valid for any geography, which I would like to share with the readers. In terms of questions related to earnings potential, last year I cited a very good and detailed article on US health economists salaries (search the blog and put “earnings”). What is missing is the same concise information on EU salary ranges per country. I wonder if there is a way to get some information – maybe some of the recruiters reading my blog would like to share some thoughts - on bands per level in order to guide young professionals on the compensation front in their career choice and potential moves. I know ISPOR is very active on the students chapter but perhaps here also some more career info could be provided going forward. In any case, I am happy to continue to answer questions or chat about the field in general as time allows… best Ulf
6.12.2008
Spain - Andalusian health agency creates comission to assess new therapies
Andalusia has always been a tough region in Spain for drugs to get on the hospital formulary. The newly created comission will evaluate new therapeutics regarding their listing on the regional hospitals formularies. Pharmacoeconomics and cost-benefit of altervative medicines will thereby play an increasing role.
For thoose of you who speak Spanish .. the article from El Global below:
El Servicio Andaluz de Salud (SAS) ha creado una comisión, denominada Comisión Asesora Central para Armonizar los Criterios de Utilización de Medicamentos en los Hospitales, que se encargará de controlar y autorizar la presencia en las guías farmacoterapéuticas de los hospitales andaluces de aquellos medicamentos registrados en los últimos cinco años.Mediante una resolución, de 21 de febrero de 2008, el Servicio Andaluz de Salud crea esta comisión que asesorará a la Secretaría General del organismo para proceder a la centralización de las decisiones de disponibilidad de determinados fármacos en los hospitales del sistema sanitario andaluz. La primera de las situaciones en las que actuaría esta comisión sería en aquellos casos en los que la Comisión Multidisciplinar de Uso Racional de Medicamentos (Cmrum) entienda que hay otras alternativas terapéuticas con mejor relación coste-beneficio. Otras, sería en caso de fármacos para los cuales la Agencia Española de Medicamentos y Productos Sanitarios autorice nuevas indicaciones y la Cmurm entienda que hay alternativas con un mejor perfil farmacoeconómico. El tercero de los supuestos incluiría la utilización de medicamentos con menos de cinco años desde su registro para los que se solicite su uso fuera de indicación.Esta nueva regulación afectará, por tanto, a todos los medicamentos que lleven registrados menos de cincos años y para aquéllos que logren una nueva indicación. El control del cumplimiento de esta resolución se llevará a cabo, por una parte desde los hospitales, ya que se indica que "los servicios de farmacia se abstendrán de dispensar aquellos medicamentos afectados" por la resolución y, por otro, por parte de los inspectores médicos, a los que se advierte de la imposibilidad de visar recetas de medicamentos que no cumplan con la nueva resolución.El SAS no valorará el texto hasta que se haya constituido la Comisión Asesora Central, algo que según las previsiones podría ocurrir dentro de un mes aproximadamente. Sí se saben ya los nombres que la compondrán: Alicia Aguilar, subdirectora de Prestaciones del SAS, lo presidirá. Junto a ella habrá 10 vocales (cuatro farmacéuticos de hospital, cuatro médicos y un representante de los Centros regionales de Farmacovigilancia y de Información del Medicamento) y la jefa de Servicio de Suministros Farmacéuticos del SAS como secretaria.
For thoose of you who speak Spanish .. the article from El Global below:
El Servicio Andaluz de Salud (SAS) ha creado una comisión, denominada Comisión Asesora Central para Armonizar los Criterios de Utilización de Medicamentos en los Hospitales, que se encargará de controlar y autorizar la presencia en las guías farmacoterapéuticas de los hospitales andaluces de aquellos medicamentos registrados en los últimos cinco años.Mediante una resolución, de 21 de febrero de 2008, el Servicio Andaluz de Salud crea esta comisión que asesorará a la Secretaría General del organismo para proceder a la centralización de las decisiones de disponibilidad de determinados fármacos en los hospitales del sistema sanitario andaluz. La primera de las situaciones en las que actuaría esta comisión sería en aquellos casos en los que la Comisión Multidisciplinar de Uso Racional de Medicamentos (Cmrum) entienda que hay otras alternativas terapéuticas con mejor relación coste-beneficio. Otras, sería en caso de fármacos para los cuales la Agencia Española de Medicamentos y Productos Sanitarios autorice nuevas indicaciones y la Cmurm entienda que hay alternativas con un mejor perfil farmacoeconómico. El tercero de los supuestos incluiría la utilización de medicamentos con menos de cinco años desde su registro para los que se solicite su uso fuera de indicación.Esta nueva regulación afectará, por tanto, a todos los medicamentos que lleven registrados menos de cincos años y para aquéllos que logren una nueva indicación. El control del cumplimiento de esta resolución se llevará a cabo, por una parte desde los hospitales, ya que se indica que "los servicios de farmacia se abstendrán de dispensar aquellos medicamentos afectados" por la resolución y, por otro, por parte de los inspectores médicos, a los que se advierte de la imposibilidad de visar recetas de medicamentos que no cumplan con la nueva resolución.El SAS no valorará el texto hasta que se haya constituido la Comisión Asesora Central, algo que según las previsiones podría ocurrir dentro de un mes aproximadamente. Sí se saben ya los nombres que la compondrán: Alicia Aguilar, subdirectora de Prestaciones del SAS, lo presidirá. Junto a ella habrá 10 vocales (cuatro farmacéuticos de hospital, cuatro médicos y un representante de los Centros regionales de Farmacovigilancia y de Información del Medicamento) y la jefa de Servicio de Suministros Farmacéuticos del SAS como secretaria.
5.22.2008
Health Economists - science or economics degree?
Recently I had an interesting conversation with an analyst at a biotech company seeking my advice as to career changes towards the area of health economics. The basic question many students or young analysts have is wether to persue an additional degree, stay in science (pharmacy, biostatistics, medicine etc.) and add on, do economics instead or both. I feel that is an interesting question for the readers as well as many of you are hiring managers - some feedback would be interesting. Now, my view is it depends where you wanne be. Headquarters based, "pure", early phase outcomes research positions may do better with scientist experienced in trial design and observational research, instrument development etc. whereas more market focused jobs clearly require thourough business knowledge and personalities. I often - granted am quite biased having graduated as a political economist - find it quite difficult to discuss certain aspects with the very science driven outcomes researchers as some of them seem to struggle with the "big picture", especially when it comes to linking health economics concepts with strategic pricing and/or general financial considerations in the market place. Here I find the pure economists/MBAs to be more pragmatic and knowledgable. I think in any case it'll be key to break down the silo mentality still existent in some places in order to maximize the skill sets available in Medical, P&R, Health Economics in order to arrive at a sound market access strategy.
So maybe it doesn't really matter which degree you have as long as you are open to learn, listen and proactively exchange knowledge with everyone at the table...
So maybe it doesn't really matter which degree you have as long as you are open to learn, listen and proactively exchange knowledge with everyone at the table...
5.20.2008
Future pharmaceutical R&D strategies
From seeking alpha
seekingalpha.com
May 13th
Big Pharma’s failure to develop enough new blockbuster drugs is combining with other forces to drive fundamental changes in pharmaceutical research and development, according to Deloitte. Chief among these will be the emergence of “NewPharmaCos” concentrating on genotyped market segments. The companies may be startups or spinoffs of existing pharma companies, Deloitte says in a new report The Changing Face of R&D in the Future Pharmaceutical Landscape.
According to the report, current R&D programs focused on developing a small portfolio of high revenue blockbusters will evolve to R&D programs focused on high efficacy treatments developed for smaller patient populations based on specific genotypes. Such treatments, and their higher demonstrated efficacy, may ultimately have the potential for higher per treatment revenues.
Looking at the issue historically, the report lays out one of the problems faced by today’s pharmecutical firms:
In a classic Catch-22 situation, the more effective companies were at developing such mass market blockbusters, the more effective they needed to be in developing even larger revenue replacements, as patents on existing products expired and markets were lost to generics.
R&D budgets have greatly increased since the late 1990s. "However, massive scale has not increased R&D productivity. FDA approvals of New Molecular Entities have at best remained steady, with only a handful of these approvals being truly innovative, first-inclass molecules. Despite recent attempts at outsourcing and other modes of increasing effeciency, results have been mixed, and a more “fundamental shift in the industry’s operating environment is under way."
Yet, while individual companies have achieved performance improvements in different aspects of R&D, no significant industry-wide gain is evident.
Phenotyping of diseases is being replaced by an understanding of disease at the molecular level. Segmentation of patients based on observable characteristics is being replaced by segmentation based on genotype (with efficacy assessed by related biomarkers). This change cannot be underestimated, Deloitte says.
Technological advances are increasingly providing companies the opportunity to link treatments and efficacy to genetically homogeneous patient groups.
While typical blockbuster efficacy rates range from 35 - 75 percent, genotyped market segments and biomarker-assessed responses promise treatments with significantly higher efficacy rates, possibly approaching 100 percent.
A critical determinant of financial success for these new entrants will be ownership of the genotype–biomarker combination that identifies high-efficacy treatments for a particular patient–disease state. Whether determined upfront, as in the case of Genentech’s (DNA) Herceptin® or Imclone’s (IMCL) Erbitux®, or retroactively in the case of Sanofi’s (SNY) Clipidogrel, this knowledge permits the evaluation of current and potential products to identify and fill possible treatment gaps.
Deloitte expects the future makeup of pharmecutical R&D to include:
R&D strategies that support the assembly of treatment portfolios for the entire disease life cycle.
Virtual, disease-specific R&D networks.
Virtual R&D processes with significant outsourcing to maximize flexibility and manage development risk.
Focused R&D programs based on genotyped patients/subjects and biomarkers.
Partnering and collaborative ventures to access disease knowledge communities.
seekingalpha.com
May 13th
Big Pharma’s failure to develop enough new blockbuster drugs is combining with other forces to drive fundamental changes in pharmaceutical research and development, according to Deloitte. Chief among these will be the emergence of “NewPharmaCos” concentrating on genotyped market segments. The companies may be startups or spinoffs of existing pharma companies, Deloitte says in a new report The Changing Face of R&D in the Future Pharmaceutical Landscape.
According to the report, current R&D programs focused on developing a small portfolio of high revenue blockbusters will evolve to R&D programs focused on high efficacy treatments developed for smaller patient populations based on specific genotypes. Such treatments, and their higher demonstrated efficacy, may ultimately have the potential for higher per treatment revenues.
Looking at the issue historically, the report lays out one of the problems faced by today’s pharmecutical firms:
In a classic Catch-22 situation, the more effective companies were at developing such mass market blockbusters, the more effective they needed to be in developing even larger revenue replacements, as patents on existing products expired and markets were lost to generics.
R&D budgets have greatly increased since the late 1990s. "However, massive scale has not increased R&D productivity. FDA approvals of New Molecular Entities have at best remained steady, with only a handful of these approvals being truly innovative, first-inclass molecules. Despite recent attempts at outsourcing and other modes of increasing effeciency, results have been mixed, and a more “fundamental shift in the industry’s operating environment is under way."
Yet, while individual companies have achieved performance improvements in different aspects of R&D, no significant industry-wide gain is evident.
Phenotyping of diseases is being replaced by an understanding of disease at the molecular level. Segmentation of patients based on observable characteristics is being replaced by segmentation based on genotype (with efficacy assessed by related biomarkers). This change cannot be underestimated, Deloitte says.
Technological advances are increasingly providing companies the opportunity to link treatments and efficacy to genetically homogeneous patient groups.
While typical blockbuster efficacy rates range from 35 - 75 percent, genotyped market segments and biomarker-assessed responses promise treatments with significantly higher efficacy rates, possibly approaching 100 percent.
A critical determinant of financial success for these new entrants will be ownership of the genotype–biomarker combination that identifies high-efficacy treatments for a particular patient–disease state. Whether determined upfront, as in the case of Genentech’s (DNA) Herceptin® or Imclone’s (IMCL) Erbitux®, or retroactively in the case of Sanofi’s (SNY) Clipidogrel, this knowledge permits the evaluation of current and potential products to identify and fill possible treatment gaps.
Deloitte expects the future makeup of pharmecutical R&D to include:
R&D strategies that support the assembly of treatment portfolios for the entire disease life cycle.
Virtual, disease-specific R&D networks.
Virtual R&D processes with significant outsourcing to maximize flexibility and manage development risk.
Focused R&D programs based on genotyped patients/subjects and biomarkers.
Partnering and collaborative ventures to access disease knowledge communities.
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