Cost of Cancer

Dear All,

please find below link of an interesting piece of work on the cost of cancer in the UK.




Survey points to an increase in spending on pharmacoeconomics

... am sure that will be very welcomed news by the consultants among the readers ;)

Pharmacoeconomics to Get Bigger Budgets, According to Preliminary Survey Results
Marketwire News Releases
Published: 02/15/10 12:12 PM EST

Cutting Edge Information Reports Findings From Ongoing Study
RESEARCH TRIANGLE PARK, NC -- (Marketwire) -- 02/15/10 -- This year, drug makers' pharmacoeconomics groups will spend more money than ever before -- a clear sign of the function's growing importance to success in the pharmaceutical and biotechnology sectors.
Early results from Cutting Edge Information's (http://www.cuttingedgeinfo.com) ongoing survey, "Improving Pharmacoeconomics and Health Outcomes," show that 2 out of 3 respondents will increase pharmacoeconomics spending throughout 2010. Zero respondents plan to reduce their budgets.
"As governments and payers worldwide keep a close eye on climbing healthcare costs, drug brands need to prove more than efficacy and safety," said Jason Richardson, president of Cutting Edge Information. "They need to show cost effectiveness."
Pharmacoeconomics, the intersection of health outcomes and financial considerations, has grown in prominence as costs and reimbursement issues pose challenges to drug makers. Just two years ago, the majority of surveyed companies waited until Phase 3 trials to launch their pharmacoeconomics work. Nowadays, teams kick off studies in Phase 2 and even in Phase 1, and more money is flowing to these early-stage endeavors.
Teams do this early work to ensure that they collect the right data, which eventually goes before regulatory agencies and payer organizations to establish a drug's overall benefit -- and win placement on payer formularies.
According to Richardson, "Neither patients nor bottom lines benefit from therapies that get buried."

The survey, open until February 19 at http://www.cuttingedgeinfo.com/surveys/pharmacoeconomics/pharmacoeconomics.htm, identifies how pharmacoeconomics strategies are changing to meet the growing demand for health outcomes data. Findings will allow survey respondents to:
-- Benchmark spending and staffing levels
-- Learn how top companies customize pharmacoeconomics strategy to meet
the needs of individual brands
-- See how the function has grown by coordinating with numerous other
internal functions
-- Understand the growing importance of health outcomes liaisons and
risk-sharing agreements
-- Discover how effective pharmacoeconomics teams measure ROI through
quantitative and qualitative assessments and prove their value to
their organizations

In exchange for completing a survey, respondents receive a complimentary copy of the results when they become available.
"This study will provide pharmacoeconomics professionals with ammunition to promote their groups and gain the resources necessary to best support brands," said Shaylyn Pike, lead analyst for the study. "Without an effective pharmacoeconomics strategy in place early in development, brands can launch at a disadvantage."

Stephanie Swanson
Email Contact

Oncology Market Access Summit Europe

Dear Readers,

a lot is going on in the Oncology environment at the moment. There is plenty to be discussed regarding health economics & pricing, market acess and patient advocay etc. and therefore I have accepted to speak at this event. It should become an interesting meeting as it is focussed on Oncology matters only therefore I thought I bring it to your attention in case you haven't seen it yet.


Oncology Market Access Summit Europe: 13th-14th April, London
eyeforpharma's Oncology Market Access Europe Summit brings together a top selection of pharma specialists and experienced professionals to share their knowledge and views on dealing with the challenges and opportunities presented by the massive growth of oncology treatment. Join our event and gain insights into enhanced market access strategies, innovative pricing agreements and effective stakeholder communication. This two day meeting is about hearing from a range of companies, learning from case studies and exchanging best-practice ideas. I look forward to seeing you there!
Camilla Ohlsson
Download the full programme here


European Medicines Agency launches consultation on its Road Map to 2015

New strategic vision continues previous Road Map initiative, setting out the Agency’s priorities for the next five years

The European Medicines Agency has launched a three-month public consultation on its Road Map to 2015, coinciding with its 15th anniversary on 26 January 2010
European and international partners, stakeholders, including patients’ and doctors’ organisations as well as pharmaceutical industry, and the public are invited to make their views known on the Agency’s future strategic vision, set out in the document ‘The European Medicines Agency Road Map to 2015: The Agency’s contribution to Science, Medicines, Health’. Comments should be sent using the Agency’s comments form by 30 April 2010 to mailto:roadmap@ema.europa.eu.
Building on the achievements made by the previous Road Map initiative between 2005 to 2010, the focus of the new Road Map to 2015 is on continuous high-quality delivery of the Agency’s core business in an increasingly complex regulatory and scientific environment. In addition, the document proposes three priority areas for future actions to strengthen the Agency’s role in protecting and promoting human and animal health in the European Union. These include:
Addressing public health needs by: stimulating research and medicines development in areas of unmet medical needs or for neglected and rare diseases; facilitating new and innovative approaches to the development of medicines; implementing effective preparedness plans to deal with public health threats.
Facilitating access to medicines by: addressing the high attrition rate during the development process of medicines; improving the Agency’s model for the assessment of benefits and risks of medicines; improving the quality and scientific and regulatory consistency of the medicines review process.
Optimising the safe use of medicines by: strengthening the evidence base on the benefits and risks of a medicine following its authorisation; applying novel pharmacovigilance methodologies and risk minimisation tools; by taking patient experience into account for improved decision-making; becoming a reference point on information about medicines evaluated by the Agency.
European Medicines Agency launches consultation on its Road Map to 2015 EMA/54050/2010 Page 2/2
Aiming for a wide consensus amongst its partners and stakeholders, the Agency will hold a number of workshops and face-to-face discussions as part of the public consultation process. The Agency will provide regular updates on the progress of its Road Map to 2015 until its final adoption through its Management Board, expected for December 2010.
1. The European Medicines Agency Road Map to 2015: The Agency’s contribution to Science, Medicines, Health is available here: http://www.ema.europa.eu/htms/general/direct/roadmap/roadmapintro.htm
2. The Agency’s comments form is available here: http://www.ema.europa.eu/pdfs/general/direct/directory/comments_roadmap2015.doc
3. The European Medicines Agency Road Map to 2010: Preparing the Ground for the Future is available here: http://www.ema.europa.eu/pdfs/general/direct/directory/3416303enF.pdf
4. This press release, together with other information on the work of the European Medicines Agency, can be found on the Agency's website: www.ema.europa.eu
Contact our press officers
Martin Harvey Allchurch or Monika Benstetter
Tel. +44 (0)20 7418 8427

Senior Health Economics Role South East England

Dear All,

this just came in. Please contact Giorgia from RSA.


(Senior) Director of HEOR

Our client is a research-based global pharmaceutical company, and is one of the leading pharmaceutical companies in the world. They research, discover, develop, manufacture and market a range of pharmaceutical products in key, strategic therapeutic areas. To strengthen and support their development programmes, they are now looking to recruit a (Senior) Director of HEOR for Europe and Asia.

The key responsibilities are:-
• Provide leadership for the health economics and outcomes Research capability in Europe and Asia and champion the long-term vision and strategy for HEOR
• Provide strategic planning, design input and implementation of HEOR programmes to support the development, approval, launch, pricing and reimbursement for products across European and Asian markets, with a view of global needs
• Provide health economic and outcomes research scientific guidance to the project and product teams and local operating companies to maximize the opportunities for the products throughout the lifecycle
• Collaborate cross-regionally and cross-functionally with internal stakeholders responsible for clinical development (e.g. Clinical Science, Clinical Operations, Regulatory Affairs) and commercialisation (e.g. Marketing, local operating companies) of their products.

The ideal person will

• Articulate the importance of HEOR strategies and influence key stakeholders to ensure incorporation of activities into drug development plans
• Follow scientific arguments, identify HEOR scientific data needs and solve HEOR issues as required
• Obtain HEOR regulatory opinions, assimilate data effectively define an HEOR regulatory strategy and communicate with FDA and other Health Authorities in meetings as required
• Understand the market and regulatory challenges for the products; and to critically review competitors’ data and assimilate HEOR strategies that take such environments into consideration.
• Have excellent qualitative and quantitative HEOR skills, with regards to study design and analysis of health insurance claims and other automated healthcare databases.
• Demonstrate excellent problem-solving and interpersonal skills are required, as are a high degree of self-motivation, initiative and attention to detail.
• Be able to work independently as well as in a team, and to manage multiple projects under tight deadlines is also essential.
• Possess excellent scientific writing, technical skills.
• Possess a PharmD plus PhD in Health Economics, Outcomes Research or (pharmaco)epidemiology, or MD plus PhD in Health Economics, Outcomes Research or (pharmaco) epidemiology with relevant experience in the pharmaceutical industry, and/or CRO health-related consulting company, and/or academia.

This role will require a reasonable amount of travel across Europe and Asia

Please note that only candidates with EU work authorisation will be considered. For further information please contact Giorgia Signoretto on +44 1707 228 612 or giorgia.signoretto@theRSAgroup.com.


Oncology Innovative Pricing deal with NICE on lung cancer drug

A new oncology patient access scheme is currently being proposed to NICE by Astra Zeneca in the UK. This is an interesting proposal of a flat fee coupled with a registry.

Key points:

- NICE is minded not to recommend gefitinib due to the lack of information provided in order to assess the most probable cost/QALY
- NICE has asked AZ to provide additional information
- A patient access scheme is envisioned, which proposes that a fixed cost is charged for each patient treated with gefitinib regardless of the length of treatment.
- AZ proposes setting up a gefitinib registry which will provide real life data. In 3years time, AZ commits to evaluating these data and renegotiating with NICE on the value of gefitinib

In summary, the Appraisal Committee could not assess whether gefitinib is a cost-effective treatment option because it did not have sufficient information to assess the most plausible ICER for gefitinib compared with standard platinum combination therapy or with pemetrexed and cisplatin. Therefore the Appraisal Committee is minded not to recommend gefitinb for the treatment of locally advanced or metastatic NSCLC. It is recommending that clarification should be sought from the manufacturerer, including analyses that use alternative survival extrapolations and application of hazard ratios, amended first-line chemotherapy costs and chemotherapy cycles, alternative prevalence rates of EGFR-TK mutations and alternative assumptions about the cost of the EGFR-TK mutation tests.

In more detail:

Appraisal Committee’s preliminary recommendations

1.1 The Committee is minded not to recommend gefitinib as a treatment option for people with locally advanced or metastatic non-small-cell lung cancer (NSCLC).

1.2 The Committee recommends that NICE requests further clarification on the clinical and cost effectiveness of gefitinib from the manufacturer as described in sections 1.3 to 1.5. This information should be made available for the next Appraisal Committee meeting.

1.3 NICE requests an exploration of alternative probability distributions for the extrapolation of progression-free survival and overall survival beyond the timeframe of the Iressa Pan Asian Study (IPASS). This should include the following.

1.4 Independent survival curves (overall survival and progression-free survival) for both gefitinib and paclitaxel/carboplatin based on the IPASS data and exploration of different approaches to applying the hazard ratio to incorporate other comparators (for example, pemetrexed and other platinum-based regimens). The different approaches to applying the hazard ratio should consider using either gefitinib or paclitaxel/carboplatin as the baseline.

1.5 Examination of alternative probability distributions and consideration of model fit to early trial data and the shape of the curves at the tail of the distribution.

1.6 Observational or epidemiological evidence on long-term survival in patients with locally advanced or metastatic NSCLC and how this relates to the most plausible model fit.

1.7 The provision of individual patient-level data from IPASS to enable the Evidence Review Group (ERG) to validate key aspects of the submitted model, including the modelling of overall survival and progression-free survival, the choice of parameter values, and structural assumptions.

1.8 NICE requests an analysis to determine the robustness of the incremental cost-effectiveness ratio (ICER) to alternative survival distributions for progression-free and overall survival, based on the independent survival curves for gefitinib and paclitaxel/carboplatin from the IPASS data. The analysis should also provide evidence on alternative approaches to applying the hazard ratio to link to other comparators. These cost-effectiveness analyses should include amended costs for first-line chemotherapy to account for a lower level of dosing in female patients and varying the number of first-line chemotherapy cycles between four and six.

1.9 NICE also requests further analyses to explore the sensitivity of the ICER to:

1.10 varying the prevalence of EGFR-TK mutations between 5% and 17%, taking into account different scenarios costs, comorbidities and the probability of obtaining a specimen suitable for testing (including possible repeat biopsy and the possibility of not obtaining a useful result)

1.11 alternative assumptions about the volume, and hence cost, of the EGFR-TK mutation tests carried out.

On the Patient access scheme:
The Committee noted that the patient access scheme involved a fixed cost being charged for each patient treated with gefitinib regardless of the length of treatment. The Committee agreed that such a scheme was probably relatively simple to administer in the NHS. However, the Committee was concerned that although such a scheme may be beneficial across the whole NHS, there could be some areas where patients receive short courses of treatment and the cost of gefitinib under such circumstances would be greater with the scheme than without it.

The NHS and the cost-benefit dilemma

New research by health economists at the University of York has raised concerns over any move to broaden the range of costs and economic benefits considered in the analysis of new NHS treatments. A study by the University’s Centre for Health Economics suggests that widening the perspective used by the National Institute for Health and Clinical Excellence (NICE) to assess the cost-effectiveness of new technologies may not benefit either the NHS or the wider economy.

The research examined a range of possible policies and a number of case studies from past NICE appraisals.

The new study suggested that taking into account effects outside the NHS would require trade-offs to be made between the overall impact on the health of NHS patients, other social concerns and wider costs and economic benefits.

Extending the NICE perspective for drug assessment beyond the NHS raises questions of how to measure and value a range of wider economic effects, requiring controversial judgments about social values.

The research found that maintaining an NHS perspective would, in many circumstances, reflect overall economic effects because technologies which are regarded as cost-effective and offer overall health improvement for patients would also be expected to result in overall net economic benefits.

In addition, extending the perspective for all technologies appraised by NICE would impose additional costs on NICE’s appraisal process and introduce the possibility of a biased assessment if the economic benefits associated with other NHS care which may be displaced are more difficult to identify.

Consideration could be restricted to exceptional cases where the external economic benefits are likely to be substantially greater or less than current NHS activities which may be displaced.

This more focused approach would require greater clarity on how wider effects will be considered by NICE, as well as criteria to identify exceptional cases, possibly based on the nature of the technology, the type of disease and the patient population. But the researchers warn that repeated application of this policy will ultimately lead to significant impacts on the NHS and a positive bias in favour of new technologies.

The independent study, which was commissioned through the Department of Health’s Policy Research Programme, will be discussed at a workshop this Spring.


Notes to editors:
The research is available at www.york.ac.uk/inst/che/publications/publicationsbyyear.htm

This is an independent report commissioned and funded by the Policy Research programme in the Department of Health. The views expressed are not necessarily those of the Department.

The Centre for Health Economics is widely recognised as a leading research centre in its field. Operating across all areas of the discipline, with a particular emphasis on methodological thinking and high policy impact, CHE is known especially for its work in health technology assessment, health status measurement, performance measurement and productivity, health care financing, and econometric methodology. The University was ranked joint first for health services research in the 2008 Research Assessment Exercise.

Contact details
David Garner
Senior Press Officer

Tel: work +44 (0)1904 432153
dcg501@york.ac.ukKeep up to date


UK and Denmark are dropped from the reference country basket for price revisions in Spain

It´s good to see that some countries health authorities finally wake up to the issues caused by the declining British pound and other non Euro currencies on pharmaceutical prices through international reference pricing, at launch or during regular revisions. In a public meeting last week a member of the pricing comission of the Spanish ministry of health stated that the UK and Denmark will from now on be excluded from that process, however the small caveat is that potentially Greek prices will get more attention.

Some more comments can be found at this weeks edition of El Global.