Patients will get approved drugs on the NHS within six months instead of waiting up to two years, as ministers announce plans to speed up the National Institute for Health and Clinical Excellence.
by Rebecca Smith, Medical Editor, The Daily Telegraph
Last Updated: 2:12PM GMT 03 Mar 2009
The drug rationing body, Nice, has been accused of being too slow in its appraisals of drugs meaning patients are forced to wait years for medicines which may prolong their lives.
Ministers have announced a package of measures to speed up the process including adding another committee of experts to consider the drugs and 'horizon scanning' earlier in the drug development programme for medicines that will need to be referred to Nice.
The move comes after Nice ordered its committees to put extra weight on the final months of life when appraising drugs for terminal patients with rare conditions.
This followed public outcry over draft guidance which did not approve four kidney cancer drugs, including Sutent, which can extend the lives of sufferers by months.
Guidance is being issued to primary care trusts which decide whether to fund drugs where Nice has not appraised the drug or has not yet come to a decision.
PCTs have their own panels which consider individual patients for 'exceptional case' funding but this has led to a postcode lottery where all people in one area may be funded but none in a neighbouring area. The guidance is aimed at making the decisions more consistent and training will be provided to help.
Health Minister, Lord Darzi, said: "Last year in High Quality Care for All I set out our commitment to speed up the Nice process. Together, the measures set out today build on this commitment and will help provide faster and fairer access to new drugs and treatments – great news for patients.
"We are delighted to be working in partnership with Nice to ensure that new drugs and treatments are assessed sooner and more quickly in future, leading to improved and higher quality care for patients.
"The guidance for PCTs will help the NHS to ensure that local decisions are robust and transparent, leading to more consistency in those exceptional cases where there is no existing NICE guidance."
Andrew Dillon, Chief Executive of Nice, said: "This is an important consultation on the way that topics are chosen and referred for Nice's world-leading appraisals of new drugs and treatments. We are very keen to ensure that our guidance is produced as quickly as possible to benefit patients and the NHS.
"Speeding up non-cancer appraisals by at least three months to come in to line with the cancer appraisals, and increasing transparency by clarifying topic selection criteria, are just some of the potential improvements we and the Department of Health are suggesting.
"The views of patients, the public, health professionals and other stakeholders on the proposed changes to the topic selection process will be very helpful, and we look forward to receiving their comments."
A consultation on the proposals will run for three months.
3.02.2009
Obama aims big with healthcare drive
by Stephen Collinson - Mon Mar 2, WASHINGTON (AFP)
President Barack Obama Monday launched a high-stakes drive to remake US healthcare, in his latest attempt to ensure his sweeping agenda is an antidote to and not a victim of the economic crisis.
The president unveiled Kansas Governor Kathleen Sebelius as his new pick to be secretary for health and human services (HHS) ahead of a bi-partisan White House healthcare summit on Thursday.
He also picked health expert Nancy-Ann DeParle as his counselor to coordinate White House efforts to achieve healthcare reform.
"If we are going to help families, save businesses, and improve the long-term economic health of our nation, we must realize that fixing what's wrong with our health care system is no longer just a moral imperative, but a fiscal imperative," Obama said in a written statement.
"Healthcare reform that reduces costs while expanding coverage is no longer just a dream we hope to achieve -- it's a necessity we have to achieve."
Both appointments replaced that of former senator Tom Daschle, originally nominated to simultaneously serve as HHS secretary and White House health czar but who was forced to pull out over a storm over unpaid taxes.
Obama shone a spotlight on healthcare after he placed the issue, a political gamble which has dogged previous Democratic presidents, at the center of his budget last week.
The president asked Congress for 634 billion dollars over 10 years as a "down payment" on refashioning a largely private system which offers some of the world's best care, but leaves nearly 46 million Americans uninsured, according to the National Coalition on Healthcare, an umbrella reform group.
His insistence on pushing the legislation confounds critics who warn Obama must curtail his political wish list because of the economic turmoil and Republicans who charge his plans are too expensive.
Sebelius, 60, who will require Senate confirmation and was once said to be in the running to be Obama's Democratic vice presidential nominee, is serving in her second term as governor of her heartland state.
News of her nomination was welcomed by Democratic Senator Max Baucus, who with ailing Democratic legend Senator Edward Kennedy, plans to pilot healthcare reform through Congress.
"Passing comprehensive health care reform is an absolute imperative this year, and as a former insurance commissioner Governor Sebelius really gets what needs to be done," Baucus said.
But the arrival of Sebelius in Washington was heralded by newspaper stories delving into the questionable success of her past efforts to reform healthcare in Kansas and Republican criticisms.
The Republican National Committee distributed research accusing the president of plotting billions of dollars of new taxes on Americans to pay for healthcare.
It accused Sebelius of being "in the pocket" of labor unions and of also being a prophet of high taxation.
White House officials have already warned Republicans would try to derail the president's healthcare plan and force a victory which would severely diminish his political clout.
Former president Bill Clinton's failed healthcare reform drive, under the direction of his wife Hillary Clinton, still sends shudders down the spines of leading Democrats.
But Obama's budget chief Peter Orszag warned on Sunday that there was no alternative to reforming healthcare -- a priority he said could end up being one of the primary drivers of economic recovery.
"We're going to get health care reform done this year. I think this proposal will get enacted," he said.
The plans are guaranteed a rough ride in Congress where attempts to cover all Americans are often derided by minority Republicans as European-style "socialized medicine."
Obama plans to finance the reforms by letting tax breaks for the rich expire in 2011, and to streamline other healthcare programs.
One of Obama's first actions after taking office in January was signing into law expanded healthcare coverage for low-income children -- a measure vetoed by former president George W. Bush.
With the US economic recession deepening, there are fears that millions more could be added to the ranks of the uninsured, since many rely on employers or their own wage checks to pay for coverage.
President Barack Obama Monday launched a high-stakes drive to remake US healthcare, in his latest attempt to ensure his sweeping agenda is an antidote to and not a victim of the economic crisis.
The president unveiled Kansas Governor Kathleen Sebelius as his new pick to be secretary for health and human services (HHS) ahead of a bi-partisan White House healthcare summit on Thursday.
He also picked health expert Nancy-Ann DeParle as his counselor to coordinate White House efforts to achieve healthcare reform.
"If we are going to help families, save businesses, and improve the long-term economic health of our nation, we must realize that fixing what's wrong with our health care system is no longer just a moral imperative, but a fiscal imperative," Obama said in a written statement.
"Healthcare reform that reduces costs while expanding coverage is no longer just a dream we hope to achieve -- it's a necessity we have to achieve."
Both appointments replaced that of former senator Tom Daschle, originally nominated to simultaneously serve as HHS secretary and White House health czar but who was forced to pull out over a storm over unpaid taxes.
Obama shone a spotlight on healthcare after he placed the issue, a political gamble which has dogged previous Democratic presidents, at the center of his budget last week.
The president asked Congress for 634 billion dollars over 10 years as a "down payment" on refashioning a largely private system which offers some of the world's best care, but leaves nearly 46 million Americans uninsured, according to the National Coalition on Healthcare, an umbrella reform group.
His insistence on pushing the legislation confounds critics who warn Obama must curtail his political wish list because of the economic turmoil and Republicans who charge his plans are too expensive.
Sebelius, 60, who will require Senate confirmation and was once said to be in the running to be Obama's Democratic vice presidential nominee, is serving in her second term as governor of her heartland state.
News of her nomination was welcomed by Democratic Senator Max Baucus, who with ailing Democratic legend Senator Edward Kennedy, plans to pilot healthcare reform through Congress.
"Passing comprehensive health care reform is an absolute imperative this year, and as a former insurance commissioner Governor Sebelius really gets what needs to be done," Baucus said.
But the arrival of Sebelius in Washington was heralded by newspaper stories delving into the questionable success of her past efforts to reform healthcare in Kansas and Republican criticisms.
The Republican National Committee distributed research accusing the president of plotting billions of dollars of new taxes on Americans to pay for healthcare.
It accused Sebelius of being "in the pocket" of labor unions and of also being a prophet of high taxation.
White House officials have already warned Republicans would try to derail the president's healthcare plan and force a victory which would severely diminish his political clout.
Former president Bill Clinton's failed healthcare reform drive, under the direction of his wife Hillary Clinton, still sends shudders down the spines of leading Democrats.
But Obama's budget chief Peter Orszag warned on Sunday that there was no alternative to reforming healthcare -- a priority he said could end up being one of the primary drivers of economic recovery.
"We're going to get health care reform done this year. I think this proposal will get enacted," he said.
The plans are guaranteed a rough ride in Congress where attempts to cover all Americans are often derided by minority Republicans as European-style "socialized medicine."
Obama plans to finance the reforms by letting tax breaks for the rich expire in 2011, and to streamline other healthcare programs.
One of Obama's first actions after taking office in January was signing into law expanded healthcare coverage for low-income children -- a measure vetoed by former president George W. Bush.
With the US economic recession deepening, there are fears that millions more could be added to the ranks of the uninsured, since many rely on employers or their own wage checks to pay for coverage.
2.11.2009
Drug Makers Fight Stimulus Provision
By ALICIA MUNDY
WASHINGTON -- The drug and medical-device industries are mobilizing to gut a provision in the stimulus bill that would spend $1.1 billion on research comparing medical treatments, portraying it as the first step to government rationing.
The fight over the provision is highlighting the tensions behind President Barack Obama's plan to overhaul the health-care system. The administration hopes to expand coverage while limiting use of treatments that don't work well, but any efforts that might reduce coverage are politically sensitive.
The House version of the stimulus package sent shudders through the drug and medical-device industry. In a staff report describing the bill, the House said treatments found to be less effective and in some cases more expensive "will no longer be prescribed."
A Senate version backed by Finance Committee Chairman Max Baucus (D., Mont.) doesn't mention cost as a subject to be studied. And the industry won a battle to add the word "clinical" in describing the research -- adding to the implication that the comparison studies won't look at bang for the buck. The final language is likely to be hammered out later this week in a House-Senate conference committee.
Mr. Obama is under pressure to find long-run health-cost savings as projections show that Medicare spending is on track to severely deplete the federal budget. "Without question, we're headed for more of a public and private push for which medicines work best at the lowest cost in particular patients," said Mark McClellan, former Medicare and Medicaid chief under President George W. Bush.
The $1.1 billion in research funding would be doled out to the National Institutes of Health and other government bodies. "We should focus on producing the best unbiased science possible," said Rep. Henry Waxman (D., Calif.), a strong proponent of the House language.
Mr. Obama supported research into comparative effectiveness during his campaign. Administration officials and leading Democrats in Congress say the idea will help government programs direct their dollars to treatments that are worth the money.
Officially, drug and device makers don't object to that sentiment. But they warn of a slippery slope where the government ends up axing useful treatments just because they cost too much. They have lined up patient groups that get industry funding to lobby Capitol Hill.
A coalition called the Partnership to Improve Patient Care includes the lobbying arms of the drug, device and biotechnology industries as well as patient-advocacy groups and medical-professional societies. Coalition spokesman David Di Martino says the research envisioned in the House bill may be used "in an inappropriate manner that may limit treatment options for patients."
A public-relations firm that is part of one of Washington's most influential lobby shops, Barbour Griffith Rogers, is representing the coalition. A major goal is to give industry a seat at the table when federal officials decide what to research with the $1.1 billion.
Companies "want to control the data, how it is reviewed, evaluated, and whether the public and government find out about it and use it," said Harry Selker, a Tufts University professor who directs its clinical-research program.
That also worries Jerry Avorn of Harvard Medical School, a frequent drug-industry critic. Comparative research "has the potential to tell us which drugs and treatments are safe, and which ones work," he said. "This is not information that the private sector will generate on its own, or that the industry wants to share."
Michael Cannon of the libertarian Cato Institute said comparative effectiveness research "isn't going to do any good because the industry will defund it as soon as it presents a threat."
When the government's Agency for Health Research Quality suggested in 1995 that there were too many unnecessary back surgeries, doctors and industry groups attacked the conclusion. Mr. Cannon noted that Congress at the time slashed the agency's budget and stripped its authority to make medicare-payment recommendations.
"They almost killed AHRQ," said Dr. Avorn. "The memory of their near-death experience hasn't been forgotten."
Dr. McClellan, the former Medicare chief, said effectiveness research can be useful but shouldn't assume pricey medicines are automatically bad. "The goal isn't to avoid expensive drugs, it's to get more value for our health-care spending," he said.
—Jacob Goldstein contributed to this article.
Write to Alicia Mundy at alicia.mundy@wsj.com
WASHINGTON -- The drug and medical-device industries are mobilizing to gut a provision in the stimulus bill that would spend $1.1 billion on research comparing medical treatments, portraying it as the first step to government rationing.
The fight over the provision is highlighting the tensions behind President Barack Obama's plan to overhaul the health-care system. The administration hopes to expand coverage while limiting use of treatments that don't work well, but any efforts that might reduce coverage are politically sensitive.
The House version of the stimulus package sent shudders through the drug and medical-device industry. In a staff report describing the bill, the House said treatments found to be less effective and in some cases more expensive "will no longer be prescribed."
A Senate version backed by Finance Committee Chairman Max Baucus (D., Mont.) doesn't mention cost as a subject to be studied. And the industry won a battle to add the word "clinical" in describing the research -- adding to the implication that the comparison studies won't look at bang for the buck. The final language is likely to be hammered out later this week in a House-Senate conference committee.
Mr. Obama is under pressure to find long-run health-cost savings as projections show that Medicare spending is on track to severely deplete the federal budget. "Without question, we're headed for more of a public and private push for which medicines work best at the lowest cost in particular patients," said Mark McClellan, former Medicare and Medicaid chief under President George W. Bush.
The $1.1 billion in research funding would be doled out to the National Institutes of Health and other government bodies. "We should focus on producing the best unbiased science possible," said Rep. Henry Waxman (D., Calif.), a strong proponent of the House language.
Mr. Obama supported research into comparative effectiveness during his campaign. Administration officials and leading Democrats in Congress say the idea will help government programs direct their dollars to treatments that are worth the money.
Officially, drug and device makers don't object to that sentiment. But they warn of a slippery slope where the government ends up axing useful treatments just because they cost too much. They have lined up patient groups that get industry funding to lobby Capitol Hill.
A coalition called the Partnership to Improve Patient Care includes the lobbying arms of the drug, device and biotechnology industries as well as patient-advocacy groups and medical-professional societies. Coalition spokesman David Di Martino says the research envisioned in the House bill may be used "in an inappropriate manner that may limit treatment options for patients."
A public-relations firm that is part of one of Washington's most influential lobby shops, Barbour Griffith Rogers, is representing the coalition. A major goal is to give industry a seat at the table when federal officials decide what to research with the $1.1 billion.
Companies "want to control the data, how it is reviewed, evaluated, and whether the public and government find out about it and use it," said Harry Selker, a Tufts University professor who directs its clinical-research program.
That also worries Jerry Avorn of Harvard Medical School, a frequent drug-industry critic. Comparative research "has the potential to tell us which drugs and treatments are safe, and which ones work," he said. "This is not information that the private sector will generate on its own, or that the industry wants to share."
Michael Cannon of the libertarian Cato Institute said comparative effectiveness research "isn't going to do any good because the industry will defund it as soon as it presents a threat."
When the government's Agency for Health Research Quality suggested in 1995 that there were too many unnecessary back surgeries, doctors and industry groups attacked the conclusion. Mr. Cannon noted that Congress at the time slashed the agency's budget and stripped its authority to make medicare-payment recommendations.
"They almost killed AHRQ," said Dr. Avorn. "The memory of their near-death experience hasn't been forgotten."
Dr. McClellan, the former Medicare chief, said effectiveness research can be useful but shouldn't assume pricey medicines are automatically bad. "The goal isn't to avoid expensive drugs, it's to get more value for our health-care spending," he said.
—Jacob Goldstein contributed to this article.
Write to Alicia Mundy at alicia.mundy@wsj.com
Faculty positions at University of Utah College of Pharmacy
Tenure Track Outcomes Research Faculty Position
Research Faculty Position
Assistant/Associate Professor
Pharmacotherapy Outcomes Research Center
Department of Pharmacotherapy
College of Pharmacy, University of Utah
This position provides opportunity for Pharmacotherapy Outcomes Research scholarly activity in a research-intensive, interdisciplinary health sciences center.
Review of applications will begin immediately and will continue until the position is filled.
Scholarly Activity:
The individual’s primary focus will be to conduct scholarly activity in health economics and outcomes research in collaboration with Pharmacotherapy Outcomes Research Center faculty and staff. The successful candidate will also be expected to pursue and direct independent outcomes research as well as seek research support from both the public and private sector. The individual will be expected to interact with individuals from the health care industry on a regular basis.
Teaching:
This individual may participate in team-taught courses for PharmD and MS students and serve as a preceptor on PharmD elective outcomes research clerkships. The individual may assist in the training of post-doctoral residents and fellows in pharmacotherapy outcomes research.
Qualifications:
A PhD degree, PharmD degree, pharmacy practice residency or equivalent experience, and fellowship or equivalent experience in health economics and/or outcomes research are preferred. Clinical practice experience and/or research experience are preferred. Excellent verbal and written communication skills and proven ability to work with other health professionals in an interdisciplinary environment are required.
Rank and Salary:
Appointment as a research track assistant or associate professor within the Department of Pharmacotherapy and a salary commensurate with qualifications and experience plus benefits will be provided. This is a calendar year appointment.
This position provides an excellent opportunity for collaboration with practitioners and faculty in a broad range of clinical and scientific disciplines in an interdisciplinary clinical environment. Interested individuals are invited to send their curriculum vitae and the names of three references to provide letters of recommendation to:
Joseph Biskupiak, PhD
Research Associate Professor, Department of Pharmacotherapy
Director, Pharmacotherapy Outcomes Research Center
Department of Pharmacotherapy
University of Utah College of Pharmacy
421 Wakara Way; Suite 208
Salt Lake City, UT 84108
Joseph.Biskupiak@pharm.utah.edu
The University of Utah is an EEO/AA employer and encourages applications from women and minorities.
Assistant Professor Rank
Department of Pharmacotherapy
University of Utah College of Pharmacy
Salt Lake City, Utah
www.pharmacy.utah.edu/pharmacotherapy/
The Department of Pharmacotherapy is seeking to fill a 12-month, tenure track faculty position at the minimum rank of Assistant Professor within the disciplines of outcomes research including health economics, biostatistics, and clinical outcomes. Applicants must possess a graduate degree in a health services research-related field such as behavioral science, pharmacoeconomics, health economics, pharmacoepidemiology, or public health. An undergraduate or professional degree in Pharmacy is preferred to facilitate teaching within the PharmD curriculum. The ideal candidate will possess demonstrated potential as an outstanding researcher, a strong interest, competence and commitment to excellence in teaching in the professional and graduate programs and a commitment to academic service.
The successful applicant is expected to complement the strong research program in the College of Pharmacy. The College of Pharmacy is situated in the foothills of the Wasatch Mountains in L.S. Skaggs Hall, which is part of the Utah Health Sciences Center, the University of Utah Hospital and Clinics, the School of Medicine, the Colleges of Health and Nursing, the Eccles Health Sciences Library and a state of the art Health Sciences Education Building. The Health Sciences Center is an environment conducive to interdisciplinary and translational research. The University of Utah College of Pharmacy is consistently ranked in the top five pharmacy schools nationally receiving National Institutes of Health funding for research. The Department of Pharmacotherapy consists of a strong foundation of clinical, tenure track faculty and research faculty, the Pharmacotherapy Outcomes Research Center, the Utah Poison Control Center and a Continuing Education Program.
Qualified applicants should send by mail and email a letter of intent, current curriculum vitae, and the names and addresses of three references to:
Diana Brixner, PhD, RPh
Chair, Outcomes Research Faculty Search
c/o Sara Ray, Administrative Officer
Department of Pharmacotherapy, University of Utah College of Pharmacy
30 South 2000 East – Room 258
Salt Lake City, UT 84112-5820
(801) 581-5984
sara.ray@pharm.utah.edu or diana.brixner@pharm.utah.edu
The University of Utah is an EEO/AA employer and encourages applications from women and minorities.
2.07.2009
Health Economics Position - Grapevinerecruiters
Folks,
this just came in, please contact Darren (see below)
best
Ulf
Associate Director of Health Economics and Outcomes
REPORTS TO: Strategic Affairs
LOCATION: Markham
OVERALL PURPOSE/MAJOR FUNCTION
• Develop timely, appropriate health economic data to support reimbursement initiatives for all products
• Manage economic and outcomes research projects in support of international and local pricing and reimbursement programs
• Provide interpretative expertise for economic/outcomes research data as needed by internal/external customers
• Mentor junior associates to improve skill sets
• MINIMUM REQUIREMENTS
• In-depth understanding of outcomes research and epidemiological study design.
• Working knowledge of biostatistics and data analysis
• Capabilities in health economic modeling
• Advanced communication capabilities
• Experience in government and patient advocacy lobbying
• Masters Degree in epidemiology, health economics, health policy
• 10 years work experience in health industry
RESPONSIBILITIES
• Implement local health economic and outcomes research strategies that support the overall reimbursement strategies
• Design health economic and outcomes research studies that are scientifically sound and timely
• Collaborate with International medical affairs to incorporate health economic measures into clinical trials
• Analyze and report results from health economics outcomes research studies, including publication and presentation of data
• Provide input into global health economics and outcomes research studies and programs.
• Communicate results of health economic and outcomes research studies to internal and external customers
• Recruit and manage investigators/vendors to conduct health economics and outcomes research studies
RECOMMENDATIONS
• Impactful outcomes in outcomes studies
• Analysis plan for health economic and outcomes studies
• GO/NO GO decisions for health economic studies
• Health economic approach for submission/presentation to customers
• Publication strategies for completed studies
Darren Kruszynski
Grapevine Executive Recruiters
269 Richmond Street West
Suite 100
Toronto, Ontario
416-581-1445 ext 225
www.grapevinerecruiters.com
Darren@grapevinerecruiters.com
http://www.linkedin.com/in/darrenkruszynski
this just came in, please contact Darren (see below)
best
Ulf
Associate Director of Health Economics and Outcomes
REPORTS TO: Strategic Affairs
LOCATION: Markham
OVERALL PURPOSE/MAJOR FUNCTION
• Develop timely, appropriate health economic data to support reimbursement initiatives for all products
• Manage economic and outcomes research projects in support of international and local pricing and reimbursement programs
• Provide interpretative expertise for economic/outcomes research data as needed by internal/external customers
• Mentor junior associates to improve skill sets
• MINIMUM REQUIREMENTS
• In-depth understanding of outcomes research and epidemiological study design.
• Working knowledge of biostatistics and data analysis
• Capabilities in health economic modeling
• Advanced communication capabilities
• Experience in government and patient advocacy lobbying
• Masters Degree in epidemiology, health economics, health policy
• 10 years work experience in health industry
RESPONSIBILITIES
• Implement local health economic and outcomes research strategies that support the overall reimbursement strategies
• Design health economic and outcomes research studies that are scientifically sound and timely
• Collaborate with International medical affairs to incorporate health economic measures into clinical trials
• Analyze and report results from health economics outcomes research studies, including publication and presentation of data
• Provide input into global health economics and outcomes research studies and programs.
• Communicate results of health economic and outcomes research studies to internal and external customers
• Recruit and manage investigators/vendors to conduct health economics and outcomes research studies
RECOMMENDATIONS
• Impactful outcomes in outcomes studies
• Analysis plan for health economic and outcomes studies
• GO/NO GO decisions for health economic studies
• Health economic approach for submission/presentation to customers
• Publication strategies for completed studies
Darren Kruszynski
Grapevine Executive Recruiters
269 Richmond Street West
Suite 100
Toronto, Ontario
416-581-1445 ext 225
www.grapevinerecruiters.com
Darren@grapevinerecruiters.com
http://www.linkedin.com/in/darrenkruszynski
2.05.2009
NICE splits renal cancer drugs assessment - "yes" for Pfizer's Sutent, "no" for Roche, Bayer, Wyeth
by Nick Smith
LONDON, Feb 4 (APM) - NICE on Wednesday split its controversial review of renal cancer drugs into two, saying 'yes' to Pfizer's Sutent (sunitinib) but rejecting three others - Wyeth's Torisel (temsirolimus), Bayer's Nexavar (sorafenib) and Roche's Avastin (bevacizumab).
In effect NICE has all but guaranteed that one product will reach patients, while pushing problematic appeals back down the appraisal process.
In a statement issued late on Tuesday for Wednesday release, NICE said in an attempt to get guidance out the NHS as quickly as possible it had published later-stage guidance recommending sunitinib as a first-line treatment option in advanced and/or metastatic renal cell carcinoma.
In a second set of guidance, bevacizumab, sorafenib and temsirolimus were not recommended as first-line treatment options for advanced and/or metastatic renal cell carcinoma.
Also in the second set of guidance, the two drugs also licensed for second-line treatment of advanced or metastatic renal cell carcinoma, sorafenib and sunitinib, are not recommended for this indication.
A spokeswoman for NICE told APM the sunitinib document was a so-called Final Appraisal Determination (FAD), which in the absence of an appeal will become guidance to the NHS. The second is a first draft which is now out for public consultation ahead of a later FAD.
RIGHT TO APPEAL?
Initially all four cancer drugs were assessed and rejected together, leading to a huge public outcry that dying people were being denied life-extending drugs.
Following this, new flexibilities for NICE's appraisal committees were announced by the government.
This gave them a more formal freedom to exceed NICE's generally understood maximum cost per quality-adjusted life year of 30,000 pounds (33,000 euros) under certain conditions, including low incidence and end-of-life cases.
In its statement, NICE says the approval of sunitinib comes under these new flexibilities and stresses its desire to get this treatment to patients as soon as possible.
NICE said: "Having decided that one of these treatments should be recommended for use in the NHS, we felt that it was in the interests of patients to get that advice out as quickly as possible.
Although this final recommendation is subject to appeal we very much hope it will form the basis of our guidance to the NHS."
The approval for sunitinib is specifically in patients with renal cell carcinoma (RCC) who are suitable for immunotherapy with an Eastern Cooperative Oncology Group performance status of 0 or 1.
Despite the mention of an appeal it was not clear what grounds companies with rejected drugs might use. It is unusual for patient organisations to appeal an approval from NICE.
The spokeswoman confirmed that after NICE split the assessment, the sunitinib FAD only deals with the Pfizer drug. Although she insisted all consultees - which would include Wyeth, Bayer and Roche - had the right to appeal regardless of whether their product was included or not, she could not say how they might benefit from an appeal.
In the absence of a rejection of their own drugs, it seems any appealing company could only succeed in slowing down access or stopping patients accessing any drug at all.
Pfizer is one of two companies which offered "patient access schemes" - incentives to the National Health Service that in some way reduce the price paid by the service - in order to gain NICE approval in cases which would otherwise have led to rejection.
Pfizer offered the NHS the first cycle of sunitinib in renal cell carcinoma free. "The independent advisory committee concluded that sunitinib does represent a cost effective use of NHS resources when used as a first-line treatment for advanced and/or metastatic RCC," NICE said in the statement without giving its estimated cost per QALY.
NICE also noted the Department of Health said the Pfizer scheme, "does not constitute an excessive administrative burden on the NHS".
Bayer also agreed a patient access scheme with the Department of Health, in which the first pack of sorafenib is free to the NHS, NICE said.
ns/ak
nick.smith@apmnews.com
[14114] 04/02/2009 09:31 GMT - INDUSTRY
LONDON, Feb 4 (APM) - NICE on Wednesday split its controversial review of renal cancer drugs into two, saying 'yes' to Pfizer's Sutent (sunitinib) but rejecting three others - Wyeth's Torisel (temsirolimus), Bayer's Nexavar (sorafenib) and Roche's Avastin (bevacizumab).
In effect NICE has all but guaranteed that one product will reach patients, while pushing problematic appeals back down the appraisal process.
In a statement issued late on Tuesday for Wednesday release, NICE said in an attempt to get guidance out the NHS as quickly as possible it had published later-stage guidance recommending sunitinib as a first-line treatment option in advanced and/or metastatic renal cell carcinoma.
In a second set of guidance, bevacizumab, sorafenib and temsirolimus were not recommended as first-line treatment options for advanced and/or metastatic renal cell carcinoma.
Also in the second set of guidance, the two drugs also licensed for second-line treatment of advanced or metastatic renal cell carcinoma, sorafenib and sunitinib, are not recommended for this indication.
A spokeswoman for NICE told APM the sunitinib document was a so-called Final Appraisal Determination (FAD), which in the absence of an appeal will become guidance to the NHS. The second is a first draft which is now out for public consultation ahead of a later FAD.
RIGHT TO APPEAL?
Initially all four cancer drugs were assessed and rejected together, leading to a huge public outcry that dying people were being denied life-extending drugs.
Following this, new flexibilities for NICE's appraisal committees were announced by the government.
This gave them a more formal freedom to exceed NICE's generally understood maximum cost per quality-adjusted life year of 30,000 pounds (33,000 euros) under certain conditions, including low incidence and end-of-life cases.
In its statement, NICE says the approval of sunitinib comes under these new flexibilities and stresses its desire to get this treatment to patients as soon as possible.
NICE said: "Having decided that one of these treatments should be recommended for use in the NHS, we felt that it was in the interests of patients to get that advice out as quickly as possible.
Although this final recommendation is subject to appeal we very much hope it will form the basis of our guidance to the NHS."
The approval for sunitinib is specifically in patients with renal cell carcinoma (RCC) who are suitable for immunotherapy with an Eastern Cooperative Oncology Group performance status of 0 or 1.
Despite the mention of an appeal it was not clear what grounds companies with rejected drugs might use. It is unusual for patient organisations to appeal an approval from NICE.
The spokeswoman confirmed that after NICE split the assessment, the sunitinib FAD only deals with the Pfizer drug. Although she insisted all consultees - which would include Wyeth, Bayer and Roche - had the right to appeal regardless of whether their product was included or not, she could not say how they might benefit from an appeal.
In the absence of a rejection of their own drugs, it seems any appealing company could only succeed in slowing down access or stopping patients accessing any drug at all.
Pfizer is one of two companies which offered "patient access schemes" - incentives to the National Health Service that in some way reduce the price paid by the service - in order to gain NICE approval in cases which would otherwise have led to rejection.
Pfizer offered the NHS the first cycle of sunitinib in renal cell carcinoma free. "The independent advisory committee concluded that sunitinib does represent a cost effective use of NHS resources when used as a first-line treatment for advanced and/or metastatic RCC," NICE said in the statement without giving its estimated cost per QALY.
NICE also noted the Department of Health said the Pfizer scheme, "does not constitute an excessive administrative burden on the NHS".
Bayer also agreed a patient access scheme with the Department of Health, in which the first pack of sorafenib is free to the NHS, NICE said.
ns/ak
nick.smith@apmnews.com
[14114] 04/02/2009 09:31 GMT - INDUSTRY
1.28.2009
More Velcade-Style Risk-Sharing in the UK?
via the IN VIVO Blog by Melanie Senior on 21/01/09
It appears that Janssen-Cilag feels a lot better now about its pay-for-performance scheme around multiple myeloma drug bortezemib (Velcade) than it did when the program was introduced in 2007.
The Velcade Response Scheme (VRS) came about out of desperation: cost-effectiveness watchdog NICE had turned down the drug as too expensive, so Janssen-Cilag, to its credit, said to the UK’s state payer, the Department of Health, ok, well if we promise to charge only when the drug is effective (and refund you if not), then will you give this to patients? The answer was yes. And now, not only have all of the UK’s Primary Care Trusts have signed up to the VRS, according to a Janssen spokesperson, but this scheme “may now be a good example of how a performance-based scheme could be structured.” That’s not a statement from Janssen; it’s from a position document issued last year by the British Oncology Pharmacy Association on risk-sharing schemes.
Indeed, such schemes have, perhaps inevitably, become a rather more regular feature of the UK drug landscape—making Janssen feel more pioneering than desperate (though Janssen isn’t the first to guarantee performance; Pfizer tried with Lipitor too).
Most of the other recent flavors of risk-sharing programs around expensive cancer drugs emerged, like VRS did, as a result of a negative NICE appraisal. Merck-Serono offered the Cetuximab Cost-Share Program around Erbitux in metastatic colorectal cancer, which involved refunding primary care trusts the cost of any vials of the drug used for patients that fell into a pre-agreed ‘non-responder’ category at up to 6 weeks. Roche instigated the ‘Tarceva Access Program’ for its NSCLC drug erlotinib, offering a rebate, in the form of a credit note against any future Roche purchase, for the amount that the drug cost over and above the cost of the incumbent NSCLC treatment docetaxel (Sanofi-Aventis' Taxotere) for an average patient duration (with an upper limit on the total number of packs).
Now granted, Roche’s program was initially introduced as a means to claw market share off docetaxel, which it was struggling to do ahead of NICE guidance. But when NICE found Tarceva to be un-cost effective—with questions around the lack of comparative data with docetaxel in particular--the scheme was formally proposed to NICE as part of a re-review. In November 2008, NICE issued positive guidance—but only on condition that the overall treatment cost remained in line with that of docetaxel. Roche had to drop the price by about 7.5%.
Critics say such programs are simply a way for industry to coerce NICE into a ‘yes’. Maybe. But there’s no denying that such schemes represent a logical way to improve patient access without breaking the bank. Indeed, the new UK drug pricing contract, the PPRS, formalizes a bunch of patient access schemes, including risk-sharing programs. And NICE, as we heard from CEO Andrew Dillon last week, would prefer such schemes to be proposed up front, before a drug is submitted for review, rather than as a last-resort of the drug fails the cost-test.
Small wonder, then, that in the last three or four months since the PPRS was published, the department of health has been in contact with various companies about schemes around several “high profile” drugs, according to David Thomson, Lead Pharmacist at the Yorkshire Cancer Network and author of the BOPA position statement.
The big problem is administration. As it is, it’s complex to administer rebates and track outcomes. The more different schemes are available, the harder that becomes. “Anecdotal evidence suggests that the VRS [and a similar scheme around Sutent] aren’t necessarily bringing the expected levels of financial benefit to the National Health Service,” Thomson told The IN VIVO Blog.
Add to this the problem of patchy uptake or availability of some of the existing handful of programs across the country, and the possibility of multiple risk-programs across a single drug for different indications, and it’s easy to see why BOPA's pushing for some sort of risk-sharing plan template....and why we may not, after all, see a flood of VRS-followers soon.
image by flickr user fboosman used under a creative commons license
© Copyright 2008 Windhover Information Inc. www.windhover.com/blog
NICE to put QALY under examination
LONDON, Jan 27 (APM) - NICE on Tuesday announced an arms-length investigation into how it values health technology, potentially putting the quality-adjusted life year (QALY) under the microscope.
In a press release, the cost-effectiveness body said NICE chairman, Professor Mike Rawlins, has written to England's top health minister announcing a "short study of how value is taken into account when looking at new health technologies". The study will involve submissions and the use of a series of workshops involving the healthcare industries, patients and the wider public, together with representatives of the NHS to explore this issue, NICE said.
NICE also said the Professor of health law, ethics and policy at University College London, Ian Kennedy has agreed to lead the study. Quoted in the release, Rawlins said: "This study which will look at whether particular forms of value are more important than others; and will explore factors that should be taken into account in establishing the value of new health technologies."
QALY
No particular mention of the QALY was made in the release but the measure is at the centre of NICE's work and has been doggedly defended by the institute despite increasing hostility from industry. However, a shift may have taken place with the new UK pricing contract which outlined a greater role for NICE, bringing it to the centre of UK drug pricing.
The pharma industry is known to have pressed for a much wider examination of the benefits of medicines including keeping people in work, reducing the workload of carers and saving the National Health Service costs in reduced hospital admissions.
Rawlins noted a recent report on the future of the biotechnology industry stressed the importance of NICE and the pharmaceutical industry working towards a shared understanding of how to value innovative new health technologies, adding, "NICE supports that view."
ns/ak
nick.smith@apmnews.com
[14027] 27/01/2009 11:02 GMT - INDUSTRY
In a press release, the cost-effectiveness body said NICE chairman, Professor Mike Rawlins, has written to England's top health minister announcing a "short study of how value is taken into account when looking at new health technologies". The study will involve submissions and the use of a series of workshops involving the healthcare industries, patients and the wider public, together with representatives of the NHS to explore this issue, NICE said.
NICE also said the Professor of health law, ethics and policy at University College London, Ian Kennedy has agreed to lead the study. Quoted in the release, Rawlins said: "This study which will look at whether particular forms of value are more important than others; and will explore factors that should be taken into account in establishing the value of new health technologies."
QALY
No particular mention of the QALY was made in the release but the measure is at the centre of NICE's work and has been doggedly defended by the institute despite increasing hostility from industry. However, a shift may have taken place with the new UK pricing contract which outlined a greater role for NICE, bringing it to the centre of UK drug pricing.
The pharma industry is known to have pressed for a much wider examination of the benefits of medicines including keeping people in work, reducing the workload of carers and saving the National Health Service costs in reduced hospital admissions.
Rawlins noted a recent report on the future of the biotechnology industry stressed the importance of NICE and the pharmaceutical industry working towards a shared understanding of how to value innovative new health technologies, adding, "NICE supports that view."
ns/ak
nick.smith@apmnews.com
[14027] 27/01/2009 11:02 GMT - INDUSTRY
1.27.2009
Wales sidesteps NICE recommendation on kidney cancer drug access
Scrip
Welsh patients will be able to receive four kidney cancer drugs that have not been
recommended by the National Institute for health and Clinical Excellence (NICE), the
Welsh health minister Edwina Hart has announced.
The decision will allow greater access to four drugs currently being reviewed by NICE
for advanced renal cancer - Pfizer's Sutent (sunitinib), Genentech's Avastin
(bevacizumab), Bayer's Nexavar (sorafenib) and Wyeth's Torisel (temsirolimus). None
of the drugs was found cost-effective a draft NICE appraisal last August; the assessment
of the treatments has since been extended, with final guidance expected this month
(Scrip Online, October 21st, 2008). However, the health minister has instructed Local Health Boards (LHBs) to provide the drugs to end-of-life patients with kidney cancer, with immediate effect, choosing not to wait for NICE's decision. Although describing the move as a "temporary arrangement", the health minister added it was "unacceptable" for patients to be kept waiting for the treatments.
The decision follows a clinical audit of Sutent issued last December. Originally, NICE
and the All Wales Medicines Strategy Group (AWMSG) issued guidance that the drug
should not be funded by the NHS as it was too expensive (Scrip Online, August 8th,
2008), thus leaving funding decisions to LHBs for individual patients. However, a study undertaken by the Medical Director of NHS Wales Professor Mike Harmer found that of 73 requests for Sutent only 23 received the treatment in 2008, raising questions of consistency; the report revealed that all patients who were recommended the treatment in Neath, Port Talbot and Bridgend received it, while only one of 13 patients received the drug in Cardiff and none of the 14 patients recommended received the drug in Swansea.
The health minister has already shown she is prepared for Wales to make its own
decisions regarding drug availability; in July last year she made Novartis's Lucentis
(ranibizumab) for wet age-related macular degeneration (AMD) in both eyes available
on the Welsh NHS, a month before final guidance for England and Wales was confirmed
by NICE (Scrip Online, July 17th 2008 and August 27th, 2008).
NICE has proposed changing its cost-effectiveness parameters for end-of-life drugs,
partly in response to a public outcry over the initial draft of its assessment of the four
kidney anticancers.
SCRIP - World Pharmaceutical News - www.scrippharma.com
FILED 26 January 2009 COPYRIGHT Informa UK Ltd 2009
PHIND: Pharma & Healthcare Ind News - today only (PHID)
Welsh patients will be able to receive four kidney cancer drugs that have not been
recommended by the National Institute for health and Clinical Excellence (NICE), the
Welsh health minister Edwina Hart has announced.
The decision will allow greater access to four drugs currently being reviewed by NICE
for advanced renal cancer - Pfizer's Sutent (sunitinib), Genentech's Avastin
(bevacizumab), Bayer's Nexavar (sorafenib) and Wyeth's Torisel (temsirolimus). None
of the drugs was found cost-effective a draft NICE appraisal last August; the assessment
of the treatments has since been extended, with final guidance expected this month
(Scrip Online, October 21st, 2008). However, the health minister has instructed Local Health Boards (LHBs) to provide the drugs to end-of-life patients with kidney cancer, with immediate effect, choosing not to wait for NICE's decision. Although describing the move as a "temporary arrangement", the health minister added it was "unacceptable" for patients to be kept waiting for the treatments.
The decision follows a clinical audit of Sutent issued last December. Originally, NICE
and the All Wales Medicines Strategy Group (AWMSG) issued guidance that the drug
should not be funded by the NHS as it was too expensive (Scrip Online, August 8th,
2008), thus leaving funding decisions to LHBs for individual patients. However, a study undertaken by the Medical Director of NHS Wales Professor Mike Harmer found that of 73 requests for Sutent only 23 received the treatment in 2008, raising questions of consistency; the report revealed that all patients who were recommended the treatment in Neath, Port Talbot and Bridgend received it, while only one of 13 patients received the drug in Cardiff and none of the 14 patients recommended received the drug in Swansea.
The health minister has already shown she is prepared for Wales to make its own
decisions regarding drug availability; in July last year she made Novartis's Lucentis
(ranibizumab) for wet age-related macular degeneration (AMD) in both eyes available
on the Welsh NHS, a month before final guidance for England and Wales was confirmed
by NICE (Scrip Online, July 17th 2008 and August 27th, 2008).
NICE has proposed changing its cost-effectiveness parameters for end-of-life drugs,
partly in response to a public outcry over the initial draft of its assessment of the four
kidney anticancers.
SCRIP - World Pharmaceutical News - www.scrippharma.com
FILED 26 January 2009 COPYRIGHT Informa UK Ltd 2009
PHIND: Pharma & Healthcare Ind News - today only (PHID)
1.20.2009
‘Comparator Report on Patient Access to Cancer Drugs in Europe’ reveals significant inequalities still remain
Brussels, 16th January 2009 РEuropean patients still face unequal access to cancer treatment, depending on where they live. This was confirmed in a report published today by Dr Nils Wilking, clinical oncologist at the Karolinska Institutet in Stockholm, Sweden, and Prof Bengt J̦nsson, Professor of Health Economics at the Stockholm School of Economics. These inequalities and gaps in survival of cancer patients are particularly noticeable when comparing Eastern Europe with Northern and Western Europe.
The report, based on findings from the 27 EU Member States (excluding Cyprus and Malta), Iceland, Norway and Switzerland, updates and improves on two earlier reports by the same authors in 2005 and 2007. This most recent report was supported by an unrestricted grant from EFPIA, the Federation of the research-based pharmaceutical industry in Europe. Analyses were conducted by i3 Innovus, a company specializing in health economics and outcomes research. “Appropriate access to new treatments is vital, and examining variations in patient access between countries is a positive way to stimulate discussions on the optimal use of new technologies and treatment,” said Brian Ager, Director General of EFPIA.
The report reveals that whereas cancer incidence is increasing, cancer mortality is decreasing, indicating the positive impact of screening programmes and improvements in treatments. “New treatments have made it possible to target diseases more effectively. For cancer patients, these newer therapies mean an improved quality of life, with less time spent in hospital and the chance to return to their day-to-day activities earlier”, said Dr Wilking.
However the report highlights wide gaps in Europe in relative survival rates. For example, in Sweden 60.3 % of men and 61.7 % of women diagnosed with cancer survive compared to only 37.7 % of men and 49.3 % of women in the Czech Republic. EUROCARE 4 data also shows that for a similar incidence, cancer patients in Sweden have greater chances of survival than those in the UK. Healthcare systems in Europe are spending more on cancer, but this expenditure remains lower than the relative burden of cancer in comparison to other diseases.
Patients in Austria, France and Switzerland have the broadest access to newer cancer treatments while Poland, the Czech Republic and the UK continue to lag behind. Prof Jönsson emphasized “The inequalities –highlighted in our original report in 2005 – still remain. For patients and society this is a real concern, as expectations are that all patients in Europe should have equal opportunity to access these treatments, particularly when evidence shows that access to cancer treatment is linked to an improvement in outcome”.
The report authors urged policy-makers to take action - 1.2 million deaths were caused by cancer in Europe in 2006 - and proposed new policies to improve treatment access for patients in Europe:
- Adapt healthcare budgets generally and hospital budgets specifically to incorporate the introduction of new cancer drugs;
- Introduce separate funding for cancer drugs, with or without requirements of an additional gathering of data;
- Expedite (regulatory and economic) review times for innovative cancer drugs
- Promote a European collaborative approach to collecting available scientific information for Health Technology Assessment (HTA)
The report is available for download on www.comparatorreports.se
The report, based on findings from the 27 EU Member States (excluding Cyprus and Malta), Iceland, Norway and Switzerland, updates and improves on two earlier reports by the same authors in 2005 and 2007. This most recent report was supported by an unrestricted grant from EFPIA, the Federation of the research-based pharmaceutical industry in Europe. Analyses were conducted by i3 Innovus, a company specializing in health economics and outcomes research. “Appropriate access to new treatments is vital, and examining variations in patient access between countries is a positive way to stimulate discussions on the optimal use of new technologies and treatment,” said Brian Ager, Director General of EFPIA.
The report reveals that whereas cancer incidence is increasing, cancer mortality is decreasing, indicating the positive impact of screening programmes and improvements in treatments. “New treatments have made it possible to target diseases more effectively. For cancer patients, these newer therapies mean an improved quality of life, with less time spent in hospital and the chance to return to their day-to-day activities earlier”, said Dr Wilking.
However the report highlights wide gaps in Europe in relative survival rates. For example, in Sweden 60.3 % of men and 61.7 % of women diagnosed with cancer survive compared to only 37.7 % of men and 49.3 % of women in the Czech Republic. EUROCARE 4 data also shows that for a similar incidence, cancer patients in Sweden have greater chances of survival than those in the UK. Healthcare systems in Europe are spending more on cancer, but this expenditure remains lower than the relative burden of cancer in comparison to other diseases.
Patients in Austria, France and Switzerland have the broadest access to newer cancer treatments while Poland, the Czech Republic and the UK continue to lag behind. Prof Jönsson emphasized “The inequalities –highlighted in our original report in 2005 – still remain. For patients and society this is a real concern, as expectations are that all patients in Europe should have equal opportunity to access these treatments, particularly when evidence shows that access to cancer treatment is linked to an improvement in outcome”.
The report authors urged policy-makers to take action - 1.2 million deaths were caused by cancer in Europe in 2006 - and proposed new policies to improve treatment access for patients in Europe:
- Adapt healthcare budgets generally and hospital budgets specifically to incorporate the introduction of new cancer drugs;
- Introduce separate funding for cancer drugs, with or without requirements of an additional gathering of data;
- Expedite (regulatory and economic) review times for innovative cancer drugs
- Promote a European collaborative approach to collecting available scientific information for Health Technology Assessment (HTA)
The report is available for download on www.comparatorreports.se
1.13.2009
Oncology Market Access Conference, April 22nd-23rd Zurich
eyeforpharma hosts the 2009 Oncology Market Access conference on 22nd-23rd April in Zurich. I have been told by the organizer that the conference is looking to be very popular. The website and brochure for the conference have been updated, please take a look.
New rules on drugs will not increase access for terminally ill: expert
New rules issued by the NHS drugs rationing body to increase access to drugs for terminally ill people will not work, an expert has said.
by Rebecca Smith, Medical Editor, Telegraph
The National Institute for health and Clinical Excellence (Nice) has told its drugs appraisals committees to be more flexible and approve drugs that would not normally be considered cost effective because they are expensive and only extend life by a short period.
The new rules were praised by charities and patient groups who felt that, for some patients with rare terminal illnesses, it could mean they would get drugs that would otherwise be denied them.
But James Raftery, Professor of Health Technology Assessment at Southampton University, says that the new arrangements will do little to improve availability of expensive drugs and may result in other patient groups being denied treatment.
Writing in the British Medical Journal online he said during 1999-2008, NICE rejected 11 drugs on the grounds of cost effectiveness.
The new advice applies to treatments that affect small numbers of patients who are not expected to live more than 24 months, and that offer demonstrable survival benefits, at least an extra three months of life, compared with current NHS practice.
Professor Raftery examined the effect the new arrangements would have had on all cancer drugs that NICE has refused or proposed to refuse because of cost effectiveness.
He found that few of the rejected drugs would qualify under the new criteria, with most failing to meet the criterion that no alternative treatment with comparable benefits existed.
He also warns that making an exception for any group sets a precedent for other groups, and that allowing more expensive treatments for a small group of patients within a fixed overall budget would result in other patient groups being denied treatment.
Prof Raftery said: "My analysis suggests that NICE's new arrangements for appraising end of life drugs may do little to improve availability of expensive cancer treatments. Few of the rejected drugs would qualify under the new criteria, with much depending on the interpretation of the criterion that no alternative treatment with comparable benefit is available through the NHS.
"NICE will celebrate its 10th birthday in 2009 having had to make a major change in its methods. Its attempt to minimise the effects of these changes will no doubt be tested in future appeals against its findings."
A spokesman for Nice said: "The supplementary advice we are now providing our Independent Committees with enables them to explore the perception that society may place greater value on extensions to life in circumstances where life expectancy is shortened. We think it likely that some treatments will be recommended where in the past they might not. We can't predict which ones will be or how many, perhaps no more than a one or two a year, but it depends to a great extent of what treatments get licensed in the future.
"We recognise that the supplementary advice is controversial and acknowledge there could be concerns that other, equally deserving, patient groups could lose out. We will therefore be ensuring an evaluation is undertaken to investigate whether the scheme is achieving its intended purpose."
1.12.2009
France to increase cost benefit assessments of new medicines
France's HAS three-year plan includes economic assessment
Scrip
France's HAS, an agency set up three years ago to advise the government on healthcare
issues, has set out a three-year work programme for 2009-11 that emphasises its dual
economic and scientific roles. The agency was reorganised last year and set up a new medico-economic committee that is charged with devising rational reimbursement policies and otherwise guiding public spending on healthcare. HAS's aim is to have systems in place by 2011 that will provide a functioning, interdisciplinary evaluation service for the government and healthcare professionals.
Until now, the agency has limited its assessments to the medical benefits of different treatments, but its 2009-11 strategy puts the cost of treatments into the equation. It expects to conduct more postmarketing studies and to develop methods for comparing the relative effectiveness of different products and practices.
The government criticised the agency last year for working too slowly. It was struggling to cut costs from the national healthcare budget and was looking to the HAS for costeffectiveness guidance on several classes of drugs. Perhaps stung by this public rebuke,the agency has set a 2011 target of completing its evaluation of newly licensed drugs within 90 days, and a 12-month timeframe for any re-evaluation of an entire class of drugs, which might be extended to 18 months for particularly complex assessments.
The HAS also plans to examine how to set up a short-response procedure and to
determine the circumstances in which an accelerated assessment might be appropriate.
Improving the quality of the information given to healthcare professionals is also among the agency's objectives for the next three years. It notes that its responsibility to inform patients and prescribers about medicines is duplicated by Afssaps, the medicines regulator, and it hopes that the two agencies can work together. Both agencies publish guidance on the use of medicines.
The HAS is also looking at the way the industry communicates with doctors and it plans to publish a report later this year on the way doctors perceive the information they get from sales reps. It plans to establish best-practice guidance for pharmaceutical companies, but here again it recognises that this effort might overlap the responsibilities of other agencies.
Besides working more closely with French organisations, the HAS says that it will coordinate its efforts with similar agencies in other countries, including NICE in the UK, Germany's IQWIG, the Danish National Board of Health and the Health Quality Authority in Ireland. It plans to deepen its participation in the European
Network for Health Technology Assessment and the European Network for Patient
Safety.
SCRIP - World Pharmaceutical News - www.scrippharma.com FILED 09
January 2009 COPYRIGHT Informa UK Ltd 2009
1.06.2009
Opportunities @ Double Helix Consulting
Hello everyone & happy 2009! Interested candidates please see contact details below.
best wishes
Ulf
Title: Consultant—Biopharmaceutical Market Access
Summary: Double Helix Consulting US (DHC US) is the newly formed US-based life sciences consulting division of London-based Double Helix Development group which has provided market research and market access consulting services to the biopharmaceutical and medical device industries for nearly 15 years. We seek a highly motivated entrepreneurial executive with experience and expertise in the area of market access, including pricing and reimbursement, to help build an exciting and dynamic consulting organization with offices in the greater NYC metro area. The ideal candidate will be able to leverage existing and foster new relationships with leading biopharma companies and win business in a highly competitive market. The Consultant will collaborate closely with DHC US senior management to (a) define service and solution offerings, (b) market and secure consulting engagements with target clients, and (c) manage project teams to complete consulting assignments on time and on budget. Compensation commensurate with experience. Generous benefits available. DHC US is an equal opportunity employer that celebrates diversity at all levels of our organization. EOE/M/F/D/V
Responsibilities:
The Consultant will work with clients and DHC US colleagues to:
• Evaluate reimbursement environment and design strategies to enhance technology adoption and coverage policies among payers, HTA and quality assurance groups (e.g., AHRQ, NCQA, JCAHO), professional societies, and other stakeholders
• Contribute to establishing and maintaining a Market Access Advisory Network including health economists, clinical opinions leaders, patient groups and policy makers
• Develop market building and expansion strategies, including programs to educate customers regarding product value
• Evaluate target product profiles and commercialization scenarios to guide clinical program and trial design, including choice of target populations, duration, comparators and endpoints
• Integrate clinical, market, and payer data to prepare HTAs and product dossier in formats defined by payers and industry associations, e.g., AMCP, WellPoint
• Develop programs/materials for use by field staff that integrate information on product value to support strategies for optimizing revenues, reimbursement, and formulary positioning across all managed markets
Education and Experience:
• MD or PharmD; or Masters or PhD/ScD in a quantitative, health-related field—health services research, economics, epidemiology, statistics or business
• Minimum 8 years’ client- and/or consultant-side biopharmaceutical industry experience, including substantial experience supporting Phase III, peri-launch and launch strategy
• Experience working with payers and decision-makers on evidence-based customer strategies
• Experience demonstrating product value, including preparing AMCP dossiers and/or submissions to HTA agencies
• Experience making substantial contributions to commercial assessment, licensing & development, portfolio management, lifecycle planning, M&A evaluation and/or alliance management desirable
Other Qualifications:
• Proven track record of excellence in written and oral communication of complex technical information
• Strong collaborative style and persuasion skills to build consensus, effectively manage project teams, and achieve objectives
• Ability and willingness to travel up to 40%, primarily domestic
Contact Information: Interested candidates should forward resume and cover note to hr@dhelixc.com
best wishes
Ulf
Title: Consultant—Biopharmaceutical Market Access
Summary: Double Helix Consulting US (DHC US) is the newly formed US-based life sciences consulting division of London-based Double Helix Development group which has provided market research and market access consulting services to the biopharmaceutical and medical device industries for nearly 15 years. We seek a highly motivated entrepreneurial executive with experience and expertise in the area of market access, including pricing and reimbursement, to help build an exciting and dynamic consulting organization with offices in the greater NYC metro area. The ideal candidate will be able to leverage existing and foster new relationships with leading biopharma companies and win business in a highly competitive market. The Consultant will collaborate closely with DHC US senior management to (a) define service and solution offerings, (b) market and secure consulting engagements with target clients, and (c) manage project teams to complete consulting assignments on time and on budget. Compensation commensurate with experience. Generous benefits available. DHC US is an equal opportunity employer that celebrates diversity at all levels of our organization. EOE/M/F/D/V
Responsibilities:
The Consultant will work with clients and DHC US colleagues to:
• Evaluate reimbursement environment and design strategies to enhance technology adoption and coverage policies among payers, HTA and quality assurance groups (e.g., AHRQ, NCQA, JCAHO), professional societies, and other stakeholders
• Contribute to establishing and maintaining a Market Access Advisory Network including health economists, clinical opinions leaders, patient groups and policy makers
• Develop market building and expansion strategies, including programs to educate customers regarding product value
• Evaluate target product profiles and commercialization scenarios to guide clinical program and trial design, including choice of target populations, duration, comparators and endpoints
• Integrate clinical, market, and payer data to prepare HTAs and product dossier in formats defined by payers and industry associations, e.g., AMCP, WellPoint
• Develop programs/materials for use by field staff that integrate information on product value to support strategies for optimizing revenues, reimbursement, and formulary positioning across all managed markets
Education and Experience:
• MD or PharmD; or Masters or PhD/ScD in a quantitative, health-related field—health services research, economics, epidemiology, statistics or business
• Minimum 8 years’ client- and/or consultant-side biopharmaceutical industry experience, including substantial experience supporting Phase III, peri-launch and launch strategy
• Experience working with payers and decision-makers on evidence-based customer strategies
• Experience demonstrating product value, including preparing AMCP dossiers and/or submissions to HTA agencies
• Experience making substantial contributions to commercial assessment, licensing & development, portfolio management, lifecycle planning, M&A evaluation and/or alliance management desirable
Other Qualifications:
• Proven track record of excellence in written and oral communication of complex technical information
• Strong collaborative style and persuasion skills to build consensus, effectively manage project teams, and achieve objectives
• Ability and willingness to travel up to 40%, primarily domestic
Contact Information: Interested candidates should forward resume and cover note to hr@dhelixc.com
12.19.2008
New short course - economic evaluation for health technology - Brazil
Location: Porto Alegre , Rio Grande do Sul, Brazil
Dates: 13-14 January 2009
Venue: University of Rio Grande do Sul (Universidade Federal do Rio Grande do Sul)
Course Organizers: Prof. Dr. Marcia Regina Godoy, Prof. Dr. Giacomo Balbinotto Neto, Prof. Dr. Ricardo Letizia Garcia
Language: Portuguese
Intended Audience:
Anyone undertaking or managing of health technology assessment, including in the context of cost-effectiveness analysis
The University of Rio Grande do Sul (UFRGS) is pleased to announce the short course "Economic Evaluation for Health Tecnology".
The short course will provide:
Background information on the theoretical basis for, & application of economic evaluation for health technology
a practical guide to data input, data analysis, and the interpretation of studies of health tecnology assessment (HTA) and economic evaluation for health tecnology
An overview of methodological issues and recent developments in the application of HTA
This short course will provide an opportunity for those interested in the application of HTA to discuss both practical and theoretical issues raised when applying the method. The short course will include group work sessions with feedback. No knowledge of economics or HTA is assumed
Contact us
If you would like to be considered for enrolment or would like to ask any questions regarding this short course, please send your e-mail to Claudia Gomes - claug@ufrgs.br
Home page: http://www.ppge.ufrgs.br/ats/minicurso.php
Dates: 13-14 January 2009
Venue: University of Rio Grande do Sul (Universidade Federal do Rio Grande do Sul)
Course Organizers: Prof. Dr. Marcia Regina Godoy, Prof. Dr. Giacomo Balbinotto Neto, Prof. Dr. Ricardo Letizia Garcia
Language: Portuguese
Intended Audience:
Anyone undertaking or managing of health technology assessment, including in the context of cost-effectiveness analysis
The University of Rio Grande do Sul (UFRGS) is pleased to announce the short course "Economic Evaluation for Health Tecnology".
The short course will provide:
Background information on the theoretical basis for, & application of economic evaluation for health technology
a practical guide to data input, data analysis, and the interpretation of studies of health tecnology assessment (HTA) and economic evaluation for health tecnology
An overview of methodological issues and recent developments in the application of HTA
This short course will provide an opportunity for those interested in the application of HTA to discuss both practical and theoretical issues raised when applying the method. The short course will include group work sessions with feedback. No knowledge of economics or HTA is assumed
Contact us
If you would like to be considered for enrolment or would like to ask any questions regarding this short course, please send your e-mail to Claudia Gomes - claug@ufrgs.br
Home page: http://www.ppge.ufrgs.br/ats/minicurso.php
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