Germany's IQWiG prepares to test new cost-benefit methodology

The German health technology assessment institute, IQWiG, plans to begin testing the
latest version of its cost-benefit assessment methodology for medicines towards the end of September. The results of the testing, which will last for about four months, will be keenly awaited by pharmaceutical companies because IQWiG's assessments will be used to set ceiling reimbursement prices for new drugs reimbursed by the health insurance bodies. Previously, IQWiG (the Institute for Quality and Efficiency in Healthcare) assessed only the clinical benefits of medicines, but under last year's healthcare competition reform law it now also has to consider the costs of therapies in relation to their benefits. To do this it has had to draft a cost-benefit methodology. A first version was put out for public consultation earlier this year, and drew many comments from stakeholders. Some were critical of the proposed methodology, particularly the "efficiency frontier analysis" that IQWiG plans to use as the basis of cost-benefit assessments (Scrip Online, April 8th,
2008). The US industry body, PhRMA, for example, said that while the efficiency
frontier was "a theoretically sound concept", it was not clear whether it would work in practice.
IQWiG claims that efficiency frontier analysis can be "used in a very flexible manner to compare the cost-benefit relation of any number of therapy alternatives". The graph produced using this analysis shows clearly which existing therapies are efficient and those that are not, it said. For drugs that are more beneficial but more expensive than those already in use, it will be possible to determine where their price would have to lie so that the cost-benefit relationship falls within the accepted efficiency range, it added.

Pricing and cost assessment
IQWiG's new methodology will help the central federal association of health insurance
funds to determine an appropriate ceiling price for drugs that are reimbursed by the
statutory health insurers but cannot be included in a reference price group, according to the institute.
If the price suggested by the manufacturer was higher than this ceiling, the manufacturer could choose whether or not to lower its price. If it did not, the patient would have to pay the difference or opt for another product. The institute's assessment will also include a budget impact analysis that can be used in estimating how a decision may affect expenditure in the healthcare system as a whole.


IQWiG said it expects to publish the next version (1.1) of the methodology at the end of September. This version will not specifically take into account the comments received, but will "clarify aspects that were misunderstood in version 1.0".
Simultaneously, the institute plans to publish a "scientific reply" to the comments, as well as the comments themselves and three additional technical documents. The
comments will be incorporated into version 2.0, which is expected to be published in
March 2009, again for public consultation. Once this consultation is complete, version 3.0 will be published, although the institute could not say at this stage when this might be.

VFA uploads comments
In the meantime, the R&D-based industry body, the VFA, has published on its own
website some of the comments sent to IQWiG on the proposed cost-benefit methodology. The VFA decided to do this in the interests of "transparency" and to allow interested parties to "play a role in the development of a future cost-benefit evaluation of medicines", said its director, Cornelia Yzer.

SCRIP - World Pharmaceutical News -
www.scrippharma.com FILED 27 August 2008 COPYRIGHT Informa UK Ltd 2008


Health Economics Position in Europe: Director of Market Access, Pricing and Reimbursement in Belgium

Dear Readers,

please find below job posting that just came in. Interested individuals please contact Michael Lister (contact details below).


Location: Belgium

The Client is a late-stage biomedical company and operates at the cutting edge of regenerative medicine and focuses on the development of innovative local treatments for damaged and osteoarthritic joints.

Major Accountabilities:

• To set up and maintain lead contacts and relationships at government authority level and develop plans to gain support and market access for company products
• To develop pricing and reimbursement strategies to ensure a premium price and favorable reimbursement on an on-going basis
• To provide tools to facilitate the negotiation process with payers.
• To respond to inquiries and to ensure implementation of specific access and reimbursement programs and their proper resolution
• To coordinate and manage external pricing & reimbursement consulting projects

Requirements for the Job:
• Experience in pharmaceutical and/or healthcare industry with experience in reimbursement, health economics, public policy, strategy development.
• Ideally direct in-depth experience of at least 1 EU reimbursement environment. General familiarity with the European reimbursement environment is essential.
• Past involvement in producing P&R tools (Core Value Dossier)
• Languages: Fluent English a must, Dutch and/or French useful, any other major European language a plus.

Michael Lister
Virdis House
Bishops Mews
Transport Way
Oxford, OX4 6HD, UK
Mobile: +44 (0) 7825 541499
Tel: +44 (0) 1865 770033
Fax: +44 (0) 1865 711776



Senators Propose Nonprofit Institute to Study Comparative Effectiveness

published in "Quality"

Democratic Senate leaders July 31 introduced legislation that would create a comparative effectiveness institute dedicated to researching and disseminating information about which health care treatments work best, without evaluating cost or health plan design factors.
The proposed Comparative Effectiveness Research Act of 2008 (S. 3408) would establish the Health Care Comparative Effectiveness Research Institute, a private nonprofit corporation that would study which medical treatments--including surgeries, pharmaceuticals, and medical devices--have the best clinical outcomes.

"Doctors and patients need reliable, unbiased information about the effectiveness of treatments to determine the best care possible, but right now that data is scarce and unorganized," Sen. Max Baucus (D-Mont.), chairman of the Senate Finance Committee, said in a statement. "This bill will advance the process of reviewing and producing valuable information and making it available to health care providers, and to all Americans."

Baucus introduced the bill, along with Sen. Kent Conrad (D-N.D.), chairman of the Senate Budget Committee. Conrad said that with the research generated by the institute "patients and their doctors can make better decisions on treatment--meaning we could lower costs and improve health care outcomes."

The institute would be funded by both private and public entities through the creation of a Comparative Effectiveness Research Trust Fund (CERTF). If the legislation is enacted, total funding for the institute would exceed $300 million after five years, according to a Finance Committee summary of the bill.

Insurers and industry groups Aug. 1 weighed in with support for the proposed legislation, saying it is a needed first step in improving the heath care system.

Institute Structure, Responsibilities

The institute would be responsible for establishing research priorities based on the need for better evidence, the burdens of a particular disease, practice variations, the potential for improved care, and the expenses associated with a given condition or care strategy, according to the summary.
The research itself would be conducted by both public and private entities, which would be approved by the institute's board of governors. The research would be peer-reviewed and include systematic reviews, observational studies, clinical trials, and randomized controlled trials.

The board of governors would include 18 public and private stakeholders, as well as the secretary of the Department of Health and Human Services, and the directors of the Agency for Healthcare Research and Quality and the National Institutes of Health.

The institute also would establish an expert methodology committee responsible for developing standards for any research the institute uses. The committee would also be responsible for studying whether cost and health plan design could eventually be incorporated into comparative effectiveness research.

Although the institute would not take costs and health plan design into consideration, a future Congress could incorporate those factors into the research, according to the Finance Committee's summary.

The institute would be required to establish public comment periods, allowed to establish additional advisory committees, and encouraged to study the differences in clinical outcomes for patient subgroups, such as racial and ethnic minorities, according to the committee summary.

Funding for the institute would come from general revenues, the Medicare Trust Funds, and from fees assessed on health plans. The Medicare Trust Funds would contribute $1 per beneficiary annually and health plans would be assessed $1 per-covered-life annually, according to the committee summary.

Industry Reactions

Insurers and other industry groups applauded the intent of the legislation, with some emphasizing the importance of excluding cost-effectiveness analyses from the research.
The Advanced Medical Technology Association (AdvaMed), device industry group, said it is pleased that, although the bill does allow for the study of cost-effectiveness, it does not authorize such study as a part of the institute's research.

"As Congress considers comparative effectiveness legislation, we believe safeguards should be included to ensure that the final determination of what treatment option works best for each patient should be made by individuals and their physicians," Stephen J. Ubl, president and chief executive officer of AdvaMed, said in a statement. "It is also essential that research recognize the unique iterative nature of device innovation when establishing research priorities and conducting studies."

The Pharmaceutical Care Management Association--which represents pharmacy benefit managers--and the Pharmaceutical Research and Manufacturers of America (PhRMA)--which represents drug manufacturers--also voiced their support for the bill, as did the Blue Cross and Blue Shield Association.

In an Aug. 1 statement, PhRMA Senior Vice President Ken Johnson said the drug industry group "supports the development and use of high-quality evidence, including comparative clinical effectiveness evidence, for healthcare decision-making. Proposals to expand government-supported comparative clinical effectiveness research should be structured to promote better patient health and timely patient access to needed therapies, and avoid denying or delaying patients' access to beneficial care, as what often occurs in Europe and Australia."

Scott P. Serota, president and chief executive officer of the Blue Cross and Blue Shield Association (BCBSA), said in a statement, "To improve tomorrow's healthcare coverage we need to change the incentives in today's healthcare system." Serota added that comparative effectiveness research "will empower patients and providers by providing information on quality and value, and improve safety and affordability of healthcare for everyone."

America's Health Insurance Plans also issued a statement commending the bill's introduction. The organization has previously indicated its support for including cost considerations in comparative effectiveness research (96 HCDR, 5/19/08 ).

"Senators Baucus and Conrad took an important step by introducing legislation to create an independent entity to give patients and their doctors the information they need to make health care decisions based on safety, effectiveness, and value. We believe this is the right time for this proposal and pledge to work with the Senators to advance comparative effectiveness legislation," Karen Ignagni, president and chief executive officer of AHIP.

The bill was referred to the Senate Finance Committee.

The text of the bill is available at http://finance.senate.gov/sitepages/leg/LEG%202008/080108%20Comparative%20Effectiveness%20Leg%20text.pdf.

A section-by-section summary of the bill is available at http://finance.senate.gov/sitepages/leg/LEG%202008/080108%20CE%20Section-by-Section.pdf.