ICER Launches Drug Assessment Program for New FDA-Approved Drugs

With drug prices for cancer, heart disease and many other conditions soaring to new highs, the Institute for Clinical and Economic Review (ICER) today announced an initiative to transform the way new drugs are evaluated and priced in the United States.

Funded by a $5.2 million grant from the Laura and John Arnold Foundation (LJAF), ICER will produce public reports on new specialty drugs near the time of FDA approval, with 15 to 20 reports planned in the first two years. The reports will include a full analysis of the drugs’ comparative effectiveness, cost-effectiveness, and potential budget impact. In addition, ICER will calculate a benchmark price for each new drug anchored to the real benefits the drug brings to patients.

ICER will issue its first two reports in September 2015. The first will evaluate PCSK9 inhibitors for cholesterol, and the second will assess Entresto™ (Novartis AG), a new drug to treat heart failure. Some experts have estimated that PCSK9 inhibitors alone could cost the health system more than $100 billion per year if all eligible patients are treated.

The reports will help payers, policymakers and other healthcare stakeholders assess the true value of drugs, and ensure excellent drugs get to market quickly at a price that is affordable to patients and the health system, without hindering the development of new and effective drugs.

Read more about the program and sign up for updates here:

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Scoping Document for ICER Review of PCSK9 Inhibitors Posted for Public Comment

The Institute for Clinical and Economic Review (ICER), has posted a draft scoping document that will inform a report on therapies for management of high cholesterol. The report will form the basis of the next public meeting of the New England Comparative Effectiveness Public Advisory Council (CEPAC), a core program of ICER. ICER’s report for CEPAC will examine the evidence on the comparative clinical effectiveness and value of drug therapies for managing high cholesterol, including review of the emerging class of drugs for this condition, PCSK9 inhibitors. The scoping document will be open to public comment for one week.

Please submit suggested refinements or additions to by 5PM on Tuesday, July 14. Comments should adhere to guidelines described in the public comment guide. 

Read ICER’s full announcement here.

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ICER Report Presents Evidence-based Guidance to Support Integration of Behavioral Health into Primary Care

Boston, Mass., June 2, 2015 – The Institute for Clinical and Economic Review (ICER) has posted the final report Integrating Behavioral Health into Primary Care and its accompanying action guides and policy brief to the CTAF and CEPAC websites. The report evaluates the evidence on the comparative clinical effectiveness and value of efforts to integrate behavioral health into primary care settings as well as providing guidance on how to apply that evidence in the real world.

Read the full press release here. 

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