- The Pharmaceutical Research and Manufacturers of America (PhRMA), the major pharma trade association, this week publicized four pointed recommendations to the Institute for Clinical and Economic Review, continuing its pushback against the research organization's methodology for valuing new drugs.
- "Frameworks that are not well-constructed or are misused put patient access and continued innovation at risk." PhRMA said, referring to ICER's approach.
- Over the past year, ICER has published several cost-effectiveness studies examining the prices and value of several categories of drugs, including treatments for hepatitis C, high cholesterol and multiple myeloma. Drugmakers have argued ICER's reviews are driven by the interests of insurers, among other critiques.
ICER's studies, some of which have judged certain drugs to be overpriced, have certainly hit a nerve inside the pharma industry. A number of drugmakers, including Bristol-Myers Squibb and Amgen, have published rebuttals of ICER's review of their drugs, and PhRMA has added its powerful voice to the backlash.
This past summer, ICER issued a national call for stakeholder feedback into its drug value frameworks. But in August, the Institute went on the offensive, publishing a lengthy rebuttal to many of the accusations laid against it.
In response to the call for feedback, PhRMA sent a letter outlining proposals to push ICER's methods in what it called a "methodologically rigorous, patient-centered direction.”
Among PhRMA’s recommendations:
- Development of a “transparent, dynamic ratings system” and removal of value-based benchmarks — one of the mainstays of ICER's analyses — from all evidence reports.
- Suspension of budget impact estimates until methods are improved.
- Changing the cost-effectiveness component of ICER review to better reflect limitations in quality-adjusted life years measurements.
- Greater transparency into how ICER works with stakeholders.
ICER has said it plans to update its framework and beginning using an improved version by January 2017. Given the continued furor over rising drug prices, its likely that third-party value analyses will still draw signficiant interest, however.