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BIO Statement: Institute for Clinical and Economic Review Framework

September 11, 2015
This week, the Institute for Clinical and Economic Review (ICER) released its Value Assessment Framework.

While we welcome a robust discussion on the value of treatments and cures, we have concerns with ICER’s methodology, which has not been validated, and preliminary conclusions which underestimate the value of innovative new medicines.

We believe that the most important priority is to empower patients with information that will be helpful in clinical decision-making with their healthcare providers, and we do not believe that the framework will serve this purpose.  Nor does the framework assess the barriers insurers place on patients trying to access these therapies.

The value assessments outlined in the framework are based on timeframes that are too short to produce meaningful and accurate assessments for a serious disease like CVD and therefore undervalue the benefits of new medicines to patients and the overall healthcare system.

Our industry holds the greatest promise for transforming patient care through next-generation biopharmaceutical innovation.

Many patients already reap tremendous value from breakthrough cures and treatments addressing debilitating and, often times, life-threatening diseases. An approach like this framework risks limiting access to novel therapies targeted to patients who have not been adequately served by existing medicines (and discourages the development of new treatments and cures.

We look forward to providing feedback and continuing the discussion on how to improve patient care and ensure access to life-saving and life-enhancing treatments and cures.