July 1, 2016 - Curant Health COO, Marc O'Connor, in Managed Healthcare Executive - Currently FDA provides an array of expedited programs and designations for specialty drugs and biologics intended to facilitate and expedite development and review of new specialty drugs to address unmet medical need in the treatment of a serious or life threatening condition: fast-track designation, breakthrough therapy designation, accelerated approval, and priority review designation. While admirable in many regards, the program has generated a situation where exorbitant prices are being paid for therapies well in excess of $100,000 per year when definitive proof of their clinical effectiveness and associated value is questionable at best.
The Institute for Clinical and Economic Review (ICER) evaluates evidence on the value of medical tests, treatments and delivery system innovations. Most recently, ICER reported its analysis of new drugs for multiple myeloma showed they were severely overpriced compared to their cost-effectiveness.
While it is significantly more difficult to ensure adherence to oral therapies versus infused therapies, efficacy and value derivation to both are critical to ensuring the long term health of the entire continuum regardless of delivery method.
For a small set of new cancer drugs, accelerated approval of breakthrough therapies could mean a $600 million bill for payers and patients for therapies that provide only hope, not an established expectation for extension of life, remission or cure. With access already highly limited to proven curative agents for hepatitis C, and a frightening dearth of new antibiotics in the pipeline, how will we pay for the next breakthrough cure when the healthcare system is already taxed with high-dollar specialty drugs that are still in the process of proving their efficacy?
To read Marc's full article, visit Managed Healthcare Executive.
To learn more about Curant Health, contact Kristin Lindsey, Senior Marketing Director, at klindsey@curanthealth.com.