The FDA has programs in place to focus on the development and designations for new specialty drugs. The problem is that high prices are being paid for drugs that don’t come with a graded, tested and proven high outcomes guarantee.
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.
The comparison of infused therapy versus oral therapy adherence rates is difficult, yet efficacy and value derivation are critical to ensuring the long term health of the entire continuum, regardless of delivery method.
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 therapies that are still in the process of proving their efficacy?
An interesting new idea regarding the pricing of oral therapy medications has come from a healthcare industry expert who has suggested that the 21st Century Cures Act needs a clause that would put a cap on the price of new drugs being brought to market through the FDA.
This is value-based sensibility that the continuum should embrace and Congress should include within the 21st Century Cures Act not only because of the lack of certainty around the economics and outcomes data involved, but more importantly because it aligns all parties.
This could work as a win-win-win: patients and providers could benefit from improved access to new therapies and payers could benefit by not being the only ones to bear 100% of the risk of inefficacy.
To read more about factors affecting specialty drug costs, visit Managed Healthcare Executive.
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