- The RepathaReady patient-assistance program offers patients financial asssistance for the expected blockbuster Amgen cholesterol drug, but requires full disclosure of a lot of personal health information, which is then freely available to Amgen and unspecified third parties. Pharmalot reports that critics are pushing back.
- Repatha (evolocumab) is a PCSK9 inhibitor that treats refractory or familial hypercholesterolemia. It costs $14,100 per year.
- Although critics have not outright accused Amgen of breaking privacy laws, the rules of engagement for the program have raised eyebrows and are a source of concern, spurring a review.
Part of Amgen's decision to review the privacy may be spurred by the fact that assistance programs offered by Sanofi/Regeneron for Praluent (alirocumab), a competing PCSK9 inhibitor, don't require as much information and have privacy parameters.
Title 2 of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 entitles patients to security and privacy of their private health information. This program seems to be on the threshold of potentially compromising HIPAA laws. Currently, Amgen is looking closely at its patient assistance program and reconsidering the privacy component.