Outcomes, Access, and Cost Issues Involving PCSK9 Inhibitors to Lower LDL-Cholesterol
The clinical importance and benefit of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors appears well established for the high-risk cardiovascular (CV) patient. This applies especially to the statin-intolerant patient or the patient who does not attain an appropriate low-density lipoprotein cholesterol (LDL-C) target. Therefore, the barriers to appropriate clinical use of the PCSK9 inhibitors involve cost and not the documented CV benefit or LDL-C lowering. Multiple roadblocks affect many high-risk CV patients in arranging approval of a PCSK9 inhibitor. Overcoming these roadblocks may require legal pressures, some increased regulation, and facilitation by competitive forces.
The author thanks Colleen McMullen, MA, MBA, for her excellent editorial critique.
Compliance with Ethical Standards
Conflict of interest
The author confirms that he has no conflict of interest involving any pharmaceutical or medical device company or any other possible conflict.
- 8.FDA approves Amgen’s Repatha (evolocumab) to prevent heart attack and stroke. 2017. http://www.amgen.com/media/news-releases/2017/12/fda-approves-amgens-repatha-evolocumab-to-prevent-heart-attack-and-stroke/. Accessed 18 Dec 2017.
- 15.Caffrey M. Rival PCSK9 makers cut prices to get approval from UK health service. AJMC.com Managed Markets Network. 2016. http://www.ajmc.com/newsroom/rival-pcsk9-makers-cut-prices-to-get-approval-from-uk-health-service. Accessed 3 July 2017.
- 16.Elgin B, Langreth R. How big pharma uses charity programs to cover for drug price hikes. Bloomberg Business Week. 2016. https://www.bloomberg.com/news/articles/2016-05-19/the-real-reason-big-pharma-wants-to-help-pay-for-your-prescription. Accessed 3 Jul 2017.
- 19.Alliance for Patient Access. 2017. https://www.guidestar.org/profile/20-5130312. 13 Oct 2017.
- 35.Tu HT, Samuel DR. Limited options to manage specialty drug spending. Res Brief. 2012;22:1–13.Google Scholar