- Recent results published in JAMA showed that treating all qualified Americans (under the current labels) with PCSK9 inhibitors was not cost-effective, compared with other treatment options.
- The analysis by Dr. Dhruv Kazi and his colleagues was driven by two major assumptions: the average cost of the two FDA-approved PSCK9 drugs, Amgen's Repatha (evolocumab) and Sanofi/Regeneron's Praluent (alirocumab), was defined as $14,350 per year, and a total of nine million Americans were deemed qualified for treatment with these drugs.
- Based on these assumptions, the analysts concluded that treating the entire eligible population with PCSK9 inhibitors is not a cost-effective proposition. The analysts concluded that in order to be cost-effective, the PCSK9 inhibitors would have to have an annual cost of $4,536.
Shortly after the exuberant headlines from last summer hailing the approval of new treatments for almost-impossible-to-treat hypercholesterolemia were written, the reality for the PSCK9 inhibitor market set in. That reality dictated that uptake would be considerably slower than expected driven by insurers' conservatism and six-month review processes, as well as physicians' concerns about prescribing either Praluent or Repatha on top of a statin when other options might be just as effective.
When Praluent and Repatha finally made it onto formulary, there was heavy wrangling and discounting involved, with Amgen and Sanofi/Regeneron giving major price concessions to payers in order to have a shot at gaining market share. Payers also used competition between the two PSCK9 products to procure additional discounts.
In short order, UnitedHealth opted to cover Praluent; CVS Health chose to cover Repatha and Express Scripts and Cigna said that they would cover both. In all cases, there were numerous criteria outlined, including pre-authorizations.
In the last year, the general contention among payers and physicians has been that many fewer patients than originally anticipated need PCSK9 inhibitors to control their cholesterol levels, especially considering the availability of generic Zetia and high-potency statins, along with lifestyle changes.
The JAMA analysis found that patient costs for PCSK9s were about $503,000 per year based on quality of life year gained per treated patient, while treatment with Zetia and add-on statins resulted in costs of about $413,000 annually —further damning the closely-watched drugs.
The major game-changer for these two drugs, of course, is the availability of cardiovascular outcomes data that could show the drugs provide protection against heart problems —unfortunately, that data isn't due out for another 12 to 18 months. In the meantime, these blockbuster hopefuls are now just disappointments.