- Uptake of the PSCK9 drugs Repatha and Praluent (marketed by Amgen and Sanofi/Regeneron, respectively) has been unexpectedly slow post-launch and is not expected to accelerate until there is convincing outcomes data available.
- Although uptake is being held back by payers, who have implemented tough prior authorization rules and have a standard six-month window before adding a drug to formulary, physicians are also skeptical.
- The sticking point for physicians is not only the $14,000 annual price of the therapies, but also the fact that there is no outcomes data available yet to demonstrate how these drugs' huge impact on LDL-C levels translates in terms of real-world outcomes.
When the PCSK9 inhibitors were approved last year on the strength of data showing LDL-C reductions of roughly 60%, hopes were high that the drugs would be rapidly brought into clinical practice as a way to treat patients who are either intolerant of statins or have refractory, hard-to-treat hypercholesterolemia.
That has not been the case. Instead, Repatha and Praluent were launched into a rapidly changing landscape in which payers are reining in use of high-cost products in lieu of cheaper alternatives. And doctors have been slow to the party, too.
The problem is not only the price, but the lack of outcomes data. Recently, the IMPROVE-IT trial, which evaluated the impact of Merck's Zetia and Vytorin on cardiovascular (CVD) outcomes, produced under-whelming results. Doctors are taking a wait-and-see approach in order to better understand what impact the PCSK9 drugs have on the risk of heart attack, stroke, and CVD-related death.
Even if the results are good enough to justify the pre-discount pricing, the first chunk of data won't become available until the end of the year, and the complete dataset is at least one to two years away.