- PCSK9 inhibitors, novel injectables in development by Amgen, Pfizer, Sanofi and Regeneron, will bring a new level of effectiveness in the quest to lower cholesterol in hard-to-treat patients—but CVS is already saying that it won't pay full price.
- CVS Health Corp. is the second largest pharmacy benefits manager (PBM) in the U.S., with about 27% of the market. Express Scripts is the largest PBM and has about 30% of the market, and has also said that PCSK9 inhibitors will be targeted for price cuts (in the wake of the company's stunning deal for AbbVie's hep C regimen Viekira Pak).
- Although PCSK9 inhibitors are still under development, it is very likely that one or more will be FDA-approved within the year. CVS claims that estimated costs are in the $7,000 to $12,000 range per year and that total costs will reach $150 billion per year. That figure is considerably higher than any industry estimates—in fact, it's about seven times the figure that analysts have been touting.
The link between high cholesterol and cardiovascular events, including heart attack, is well established. What's more, there are roughly 620,000 Americans who have a form of hypercholesterolemia caused by a genetic variation that is recalcitrant to treatment. This is the group most likely to benefit from PCSK9 inhibitors, which have an unprecedented level of effectiveness.
In fact, in clinical trials, alirocumab, co-developed by Regeneron and Sanofi, helped 10 times as many high-risk, statin-averse patients with hypercholesterolemia as Merck's Zetia (ezetimbe)—the first non-statin drug used to lower cholesterol.
However, like other specialty classes, PCSK9 inhibitors are being targeted by PBMs for being too expensive. With Gilead's Sovaldi and AbbVie's Viekira Pak as high-profile examples, PBMs are determined to start discount negotiations early—while drugs are still in clinical development and under regulatory consideration.
But is CVS over-playing its hand early on here? Some have suggested that, in order to get to the PBM's $150 billion PCSK9 estimate, you'd have to assume that PCSK9s penetrate a massive portion of the current statin market, which isn't really what the drugs are intended to do.