CVS Health says PCSK9 inhibitors to cost US healthcare system $150 billion annually

CVS Health warned Tuesday that PCSK9 inhibitors, the first of which could be approved by the FDA in mid-2015, may cost the US healthcare system as much as $150 billion per year. The pharmacy chain operator suggested that the treatments for high cholesterol will be priced in the range of $7000 to $12 000 per year. Troyen A. Brennan, chief medical officer at CVS, noted that the therapies "pose a...complex financial dilemma since...PCSK9 inhibitors will be prescribed as ongoing maintenance therapy for the duration of patients' lives."

CVS said that estimates suggest the cost of these drugs could eclipse those of Gilead Sciences' hepatitis C drug Sovaldi (sofosbuvir) at its launch, adding that because PCSK9 inhibitors are biologics, lower-cost biosimilars may not be available for at least a decade.

The company also noted that while the first patients to be prescribed PCSK9 inhibitors are likely to be those with familial hypercholesterolaemia, the indications could be expanded to patient populations such as those who are intolerant or unresponsive to statins. Experts including Brennan and CVS chief scientific officer William Shrank indicated that the expanded use of these drugs could be supported by the findings of the IMPROVE-IT study, which illustrated that reductions in LDL cholesterol levels can lead to improvements in patient outcomes.

As such, CVS said that as many as 15 million people in the US could be considered candidates for treatment with PCSK9 inhibitors. "High cholesterol is one of the most prevalent conditions in the developed world and with primary prevention of high cholesterol as the eventual target for manufacturers, PCSK9 inhibitors will likely be the highest selling class of medications in history," remarked Shrank, adding "with a robust pipeline of expensive specialty drugs this is just the beginning, and the resilience and ability of our health care system to absorb such high costs will be tested if rigid cost control mechanisms are not put in place."

CVS executives indicated that carefully managed care oversight and compliance with clinical guidelines will be critical to controlling healthcare costs once PCSK9 inhibitors become available. They also stated that the availability of this new drug class should stimulate discussion on the use of resources and generate consensus in the healthcare industry concerning the pricing of new specialty treatments for large patient populations.

The drugmakers developing PCSK9 inhibitors include Amgen and a partnership between Sanofi and Regeneron. Last month, Sanofi and Regeneron's investigational PCSK9 inhibitor Praluent (alirocumab) was granted priority review by the FDA for the treatment of hypercholesterolaemia, while the agency accepted Amgen's experimental therapy evolocumab for review for the same indication last November (for related analysis, see ViewPoints: Sanofi/Regeneron succeed in plan to leapfrog Amgen in PCSK9 race – will they be willing to compete on price?).

For further analysis on the PCSK9 inhibitor class, see ViewPoints: Scrutiny of PCSK9 inhibitor competitive positioning set to increase. See also Spotlight On: Where will US payers strike next?

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