Study Finds PCSK9 Inhibitors Are “Still Too Pricey”

Annual list costs need to drop dramatically to meet cost-effectiveness thresholds

New research published online has found that evolocumab (Repatha, Amgen, Inc.) would need significant price reductions in order to meet a measure of cost-effectiveness for certain patients—even when taking into account the proven cardiovascular benefit of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor shown in Amgen’s FOURIER outcomes trial.

In the study's simulation, adding evolocumab to statin therapy for all eligible U.S. adults would prevent nearly 2.9 million more major cardiovascular adverse events than the pairing of the commonly used ezetimibe with statins. Yet evolocumab’s annual list cost would need to come down by 71% to meet the cost-effectiveness threshold used by the study's authors.

Amgen has faced pushback from payers on the relatively high annual cost of evolocumab (roughly $14,000 a year), and both evolocumab as well as a rival PCSK9 inhibitor, alirocumab (Praluent, Sanofi/Regeneron Pharmaceuticals), have struggled to gain traction on the market despite superior efficacy in lowering low-density lipoprotein-cholesterol (LDL-C), according to a recent BioPharma Dive article.

The slow starts for both PCSK9 inhibitors reflect both the tightening pricing environment in the U.S. as well as the state of the current cholesterol-lowering market. Statins—previously blockbuster branded products—are now generic and cheap, making it more difficult for the PCSK9 drugs to stand out on their LDL-C–lowering abilities alone. Cost analyses continue to highlight the cost of evolocumab and alirocumab as a potential hurdle, the article states.

The latest study, published as a research letter in the Journal of the American Medical Association, updated a previous 2016 analysis to reflect the impact of the FOURIER results on the cost-effectiveness of evolocumab and the PCSK9 class more broadly.

Looking only at patients with atherosclerotic cardiovascular disease who are already taking statins, the current average annual list price for PCSK9 inhibitors exceeded the study's targeted threshold of $100,000 per quality-adjusted life year (QALY)—a commonly used, if controversial, benchmark.

"The 71% price reduction required to make PCSK9 inhibitor therapy cost-effective is greater than the 25% to 30% discounts typically offered by manufacturers," the study authors wrote, citing a March article from Reuters, which reported that Amgen sells evolocumab at a discount of about 30% to its annual list price.

Amgen disputes the finding, highlighting that list prices don't reflect the average net cost payers end up paying.

"Several published analyses have shown value-based price ranges that support our current average net selling price, which has been incorporated in several value-based arrangements with payers," Amgen said in an emailed statement to BioPharma Dive. "Key differences that need to be considered are real-world event rates and value for patient life years in the U.S."

Sales of evolocumab totaled $83 million in the second quarter, $60 million of which was earned in the U.S. market. The FDA is expected to decide by early December on whether to update evolocumab’s label to include the FOURIER results—a potential competitive advantage that could boost sales. An expanded label would allow Amgen to market the drug's cardiovascular benefit directly to physicians and patients.

In comparison, alirocumab pulled in only $26 million in U.S. sales last quarter, hampered by "significant payer utilization management restrictions," the article said.

Amgen has conducted its own cost-effectiveness study in partnership with cardiologists and expects the results to be published soon.

Source: BioPharma Dive; August 22, 2017.