Despite CV benefit, Amgen still facing challenges over Repatha cost

Dive Brief:

  • Amgen continues to face pushback on the cost of its pricey PCSK9 inhibitor Repatha (evolocumab), even after its FOURIER outcomes study demonstrated the cholesterol drug's cardioprotective benefit.
  • In light of the new outcomes results, the Institute for Clinical and Economic Review (ICER) updated its 2015 review of the PCSK9 class, upgrading Repatha's clinical effectiveness rating for patients with atherosclerotic cardiovascular disease uncontrolled by statins alone to "comparable or better."
  • But ICER, a looked-to research group on drug costs, expects to issue a revised and lower value-based price benchmark for Repatha in the coming months because the drug failed to show a statistically significant mortality benefit in FOURIER. The conclusion could add further weight to claims Repatha is too expensive.

Dive Insight:

Repatha, along with Sanofi and Regeneron's rival PCSK9 Praluent (alirocumab), has proven to be dramatically effective at further lowering LDL-C levels in high-risk patients already on maximum statin therapy. Despite the benefit, uptake has been slow as payers have pushed back on the drugs' high list prices (roughly $14,000 a year).

Payers have set up strict utilization management criteria and pushed for higher discounts on the drugs. Research highlighted by Amgenhas shown nearly 80% of claims for Repatha coverage across commercial and Medicare plans were initially rejected.

In FOURIER, Amgen demonstrated Repatha lowered a composite of cardiovascular risks, including heart attack, stroke and other related events, by 15% — meeting the study's primary endpoint. On a more narrow basis looking at just cardiovascular death, heart attack or stroke, treatment with Repatha reduced risk by 20%.

While the benefit on those measures was clear, the drug failed to show a statistically significant effect on cardiovascular death and the magnitude of relative risk reduction was lower than some had hoped to see.

With FOURIER data in hand, Amgen has offered money-back guarantee to payers who ease restrictions, saying it will fully refund the drug's cost if a patient is hospitalized with either a heart attack or stroke. New England-based insurer Harvard Pilgrim was the first to take up Amgen's offer.

Still, ICER's report could put a further squeeze on Amgen to demonstrate Repatha's cost-effectiveness.

ICER's initial study suggested a benchmark price of $5,404 to $7,735 for annual treatment with PCSK9 inhibitors, assuming a mortality benefit. With the results showing no statistical improvement on that metric, ICER now expects to issue a lower value-based price benchmark for Repatha in the forthcoming second part of its 2017 update.

Amgen pushed back on ICER's conclusions in a statement: "In its report ICER failed to acknowledge the important point that none of the lipid-lowering studies comparing more versus less intensive LDL-C lowering, conducted over the last decade, have shown significant cardiovascular mortality benefit."

ICER has issued a number of reports calling for lower drug prices on to meet its thresholds for cost effectiveness, covering therapeutic classes such as the anti-PD1 drugs, treatments for multiple sclerosis, and rheumatoid arthritis therapeutics.

Unsurprisingly, these reports aren't well received by the drug industry, with major trade lobby PhRMA and individual drugmakers lobbing pointed criticisms of ICER's methodologies. ICER has responded in kind, releasing detailed rebuttals to the industry's complaints.

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Filed Under: Regulatory / Compliance
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