Amgen puts Repatha outcomes data to work in refund deal with Harvard Pilgrim

Amgen signed a first-of-its-kind refund deal on Repatha with Harvard Pilgrim on Wednesday.

On the heels of highly anticipated cardiovascular outcomes data for PCSK9 med Repatha, Amgen has signed a money-back guarantee with Harvard Pilgrim. Through the first-of-its-kind contract, if a patient on Repatha has a heart attack or stroke, the drugmaker will provide a full refund.

As the partners note, it’s a novel contract based on data from Amgen’s Fourier study, presented in March at the American College of Cardiology in Washington, D.C.—and if Amgen has its way, it will be the first of many.

That study showed that Repatha cut heart attack risks by 27% and stroke risks by 21% over a two-year period. Together, patients saw a 19% risk reduction against heart disease and stroke in the first year and 33% afterward, SVP of global development Elliott Levy explained at the time.

Still, the drug’s performance against its primary endpoint, a composite measure, and against cardiac death risks prompted concern from analysts, pricing experts and investors. Since then, Amgen reported a quarter-over-quarter sales decline for its important launch—which the company attributed to a fourth-quarter sales tender that didn't repeat in the first quarter—and now it’s working to build demand to overcome payer resistance to its $14,000 list price for Repatha.

RELATED: Did Amgen's Repatha cut CV risks enough to make it cost-effective? Analysts say no

The deal with Harvard Pilgrim builds on a previous pay-for-performance contract signed by the companies back in 2015. In that exclusive arrangement, the two agreed on specific cholesterol targets for various patient groups, and if Repatha doesn't help patients hit those goals, the insurer can collect additional rebates.

Harvard Pilgrim provides health coverage for about 2.7 million patients in the northeastern U.S., according to Wednesday’s release.

Amgen’s willingness “to go at financial risk for patients with elevated LDL-C levels who are adherent to Repatha and suffer cardiovascular events shows that they are willing to stand by their data,” Harvard Pilgrim CMO Michael Sherman, M.D., said in the statement.

And in what might be a nudge to the health plan's payer peers, Sherman added that the Repatha deal “sends a strong positive message to health plans, prescribing physicians and patients.”

RELATED: Amgen scores PCSK9 exclusive in pay-for-performance deal with Harvard Pilgrim

As payers have ratcheted up the pressure against pricey new drug launches in recent years, drugmakers have turned to creative contracting as one way to secure coverage. Along with competitor Sanofi with its PCSK9 option Praluent, Amgen also has a Repatha outcomes-based deal with Cigna. The drugmakers will provide bigger rebates if their drugs don’t deliver in that deal.

RELATED: Amgen strikes Enbrel 'outcomes' contract with Harvard Pilgrim

The California big biotech continues to work on new pay-for-performance deals. “We look forward to partnering with other payers to create similar outcomes-based contracts for Repatha,” Joshua J. Ofman, M.D., Amgen’s SVP of global value, access and policy, said in the Wednesday statement.

Elsewhere in its portfolio, Amgen recently teamed up with Harvard Pilgrim for an outcomes contract on rheumatoid arthritis blockbuster Enbrel, providing discounts based on an “effectiveness algorithm.”

That deal, which was touted as a first-of-a-kind arrangement upon its announcement in February, looks at compliance, dose escalation, switching or adding drugs and steroid interventions.