Risky business

How Amgen is approaching Repatha access post FOURIER data

Amgen Inc.’s proposal to increase access to cholesterol drug Repatha evolocumab will hinge on increasing medication adherence rates. In addition to continuing its existing adherence programs that use electronic alerts, the biotech hopes to take a page out of the playbooks of PBMs that have developed programs for HCV.

Data presented at the American College of Cardiology provided grist for Amgen to persuade payers to increase access to Repatha, and also put a fine point on the challenges it will face in doing so.

The company presented detailed results from the Phase III FOURIER cardiovascular outcomes trial, which showed a statistically significant 15% reduction in the relative risk of major adverse cardiovascular events, including hospitalization for unstable angina, coronary revascularization, heart attack, stroke or cardiovascular death (p<0.001).

Repatha also showed a 20% relative risk reduction on a secondary composite endpoint that consisted only of heart attack, stroke and cardiovascular death (p<0.001).

“We can only take a risk on the outcomes if the patients are adherent to therapy.”

Joshua Ofman, Amgen

Based on the data, the company has proposed to trade refunds for patients who have heart attacks or strokes for broader reimbursement of Repatha.

A different ACC presentation showed the size of the challenge.

Amgen’s retrospective analysis showed prescriptions were initially rejected for 79.2% of 45,029 patients prescribed a PCSK9 inhibitor between August 2015 and

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