March 25, 2017


Risky Business

By Erin McCallister

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 July 2016. Only 47.2% of prescriptions were subsequently approved, and only 30.9% of initial prescriptions were dispensed.

A second analysis of 44,234 prescriptions showed 83% of claims were initially rejected. This analysis looked for but did not find any major clinical characteristics linked to the rejections, suggesting inconsistency in the ways prior authorization criteria were applied.

Also in the challenge category was a presentation from Amgen and Quintiles IMS Holdings Inc. that showed poor adherence. The biotech’s money-back offer would be limited to patients who remain on both Repatha and concomitant cholesterol lowering drugs as prescribed.

The analysis of QuintilesIMS’s longitudinal prescription claims database showed that among 4,853 patients who initiated treatment with a PCSK9 inhibitor between August 2015 and January 2016, adherence was just 57%.

“We can only take a risk on the outcomes if the patients are adherent to therapy, so we’ll be measuring adherence and making sure patients are maintained,” said Joshua Ofman, SVP of global value, access and policy at Amgen.

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