Amgen Signs Outcomes-Based Contract for Repatha

The agreement is based on the results from the FOURIER trial presented recently at the American College of Cardiology Scientific Sessions.

In March, when cardiovascular outcomes results were presented for evolocumab (Repatha) at the 66th Scientific Sessions of the American College of Cardiology (ACC), manufacturer Amgen announced a first-of-its-kind offer: the company would pay a refund for all eligible patients who had a heart attack or stroke while taking the cholesterol-fighting injection.

This week, Amgen announced that that health services company Harvard Pilgrim has taken the deal. The company, which covers 2.7 million people centered in New England, has signed an outcomes-based contract that some call groundbreaking and others say don’t address the high price of the drug, which lists for more than $14,000 a year but reduces low-density lipoprotein (LDL) cholesterol by 60%.

“Amgen is committed to combating cardiovascular disease, one of the largest public health concerns in the world, and our value-based partnership with Harvard Pilgrim further demonstrates our confidence in the significant value that Repatha can bring to patients, payers and society,” Joshua J. Ofman, MD, MSHS, senior vice president of Global Value, Access and Policy at Amgen, said in a statement.

“Given the urgency to reduce LDL cholesterol in patients at high risk of cardiovascular events, we value our relationship with leading health plans like Harvard Pilgrim who have worked with us to refine their utilization management criteria to accelerate access for their high-risk patients. We look forward to partnering with other payers to create similar outcomes-based contracts for Repatha.”

High list prices for evolocumab and its competitor, Sanofi-Regeneron’s alirocumab (Praluent) have caused health plans to balk at filling prescriptions, causing frustration among cardiologists and patients alike. Separate studies presented at ACC show that around three-fourths of the initial prescriptions submitted for the drugs, the first of a class called PCSK9 inhibitors, were rejected, although many were filled on the second try.

Health plans are requiring lab reports and additional forms of proof that the drug only goes to those patients that fit the terms of the FDA label, which approved the drugs only for the highest-risk patients with clinical atherosclerotic cardiovascular disease (ASCVD) who were already taking maximum doses of statins, and for patients with familial hypercholesterolemia. Cardiologists complained loudly during the ACC session about the behavior of health plans.

At ACC, the results of the FOURIER trial showed that evolocumab reduced the combined risk of heart attack, stroke, and cardiovascular death 15% to 20%, and 25% beyond the first year. No early death reduction in overall deaths were seen, which some found disappointing. However, the cardiologists at ACC said the results were sufficient for health plans to approve PCSK9 inhibitors without delay. The problem, most acknowledged, is the cost. When the new class was approved, health plans and pharmacy benefit managers were upfront about plans to set up strict protocols to make sure only those patients most in need of the drug had access.

Amgen’s desire to show evolocumab’s value was the thinking behind the value-based contract. In their statement, company officials said it follows earlier efforts to find innovative ways to work with healthcare systems.

“As an organization, we are looking to pay for interventions that demonstrate value and are effective in treating serious illnesses, such as cardiovascular disease,” said Michael Sherman, chief medical officer, Harvard Pilgrim. “That Amgen is willing 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, and that sends a strong positive message to health plans, prescribing physicians and patients."