Amgen, Harvard Pilgrim sign outcomes-based refund contract for cardiovascular medication

Harvard Pilgrim Health Care signed an outcomes-based refund contract with Amgen pertaining to evolocumab (Repatha), the company’s cholesterol-lowering medication.

As part of the deal, Harvard Pilgrim will receive a rebate for the cost of evolocumab if an eligible patient is hospitalized with an MI or stroke after taking the medication for six months or more and maintaining an appropriate level of compliance.

Amgen announced the contract May 2 at the World Medical Innovation in Boston.

In August 2015, the FDA approved evolocumab for adults with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of low-density lipoprotein (LDL) cholesterol. The injectable drug is part of a class of medications known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.

Shortly after the drug’s approval, Harvard Pilgrim and Amgen signed an outcomes-based contract. Per the terms of that deal, Amgen provided Harvard Pilgrim a discount if the health plan members who took evolocumab had less of an LDL cholesterol reduction than was observed in clinical trials.

“As an organization, we are looking to pay for interventions that demonstrate value and are effective in treating serious illnesses, such as cardiovascular disease,” Michael Sherman, MD, MBA, MS, Harvard Pilgrim’s chief medical officer, said in a news release. “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.”

For the first quarter of 2017, Amgen reported $49 million in sales of evolocumab, which was down from $58 million during the fourth quarter of 2016. For fiscal year 2016, worldwide sales of evolocumab reached $141 million, including $101 million in the U.S., up from $10 million in 2015.

The Harvard Pilgrim deal occurred shortly after Amgen reported results of the randomized FOURIER trial, which found that patients who received evolocumab had a statistically significant 15 percent reduction in the risk of the composite primary endpoint of cardiovascular death, MI, stroke, hospitalization for unstable angina or coronary revascularization compared with a placebo group.

Although the trial met its primary endpoint, Amgen’s shares declined 7 percent to $167.58 in the hours after the results were presented at the ACC scientific session on March 17 in Washington, D.C. As of 1:40 p.m. Eastern Time on May 4, Amgen’s common stock price was $164.34 per share.

So far, sales of evolocumab have been lower than expected in part due to the drug’s high wholesale acquisition cost of $14,100 per year. Payers and physicians have chosen to cover and prescribe cheaper alternatives such as statins.

"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, Amgen’s senior vice president of Global Value, Access and Policy, said in a news release. “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.”