- Amgen, looking to jumpstart sales of its slow-growing heart med Repatha (evolocumab), has signed a deal with the insurer Harvard Pilgrim to fully refund the drug's cost if a patient is hospitalized with either a heart attack or stroke.
- Some conditions apply: a patient must have taken Repatha properly for at least six months before a cardiac event for Amgen to refund the insurer the cost of treatment. In return, Harvard Pilgrim will relax some of its utilization restrictions on coverage for high-risk patients.
- Despite high initial sales expectations for the PCSK9 inhibitor, Repatha has so far failed to gain traction on the market, earning only $141 million in revenue last year. Amgen hopes recent study results proving Repatha's cardio-protective benefit can change that, and has offered a money-back guarantee for payers that drop barriers to coverage.
Amgen's deal with Harvard Pilgrim is the first refund contract signed by the drugmaker following release of positive results from the closely watched FOURIER cardiovascular outcomes trial.
Data from that study, unveiled in March, showed treatment with Repatha reduced the risk of major adverse cardiovascular events by 15% — a significant finding that helps firm up the evidence supporting the cardiovascular benefit of lowering LDL cholesterol.
But the effect was smaller than some had hoped to see, and the drug failed to show a statistically significant effect on cardiovascular death. Given the low cost of generic statins, and payers existing reticence to broadly cover the pricey PCSK9 class, the results didn't appear to be the kind of slam dunk that would catalyze a rapid commercial turnaround.
In that context, Amgen announced it would offer refunds in certain cases to payers willing to lower coverage restrictions — a bet on the strength of Repatha's data.
That Amgen reached an agreement with Harvard Pilgrim first is not surprising. The New England-based insurer has worked with Amgen in the past, inking value-based payment deals for both Repatha and the drugmaker's blockbuster anti-inflammatory drug Enbrel (etanercept).
As an integrated program, Harvard Pilgrim provides health coverage as well as negotiating drug contracts, making tracking of prescriptions and patient events more straightforward than with an insurer that relies on a pharmacy benefit manager.
Amgen hopes to reach similar deals with other payers as well.
"We are focused on reducing barriers and improving processes to make it easier for a physician to prescribe Repatha and for patients to get access to this important therapy," Amgen's Tony Hooper, head of commercial operations, said on an earnings call last month. "We expect payers will start changing utilization management criteria and processes over the coming months."
To date, utilization management practices on the part of payers have largely stymied initial attempts to fill prescriptions for either Repatha or Sanofi and Regeneron's competing Praluent (alirocumab).
In 2016, more than 88% of initial fill requests for the PCSK9 drugs were rejected for patients covered by commercial plans, according to data from Symphony Health Solutions. For patients on Medicare, the denial rate on first attempt was 73%.
Final approval rates were more palatable, but still high: 73% on commercial plans and 39% for Medicare.
It remains to be seen how much FOURIER data will turn around the drug's fortunes, and whether payers will bite on Amgen's attractive offer of a guarantee. Sales of Repatha were only $49 million in the first quarter, up from a year ago but $9 million less than in the fourth quarter of last year.
If nothing else, Amgen's offer underscores the company's faith in the drug's benefit. Coupled with the FOURIER data, Amgen hopes to reset payer calculus around Repatha and spur easing of restrictions for those patients likely to benefit.
"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," said Michael Sherman, Harvard Pilgrim's chief medical officer.