Drug Development

Is Amgen still shooting blanks in its war with payers over Repatha reimbursement?

Sean Harper, Executive Vice President, Research and Development

Sean Harper, Executive Vice President, Research and Development

With only $40 million in anemic Q3 Repatha sales, Amgen $AMGN has been quietly seething over the slight market traction it’s seeing for a cholesterol drug that promised to help rewrite prescribing habits in the field. But payers have been loathe to cover the pioneering PCSK9 drug — as well as a rival from Regeneron/Sanofi.

Now, they’re hoping that evidence of its impact on an important biomarker for cardiovascular disease will persuade payers to start tearing down the walls they built to keep patients away from the drug. But once the data gets a thorough review, Amgen and its rivals may find themselves still far from the promised land of blockbuster sales.

Here’s the positive aspect of what they reported at the big AHA meeting in New Orleans:

Patients in their Repatha/statin arm experienced a 0.95% decrease in what’s called the percent atheroma volume (PAV), a measure of plaque in arteries, which has a well known link to cardiovascular disease. Patients in the placebo/statin arm had a 0.05% increase in PAV. Also significantly, 64.3% of Repatha patients experienced plaque regression in PAV compared to 47.3% of the placebo arm.

By one measure of plaque volume, there was a mean decrease of 5.8mm in the drug arm compared with 0.9mm seen in the placebo arm. And the drug clearly slashed levels of ‘bad’ LDL.

These are all statistically significant indications of the drug’s impact on disease progression along with fresh evidence of its impact on LDL. That’s all good.

The study, though, was not designed to provide evidence of the drug’s ability to improve outcomes for patients. But they did an “exploratory analysis” in any case and found major cardiovascular events occurred in 12.2% of patients receiving Repatha and 15.3% in those receiving placebo.

Again, the data were positive, but they were also not conclusive — and no huge gap appeared, raising questions over whether the preliminary number may have fallen into a margin of error.

That didn’t stop Steve Nissen at the Cleveland Clinic from touting the cardio benefits they saw.

“This is the first time anyone has shown these drugs do anything other than lower cholesterol,” Nissen told reporters, according to a Bloomberg piece. And he hit on a lower number of heart attacks and artery-clearly surgeries as proof — though he also acknowledged that it wasn’t conclusive.

You could hear the frustration at Amgen, where R&D chief Sean Harper had this for his prepared statement:

We remain concerned that many patients are experiencing barriers to accessing Repatha, despite their physician’s treatment recommendations. We look forward to our outcomes study, FOURIER, and will continue to work with payers to improve access for patients who need additional LDL-C lowering.

Payers, though, are likely going to continue to wait for real proof, not inconclusive trends. Amgen still has plenty of work ahead in convincing them to cover the prescriptions that are being written. And the jury is still out on that score, leaving Amgen’s big bet on PCSK9 up against some daunting odds.

Amgen’s shares edged up yesterday on the news, then edged back down in pre-market trading. Investors haven’t been impressed, either.


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RAPS Regulatory Convergence 2017