Amgen has a lot riding on its Repatha launch, and it’s thrown a hefty sales force and millions in ad spending at the effort, not to mention pay-for-performance deals with some payers, and now, some long-awaited outcomes data.
But the signs aren’t pointing in the right direction.
The drug may be gaining market share in the PCSK9 cholesterol field, but that didn’t translate into enough sales to hit analyst expectations for the first quarter. In fact, Repatha saw a quarter-over-quarter decline, to $49 million worldwide, 35% below consensus forecasts.
It may have posted those outcomes data in March, but skeptical payers haven’t thrown open their gates for coverage, and that’s not likely to change anytime soon.
And then there’s this basic problem that’s likely to linger even if the Fourier data do trigger a change in influential treatment guidelines and better formulary placement with pharmacy benefits managers and other payers. Doctors hate the paperwork, and according to Amgen executives, they’re not filling it out correctly.
Part of Amgen’s strategy for a turnaround, according to analysts, is to push demand. DTC ads would trigger the classic “ask your doctor” response, which, in turn, would help persuade doctors to prescribe and—perhaps—work harder to get the paperwork done. It could also prompt physicians to lobby payers for better access. That’s one solution, but not a short-term one, Piper Jaffray analyst Joshua Schimmer wrote in a note after Amgen’s earnings were announced last week.
“[Amgen] seems to be focused on increasing demand for the product as a strategy to enable access,” Schimmer wrote. “We expect this to succeed over time, although it may be slower than some are hoping for.”
The company’s counting on physicians’ frustration with that paperwork—including the requirement to get “accurate data” on patients’ authorization forms—to end up helping Repatha turn the tide with payers, Bernstein analyst Ronny Gal said in a note last week. To qualify for coverage, patients have to show they’ve tried intensive statin therapy and that their “bad cholesterol” levels are serious enough to warrant a $14,000-list-price drug.
“Amgen calls this a 'hassle factor' but payers will argue they need to have some data before they allow patients on an expensive drug (one payer noted to us that 50% of the forms they get do not have LDL-C levels),” Gal wrote.
“The argument that the clinical data is outstanding does not directly address that point,” he added, “and the answer Amgen provides is that they will generate physician anger against the PBM until they relent.”
The Fourier outcomes data presented at the American College of Cardiology meeting in March showed some impressive reductions in heart attacks and strokes, particularly after a year's worth of therapy, but disappointed market-watchers because it didn't show a decrease in the risk of cardiovascular death. Amgen plans to file the data with the FDA mid-year, which could mean a new indication in early 2018.
Amgen execs blamed the Q1 sequential decline on a tender in the Middle East in the fourth quarter of 2016, which wasn’t repeated in Q1, and a “slight adjustment” to net price, Mizuho Securities analyst Salim Syed wrote after earnings were announced.
To its credit, Amgen itself isn’t predicting that one key event might jump-start the launch. During its earnings call, the company “didn’t cite any one particular event that they would describe as the point of inflection for Repatha scripts, but rather described continued uptake as a ‘gradual process,’” Sayed wrote. “The ‘coming months’ language on the call referenced more that payors would relook at their utilization management criteria.”
Gal, however, is one of the analysts unconvinced that, even if all the basics go Amgen’s way, the PCSK9 med will gather speed to the extent the company wants: “We believe Repatha will do better, just not that much better.”