It is getting increasingly difficult to find good news for new cholesterol-lowering drugs Repatha and Praluent. A collision of disappointing clinical data and payer pressure have caused forecasts for the class to drop by nearly half in the past year, and the situation does not look like it will improve.
The latest blow came with a report from a US cost-effectiveness institute, which stated it expects its value-based price benchmark to fall thanks to Repatha's underperformance on cardiovascular outcomes. Amgen (NASDAQ:AMGN), Repatha's developer, is embroiled in patent litigation with rival Regeneron (NASDAQ:REGN), but it looks like the two are fighting over the rubble.
The Institute for Clinical and Economic Review (ICER) yesterday updated its report on the PCSK9-inhibiting drugs based on the Fourier trial readout at the American College of Cardiology meeting (ACC - No Repatha of glory, March 17, 2017).
ICER had made an earlier cost-effectiveness call centered on estimates that Repatha would reduce cardiovascular events and deaths by 30% based on a 64% reduction in low-density lipoprotein (LDL) (ACC - Repatha's next challenge is expectations, March 6, 2017).
With Fourier detecting a 15% reduction instead, ICER published a short clinical update noting that it now needs to lower the drug's value-based price benchmarks from the original $5,404-$7,735 annual estimate. Repatha's failure to reduce cardiovascular death, in particular among patients followed for two or more years, "is concerning," the report states. Both Repatha and Praluent have a list price of around $6,500 a year, although most insurers probably pay less than that.
The institute added that data from the Odyssey Outcomes trial, a longer-term follow up from Fourier, could change its assessment of the PCSK9 class yet again.
Data published by Regeneron and partner Sanofi (NYSE:SNY) at the American Diabetes Association meeting this week do not necessarily point to any better outcomes. The Odyssey DM Insulin study and Odyssey DM Dyslipidemia studies showed 48.2% and 43.3% reductions in LDL from baseline, respectively.
Amgen last week submitted the Fourier data to the FDA in a bid to have the prevention of cardiovascular events added to the Repatha label.
Will Praluent be around?
Meanwhile, the patent dispute between Amgen and Regeneron over PCSK9 reached a hearing in the Court of Appeals for the Federal Circuit. Lower courts have sided with Amgen in this dispute, which earlier this year that threatened to drive Praluent from the market (Praluent stay not enough to save Regeneron, February 9, 2017).
The risk that the courts will rule that Regeneron has violated Amgen's patents runs between 55-90%, according to attorneys consulted by Mizuho Securities. Amgen's claims appear strong, but judges may favor Regeneron nonetheless because of a desire to keep two options on the market - a position that would be stronger if Odyssey Outcomes data were available.
In the event that Amgen wins, Regeneron also could conceivably keep Praluent on the market by paying a settlement or royalties.
The irony is that Amgen's salvation might be in Praluent delivering more positive cardiovascular outcomes data than Repatha did, allowing for more generous cost-effectiveness calculations. In that event, if patent rulings have pushed Praluent from the market, some legal and policy questions will have been raised.