PCSK9 drug makers and their pharma peers have hit out at the Institute for Clinical and Economic Review, arguing that the self-appointed cost watchdog uses flawed methods to assess new medications. Now, ICER is going even further on its claim that Amgen's new cholesterol fighter isn't worth what the company's charging.
ICER previously determined a value-based price benchmark of $5,404 to $7,735 for Repatha, compared with a list price of $14,100 per year. On Wednesday, based on new cardiovascular outcomes data Amgen released since that assessment, the nonprofit said that target is too high. Amgen has said its net price after rebates ranged from around $7,700 to $11,200 annually, which it sees as good value for money.
The group’s previous assessment, released in 2015, assumed a mortality benefit for the med that was not seen in the much-anticipated Fourier trial results unveiled by Amgen at the American College of Cardiology annual meeting in March.
Because Fourier didn’t show the mortality benefit ICER had included in previous calculations, the institute said Wednesday it will soon release a new, lower price benchmark.
Ahead of the latest ICER missive, Amgen's Martin Zagari said in an interview that the other Fourier outcomes data is significant, particularly the reduction in heart attacks and strokes, in light of the fact that the Fourier patient population was at very high risk of CV problems. The relative risk reduction for heart attack and stroke after a year's therapy, he noted, was 33%.
ICER's downward shift comes even as the CEO for Regeneron, which makes a rival med with Sanofi, blasted the initial review for lacking “intellectual honesty.” A similar outcomes trial for Praluent is set to finish at the end of 2017. Amgen, for its part, has said ICER’s process is “far from fully transparent,” among other complaints.
Assessments from groups like ICER can hurt new drug launches as payers look to limit their expenses, sometimes utilizing such calculations to justify limiting coverage. PCSK9 meds haven’t done as well on the market as their makers had hoped, and now the companies are working in value-based contracting as they work to grow sales.
Since ICER started reviewing drug values in 2015, pharma companies haven’t been shy about lambasting its methods and motives. At one point, industry group BIO claimed that insurance companies were funneling money to the organization put pressure on drug prices.
After more than a year of criticism for its assessments on drugs to treat multiple myeloma, cancer and other conditions, ICER last year invited stakeholders to give feedback as it looked to tweak its review methodology.
Those discussions resulted in ICER’s proposed framework changes to widen its quality-adjusted life year threshold and review drug prices after rebates and discounts, rather than list prices, among other adjustments.