Amgen has released a new economic analysis of the evolocumab (Repatha) outcomes study, Fourier, which initially failed to sway the market when unveiled earlier this year. The gist, according to Fierce Pharma: The PCSK9 drug is cost-effective at $9,669 per year or less, almost $5,000 off its list price.
That’s a reduction of 31%—and it’s in line with typical discounts, Amgen says—but it’s still too pricey under previous assessments, including one published August 22 in the Journal of the American Medical Association, which favored a price cut of 71%.
But Amgen says this new study is different, Fierce Pharm reports, because it includes real-world data, among them rates of cardiovascular events outside of clinical trials. One of the criticisms of the Fourier results was the number of patients treated to prevent one heart attack or stroke—and the cost of treating all those patients compared with the cost of statins. Amgen has argued that, in patients at high risk, that number is considerably lower.
“With statins, there’s often less than a 1% annualized risk of an event. The risk of people who get Repatha is 11%, 12%, 13%, an order of magnitude higher,” Martin Zagari, Amgen’s Vice President of Global Health Economics, said in an interview with Fierce Pharma earlier this year. “In the Repatha patient versus the statin patient, the same relative risk reduction prevents 10 times more events. That’s the story we are trying to get people to understand.”
Amgen’s new data, published August 23 in JAMA Cardiology, seeks to illustrate that difference. After running several clinical scenarios—using a combination of real-world and Fourier data—the researchers determined that in a “typical” U.S. patient with atherosclerosis, Repatha is worth the price at $9,669. But in patients with a low-density lipoprotein-cholesterol (LDL) level of 100 or more, despite aggressive statin therapy, the cost-effective price is $13,225.
“This study affirms the clinical benefits and economic value of delivering Repatha to the right high-risk patients, specifically patients who have had a heart attack or stroke with high LDL levels despite maximally-tolerated statin therapy,” Joshua Ofman, Senior Vice President of Global Value, Access and Policy, said in a statement. “The actual net prices for payers in the market today after discounts and rebates are quite aligned to the value-based price range identified in this study.”
Here’s how the calculation using real-world data stacks up against an analysis with just the Fourier results. Using that trial data, the researchers found a cost-effective price of $6,780.
That’s higher than the price with a 60%-or-greater discount ($5,720) recommended in 2015 by the Institute for Clinical and Economic Review (ICER), an unofficial cost-effectiveness watchdog in the U.S. And it’s still higher than the $4,147 price with the 71% discount recommended in JAMA a day earlier.
"The 71% price reduction required to make PCSK9 inhibitor therapy cost-effective is greater than the 25% to 30% discounts typically offered by manufacturers," the study authors wrote.
But, obviously, it’s lower than the real-world analyses. That’s something new that Amgen might be able to parlay into a better reception from payers, which have put up hurdles to PCSK9 prescriptions and thus limited the drug’s uptake. By identifying patients most likely to benefit, it limits the eligible population while also highlighting its effectiveness.
“The analysis identifies the types of high-risk patients for whom this therapy is both clinically beneficial and cost-effective,” according to lead author Gregg Fonarow, M.C., who’s a professor at the UCLA David Geffen School of Medicine. “This study provides a critical input to the overall cost-effectiveness debate that has surrounded PCSK9 inhibitors.”
Source: Fierce Pharma; August 23, 2017.