- Major U.S. insurers appear to be opening up to a relatively new and expensive class of cholesterol-lowering drugs. They accepted nearly three-fourths of claims for the drugs in 2017, according to a new report — a marked improvement from prior years.
- Institute for Patient Access, the pharma-backed group behind the report, found claims for PCSK9 inhibitors had an initial rejection rate of 46% and a final rejection rate of 26% market wide. The drugs fared better with Medicare than commercial managed care organizations, with final rejection rates of 15% and 46%, respectively.
- The data paint a rosier outlook for PCSK9 inhibitors, which have had trouble gaining favor with payers. In 2016, commercial insurance plans rejected 73% of claims for the treatments while Medicare rejected 39%, according to Symphony Health Solutions.
PCSK9 inhibitors came to the market in 2015 with Amgen Inc.'s Repatha (evolocumab) and Sanofi SA and Regeneron Pharmaceuticals Inc.'s Praluent (alirocumab). While very effective at lowering low-density lipoprotein (LDL) cholesterol, both products carry hefty price tags that have deterred pickup from insurers and pharmacy benefit managers.
Amgen, Sanofi and Regeneron expected big returns on the drugs, but payer pushback has resulted in fairly modest revenue. Repatha sales clocked in at about $340 million last year, while Praluent sales as recorded by Sanofi totaled $195 million.
To ratchet up revenue, the companies have turned to value-based deals to get on formulary lists and insurance plans. As of early 2017, four payers had inked such contracts for Repatha and two had for Praluent.
Those efforts appear to be helping.
Investment bank Cowen & Co. found that from early November through March, the total script volume for Praluent and Repatha collectively increased by almost 1,000, or 40%. And in an April 6 note, Mizuho analyst Salim Syed said total prescription for Repatha and Praluent were each up 5% week-over-week for the week ending March 30.
Barriers remain, however. A recent study found that Amgen's outcomes-based payment scheme wouldn't be all that consequential in making Repatha more cost-effective.
Other analyses, including one from the cost watchdog Institute for Clinical and Economic Review, have noted that the roughly $14,000 price tags on both Repatha and Praluent would need to come way down before the drugs qualify as cost-effective.
Rebates and discounts on the drugs have resulted in annual net prices below $14,000, but the drugs' costs remain above ICER's benchmarks.
Last month, Sanofi and Regeneron did offer to lower Praluent's cost if payers agreed to provide smoother inroads for coverage.
Amgen, however, has stood by Repatha's price tag. It even commissioned its own study to assess the cost-effectiveness of the drug. Notably, the study found that Repatha would meet an oft-cited figure of cost-effectiveness if its price were 30% below list price — a level near the drug's reported net price in the market.
In its report, Institute for Patient Access determined that 292,000 scripts for PCSK9 drugs were written last year, of which 78,700 were rejected. The group is funded in part by a large number of big-name pharmaceutical companies, including Sanofi, Regeneron and Amgen.