- Novartis would need to price its experimental high cholesterol therapy inclisiran roughly on par with or less than two currently marketed injectable drugs in order for the medicine to be cost effective for a broad population of patients likely to be eligible for treatment, according to a review by the Institute for Clinical and Economic Review.
- An annual price of between $3,600 and $6,000 would be appropriate for inclisiran, ICER said, given the clinical data disclosed to date showing the drug can powerfully lower LDL cholesterol when given to people already taking a maximum dose of statin therapy.
- Amgen's Repatha and Regeneron's Praluent, both injectable drugs for high cholesterol that have the same biological target as inclisiran, have a list price of between $5,400 and $5,800 per year. Both companies sharply reduced their prices from over $14,000 per year after slow sales and difficulties securing broad insurance coverage.
Novartis had hoped to win U.S. approval for inclisiran last month. But after the Food and Drug Administration was unable to inspect a factory in Italy due to coronavirus-related restrictions on travel, the agency told the Swiss drugmaker it would be unable to complete its review on schedule.
Inclisiran is now in limbo, with a delay of at least several months expected. The setback is costly for Novartis, which spent nearly $10 billion in late 2019 to buy inclisiran's developer, The Medicines Co.
Importantly, however, Novartis said the FDA did not raise any issues with the safety or efficacy of inclisiran, making an eventual approval likely.
Should a clearance come, the drugmaker could face a challenging market. Both Amgen and Regeneron (along with partner Sanofi) for years struggled to sell their respective drugs Repatha and Praluent, which are also proven to sharply lower LDL cholesterol on top of statins.
The drugs are now more widely used, after the companies' sharp price reductions and data for each showing treatment has a modest benefit in reducing heart attacks and strokes. Novartis won't have study results on that latter point for some time, potentially putting inclisiran at a disadvantage.
The remaining question mark is what Novartis will charge, and whether the company will try to undercut the prices of Repatha and Praluent in a bid for wider coverage.
"We will price at a level that allows us to have a broader impact on society and allows us to minimize non-clinical barriers," said Victor Bulto, president of US Pharmaceuticals for Novartis, in a December interview.
ICER's analysis, which was released in a finalized evidence report Thursday, could help Novartis justify pricing on par, although the cost watchdog assumed inclisiran's LDL cholesterol lowering would result in a cardio-protective effect.
Unlike Repatha and Praluent, which are dosed every two weeks, incisliran is administered every six months after an initial "loading" regimen to begin treatment. Novartis is counting on that to help patients adhere to therapy — an "untested assumption," ICER said.
Inclisiran isn't the only new cholesterol treatment. Esperion Therapeutics last year won U.S. approval for two formulations of its pill bempedoic acid, sold as Nexletol and Nexlizet. The latter drug, which combines bempedoic acid with ezetimibe, costs about $4,000 a year at list price. ICER estimates a discount of between 36% to 60% would be needed for the drug to be considered cost-effective.