A recent controversy over data manipulation during the development of Novartis’ new gene therapy, Zolgensma, has overshadowed another issue pressuring the spinal muscular atrophy (SMA) treatment: its $2.1 million price.
But Zolgensma’s sticker price remains a hurdle—and the same goes for the high cost of the other gene therapy on the market, Spark Therapeutics’ $850,000 eye drug Luxturna.
Fortunately for Novartis and Spark, one major payer, Cigna, says it has figured out how to cover those two pricey treatments. Even better? It’s at no cost to patients.
Cigna announced that patients who receive Zolgensma or Luxturna will be fully covered, with zero out-of-pocket costs. The new gene therapy program will bring together services from many of Cigna’s business segments, including the pharmacy benefit manager Express Scripts, to offer patients “personalized and expert care,” the insurer said in a statement.
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Steve Miller, M.D., chief clinical officer of Express Scripts and a longtime critic of rising drug prices, said expensive therapies for rare diseases remain a growing challenge for the healthcare system. Cigna acquired Express Scripts for $67 billion last year.
“The trouble is, while [gene therapies] are incredibly innovative and very effective, they are wildly expensive,” Miller said in a video posted on Express Scripts’ website. “Just like the pharmaceutical companies have been very innovative in bringing these products to the marketplace, we have to be equally innovative in figuring out how we make them accessible and affordable for the patients and their families.”
Under the Cigna program, health plans will pay for the gene therapies on a per-member, per-month schedule. In the video, Miller called it a “cost-recovery” model for Cigna. “So we are not looking to profit off this,” he said.
The Cigna plan marks the second piece of good reimbursement-related news in as many days for Novartis. The company markets Spark’s Luxturna outside the U.S., and Wednesday, England’s National Institute for Health and Care Excellence (NICE) said it would back the drug.
Zolgensma is not yet approved in Europe—Novartis is expecting a verdict in the fourth quarter—but the company will no doubt face reimbursement challenges there as well. To win NICE’s backing for Luxturna, it had to offer England’s National Health Service a confidential discount.
As for the ongoing data-manipulation drama, Novartis is still working to calm regulators’ nerves. In August, a newly released FDA report revealed details about how some data from a mouse study of Zolgensma had been inaccurately reported. The FDA has said it believes the treatment is safe and effective, and it will remain on the market, but the agency is weighing civil or criminal action.
AveXis President David Lennon told analysts in August that the European Medicines Agency is aware of the FDA’s investigations into the Zolgensma data issues and that he doesn’t expect any delays in the approval of Zolgensma in Europe
Novartis is so optimistic about gene therapy, in fact, the company’s executives reportedly told journalists in Germany this week that gene and cell therapies would ultimately account for 15% of total revenues. It has a long way to go, however: Novartis’ CAR-T treatment for blood cancer, Kymriah, has brought in just $103 million of the company’s $23 billion in sales so far this year.
Novartis has not yet announced sales numbers for Zolgensma. In July, CEO Vas Narasimhan would only say the launch is “on track” and in line with expectations.
Cigna’s new payment plan for gene therapy will no doubt be viewed as good news for Roche, too, as it works to complete its planned $4.8 billion acquisition of Spark. The company has delayed its tender offer several times, citing antitrust investigations, but it still expects to seal the deal by the end of the year.
Meanwhile, Cigna’s Miller remains vocal on the high cost burden presented by new gene therapies. Two years ago, he noted that there were more than 1,000 gene therapies in the biopharma pipeline, and clearly he’s still worried about how the health system will pay for them. Cigna’s new program, he said in the video, “just takes care of the first two [gene therapy] drugs that are in the marketplace, but we know many drugs are behind that.”
Date: September 11, 2019
Source: Fierce Pharma
