Express Scripts chief medical officer Steve Miller suggested that Novartis' recently approved CAR-T cell therapy Kymriah (tisagenlecleucel), "and other groundbreaking gene therapies that will follow, [require] new models for collaboration among payers, pharmaceutical companies, and pharmacy benefit managers." Miller acknowledged that "gene therapy holds great promise," but unlike regular medications, gene therapies are administered only once, "and therein lies the challenge…pharmaceutical companies have a single opportunity per patient to get paid," resulting in "very high price tags."
Kymriah became the first gene therapy approved in the US when the FDA cleared it late last month for certain patients with acute lymphoblastic leukaemia. Miller stated that Kymriah's price of $475 000, while lower than the $600 000 to $750 000 some analysts had expected, is "still dramatically higher than other specialty drugs."
According to Miller, Express Scripts is collaborating with drugmakers, policymakers, patient advocacy groups and payers on "innovative approaches" to improve access to gene therapy. He said some ideas being considered include paying for treatments over time, creating insurer risk pools and financing one-time payments. "A successful model must address patients who change insurers or employers, and [track] their health outcomes over time to ensure payments aren't being made if the treatment stops being effective," Miller added.
Meanwhile, Novartis has indicated that it will seek to address pricing difficulties through a new initiative, under which it would only be paid for Kymriah if patients covered by US government programmes showed improvement within a month of receiving the treatment. The company also said that other value-based payment approaches for Kymriah and CAR-T therapies are being negotiated. "We are committed to doing everything we can to help children and young adults who can benefit from Kymriah have access to the therapy," Novartis commented, adding "we are working with payers to ensure they fully understand the value of Kymriah and provide coverage for patients."
The US approval of Kymriah came shortly after Gilead Sciences announced an $11.9-billion deal to acquire Kite Pharma, which is developing axicabtagene ciloleucel, a CAR-T therapy candidate the FDA is expected to make a decision on by November 29.
For related analysis, see ViewPoints: Novartis sets the stage for CAR-T commercialisation, but your price may vary. See also, ViewPoints: Gilead makes its long-awaited splash in oncology.
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