Shares of Swiss drugmaker Novartis were down slightly Thursday morning after the UK’s drug-pricing watchdog preliminarily rejected the company’s CAR-T therapy for lymphoma despite previously recommending coverage for it it in pediatric leukemia.
The National Institute for Health and Care Excellence, or NICE, said it would not recommend Kymriah (tisagenlecleucel) for routine use by the National Health Service in its approved indication of relapsed/refractory diffuse large B-cell lymphoma. The determination was made despite Novartis offering confidential discounts on the therapy, though it is not final and is subject to further negotiation. The decision is similar to the one it reached last month for competitor Gilead Sciences’ CAR-T Yescarta (axicabtagene ciloleucel), shortly after both CAR-Ts won European Medicines Agency approval.
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Shares of Novartis opened down 1 percent Thursday on the New York Stock Exchange following the news.
In a statement, the company said it strongly disagreed with the decision and that it was surprised NICE has not supported the “end-of-life” criteria for the targeted population of DLBCL patients, those who have failed at least two prior therapies and whose life expectancies are typically a matter of months. The company contrasted the determination with the one NICE reached last month for Yescarta, which the agency did determine to meet its criteria to be considered a life-extending, end-of-life treatment.
NICE typically considers new treatments cost-effective if their cost per quality-adjusted life year, or QALY, gained is between £20,000-30,000 ($26,268-39,402), meaning the cost to the NHS for a year of good health does not exceed that threshold. However, even with the discounts Novartis offered off of the list price of £282,000 ($370,382), Kymriah’s cost per QALY would be £54,000 ($70,924) per QALY gained, meaning well outside the range that NICE regards as cost-effective. The cost per QALY was determined by comparing Kymriah with various salvage chemotherapy combinations.
The European Medicines Agency approved Kymriah for pediatric ALL and DLBCL last month, while also approving Yescarta for DLBCL alone. NICE has recommended Kymriah for NHS coverage in pediatric ALL, but it turned down Yescarta in a decision that is also not final. The UK list price for Kymriah is similar to the $373,000 list price for DLBCL that both CAR-Ts carry in the US, but Gilead’s price for Yescarta when it approached NICE was confidential, according to agency documents. Kymriah’s US list price in pediatric ALL is $475,000.
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How to pay for CAR-Ts – which in addition to their high list prices also come with hefty supportive care costs – has been a thorny issue in the US as well, particularly for DLBCL. A non-binding vote last month by a Medicare advisory panel could make patient-reported outcomes in clinical trials mandatory for coverage of CAR-Ts, while an expert suggested in a New England Journal of Medicine paper that price competition or randomized trials could be a way to ensure even coverage of the therapies. Meanwhile, the Centers for Medicare and Medicaid Services quietly pulled out of a deal with Novartis earlier this year amid reservations the agency had about alleged company influence.
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