- Adult cancer patients in England with B-cell lymphoma will now be able to access to Gilead Sciences' CAR-T therapy Yescarta, after the drugmaker and NHS England reached a commercial agreement to provide the pricey treatment through a provisional fund.
- The deal, announced Friday, resolves for the present an impasse between Gilead and the English health service over reimbursement of Yescarta. In August, a government cost agency judged the CAR-T therapy to be too expensive for routine coverage.
- Yescarta will now be included in NHS England's Cancer Drugs Fund, which provides managed access to new treatments while additional evidence is generated to support full coverage. No negotiated price was disclosed for Gilead's treatment, which costs $373,000 per patient at full list price.
England's National Health Service has been grappling with how to reimburse CAR-T therapy since August, when the European Commission OK'd both Yescarta (axicabtagene ciloleucel) and Novartis' rival treatment Kymriah (tisagenlecleucel).
Both therapies, while potentially transformative for a subset of patients with two types of blood cancer, come at a high cost that has spurred worries over patient access.
While the European Medicines Agency and EC work to grant centralized approvals for medicines, EU member governments can negotiate reimbursement independently.
In September, Novartis reached an agreement with NHS England for coverage of Kymriah for pediatric or adolescent patients with B cell acute lymphoblastic leukemia (ALL). In doing so, the Swiss drugmaker cut the therapy's price from $475,000 per ALL patient to roughly $365,000.
Put in place two weeks after the EC approval, the deal was one of the fastest funding approvals in NHS history, the government agency said at the time.
Finding common ground on coverage has been more difficult, however, for adult patients with diffuse large B cell lymphoma (DLBCL). Both therapies carry EU approvals for the more common blood cancer and, at least by wholesale acquisition cost, are priced similarly.
The National Institute for Health Care Excellence, a governmental body tasked with assessing the cost-effectiveness of new treatments, initially recommended against routinely covering either Kymriah or Yescarta for DLBCL.
Now, Yescarta will be covered provisionally through the Cancer Drugs Fund. Details on the commercial agreement were not specified, so it's not clear how much of a discount Gilead offered to merit reimbursement.
In draft guidance from August, NICE initially said Yescarta did not meet the criteria for inclusion in the Fund. A finalized recommendation is expected in December.
As many as 200 patients per year could receive treatment with Yescarta after the agreement with NHS England, the agency said.
CAR-T therapy will initially be offered at five NHS hospitals, including one in London, over the coming weeks.
While a much smaller commercial opportunity than the U.S., England is a key European market, and NHS England's negotiations with Gilead and Novartis set the stage for other discussions across the continent.