- Novartis will be the first pharmaceutical company to bring a CAR-T cancer therapy to market in the U.K., as the country's National Health Service announced Wednesday it had reached a funding deal for the Swiss drugmaker's Kymriah.
- As part of the agreement, the U.K. list price for the cancer therapy will be nearly a quarter cheaper than its $475,000 U.S. price tag. NHS said the full list price is £282,000 per patient, or roughly $365,000.
- NHS licensed the treatment for patients up to 25 years old with B-cell acute lymphoblastic leukemia (ALL) that is either refractory, in relapse post-transplant or in second or later relapse.
As other pharmas have recently struggled to secure drug coverage in the U.K., Novartis took the most direct route: make it cheaper. Novartis dropped the list price of Kymriah (tisagenlecleucel) more than $100,000 from what it's selling the CAR-T therapy stateside.
A Novartis spokesperson told BioPharma Dive in an emailed statement the reduced price is "because healthcare systems and infrastructures are vastly different between U.S. and EU and even among EU countries," so "a one-size fits-all approach is not possible."
While it's unclear exactly how the new amount was reached in the negotiation — specifics were scarce in the initial statements — a top British health official did highlight the company's flexibility in a Sept. 5 statement.
"The constructive fast-track negotiation also shows how responsible and flexible life sciences companies can succeed — in partnership with the NHS — to make revolutionary treatments available to patients," NHS chief executive Simon Stevens said in the statement.
The deal also happened quickly. NHS called it "one of the fastest funding approvals in the 70 year history of the NHS." Kymriah received marketing authorization for Europe on Aug. 27. And now, less than two weeks later, it has a deal in place for the U.K., a major European market.
Novartis' Kymriah is the first CAR-T therapy NHS will make available. "So far, CAR-T has only been available to patients in Europe through clinical trials," NHS said in a statement.
The deal puts Novartis ahead of Gilead Sciences in establishing market share in the U.K. Gilead also received an OK from European regulators for its CAR-T therapy Yescarta (axicabtagene ciloleucel) in a different type of blood cancer on Aug. 27, but the U.K.'s cost agency deemed it too expensive the next day.
Novartis, though, faces production challenges with the expansion in commercial service. The company acknowledged manufacturing issues for Kymriah in July, raising questions of whether it can meet demand.
The deal for Kymriah also did not include coverage for patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), the most common version of non-Hodgkin's lymphoma. The European Commission had approved Kymriah as a third-line treatment for adults with that condition.
The FDA OK'd the therapy for that second indication in May, and Novartis remains hopeful NHS will also expand its accepted use.
"We trust that the NHS will continue this collaboration and flexibility in granting tisagenlecleucel access to adult patients with diffuse large B cell lymphoma," Mari Scheiffele, Novartis' general manager for oncology in the U.K. and Ireland, said in a statement, using Kymriah's scientific name.
The Cancer Drugs Fund, which is an NHS entity designed to provide quicker access to certain new cancer treatments, will fund the treatment.
NHS expects the therapy to begin in hospitals in London, Manchester and Newcastle "in a matter of weeks" after they pass accreditation requirements, the organization said in a statement.