Dive Brief:
- 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 will be nearly a quarter cheaper than the $475,000 U.S. price tag. NHS said the full list price is 282,000 pounds 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.
Dive Insight:
As other pharmas have recently struggled to clear value-based pricing decisions in the U.K., Novartis took the most direct route: make it cheaper. Novartis dropped the list price more than $100,000 from what it's selling Kymriah (tisagenlecleucel) at 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 statement Wednesday.
"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 fast. 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 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 will leave Novartis well ahead of Gilead Sciences in its head-to-head battle for market share. Gilead also received the OK from European regulators for its CAR-T therapy Yescarta (axicabtagene ciloleucel) on Aug. 27, but the U.K.'s cost agency deemed it too expensive the next day.
However, Novartis will face increased production challenges with the expansion in service. The company acknowledged manufacturing issues for Kymriah in July, raising questions of whether it can meet demand.
The deal 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 did approve it as a third-line therapy 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.