- Two weeks after becoming the first CAR-T therapy cleared for coverage by the U.K.'s National Health Service, Novartis' Kymriah has hit a snag with National Institute for Health and Care Excellence.
- NICE, the agency responsible for recommending whether NHS should pay for a drug, deemed Kymriah too pricey as a treatment for adults with diffuse large B-cell lymphoma (DLBCL). European regulators in August approved the therapy for certain adult DLBCL patients as well as a subset of pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).
- NICE said Novartis "offered a confidential discount" on a list price of £282,000, or roughly $370,000, per patient, but it wasn't enough. Despite recognizing the CAR-T therapy's clinical benefits, the reviewing committee honed in on a lack of comparative data pitting Kymriah against salvage chemotherapy.
In securing National Health Service coverage for Kymriah (tisagenlecleucel), Novartis slashed the U.K. list price for Kymriah by nearly a quarter compared to the U.S. for treating ALL patients under 25 whose disease was refractory, in relapse post-transplant or in second or later relapse.
Now, Novartis is attempting to gain U.K. clearance for adults with the most common form of non-Hodgkin's lymphoma, DLBCL.
The Swiss pharma offered a "confidential discount" on the therapy, NICE said. A Novartis spokesperson declined to comment on the offer, or even confirm it was made, citing confidentiality.
Beyond pricing, the NICE draft decision stated "longer follow-up is needed and there are no data comparing [Kymriah] with salvage chemotherapy."
All of NICE's cost-effectiveness estimates were above £40,000 per quality-adjusted life year (QALY), a commonly used value metric, with the "most plausible" ratio being "much more than £54,000 per QALY gained." NHS' normally acceptable range is between £20,000 and £30,000 per QALY gained.
The reviewing committee also said Novartis did not make the case for Kymriah to be included in the Cancer Drugs Fund.
A Novartis spokesperson expressed disappointment in the decision in an email to BioPharma Dive, adding "it may be challenging to adequately compare Kymriah to current treatments" because of its "radically different treatment approach."
Novarits also singled out NICE's conclusion that Kymriah did not meet criteria to be considered a life-extending treatment at end of life.
"We were surprised that NICE have not supported the 'end of life' criteria for this population of DLBCL patients and strongly disagree with this decision," the spokesperson said.
The decision means Kymriah is in about the same spot as Gilead Sciences' rival CAR-T therapy for DLBCL, Yescarta (axicabtagene ciloleucel). Yescarta was also not recommended for DLBCL last month in a NICE draft decision. Gilead will face a follow-up appraisal meeting Sept. 27.
Novartis said it plans to work with NICE "to define the most relevant comparator studies and reconsider the 'end of life' decision." The cost agency said it also welcomes further discussions.
NICE will accept comments and new evidence regarding the decision until Oct. 10. Its next committee meeting is set for Oct. 23.