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UK panel rejects Kymriah for adults with lymphoma due to cost
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An independent body that offers guidance to improve health and social care in England recommended against the use of tisagenlecleucel, a chimeric antigen receptor T-cell therapy, in adults with relapsed or refractory large B-cell lymphoma.
The National Institute for Health and Care Excellence (NICE) issued draft guidance today that said tisagenlecleucel (Kymriah, Novartis) — which is approved in the United States and European Union — is too expensive to justify its use in England’s National Health Service (NHS) for adults with lymphoma.
The rejection comes 2 weeks after NICE announced it had reached a deal with Novartis to fund the use of tisagenlecleucel for children and young adults aged younger than 25 years with refractory acute lymphoblastic leukemia.
In August, NICE also recommended against the use of axicabtagene ciloleucel (Yescarta; Kite Pharma, Gilead) — the second FDA-approved chimeric antigen receptor (CAR) T-cell therapy — for patients with diffuse large B-cell lymphoma and primary mediastinal B-cell lymphoma.
Novartis had offered a confidential discount on the list price of £282,000 (approximately $371,000) for tisagenlecleucel, according to NICE. However, the panel deemed that expense above the range of an “acceptable use of NHS resources.”
“We have seen promising results for CAR-T therapies in early trials and believe there is great potential for tisagenlecleucel-T to help people who have not responded to other forms of therapy,” Meindert Boysen, director of the center for health technology evaluation at NICE, said in a statement. “Although we could not recommend tisagenlecleucel-T for adults with lymphoma, we welcome further discussions around the cost-effectiveness of the treatment and engagement with stakeholders.”
Julie Masow, a Novartis spokeswoman, issued the following statement to HemOnc Today and Healio.com:
“While we are disappointed with this preliminary decision, we recognize that this one-time therapy is an innovative and radically different treatment approach with curative intent, and it may be challenging to adequately compare Kymriah to current treatments for patients with this type of blood cancer who have limited options,” she said.
“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,” she continued. “This relates to individuals who have already failed two previous therapies, and for the vast majority of this population, life expectancy can be counted in months rather than years. This is in contrast to a recent review for the same class of treatment and population of patients.”
NICE extended a call for “comments and further evidence” that could lead to tisagenlecleucel being made available through NHS. Feedback will be accepted until Oct. 23.
“It is important to note that this appraisal is not NICE's final guidance on Kymriah,” Novartis stated. “The recommendation may change after consultation. We are working together with NICE to define the most relevant comparator studies and reconsider the ‘end-of-life’ decision. We will continue to collaborate closely to support the adoption of this medical innovation for patients who have limited treatment options.”
The FDA approved tisagenlecleucel last year for the treatment of children and young adults aged up to 25 years with refractory B-cell precursor ALL, as well as those whose disease is in second or later relapse.
In May, the FDA expanded the approval to include treatment of patients with relapsed or refractory large B-cell lymphoma.
The second FDA-approved CAR T-cell therapy — axicabtagene ciloleucel — is indicated for treatment of adults with relapsed or refractory large B-cell lymphoma who received two or more lines of systemic therapy. – by Cassie Homer