NICE have issued draft guidance concluding that Novartis’ (Basel, Switzerland) CAR-T cell therapy Kymriah® (tisagenlecleucel) is too expensive to recommend as a treatment for certain adults with lymphoma.
However, the agency said that as the therapy has significant clinical benefits and that it would welcome further discussions on its cost-effectiveness for adults who have relapsed or refractory diffuse large B-cell lymphoma after 2 or more lines of systemic therapy.
Kymriah was recently given the green light by NICE for patients up to 25 years old with B cell acute lymphoblastic leukaemia that is refractory, in relapse post-transplant or in second or later relapse. This approval was one of the fastest funding approvals in the 70 year history of the NHS.
However, NICE noted that as there is no data in diffuse large B-cell lymphoma comparing Kymriah to salvage chemotherapy, the most common treatment for this form of cancer. Therefore they have stated that it makes it difficult to determine the exact benefits in this case.
The committee concluded that Kymriah is not cost-effective for routine funding or use within the Cancer Drugs Fund for adults with lymphoma. They added that there are also a number of side effects a person may experience from Kymriah and extensive monitoring by trained specialists is needed.
“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,” commented Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE.
Novartis had offered a confidential discount on the list price of £282,000, however, the cost-effectiveness estimates were still above the range that NICE considers an acceptable use of NHS resources.
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“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,” Boysen concluded.