SMC says ‘no’ to Novartis’ Kymriah for adults with lymphoma

The Scottish Medicines Consortium said it could not accept Kymriah (tisagenlecleucel) for adult patients with diffuse B cell lymphoma who have relapsed or not responded after two previous lines of treatment.

Despite being considered under the PACE process, the committee did not recommend tisagenlecleucel "because of uncertainties in the company’s evidence around its long term benefits".

The decision follows that of the National Institute for Health and Care Excellence last year, which also rejected Kymriah for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) having concluded that it is not cost effective for routine funding on the NHS in England and Wales or use within the Cancer Drugs Fund (CDF).

A key sticking point is the fact that there is no data comparing Kymriah to salvage chemotherapy, the most common treatment currently used, making it difficult to determine the exact benefits of the therapy, NICE said.

Both cost regulators have approved NHS funding for use of Kymriah within its other licensed indication – the treatment of acute lymphoblastic leukaemia in children and young adults who have not responded to previous treatment or in whom the condition has relapsed.

On the flip side, the SMC did approve NHS funding for Jazz Pharmaceuticals’ chemotherapy Vyxeos (liposomal daunorubicin/cytarabine) and MSD’s antiviral Prevymis (letermovir).

Vyxeos was accepted for the treatment of adults with a high-risk type of acute myeloid leukaemia (AML), a rare, aggressive and rapidly progressing cancer of the white blood cells.

According to the SMC, the treatment can improve remission rates and overall survival, and offers an increased chance of stem cell transplant, which is a potentially curative option. It also has the advantage of fewer doses and shorter inpatient stays than current treatment options.

Prevymis was backed as a means to prevent illness due to cytomegalovirus (CMV) infection in patients who have received a stem cell transplant.

Through PACE, the committee heard that while rare, CMV infection can result in serious illness and delay recovery from stem cell transplantation, and that there are limited treatment options for patients at present.

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