Package advice tisagenlecleucel (Kymriah®) for the treatment of r/r DLBCL
The National Health Care Institute has completed its reassessment whether tisagenlecleucel (Kymriah®) can be included in the insured package. Tisagenlecleucel is indicated for the treatment of patients with relapsing or refractory (r/r) diffuse large B-cell lymphoma (DLBCL, a specific form of lymphoma) after 2 or more lines of systemic therapy. The National Health Care Institute recommends the Minister to include tisagenlecleucel (Kymriah®) in the health insurance package, provided the price negotiations with the marketing authorisation holder successfully deliver a net price that does not exceed that of the existing treatment.
Tisagenlecleucel (Kymriah®) is indicated for the treatment of:
- paediatric and young adult patients up to age 25 with refractory B-cell acute lymphoblastic leukaemia (r/r B-cell ALL), with a recurrence after transplantation or with a second or later recurrence of B-cell ALL;
- adult patients with recurring or refractory diffuse large cell B-cell lymphoma (r/r DLBCL) after 2 or more lines of systemic therapy.
At the time, the National Health Care Institute also ruled that tisa-cel did not meet the criterion of established medical science and medical practice for the second indication, r/r DLBCL after two or more lines of systemic therapy.
The National Health Care Institute deemed the effect of tisa-cel on survival gain too uncertain. Important points of criticism were the as yet immature data on overall survival, uncertainty about the standalone effect of tisa-cel compared to the effect of bridging therapy, and the large dropout rate among patients after inclusion in the study but before tisa-cel administration.
The above-mentioned criticisms have been refuted by newly published long-term data from the tisa-cel registration study. The standard treatment nowadays for patients with r/r DLBCL after two or more lines of systemic therapy consists of axicabtagene ciloleucel (axi-cel, Yescarta®), which is also an anti-CD19 CAR-T cell therapy. This is why an indirect comparison was made between tisa-cel and axi-cel in the reassessment.
The National Health Care Institute recommends the Minister to include tisagenlecleucel (tisa-cel, Kymriah®) in the health insurance package for treating adult patients with recurrent or refractory diffuse large-cell B-cell lymphoma (r/r DLBCL) after 2or more lines of systemic therapy, provided that the net price does not exceed the net price of the existing treatment with axicabtagene ciloleucel after successful price negotiations with the marketing authorisation holder. As the value is equal when compared to axi-cel, which is already being reimbursed, and there are no indications that either product is preferable to the other, we advise the Minister to take the existing discount on axicabtagene ciloleucel into account during the price negotiations. We would like to point out that the Insured Package Advisory Committee has recommended that the price for a treatment should be reduced when more resources are available.