The National Institute for Health and Care Excellence (NICE) has approved the use of Novartis' lymphoma treatment tisagenlecleucel, brand name Kymriah.
Kymriah is recommended for use within the Cancer Drugs Fund as an option for treating relapsed or refractory diffuse large B-cell lymphoma in adults after 2 or more systemic therapies and only if the conditions in the managed access agreement are followed.
Managed access schemes are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.
NICE state that:
'More evidence on tisagenlecleucel is being collected, until June 2023. After this NICE will decide whether or not to recommend it for use on the NHS and update the guidance. It will be available through the Cancer Drugs Fund until then.
If you are not eligible for tisagenlecleucel therapy but are already having it, you should be able to continue until you and your doctor decide when best to stop.'
The NICE committee made the following observations.
Diffuse large B-cell lymphoma is an aggressive sub-type of non-Hodgkin lymphoma. Outcomes for people with refractory or relapsed disease are poor.
The disease has low levels of response to treatment, and is associated with limited survival. A patient expert explained that in a survey of over 100 people with the disease, the most commonly reported side effects of treatment included fatigue, hair loss, memory loss and joint pain.
The clinical experts explained that there is no standard treatment for people with relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapies and there are limited curative options.
They also explained that treatment after 2 or more systemic therapies may be offered with palliative intent, but chimeric antigen receptor (CAR) T‑cell therapy offers a potential cure.
The committee understood that CAR T‑cell therapies (such as tisagenlecleucel) are advanced therapies for cancers and belong to a new generation of personalised cancer immunotherapies that are based on collecting and modifying patients' own immune cells to treat their cancer.
The committee concluded that there is an unmet need in this population and that as a CAR T‑cell therapy, tisagenlecleucel offers a potential new treatment option that may improve the chance of survival.
About Kymriah (source NICE)
Tisagenlecleucel (Kymriah, Novartis) is indicated for the 'treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after 2 or more lines of systemic therapy'.
Tisagenlecleucel is an immunocellular CAR T‑cell therapy. It contains the patient's own T cells (a type of white blood cell) that have been modified genetically in the laboratory so that they make a protein called chimeric antigen receptor (CAR). CAR can attach to another protein on the surface of cancer cells called CD-19. When tisagenlecleucel is given to the patient, the modified T cells attach to and kill cancer cells, thereby helping to clear the cancer from the body.
Kymriah was first made available in the EU in 2018. It is manufactured by Novartis.
European Medicines Agency website page for Kymriah
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NICE information on Kymriah in treating lymphoma
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About Diffuse large B-cell lymphoma
About Non-Hodgkin lymphoma