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NICE issues restricted approval for the use of brentuximab vedotin

written by

Leukaemia Care, Charity

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Brentuximab vedotin is indicated for the treatment of adults with relapsed or refractory ALCL and has been available for use through the Cancer Drugs Fund since 2013. The drug is named Adcetris® and manufactured by Takeda. 

NICE have today issued final guidance, recommending brentuximab vedotin to treat relapsed or refractory systemic anaplastic large cell lymphoma in adults - only if they have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Prior to this, there has been an unmet clinical need for patients with relapsed/refractory ALCL. The standard treatment has previously been chemotherapy and patients typically have short-term overall survival.

NICE have acknowledged this unmet need and see the value in using brentuximab vedotin as an alternative salvage therapy for relapsed/refractory ALCL. The treatment significantly increases quality of life of patients and causes fewer, more manageable, side effects compared to current therapies.

Their decision to limit the use to patients with an ECOG performance status of 0 or 1 was based upon a similar restriction in the criteria for entry to the clinical trials. Hence, NICE claim the evidence and conclusions on quality of life improvements and cost effectiveness were limited to this patient group. This is however a surprising restriction as, for example, a similar patient group was used in the clinical trials for brentuximab vedotin in the treatment of Hodgkin lymphoma, yet the NICE approval recommended the use for all patients. 

The limitation to patients with an EGOC score of 0 or 1 means that brentuximab vedotin is only available to patients who are, at worst, restricted in physically strenuous activity but are still able to carry out light work such as an office job or house work. ALCL patients with an EGOC score of 2 or higher will be unable to access brentuximab vedotin. This equates to around 10-15 of the 45 ALCL patients who would otherwise be eligible to be treated with brentuximab vedotin each year. With these patients being most affected by ALCL, it is likely that the drug could have made a big impact on quality of life of these patients.