NICE Draft Guidance Approves Lenalidomide as Maintenance Treatment for Multiple Myeloma

Dawn O'Shea

January 29, 2021

The National Institute for Health and Care Excellence (NICE) has published draft guidance recommending lenalidomide (Revlimid, Bristol-Myers Squibb) as first maintenance treatment after an autologous stem cell transplant for newly diagnosed multiple myeloma.

The decision follows a review of clinical trial evidence from the phase 3, open-label, randomised Myeloma XI. The NICE appraisal committee concluded that the data suggest that lenalidomide as a maintenance treatment is associated with improved progression-free survival and overall survival.

NICE has requested an exception direction from the Department of Health and Social Care to permit off-label use. However, NHS England and NHS Improvement have agreed that the treatment will be funded in the usual way.

Lenalidomide costs £3780 per treatment cycle at its list price. NICE says a confidential commercial arrangement has been agreed with the company which makes lenalidomide available to the NHS at a discounted price.

Lenalidomide is administered as an oral capsule taken daily and does not require the patient to attend hospital. The drug has a licensed schedule of 28 days of dosing per 28-day cycle. However, NICE is recommending 21 days of dosing per 28-day cycle, saying this treatment schedule better aligns with standard NHS dosing practices and lowers costs, and has been shown to be clinically effective.

Consultees now have the opportunity to appeal against the draft recommendations. If no appeals are received, final guidance is expected to be published next month.

This article originally appeared on Univadis, part of the Medscape Professional Network.

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