NICE U-turn on Celgene’s Revlimid for myelodysplastic syndromes

UK drugs watch dog the National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending US biotech firm Celgene’s (Nasdaq: CELG) Revlimid (lenalidomide) as an option, for treating myelodysplastic syndromes, reversing an  earlier negative decision.

Myelodysplastic syndromes (MDS), which are diagnosed in around 2000 people each year in England, are a group of bone marrow disorders characterized by the underproduction of one or more types of blood cells due to dysfunction of the marrow. MDS can lead to life threatening disease including acute myeloid leukemia (AML), as well as anemia and increased risk of bleeding and infections.

This appraisal focused on the use of lenalidomide for treating people with a specific type of MDS that is characterized by a chromosomal abnormality called an isolated deletion 5q cytogenetic abnormality. At the moment the main treatment option for people with the particular kind of MDS considered in this appraisal is best supportive care including regular blood transfusions.

Change of view based on further info and reduced cost of drug to NHS

NICE chief executive Sir Andrew Dillon said: “The committee heard from clinical experts that lenalidomide is an effective therapy. Celgene – who market lenalidomide – worked with us to provide enough evidence to make it possible for us to recommend it for this group of people. Celgene provided a revised analyses and further information on their proposal for a reduction in the cost of the drug to the NHS (patient access scheme).”

Celgene’s patient access scheme involves the National Health Service paying for lenalidomide treatment for up to 26 monthly cycles. The company will provide the drug free of charge for those people who receive more than 26 monthly cycles.

The draft guidance is now with consultees, who have the opportunity to appeal against it. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.