NICE draft guidance negative on Celgene’s Revlimid

UK health care cost watchdog the National Institute for Health and Care Excellence (NICE) has today issued draft guidance that does not recommend US biotech firm Celgene’s (Nasdaq: CELG) Revlimid (lenalidomide) for treating low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

Myelodysplastic syndromes (MDS), which are diagnosed in around 2,000 people each year in England, are a group of bone marrow disorders characterised 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 anaemia 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 characterised by a chromosomal abnormality called a deletion 5q cytogenetic abnormality. At the moment, for patients with the particular kind of MDS considered in this appraisal who are have increased transfusion-dependence, the main treatment option is best supportive care, which includes blood transfusions.

Uncertainty as to whether lenalidomide actually extends lives

Commenting on the draft guidance, NICE chief executive Sir Andrew Dillon said: “The committee heard from clinical experts that lenalidomide is an effective therapy. However, the data provided by the company showed uncertainty about whether lenalidomide actually extended lives.”

Consultees, including the manufacturer, health care professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation. Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued. Closing date for comments on the draft guidance is June 11, 2014.

Until final guidance is issued, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.

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