Regulatory Focus™ > News Articles > NICE Issues Draft Rejection for Celgene's Myelodysplastic Syndrome Drug Revlimid

NICE Issues Draft Rejection for Celgene's Myelodysplastic Syndrome Drug Revlimid

Posted 12 July 2013 | By Louise Zornoza

The UK's National Institute for Health and Care Excellence (NICE) issued new draft guidance on 12 July 2013 recommending against reimbursement for Celgene's Revlimid (lenalidomide) for treatment of myelodysplastic syndromes (MDS) - a decision made against the advice of clinical experts who said the drug is an effective therapy that decreases the need for blood transfusions and decreases hospitalization time.

NICE based its decision on the finding that Celgene "did not provide enough certain evidence to justify the price they are asking the National Health Service (NHS) to pay." 

Myelodysplastic syndromes are a group of bone marrow disorders characterized by the underproduction of one or more types of blood cells due to dysfunction of the bone marrow. Around 2,000 people are diagnosed with the syndromes each year in England. MDS can lead to life threatening disease including acute myelogenous leukemia (AML), as well as anaemia and increased risk of bleeding and infections. NICE's evaluation of Revlimid 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.

Commenting on the draft guidance NICE Chief Executive Sir Andrew Dillon noted that another drug, Azacitidine, is also available for treating MDS and has been recommended for use by NICE and NHS. "However, at the moment, for patients with this particular kind of MDS, the main treatment option is best supportive care, which includes blood transfusions," he added.

NICE Draft Guidance

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