Patients with a specific type of bone marrow disorder in England and Wales will be disappointed by news that cost regulators have not approved National Health Service use of Celgene's Revlimid (lenalidomide).
In draft guidance published this week, the National Institute for Health and Care Excellence (NICE) has turned down funding for the drug in patients with myelodysplastic syndromes characterised by a a certain chromosomal abnormality called a deletion 5q cytogenetic abnormality.
This is because while clinical experts told the committee that Revlimid is an effective therapy, the data provided by Celgene "showed uncertainty about whether lenalidomide actually extended lives", the Institute said, although it's Committee did concede that a survival benefit was plausible.
Currently, for patients with the particular kind of MDS considered in this appraisal who have increased transfusion-dependence, the main treatment option is best supportive care (BSC).
But the Committee found that even with a patient access scheme (PAS) the cost per QALY for Revlimid compared with BSC could be considerably higher than £25,300 per QALY gained as presented by the manufacturer, and so it could not recommend the drug as a cost-effective option at this time.
Consultees can now comment on the preliminary recommendations until June 11.
The drug was rejected in draft guidelines last year, and further data provided since have thus far failed to sway the Institute's decision.