New draft guidance from NICE does not recommend the use of Celgene’s Revlimid (lenalidomide) to treat multiple myeloma in patients who have relapsed after taking Janssen’s Velcade.
There is currently no cure for this type of cancer, which develops from cells in the bone marrow, but a thalidomide regimen is typically used as a first-line treatment to slow the disease’s progress.
Velcade (bortezomib) is already recommended on the NHS as an option for people who are unable to take thalidomide – but, despite Celgene providing more information on Revlimid, NICE’s has not recommended the brand for this indication.
The cost-effectiveness watchdog has now put this draft guidance out to consultation. If finalised it would not recommend Revlimid, in combination with dexamethasone, to treat multiple myeloma in people whose condition has relapsed for the first time and who have received one prior treatment with bortezomib.
Revlimid would also not be recommended in those for whom thalidomide is contraindicated or cannot be tolerated and for whom stem cell transplantation is not appropriate.
NICE chief executive Sir Andrew Dillon said: “We are now looking specifically at how well lenalidomide works after someone has received bortezomib, and whether it provides value for money.
“There is very little evidence in the population we are currently appraising this drug for, and the analyses indicate that lenalidomide is not a good use of NHS resources,” he concluded.
No clinical studies have been done since 2009 to find how well Revlimid works versus other therapies and Celgene’s further data “did not lessen the uncertainty in the results”, NICE said.
Celgene has not yet presented NICE with a patient access scheme for this new appraisal – although current guidance for the drug is based on a scheme where the manufacturer funds it beyond 26 cycles, normally for two years.
A 21-capsule pack containing capsules of the recommended 25mg starting dose costs £4,368: the drug is taken orally once a day on days 1–21 of repeated 28 day cycles.
Revlimid is approved in Europe to treat patients with a rare form of the blood cancer myelodysplastic syndrome (MDS) as well as in combination with dexamethasone to treat multiple myeloma. In the US, the drug is marketed for both of these plus a mantle cell lymphoma indication.