Scottish Medicines Consortium disappoints Celgene
pharmafile | July 8, 2014 | News story | Sales and Marketing | Celgene, SMC, Scottish Medicines Consortium, imnovid, myeloma
Celgene admitted it is ‘disappointed’ with the Scottish Medicines Consortium decision not to recommend blood cancer therapy Imnovid for patients with multiple myeloma.
The manufacturer had hoped that Imnovid (pomalidomide) would be used in Scotland in combination with dexamethasone for adults with relapsed and refractory forms of the disease – which is incurable – who have received at least two prior treatments.
These could include its own Revlimid (lenalidomide) and Janssen’s Velcade (bortezomib), and patients would have demonstrated disease progression on the last therapy.
Multiple myeloma causes plasma cells in the blood to replicate uncontrollably, disrupting the normal production of blood cells, and can affect any part of the body where bone marrow is present.
But although trials found that Imnovid plus dexamethasone ‘significantly increased’ progression-free survival compared with high-dose dexamethasone in this patient group, the SMC found a number of problems with Celgene’s submission and does not think the evidence stacks up.
The firm “did not present a sufficiently robust economic analysis and in addition their justification of the treatment’s cost in relation to its benefits was not sufficient to gain acceptance by SMC,” a statement from the organisation suggests.
“We are obviously disappointed with today’s decision especially since the SMC acknowledged that pomalidomide substantially improved the life expectancy of patients with relapsed and refractory multiple myeloma,” says Adrian Kilcoyne, medical director, Celgene UK & Ireland.
“We will of course do everything we can to try and ensure that patients in Scotland are able to access the treatment and have therefore already re-entered into discussions with the SMC,” he adds.
Multiple myeloma is the second most common type of blood cancer and there are around 400 new cases per year in Scotland: it affects an estimated 9,900 people in the UK and Ireland.
“This is a very disappointing decision for myeloma patients in Scotland,” says Myeloma UK chief executive Eric Low. “The absence of approved treatments in the multiply relapsed setting is a major area of unmet need and we know that Imnovid offers a significant survival advantage compared to currently available treatments.”
He adds: “We are frustrated that the SMC and the manufacturer did not resolve their differences regarding the cost-effectiveness of Imnovid during the appraisal process.”
The charity said last year it would conduct a trial that will provide access to the drug, which was launched in the UK in August, for 250 relapsed and refractory myeloma patients in the UK.
Part of the innovative Myeloma UK Clinical Trial Network, the trial will be looking at combinations of pomalidomide and dexamethasone.
Adam Hill
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