NICE issues final draft guidance on pomalidomide for blood cancer
NICE has issued final draft guidance not recommending pomalidomide, also known as Imnovid, for treating multiple myeloma.
Multiple myeloma is a type of cancer that affects plasma cells, which are white blood cell found in the bone marrow. Although it is incurable, there are a number of treatment options to help slow the progress of the disease and improve quality of life. NICE recommends thalidomide for most patients as a first line treatment, and bortezomib for people who are unable to take thalidomide and also as an option after the first treatment has stopped working. For people who have received two prior treatments NICE recommends lenalidomide. This appraisal considers the use of pomalidomide for treating multiple myeloma after third or subsequent relapse.
Commenting on the draft guidance, Sir Andrew Dillon, NICE chief executive, said: "NICE has already recommended a number of treatment options for multiple myeloma – thalidomide, bortezomib and lenalidomide – which can greatly improve the length of time someone can live with the disease and their quality of life. Unfortunately we cannot recommend pomalidomide as the analyses from Celgene, the company that markets pomalidomide, showed that the drug does not offer enough benefit to justify its high price."
The draft guidance is now with consultees, who have the opportunity to appeal against it. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. This draft guidance does not mean that people currently taking pomalidomide will stop receiving it. They have the option to continue treatment until they and their clinicians consider it appropriate to stop.
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Notes to Editors
About the draft guidance
Pomalidomide, in combination with dexamethasone, is not recommended within its marketing authorisation for treating relapsed and refractory multiple myeloma in adults who have had at least 2 prior treatments, including lenalidomide and bortezomib, and whose disease has progressed on the last therapy.
The draft guidance is available at /guidance/indevelopment/GID-TAG448.
Due to the limitations in the evidence presented by the company, the Committee was not able to judge with any confidence how much more effective pomalidomide was compared with the current treatment options.
Pomalidomide is administered orally. The recommended dosage is 4 mg once daily, taken on days 1 to 21 of repeated 28 day cycles. Treatment should continue until disease progression. Adverse reactions may be managed by interrupting or reducing the dose. The price of a pack (21 tablets) of 1 mg, 2 mg, 3 mg or 4 mg tablets is £8,884.
All cost per QALY (Quality Adjusted Life Year) figures presented by the company were over £50,000 compared with bortezomib, and over £70,000 compared with bendamustine plus thalidomide and dexamethasone, and would further increase when a number of more realistic assumptions were included in the model.
The Committee was not able to judge with any confidence how much more effective pomalidomide was compared with the current treatment options based on the available evidence provided before and after consultation. However, bearing in mind the magnitude of the differences in the overall survival estimates between pomalidomide and high dose dexamethasone in the trial, and all data presented to the Committee for comparators, the Committee was persuaded that pomalidomide extends life for at least 3 months on average when compared with standard NHS care. However, considering the currently presented ICERs, the Committee concluded that even with the end-of-life criteria met, the weighting that would have to be placed on the QALYs gained would be too high to consider pomalidomide a cost-effective use of NHS resources. Also, the Committee concluded that the uncertainty in the relative effectiveness of pomalidomide compared with established NHS practice would affect any weighting that could be placed on the QALYs gained.
Pomalidomide is not recommended for use within NHS Scotland (http://www.scottishmedicines.org.uk/SMC_Advice/Advice/972_14_pomalidomide_Imnovid/pomalidomide_Imnovid).
The company estimates a patient population of 669 in England.
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