NICE says Revlimid costs too much
This article was originally published in Scrip
Celgene's Revlimid (lenalidomide) is not sufficiently cost-effective for routine treatment of multiple myeloma in the national health service in England and Wales, the National Institute for health and Clinical Excellencehas found. Draft guidance from the institute says lenalidomide in combination with dexamethasone is not recommended for the treatment of multiple myeloma in people who have received at least one prior therapy.
The provisional guidance – which might be altered after a consultation period that ends on November 18th – is likely to reignite controversy over health technology assessment in the UK. Revlimid came to national attention last month when a 55-year-old patient won an emergency injunction ordering that the product be used to treat his multiple myeloma (Scrip Online, September 11th, 2008).
Until NICE has issued guidance, local healthcare authorities can decide whether or not to use individual treatments, sometimes on a case-by-case basis; once NICE guidance is published, NHS organisations across the country are expected to implement it within three months. If the institute's negative assessment of Revlimid is confirmed, no patients would be likely to receive the drug or have it administered at public expense. The government is now considering whether to allow patients to purchase expensive drugs independently while receiving associated healthcare in the state-run system.
The NICE appraisal committee accepted that lenalidomide was an important advance in the treatment of multiple myeloma and could be considered as an alternative to Janssen-Cilag's (Johnson & Johnson) Velcade (bortezomib). NICE recommended Velcade in the same indication last year, but only after the company agreed to a risk-sharing scheme through which the company would assume the cost of treating non-responders (Scrip Online, October 24th, 2007).
In considering the clinical and cost-effectiveness of Revlimid, the committee noted that the optimal sequence of agents to use in treating multiple myeloma was unclear and would depend on several factors, including a patient's treatment history, comorbidities and disease characteristics.
Each of the scenarios considered by the committee in treating multiple myeloma showed an incremental cost-effectiveness ratio for Revlimid that was outside the range that would normally be considered acceptable. A comparison of lenalidomide plus dexamethasone with bortezomib, for example, resulted in a particularly high incremental cost-effectiveness ratio, and this would increase further if the bortezomib response scheme were taken into account, the committee noted.
The appraisal committee also noted other weaknesses in the manufacturer's model. The costs and utility decrements due to adverse effects were not fully included. The cost-effectiveness ratio would be higher still if the costs of anti-thrombosis prophylaxis were used in the model. And the utility in the model for the pre-progression state was that of the normal population at age 54, which the committee said was considerably younger than the average age of people who usually develop multiple myeloma.