The health care system in England and Wales may soon stop funding the use of the drug Revlimid ^[1] (lenalidomide) to treat multiple myeloma ^[2].

The agency responsible for controlling health care costs in those countries has issued a preliminary ruling that treating myeloma with Revlimid is not cost effective.

The agency – the National Institute for Health and Clinical Excellence ^[3] (NICE) – admits that the drug is clinically effective. The once-a-day capsule has been shown to extend the lives of myeloma patients by nearly three years. As a result, Revlimid is now a standard treatment for myeloma in much of Europe and the United States and is used in more than 60 countries across the world.

NICE, however, argues that Revlimid’s cost is too great for the benefit it typically provides. In England and Wales, Revlimid costs about £4,500 ($7,300) per month of treatment.

If NICE’s preliminary ruling is reflected in the agency’s final decision – due next January – it would prevent most multiple myeloma patients in England and Wales from being treated with Revlimid. The government funded National Health Service, which must adhere to NICE’s guidelines, provides almost all health care in England and Wales.

Myeloma patient organizations in the United Kingdom are dismayed by the NICE decision. The chief executive of Myeloma UK said “This is yet another instance of patients losing out because NICE and the pharmaceutical company have failed to effectively interpret an impressive set of [clinical trial] data in what is no more than a game of professional one-upmanship.”

“NICE and a pharmaceutical company have once again failed to achieve excellence in what they do.”

Some analysts believe, though, that NICE and Revlimid’s manufacturer, Celgene, will reach a compromise that will allow Revlimid to be used regularly in England and Wales.

NICE and the manufacturer of another myeloma medication, Velcade, were able to reach such a compromise last year.

In the Velcade case – as with Revlimid – NICE initially ruled that the drug was not cost effective. NICE changed its guidance in its final ruling, however, when Velcade’s manufacturer agreed to cover the cost of the drug for patients who do not respond to it.

Revlimid’s manufacturer, Celgene, believes NICE’s recent ruling ignores important issues. Andrew Robertson, the company’s general manager for the U.K. and Ireland, said: 'Whilst we recognize that NICE has an important role in recommending medicines that offer greatest value for money to the [National Health Service], we believe that the current appraisal process disadvantages patients with rarer diseases, where it is proportionately more expensive to develop new medicines.”

Robertson added, though, that “Celgene is committed to working with NICE, the Department of Health and the myeloma community to ensure that the final NICE guidance will be positive and patients with myeloma can have the opportunity to live longer with their cancer controlled. “

Further details on the NICE decision can be found in an article ^[4] from the Daily Mail and in another article ^[5] from PharmaTimes.Com. The full text of NICE's ruling is available as a PDF document here ^[6].