October 30, 2008

Celgene: NICE Negative Recommendation to Restrict Revlimid Sales

Revlimid has become the latest in a series of oncology drugs that have failed to satisfy NICE's cost-effectiveness criteria. As a result, Celgene's drug will not be available to multiple myeloma patients on the UK's National Health Service. The regulatory decision will restrict Revlimid's commercial potential with patients now likely to be switched to other treatments such as Thalomid and Velcade.

Revlimid (lenalidomide) was approved in combination with dexamethasone for the treatment of myeloma by the FDA in June 2006 and by the EMEA in June 2007. Approval followed positive results from two Phase III trials (MM-009 and MM-010), in which Revlimid in combination with dexamethasone was compared to dexamethasone alone for the second-line treatment of refractory multiple myeloma.

However, the National Institute for Health and Clinical Excellence (NICE) stated that it would not recommend Revlimid for treatment of myeloma in the UK because it is not cost effective. In addition, NICE criticized the study design which led to Revlimid's approval. NICE claims that validity of the clinical data obtained from the MM-009 and MM-010 trials may have underestimated the treatment effect in the dexamethasone comparator arm. Overall survival in the dexamethasone arm may have improved over time since completion of these trials, thereby making Revlimid plus dexamethasone worse value for money because the survival benefit may not be as large.

The NICE appraisal committee did nevertheless concede that Revlimid is an important step forward in the treatment of multiple myeloma and could be used as an alternative to Velcade (bortezomib; Johnson & Johnson). The UK medicines watchdog has received much criticism recently from UK clinicians who claim that its decisions result in UK patients receiving sub-standard therapy in comparison with other major markets.

NICE's negative recommendation will restrict Revlimid sales to private sector patients who form a small percentage of the total patient population. Patients who were receiving Revlimid on the NHS may switch to Thalomid (thalidomide; Celgene/Pharmion) or Velcade, leading an increase in UK sales for the two drugs. It is important to note, however, that NICE did not initially recommend Velcade for use in the UK but rethought its decision after Johnson & Johnson offered to reimburse treatment costs of unresponsive patients. The UK market now represents about 2.9% of Velcade's worldwide sales.

It seems that Johnson & Johnson has set a precedent in UK oncology drug pricing, which may be the way to secure a NICE recommendation. Although it is uncertain as to whether Celgene will look to follow this strategy, the company has until November 18, 2008, when NICE's decision becomes final, to address the issues raised.