12:00 AM
Nov 24, 2008
 |  BioCentury  |  Regulation

NICE makes an exception

Draft supplementary advice released this month by the U.K.'s National Institute of Health and Clinical Excellence would allow appraisal committees to recommend NHS coverage of drugs for terminally ill patients even if the treatments normally would be considered too expensive - provided the drug meets patient population and efficacy criteria.

The new criteria won't make a difference for drugs NICE already has rejected. But the benchmarks could provide a new lease on life for four drugs to treat renal cell carcinoma (RCC) and one to treat multiple myeloma (MM) that have received negative preliminary recommendations.

The advice outlines the circumstances in which it may be appropriate to recommend the use of life-extending drugs indicated for small populations with terminal illnesses that would otherwise be considered too expensive by NICE. The criteria will be taken into account for ongoing and new appraisals beginning in January.

The first criterion is that the drug must be licensed for a terminal illness, which NICE defines as one in which a patient is not expected to live for more than 24 months, on average.

A second criterion is that the drug's incremental cost effectiveness ratio (ICER) exceeds £30,000 ($44,000), the upper end of the range NICE normally considers cost effective.

Third, the patient population for which the drug is indicated should not normally exceed 7,000 patients per year. NICE told BioCentury the number is meant to be a guide for the committees,...

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