The U.K.’s National Institute for Health and Care Excellence (NICE) has published draft guidance rejecting the combination of venetoclax and rituximab for the treatment of chronic lymphocytic leukemia (CLL). The drugs, produced by AbbVie and Roche, respectively, also failed to win approval from the nation’s Cancer Drug Fund, which provides funding and access to experimental treatments.
NICE based its preliminary decision on data that failed to show that the venetoclax-rituximab combination performed better than ibrutinib, a standard CLL treatment. The agency also said that inconsistencies in AbbVie’s economic models prevented the creation of a plausible cost-effectiveness estimate for venetoclax, currently listed at £4,789.47, or about $6,100, for a 12-tablet pack.
The comment period for the draft guidelines will extend into mid-November, and the appraisal committee will meet at the end of the month for a final recommendation. The manufacturers will likely seek to win approval by lowering the drugs’ costs and providing new evidence for the treatment’s cost-effectiveness.
The combination was approved to treat CLL the by U.S. Food and Drug Administration in July, venetoclax’s second indication for the disease in the U.S.