Venclyxto sales and marketing update

NICE issued draft guidance recommending against the use of Venclyxto venetoclax from AbbVie to treat chronic lymphocytic leukemia (CLL) in adults. The committee found “substantial shortcomings” in the clinical effectiveness data submitted by AbbVie and concluded that treatment benefits of venetoclax were uncertain. In December, the European Commission conditionally approved Venclyxto to treat CLL in patients with chromosome 17p deletions or tumor protein p53 (TP53; p53) mutations who are unsuitable for or have failed a B cell receptor pathway inhibitor or in patients without 17p deletions or TP53 mutations who have failed both chemo-immunotherapy and a B cell receptor pathway inhibitor.

NICE was concerned that the clinical effectiveness data for venetoclax only came from single-arm trials that were conducted in a broader patient population than the product’s approved indication.
The committee also said the incremental cost-effectiveness ratios (ICERs) for venetoclax compared with best supportive care were higher than the normally range considered cost-effective for use in the NHS. A 112-pack of 100 mg Venclyxto tablets, which is enough for 28 days of treatment at the recommended daily dose of 400 mg starting at week 5 after dose titration, costs £4,789.47 ($5,994.50)...