Cost regulators have issued a preliminary rejection of Janssen Cilag's Velcade (bortezomib) for certain patients with newly diagnosed multiple myeloma (MM), asking for more data comparing its drug to standard treatment.

The National Institute for Health and Care Excellence (NICE) has issued draft guidance turning down the first-line use of Velcade in patients with the blood cancer, after uncertainties in the data led an independent appraisal committee to conclude that its cost per QALY would likely "substantially" exceed £39,000.

Nevertheless, it also agreed that treatment with Velcade and dexamethasone was associated with statistically significant improvements in post-induction overall response rates compared with vincristine, adriamycin and dexamethasone, while induction treatment with Velcade, thalidomide and dexamethasone boosted overall response rates and progression-free survival compared with thalidomide and dexamethasone. 

The Institute has therefore asked for further evidence from Janssen on the use of its drug (with dexamethasone and thalidomide) compared with the current standard regimen (cyclophosphamide, thalidomide and dexamethasone), to help it better determine whether the regimen could offer the NHS value for money in this setting,

NICE already recommends Velcade as an option for the treatment of progressive MM in people who are at first relapse having received one prior therapy and who have undergone, or are unsuitable for, bone marrow transplantation. 

The drug's price tag is £762.38 per 3.5mg vial, which equates to an average cost of a course of treatment when given with dexamethasone of £12,260.91, and £24,840.10 when administered with dexamethasone and thalidomide.