MabThera regulatory update

The U.K.'s NICE issued a preliminary appraisal recommending MabThera rituximab from Roche in combination with glucocorticoids to induce remission in adults with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, also known as severely active granulomatosis with polyangiitis and microscopic polyangiitis. NICE only recommends MabThera if further cyclophosphamide treatment would exceed the maximum cumulative cyclophosphamide dose. The committee said the most plausible incremental cost-effectiveness ratios (ICERs) for MabThera in patients with ANCA-associated vasculitis who can have cyclophosphamide was £12,100 (19,331) per quality-adjusted life year (QALY) gained for the comparison of 2 courses of cyclophosphamide followed by 1 course of MabThera with 2 courses of cyclophosphamide. Comments are due Oct. 24, with a second appraisal committee meeting scheduled for Nov. 27. Final guidance is expected in March 2014.

The draft reverses a preliminary appraisal issued in July (see BioCentury, July 29). Roche submitted clarification on the definition of severe disease and of the subgroup of people for whom avoiding cyclophosphamide treatment is desirable. The pharma also submitted 18-month follow-up data from the Phase II/III RAVE trial with MabThera and a revised economic model, which represents the management of severe ANCA-associated vasculitis in the U.K., including current comparators and routine clinical practice. Roche did not submit a patient access scheme. ...