Tarceva erlotinib regulatory update

The U.K.'s NICE issued a second preliminary appraisal recommending against Tarceva erlotinib from Roche for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients with stable disease after platinum-based first-line chemotherapy. The decision reiterated an initial appraisal issued in June (see BioCentury, June 21). NICE continued to estimate the incremental cost effectiveness ratio (ICER) to be greater than £50,000 ($77,965) per quality adjusted life year (QALY).

The agency also said there was "considerable uncertainty" about the clinical effectiveness of Tarceva as a maintenance treatment. NICE conducted the second appraisal after Roche submitted additional clinical and cost-effectiveness data that were not included in its original evidence submission, which occurred before Tarceva had received European approval in the indication in April. ...