Herceptin trastuzumab regulatory update

The U.K's NICE issued a final appraisal determination (FAD) recommending Herceptin trastuzumab in a more limited population than its approved indication, for which NICE rebuffed the Roche drug in July. The committee now recommends Herceptin in combination with cisplatin and capecitabine or 5-fluorouracil (5-FU) to treat HER2-positive, metastatic adenocarcinoma of the stomach or gastro-esophageal junction in patients who have not received prior treatment and whose tumors express high levels of HER2, as defined by a positive immunohistochemistry score of 3 (IHC3 positive). NICE said gastric cancer affects 8,200 patients in the U.K. each year - of whom about 500 would be eligible to receive Herceptin under NICE's recommendation.

The FAD reverses a July preliminary appraisal recommending against Herceptin in the indication, irrespective of IHC score. NICE said Roche submitted a new analysis of a subgroup of patients with the highest levels of HER2. The committee concluded that Herceptin for this group of patients met the criteria for a life-extending, end-of-life treatment, and therefore was cost-effective. NICE said the most plausible incremental cost-effectiveness ratio (ICER) estimates for the subgroup were in the range of £45,000-£50,000 ($71,000-$79,000) per quality-adjusted life year (QALY) gained. ICER estimates for the full approved population were in the range of £63,100-£71,500 ($100,000-$113,000) per QALY gained (see BioCentury, July 12). ...