NICE seeks more Glivec data

The U.K.'s NICE issued a preliminary appraisal for Glivec imatinib from Novartis AG (NYSE:NVS; SIX:NOVN) for the adjuvant treatment of gastrointestinal stromal tumors (GISTs) after surgery. The committee requested further clarification of existing data, including a revised cost-effectiveness analysis for patients at significant risk of recurrence and for the subgroups with a moderate risk and a high risk of recurrence. Glivec ( Gleevec - U.S.) is approved for the adjuvant treatment of adult patients who are at significant risk of relapse following resection of stem cell factor ( SCF) receptor tyrosine kinase (c-Kit; KIT; CD117)-positive GIST.

The agency noted the incremental cost-effective ratios (ICERs) for Glivec compared with no adjuvant treatment in Novartis' submission were below L30,000 ($45,032) per quality-adjusted life year (QALY) gained for most scenarios, including an ICER of L6,100 per QALY gained for the high-risk subgroup with one year of treatment. However, NICE said the ICERs were also associated with a great deal of uncertainty. It is generally accepted that a technology must have an incremental cost less than or equal to L20,000-L30,000 per QALY for NICE to consider it cost-effective. ...