In two decisions published on Feb. 15, Germany’s Institute for Quality and Efficiency has turned down GlaxoSmithKline PLC/Valeant Pharmaceutical International’s Trobalt (retigabine) for epilepsy and Novartis AG’s combination anti-hypertensive Rasilamlo (aliskiren/amlodipine). With the decisions, IQWiG has sent a clear warning to manufacturers that any deviation from the comparator selected by the senior reimbursement regulator, the joint federal committee (G-BA), will give their applications little chance of success.
Germany’s IQWiG Downs Two Drugs In One Day
IQWiG turned down both GSK/Valeant’s Trobalt and Novartis’ Rasilamlo for lack of evidence of added benefit, after manufacturers’ choice of comparator deviated from those selected by the G-BA.