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Germany’s IQWiG Downs Two Drugs In One Day

 
• By Faraz Kermani

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.

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.

IQWiG said it was unable to find any evidence of additional benefit of Trobalt – marketed in the U.S. as Potiga and approved by FDA on June 10, 2011 – for partial seizures associated with epilepsy over existing therapies. The decision should not have come as a surprise to GSK/Valeant, since it did not use the active comparator requested by G-BA in its dossier submission

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