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.
More from Europe
England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.
In a historic move for Africa, five products have been backed for approval via a pilot that tested a continental listing process.
Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.
The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.
More from Geography
The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.
In a historic move for Africa, five products have been backed for approval via a pilot that tested a continental listing process.
CMED, which sets medicine prices in Brazil, has published the maximum price adjustment index for 2025.