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The German Financial Stabilization of Statutory Health Insurance System Act

October 31, 2022 Executive Summary: Key Policy Updates AMNOG Rebate Negotiations AMNOG* rebate negotiations will be modified to give the GKV-SV increased powers in the pricing negotiations. HIGH P&MA IMPACT: The new negotiation framework increases the threshold of added benefit required for therapies to receive a premium vs. comparator therapies, specifically by limiting the pricing […]

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Pharmaceutical Innovation: Italy’s AIFA Algorithm for Assessing New Products

April 8, 2022 The Assessment Process of Innovativeness of a New Medicine in Italy In April 2017, AIFA (Agenzia Italiana del Farmaco, Italian Medicines Agency) released an upgraded algorithm to assess and evaluate the level of innovativeness of new drugs seeking reimbursement from the EUR one billion innovative medicine fund made available by the Italian […]

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France Pilots Opportunity to Increase Speed to Reimbursement for Select Innovative Products

French president Emmanuel Macron announced a two-year trial that will allow pharmaceutical products that receive an ‘Amélioration du Service Médical Rendu’ (ASMR) rating of IV or better to get reimbursement […]

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