Across Europe, 2025 accelerated a shift from sequential regulatory and access steps to more connected process through the Joint Clinical Assessment. Regulatory approvals, and clinical portion of HTA evaluation are now more tightly linked, which has the potential to bring…
March 2025 marked a pivotal moment for pharmaceutical and biotech companies operating in the European Union (EU) as the first two molecules began to proceed through the Joint Clinical Assessment (JCA) process. At a recent seminar hosted by…
Germany's Medical Research Act (Medizinforschungsgesetz or MFG), which came into force on October 30, 2024, is a major legislative reform aimed at strengthening Germany’s position as an attractive environment for medical innovation and pharmaceutical development. The act provides for…
One trend Trinity Life Sciences has observed and that was reinforced by stakeholders at ISPOR EU is the importance of evidence in healthcare decision-making. This trend was highlighted particularly in the context of joint clinical assessments (JCA) and health…
Executive Summary The global payer landscape is rapidly evolving and is expected to continuously impact manufacturers' decisions about new launches, portfolio management, trial design and importantly, pricing and market access strategy. In the UK, several policy reforms have been…
Executive Summary The latest publication of new reimbursement regulations in the French Social Security Financing Act (PLFSS 2024), coupled with the recent approval of HEMGENIX® through the direct access scheme in France this past December, underline continued efforts in France…
Executive Summary The Italian Medicines Agency (AIFA) underwent transformative changes on January 30, 2024, following a much-anticipated reorganization. AIFA’s restructuring has already faced challenges, with the recent resignation of the newly created Scientific and Economic Commission's (CSE) chairman followed…
Executive Summary Multiple cost-containment reforms, such as the introduction of a 20% rebate on brand-brand combinations and a temporary increase in the mandatory rebate on drugs to 12%, were implemented under Germany’s ‘Financial Stabilization of Statutory Health Insurance System’…
Trinity Life Sciences recently attended the ISPOR Europe 2023 conference in Copenhagen, Denmark. The main theme of the conference was “HEOR at the Nexus of Policy and Science,” and the event featured unique discussions and workshops across different stakeholders from…
Last month, Trinity attended the ISPOR Europe 2022 conference in Vienna. The main theme of the conference was “Collaborating Across Borders: Building & Using Evidence to Enable Access”, which facilitated many interesting discussions amongst different stakeholders in life sciences,…