Home / Intelligence /

Search

Key Takeaways from the ISPOR Europe 2022 Conference

December 12, 2022 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, including manufacturers, regulatory leaders and health economists. Among the myriad of topics covered, digital health emerged as a hot topic for podium sessions, poster presentations and group discussions. A highlight for Trinity Life Sciences was presenting two posters,…

Read Now

The German Financial Stabilization of Statutory Health Insurance System Act

October 31, 2022 Executive Summary: Germany’s ‘Financial Stabilization of Statutory Health Insurance System’ Act (GKV-Finanzstabilisierungsgesetz) was first proposed in March 2022 by Health Minister Professor Karl Lauterbach to help tackle the country’s economic deficit Updated (January 13, 2023): The act was adopted by the Bundestag (German Federal Parliament) in October 2022. Most reforms have entered into force in November 2022, with the exception of the reduced sales threshold for orphan drugs (December 2022), the increased manufacturer rebate (January 2023) and…

Read Now

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 MoH (Ministero della Salute, Ministry of Health). The algorithm introduced in 2017 provides a multi-dimensional approach: innovativeness will be judged by AIFA’s CTS (Commissione Tecnico-Scientifica,…

Read Now

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

March 29, 2022 Executive Summary 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 immediately after the evaluation by the Transparency Committee (TC) In these cases, price negotiations will start while the new therapies are already on the market This new reform started in January 2022 as part of a two-year pilot project and is expected to significantly reduce…

Read Now

EU Adopts Regulation on Pan-European Health Technology Assessment

February 18, 2022 Executive Summary A new pan-European Health Technology Assessment (HTA) regulation that will redefine the processes for the evaluation of new medicines in the EU entered into force in January 2022 Although it will not become fully active until 2025, the new regulation will require EU member states to give “due consideration” to joint clinical assessment (JCA) reports and provide feedback to the European Commission These new JCAs will only focus on the clinical domain of HTAs and…

Read Now

Key Changes to Health Technology Assessments (HTAs) in the UK

February 02, 2022 The National Institute for Health and Care Excellence (NICE) will mark the start of 2022 by implementing changes to health technology assessments (HTAs), demonstrating adaptability of regulatory bodies as medical technologies continue to evolve. The final HTA changes aim to provide earlier and more equitable access to treatments as well as display increased flexibility in the evaluation of new health technologies. As part of NICE’s plan to modernize healthcare, the changes will apply to both digital therapeutics…

Read Now

Bypassing NICE: Manufacturers are Looking Towards NHS England to Support Early Access

December 07, 2021 Executive Summary The National Institute for Health and Care Excellence (NICE) is the major reimbursement body and pathway to achieving market access in England, although products that have not been evaluated by NICE or have received a negative NICE outcome can still achieve local access through CCGs (Clinical Commissioning Groups) In 2017, NHS England announced deals facilitating patient access to two innovative treatments (KADCYLA and STRENSIQ). KADCYLA’s previous negative NICE recommendation in HER2+ breast cancer and strong…

Read Now