Home / Intelligence /

Search

Blog

Rise with the waves: Germany – A tale of two high impact policies shaping pharma’s future

Published February 26, 2024

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’ Act (GKV-Finanzstabilisierungsgesetz) in 2023. The evaluation report of these strategies showed that the actual savings for the year fell short of the proposed target (25% deficit, €1.4 Bn vs. target of €1.9 Bn) for all such reforms except 30% higher savings…

Read Now

Blog

Key Takeaways and Learnings from ISPOR Europe 2023

Published December 7, 2023

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 both academics and the life sciences industry, including manufacturers, regulatory leaders and health economists, to consider the latest challenges and opportunities being addressed by health economics and outcomes research. Topics included Joint Clinical Assessments (JCAs), access to innovative therapies, environmental…

Read Now

Webinars

Winning in Europe: How to Approach Go-To-Market?

Available On Demand

Join Leslie Orne, President and CEO at Trinity Life Sciences, as she discusses how Trinity is helping life sciences companies launch in Europe at the Jefferies London Healthcare Conference. Key Topics: Trinity’s data-driven and insight-driven approach to support clients across their commercial journey. Trinity’s expertise in helping clients plan market access, evaluate strategic options, develop a shortlist of partners and optimize their approach. How Trinity’s local team in Europe can bring in-depth expertise, local language, regulatory experience and in-market experience…

Watch Now

Blog

Key Takeaways from the ISPOR Europe 2022 Conference

Published 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, and one podium…

Read Now

Blog

The German Financial Stabilization of Statutory Health Insurance System Act

Published 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 the additional rebate…

Read Now

Scientific Publications

Burden of cremophor-related paclitaxel therapy on patients with ovarian cancer: A patient focused study from the United Kingdom, Germany, and Spain.

Cremophor EL (CrEL) is a solubilizer used in paclitaxel and is associated with side effects (i.e., hypersensitivity reactions, peripheral neuropathy). Current CrEL-containing therapies require long infusion times (2-4 hours) and pre-medication with steroids to manage these side-effects. However, the holistic burden of CrEL on patients is not well studied. This study aimed to characterize the burden associated with CrEL-paclitaxel treatment on patients with ovarian cancer, including clinical, safety, and quality of life (QoL) implications. Authors Diana Brixner, Anke-Peggy Holtorf, Ayesha…

Read Now

Blog

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

Published 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, Technical and Scientific…

Read Now

Blog

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

Published 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 the average time…

Read Now

Blog

EU Adopts Regulation on Pan-European Health Technology Assessment

Published 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 thus they will…

Read Now

Blog

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

Published February 2, 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 as well as…

Read Now