Blog
Published March 20, 2024
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 by the appointment of a new acting chairman, highlighting the need for a stable and collaborative leadership within AIFA.
Although AIFA’s overhaul has been implemented following a year-long delay due to bureaucratic complexities and is currently facing uncertainties, it will be…
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Webinars
Available On Demand
Trinity Life Sciences is pleased to release our highly anticipated white paper, the Annual State of Global Market Access. This year’s white paper focuses on six key global market access trends and provides payer perspectives on these trends. We explore the consequences of new therapeutic advances and policies aiming to control costs globally and the impacts for pharma manufacturers.
Register for this webinar for a deeper dive into a few trends in the white paper. Join experts from our Evidence,…
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Blog
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…
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Blog
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…
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Webinars
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…
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Blog
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…
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Blog
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…
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Scientific Publications
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…
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Blog
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…
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Blog
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…
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