Blog
Published April 22, 2024
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 to innovate its healthcare system.
The 2024 PLFSS emphasizes:
Drug access and cost containment, with a higher payback trigger aimed at reducing the government’s payback collections
Temporary reimbursement to ensure continuous treatment of patients with medicines benefitting from the early…
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Blog
Published April 5, 2024
Executive Summary
Canada has undertaken meaningful strategies to transform patient access and ultimately improve health outcomes across the country. Two such potentially high-impact strategies include the planned transformation of the former Canadian Agency for Drugs and Technology in Health (CADTH) into the new Canadian Drug Agency (CDA) over the course of the next five years, as well as the implementation of time-limited reimbursement for specific drugs.
While the Canadian Drug Agency is set to advance Canada’s pharmaceutical system by standardizing…
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Blog
Published April 5, 2024
Executive Summary
“Transparency in Coverage” (TIC) data is a newer data source that has recently become available for mining unique insights in the reimbursement/economics between payers and providers. In 2020, the Federal Government TIC Rule required health insurers and group health plans, including self-funded clients, to provide cost-sharing data to consumers via machine-readable files and a consumer price transparency tool. Beginning July 1, 2022, machine-readable files were published publicly, and include pricing data for covered items and services based on…
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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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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 February 15, 2024
2023 was a busy year for cell and gene therapies (C>). There were regulatory approvals in the U.S. and EU, including both in rare pediatric conditions with no current effective options (e.g., Duchenne muscular dystrophy (DMD)), as well as in indications where competition is better established (e.g., hemophilia A and B).
Towards the end of the year, the FDA approved not one, but two sickle cell gene therapies on the same day, creating instant competition between them. One of these…
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Blog
Published January 29, 2024
Introduction
In the summer of 2023, many oncologists and cancer patients faced an impossible choice. Amidst many challenging treatment decisions, they had to determine how to proceed without two mainstays among oncology therapeutics: cisplatin and carboplatin. While it can sometimes be expected that there may be delays for the newest and most innovative treatments to reach patients, both cisplatin and carboplatin have been available for over twenty years, are used frequently in oncology regimens and are not considered particularly expensive.…
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Blog
Published January 12, 2024
Introduction
The Trinity Life Sciences’ team recently attended the 65th ASH Annual Meeting and Exposition from December 9-12, 2023, in San Diego, California. The conference brought together physicians, scientists and industry experts to share and collaborate on advances in understanding and treating blood cancers and blood disorders. Below are a few of the key insights that the Trinity team observed during the conference:
Advances in CAR-T Therapy: Expansion into New Targets and Therapeutic Areas
Numerous groups across the industry are…
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Blog
Published December 18, 2023
First, A Few Potentially Unsettling Truths
Adoption and adaptation to Generative AI (GenAI) is a strategic imperative for pharma commercial insights departments if they want to maintain and enhance their relevance, impact, and strategic value within their organizations.
Organizations are increasingly data-driven; market research teams that do not leverage AI will struggle to provide the timely, nuanced insights that modern pharma marketing organizations demand, diminishing their role in critical decision-making processes.
Top talent gravitates towards innovation. Departments that fail to…
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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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