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Using Transparency in Coverage Reimbursement Insights to Inform Payer and Provider Contracting Strategy

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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Rise with the Waves: Italy – AIFA Restructuring and Budget Reforms – Stepping into a New (Uncertain) Future?

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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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…

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Cell and Gene Therapies: Six Global Trends We Are Watching in 2024

Published February 15, 2024

2023 was a busy year for cell and gene therapies (C&GT). 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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Priced Out: Generic Therapy Price Competition and Drug Shortages

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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Key Takeaways and Learnings from ASH 2023

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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Insights & Analytics in Life Sciences: How to Embrace a Future with Generative AI

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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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…

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Closing the Gap: Reflections on the 2023 Milken Institute Future of Health Summit

Published November 17, 2023

Introduction The Trinity team recently attended the Milken Institute’s 2023 Future of Health Summit in Washington, DC. Its theme was “Closing the Gap” in healthcare – as chronic disease becomes more prevalent worldwide and the average life expectancy in the US declines to its lowest level since the early 1990’s, what can be done? The sessions explored how industry leaders, government officials, nonprofits, and patients can work together to reverse the declining and diverging metrics we see in healthcare outcomes…

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Beyond the Price Tag: Understanding Colombia’s New Pricing Policy

Published November 7, 2023

In August 2023, the Colombian government published a new pricing policy outlining that the list price of new medicines in Colombia will be established based on their therapeutic value category, resulting from an assessment conducted by the Instituto de Evaluation Tecnológica en Salud (IETS). The outcomes of the therapeutic assessment are then reported to the National Commission for Prices of Medicines and Medical Devices (CNPMDM), which is responsible for setting the list price of the new drugs. Up until now,…

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