Blog
Published June 13, 2025
March 2025 marked a pivotal moment for pharmaceutical and biotech companies operating in the European Union (EU) as the first two molecules began to proceed through the Joint Clinical Assessment (JCA) process. At a recent seminar hosted by Trinity Life Sciences, stakeholders gathered to explore the implications of this new regulatory framework and how to prepare for it.
What is the JCA?
The JCA is a centralized EU initiative designed to harmonize the clinical assessment component of Health Technology Assessments…
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Blog
Published June 9, 2025
Germany’s Medical Research Act (Medizinforschungsgesetz or MFG), which came into force on October 30, 2024, is a major legislative reform aimed at strengthening Germany’s position as an attractive environment for medical innovation and pharmaceutical development. The act provides for confidential negotiated drug pricing, incentives for local clinical trials, simplified clinical trial approvals and harmonization of ethics committee processes.
The MFG is a key part of Germany’s National Pharmaceutical Strategy, adopted by the federal cabinet in December 2023. This National…
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Blog
Published April 29, 2025
The first 100 days of President Trump’s return to the White House have been anything but ordinary. With a true “Flood the Zone” strategy, there has been a flurry of executive orders, leadership reshuffles, and a re-assertion of executive power, which has signaled the administration is interested in seeing what policy options can “stick.” While campaign rhetoric once suggested bold de-regulation with the potential for an industry-friendly reset, the governing reality has been less coherent and opens multiple fronts for…
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Webinars
Available On Demand
Join Value, Access and Pricing experts Max Hunt, Mary Fletcher-Louis and Pinar Bilir as they delve into the emerging role of health equity considerations as a differentiator in value narratives for global HTA (Health Technology Assessment) submissions. NICE’s proposed methods update focused on manufacturer-submitted evidence on health inequalities.This session will explore how HTA agencies are beginning to include health equity in their access recommendations and discuss the practical impact of this trend. Our experts will share insights from Trinity Life…
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Webinars
Available On Demand
Join Trinity Life Sciences for a virtual demo where value, access and pricing experts Max Hunt and Andreia Ribeiro will demonstrate Trinity HTA Vision, our cloud-based dashboard with GenAI capabilities.It is not enough to know what the health technology assessment (HTA) decisions are and when they are made—with the landscape continually evolving, analogues and future impact cannot be judged by looking at decisions alone. Nuanced implications come from expert knowledge of countries/agencies, therapeutic areas and lifecycle stage.Discover the power of HTA…
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Blog
Published January 28, 2025
Health equity continues to be a hot topic in the life sciences industry. ISPOR EU sessions addressed several key questions surrounding the impact of health equity on HTA decision-making, the methodologies that should be employed, and the opportunities and challenges of incorporating health equity into health technology assessment (HTA).
Ahead of ISPOR EU, Trinity’s HTA Vision team analyzed the impact of health equity on HTA agency behavior across six recent pharmaceutical launches and seven countries: Australia, Canada, England, France, Germany,…
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Blog
Published January 24, 2025
On January 20, 2025, CMS announced the set of fifteen drugs targeted for the second round of Maximum Fair Price (MFP) “negotiations” under IRA. With the outcomes of the first price “negotiations” announced only last August, the IRA MFP process is still in its early development and there remains uncertainty over how it will evolve – particularly in terms of the extent to which CMS will aim for true drug cost reductions vs. generating political capital via nominal “savings” on…
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Blog
Published January 10, 2025
Cell and gene therapies (CGTs) have ushered in a new era of medicine, offering patients transformative, even potentially curative solutions, with a single treatment. Despite the clinical promise, barriers to patient access remain given administration complexity, gaps in patient outcome evidence and high costs. As cell and gene therapies become available in new indications beyond oncology and rare pediatric diseases, developers of innovative therapies need to develop strategies targeting patients, providers and payers to overcome these challenges and promote access…
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Blog
Published December 12, 2024
Key impacts on the market access and payer environment are beginning to unfold from policies enacted in 2023 and new policies enacted in 2024. To gather insights into the latest trends, Trinity Life Sciences conducted interviews with key stakeholders across various pricing and market access landscapes. Trinity is closely monitoring the evolving global advanced therapeutics market environment, including the trends below, to determine implications for payers and manufacturers and help them prepare for the year ahead.
Key Trends
Continued Emphasis…
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Briefs
The healthcare industry has long been known for its significant environmental impact, including contributing ~5% of total global emissions. As awareness of this impact has increased, life sciences companies are now actively committing to climate resilience and environmental sustainability through various initiatives, including net-zero commitments.
Trinity Life Sciences has identified several recent trends driving this shift including increasing Health Technology Assessment (HTA) requirements, investment reporting, patient and healthcare provider (HCP) demands for greener options, heightened awareness of waste and a…
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