Webinars
Available On Demand
The second webinar in our “Next Era in U.S. Healthcare Policy & Access” series looks at the evolving healthcare policy landscape from a different perspective. Join us as we explore how U.S. policy changes are impacting health plans, how health plan decision-making needs to adapt, and what this means for biopharma companies. The webinar will feature an engaging panel discussion hosted by Max Hunt, Partner at Trinity Life Sciences, with special guests Stephen George and Matthew Hayes, clinical and actuarial…
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Webinars
Available On Demand
As healthcare policy and the access landscape evolve, biopharma companies face challenges in navigating this ever-changing space. To help organizations prepare for and adapt to these changes, Trinity Life Sciences is offering a new webinar series, The Next Era in U.S. Healthcare Policy & Access.Join us for the first webinar in the series, Looking Ahead to the November Election and Beyond, where Maximilian Hunt, Partner at Trinity, will host an interactive discussion with health policy expert, Lisa Joldersma, Founder and President, Birch…
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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 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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Blog
Published July 27, 2023
Trinity’s Take
Recent guidance for the Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program released by CMS retains all major provisions of the program as written in the IRA
The guidance details negotiation methodology, including that CMS will not leverage any type of formulaic mechanism to determine the offered Maximum Fair Price (MFP) but rather leverage the nine negotiation factors published in the IRA as a platform for negotiation
Although CMS will offer a public explanation for each final…
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Scientific Publications
Autoimmune screening panel (ASP) is routinely ordered as a part of diagnostic work-up in people with suspected multiple sclerosis (MS). However, data on prevalence and significance of ASP seropositivity in MS is scarce.
Authors
D. Bandari, M. Adamson, M. Bowman, A. Gutierrez, A. Athavale, B. Oak, N. Hadker, F. Branco, C. Geremakis, J. B. Lewin, S. L. Shankar
Journal
ECTRIMS 2022
View publication…
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Webinars
Available On Demand
What do ‘pricing inflation penalties’ actually mean for manufacturers of biopharma products?
Explore the impact of the Inflation Reduction Act (IRA) on biopharmaceutical product net prices and contract strategies as manufacturers adapt to new U.S. market conditions.
In this webinar, Trinity Life Sciences’ Evidence, Value, Access & Pricing practice experts will provide a high-level review of IRA policy updates before exploring the implications for currently marketed Medicare Part B and Part D therapies, as well as for future product launches.…
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Blog
Published August 12, 2022
Long-awaited Medicare price negotiations look more like statutory discounts than the value-based negotiations seen in global healthcare systems; combined with expanded price increase rebates and out of pocket limits, new regulation may drive prices for new drugs up more than down. Trinity explores the impact and implications for manufacturers of innovative medicines.
Headline Summary:
After over a year of drafting, Congress recently passed the Inflation Reduction Act, and on August 16th President Biden formally signed the act into law
The…
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Blog
Published November 2, 2021
Executive Summary
In March 2020, the FDA amended its classification of add-on insulin products, changing the approval pathway from that of a chemical drug follow-on to a biosimilar and more closely aligning with the EMA’s longstanding biosimilar insulin approval pathway
The FDA approved the Semglee Pen (insulin glargine) as the first product through the new biosimilar insulin approval pathway in July 2021; the Semglee was priced as almost three times less costly in the USA than the previously approved biosimilar…
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Blog
Published September 1, 2021
Executive Summary
The COVID-19 pandemic has called into question many elements of the US healthcare system across key stakeholders, resulting in changes across patients, providers, payers, researchers, and manufacturers
The pandemic has required many healthcare providers and patients to provide telemedicine options, which for many specialties has proved to be an effective way to dispense and receive care
For payers at the national level, CMS has implemented reimbursable telehealth codes for all medical services that may be provided remotely, while…
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