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…
Read Now
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…
Read Now
Blog
Published August 16, 2024
Yesterday, CMS released the results of the first round of “negotiated” prices for the Inflation Reduction Act (IRA).1
The IRA is a historical landmark legislation for the pharmaceutical industry, and the results from these “negotiations” involving 10 of the top Medicare Part D drugs in terms of spend were eagerly awaited by many.
Immediately, both the Biden Administration and the Harris-Walz campaign commented on the public savings that these “negotiations” have generated, claiming this as a “beginning”.
“Medicare has reached…
Read Now
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…
Watch Now
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…
Watch Now
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,…
Watch Now
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…
Read Now
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…
Read Now
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…
Read Now
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.…
Watch Now
