Briefs
Joint clinical assessment (JCA) is a European Union (EU) initiative intended to improve patient access to health technologies in Europe through a harmonized clinical health technology assessment (HTA) process. From January 2025, all new oncology medicines and advanced therapy medicinal products will go through the JCA process, followed by all orphan medicinal products from 2028 and all new medicines from 2030.
The JCA process will run parallel to European Medicines Agency (EMA) regulatory evaluation and will involve submission of a…
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Briefs
The Institute for Clinical and Economic Review (ICER) is an independent, non-profit research organization dedicated to assessing the value of healthcare interventions, including diagnostics, devices, digital therapeutics and prescription drugs. Although ICER’s assessments do not represent a mandate for product funding or pricing in the U.S. in the same way as, for example, National Institute for Health and Care Excellence (NICE) assessments in the U.K., public reports on a product’s value are bound to influence discussions and negotiations between payers…
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Webinars
Available On Demand
Working at the cutting edge of pricing and market access for innovative therapies launched over the last decade, Trinity Life Sciences has seen new diseases, technologies and decision drivers emerge. These have demanded the innovation and testing of new methods and concepts for communicating value to healthcare payers.
In this webinar, we will briefly review the core, timeless principles of value communication. We will then dive into the challenges that each innovation has created for industry teams developing value strategy and value communication tools. We will review…
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White Papers
Experts at Trinity Life Sciences interact with the inner workings of pharma from many perspectives as they engage with teams across life sciences organizations.
A common observation is that teams are working in silos: often unaware of what other teams are doing, sometimes pulling in different directions and frequently experiencing frustrations.
Internally, siloed working can create delays, unnecessary budget burn and re-work. Externally, it can result in negative coverage decisions or market underperformance, which ultimately impacts the patient. In some…
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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…
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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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Blog
Published June 13, 2024
Trinity Life Sciences recently worked with a large global pharma company to develop a new process for creating global value dossiers (GVDs) that better met the needs of regional affiliates. Matt O’Hara, who leads Trinity’s Evidence Strategy practice, shares insights into the project with Mary Fletcher-Louis, who recently joined Trinity to head Trinity’s Value Center of Excellence.
Understanding the Challenge
The project involved reviewing the client’s 15 most recent GVDs and scoring each chapter for effectiveness, ease of use, level…
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Blog
Published May 23, 2024
Executive Summary
The global payer landscape is rapidly evolving and is expected to continuously impact manufacturers’ decisions about new launches, portfolio management, trial design and importantly, pricing and market access strategy. In the UK, several policy reforms have been introduced which are expected to improve patient access while balancing financial healthcare sustainability and overall market attractiveness. A few key developments announced or already implemented include:
The shift of the much-debated Voluntary Scheme for Branded Medicines Pricing and Access (VPAS) to…
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Webinars
Available On Demand
A number of critical manufacturer activities are informed by understanding health technology assessment (HTA) agency behavior across geographies and therapeutic areas—from pipeline, business development and licensing to launch planning preparation through to lifecycle management strategy. Join Max Hunt, a Partner in Trinity Life Sciences’ Evidence, Value, Access & Pricing Practice, as he hosts a lively discussion on the benefits of rapid access to cumulative, compounded learnings generated from in-depth analysis of global HTA recommendations, with presenters Mary Fletcher-Louis, Managing Director…
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