White Papers
Since the passage of the Inflation Reduction Act (IRA) in 2022, the pharmaceutical industry has significantly altered how they approach and plan for evidence generation activities to best support product launches and pricing and access negotiations. Leading life science companies are taking proactive steps to adjust how and when they develop evidence and how they deploy it to better support their innovative medicines at launch and beyond.
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White Papers
In 2023, the life sciences industry saw key therapeutic advances in sickle cell disease, obesity/weight management, and Duchenne muscular dystrophy, among others, and the continued approvals of therapies with cutting edge mechanisms, including the first CRISPR therapy. While 2022 was characterized by accelerated development processes and the rapid evolution of therapeutic standards, 2023 featured increased implementation of cost-effectiveness policies and the emergence of the consequences of these pricing controls and cost-effectiveness measures, including the Inflation Reduction Act (IRA) and Germany’s…
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Blog
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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Blog
Published October 12, 2023
Recently Trinity Life Sciences’ team members had the opportunity to attend the Intellus Worldwide Institute in Boston. The institute featured interactive discussions about topics impacting health insights and analytics, including the evolving payer landscape, increasing importance of patient segmentation and growing role of AI in healthcare.
Evolving Payer Research Landscape
Discussions about the payer research landscape centered on the importance of increasing the visibility of payer insights across research phases and brand verticals, especially in light of greater cost consciousness. …
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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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Blog
Published July 10, 2023
While attending the ISPOR US 2023 conference in Boston this year, Trinity team members had the opportunity to connect with industry colleagues, present original research, and participate in research panels and discussions regarding key industry trends. One top of mind industry topic for many attendees and presenters was the recent enactment of the 2022 Inflation Reduction Act (IRA). Throughout the conference, several key health policy implications stemming from the IRA for the biopharma industry were explored.
Long-term Pricing Pressure for…
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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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