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Inflation Reduction Act (IRA): ISPOR Key Takeaways

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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ISPOR 2023 Trinity Panel: Enabling Patient Access to Digital Therapeutics – The Optimal Approach?

Published June 21, 2023

Monica Martin de Bustamante, Sr. Partner of Trinity’s Evidence, Value, Access, and Pricing (EVAP) team, moderated an exciting conversation at ISPOR 2023 Global in Boston earlier this month. Monica spoke with Lisa Marsch, Ph.D., Benjamin Parcher, PharmD, MS, and Fulton Velez, MD, MS, MBA, all experts in the field of Digital Therapeutics (DTx), about the role of evidence development in the approval of DTx to date, and what evidence development requirements could look like in the next five years. Past…

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ISPOR US 2023: Key Topics and Themes

Published June 16, 2023

Last month, Trinity attended the ISPOR 2023 conference in Boston. The main theme of the conference was “Impacting Innovation, Value and Healthcare Decision Making”, which facilitated unique discussions and workshops across different stakeholders in the life sciences, including manufacturers, regulatory leaders and health economists. Topics included discussions on the role of artificial intelligence (AI) in HEOR, innovation in evidence generation, the latest trends in health policy and a myriad of others. A highlight for Trinity Life Sciences was presenting 12…

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The Last Mega Blockbuster Drug: Goodbye Humira, Hello Future

Published April 21, 2023

Executive Summary Biosimilar versions of adalimumab have launched in the U.S., ending blockbuster therapy Humira’s lengthy market exclusivity and long-running commercial success. In parallel, in the creation of the Inflation Reduction Act (IRA), the U.S. joins Europe and other major markets in constraining the opportunity for medicines during their market exclusivity window. Trinity’s Take These events usher in a new era for the life sciences industry, necessitating new thinking around development and commercialization strategy. Historic reliance on the U.S. market…

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Highlights of the 2022 National Reimbursement Drug List (NRDL) Negotiation Outcome

Published March 10, 2023

Executive summary 83 non-traditional Chinese medicines successfully entered the National Reimbursement Drug List (NRDL) for the first time. This is a >20% increase from the 2021 and 2020 NRDL updates, indicating the growing interest of both manufacturers and payers to ensure reimbursement for novel therapies in China. The percentage of products achieving NRDL inclusion within one year of regulatory approval continues to increase steadily, from 24% in 2020 to 53% in the 2022 update, keeping up the strong momentum of…

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From Customer Relationship Management to Providing Customers Quality Multi-Experience Engagements: What to Keep in Mind as You Embrace the Shift

Published March 2, 2023

Meet Melissa Leonhauser: Melissa has over 20 years of experience managing analytic solutions that support pharmaceutical brand teams. She has helped introduce and shape how pharmaceutical manufacturers use Real World Data to understand the patient journey and inform their decision making. I’m not sure if ‘multi-experience engagements’ is just the newest buzz phrase, but I like it. It’s similar to ‘omnichannel marketing’ but with a focus on the customer instead of your efforts, and I appreciate that nuance. Let’s break…

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Japan’s Latest Drug Pricing Policy Updates: Off-Year Revision and Other Anticipated Changes in 2023

Published February 27, 2023

Executive Summary:   The 2023 off-year Drug Price Revisions are the second implementation of the off-year re-pricing approach by the Japanese Ministry of Health, Labor and Welfare (MHLW) and are predicted to result in additional price cuts to 48% of listed products across multiple therapeutic areas.   Although the MHLW continues to maintain a stance of leveraging price revisions to achieve budget savings, other policies (i.e., expansion of Orphan Drug Designation and Price Maintenance Premium revisions) signal an intent to foster and…

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Key Takeaways from the ISPOR Europe 2022 Conference

Published December 12, 2022

Last month, Trinity attended the ISPOR Europe 2022 conference in Vienna. The main theme of the conference was “Collaborating Across Borders: Building & Using Evidence to Enable Access”, which facilitated many interesting discussions amongst different stakeholders in life sciences, including manufacturers, regulatory leaders and health economists. Among the myriad of topics covered, digital health emerged as a hot topic for podium sessions, poster presentations and group discussions. A highlight for Trinity Life Sciences was presenting two posters, and one podium…

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The Enhancing Oncology Care Model: Where Public Health Meets Oncology Care

Published November 7, 2022

Executive Summary The Oncology Care Model (OCM) was designed to test whether financial incentives can improve care and lower Medicare (U.S. federal health insurance program) spending, emphasizing value-based care within oncology treatment. This model supported a wide range of services such as high-cost emergency room visits, 24/7 access to clinicians and specialized, patient-specific coordinated care plans. The Enhancing Oncology Model (EOM) builds on the structure of OCM with an increased focus on managing provider risk, promoting patient-centric care and addressing…

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The German Financial Stabilization of Statutory Health Insurance System Act

Published October 31, 2022

Executive Summary: Germany’s ‘Financial Stabilization of Statutory Health Insurance System’ Act (GKV-Finanzstabilisierungsgesetz) was first proposed in March 2022 by Health Minister Professor Karl Lauterbach to help tackle the country’s economic deficit Updated (January 13, 2023): The act was adopted by the Bundestag (German Federal Parliament) in October 2022. Most reforms have entered into force in November 2022, with the exception of the reduced sales threshold for orphan drugs (December 2022), the increased manufacturer rebate (January 2023) and the additional rebate…

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