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RWE + PMR = Tethering Demand Forecasts to Reality

Published April 8, 2024

Reliable forecast models are a cornerstone of any successful commercialization plan. The inputs that drive those forecast models are critical. From 2020 through 2022: Only 1 in 10 products had performance aligned with forecasted expectations* Nearly 60% underperformed their forecast expectations More than 30% overperformed Forecast models often rely on healthcare professional (HCP)-reported behavioral data. Various subjective calibration factors are required to render the data usable, even after implementing robust market research design elements. Data from primary market research (PMR)…

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Rise with the waves: Canada – A Coming (R)evolution: Transforming Pharmaceutical Market Access

Published April 5, 2024

Executive Summary Canada has undertaken meaningful strategies to transform patient access and ultimately improve health outcomes across the country. Two such potentially high-impact strategies include the planned transformation of the former Canadian Agency for Drugs and Technology in Health (CADTH) into the new Canadian Drug Agency (CDA) over the course of the next five years, as well as the implementation of time-limited reimbursement for specific drugs. While the Canadian Drug Agency is set to advance Canada’s pharmaceutical system by standardizing…

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Using Transparency in Coverage Reimbursement Insights to Inform Payer and Provider Contracting Strategy

Published April 5, 2024

Executive Summary “Transparency in Coverage” (TIC) data is a newer data source that has recently become available for mining unique insights in the reimbursement/economics between payers and providers. In 2020, the Federal Government TIC Rule required health insurers and group health plans, including self-funded clients, to provide cost-sharing data to consumers via machine-readable files and a consumer price transparency tool. Beginning July 1, 2022, machine-readable files were published publicly, and include pricing data for covered items and services based on…

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Rise with the waves: Italy – AIFA restructuring and budget reforms – Stepping into a new (uncertain) future?

Published March 20, 2024

Executive Summary The Italian Medicines Agency (AIFA) underwent transformative changes on January 30, 2024, following a much-anticipated reorganization. AIFA’s restructuring has already faced challenges, with the recent resignation of the newly created Scientific and Economic Commission’s (CSE) chairman followed by the appointment of a new acting chairman, highlighting the need for a stable and collaborative leadership within AIFA.   Although AIFA’s overhaul has been implemented following a year-long delay due to bureaucratic complexities and is currently facing uncertainties, it will be…

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Rise with the waves: Germany – A tale of two high impact policies shaping pharma’s future

Published February 26, 2024

Executive Summary Multiple cost-containment reforms, such as the introduction of a 20% rebate on brand-brand combinations and a temporary increase in the mandatory rebate on drugs to 12%, were implemented under Germany’s ‘Financial Stabilization of Statutory Health Insurance System’ Act (GKV-Finanzstabilisierungsgesetz) in 2023. The evaluation report of these strategies showed that the actual savings for the year fell short of the proposed target (25% deficit, €1.4 Bn vs. target of €1.9 Bn) for all such reforms except 30% higher savings…

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Cell and Gene Therapies: Six Global Trends We Are Watching in 2024

Published February 15, 2024

2023 was a busy year for cell and gene therapies (C&GT). There were regulatory approvals in the U.S. and EU, including both in rare pediatric conditions with no current effective options (e.g., Duchenne muscular dystrophy (DMD)), as well as in indications where competition is better established (e.g., hemophilia A and B). Towards the end of the year, the FDA approved not one, but two sickle cell gene therapies on the same day, creating instant competition between them. One of these…

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Priced Out: Generic Therapy Price Competition and Drug Shortages

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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Key Takeaways and Learnings from ASH 2023

Published January 12, 2024

Introduction The Trinity Life Sciences’ team recently attended the 65th ASH Annual Meeting and Exposition from December 9-12, 2023, in San Diego, California. The conference brought together physicians, scientists and industry experts to share and collaborate on advances in understanding and treating blood cancers and blood disorders. Below are a few of the key insights that the Trinity team observed during the conference: Advances in CAR-T Therapy: Expansion into New Targets and Therapeutic Areas Numerous groups across the industry are…

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Insights & Analytics in Life Sciences: How to Embrace a Future with Generative AI

Published December 18, 2023

First, A Few Potentially Unsettling Truths Adoption and adaptation to Generative AI (GenAI) is a strategic imperative for pharma commercial insights departments if they want to maintain and enhance their relevance, impact, and strategic value within their organizations. Organizations are increasingly data-driven; market research teams that do not leverage AI will struggle to provide the timely, nuanced insights that modern pharma marketing organizations demand, diminishing their role in critical decision-making processes. Top talent gravitates towards innovation. Departments that fail to…

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Key Takeaways and Learnings from ISPOR Europe 2023

Published December 7, 2023

Trinity Life Sciences recently attended the ISPOR Europe 2023 conference in Copenhagen, Denmark. The main theme of the conference was “HEOR at the Nexus of Policy and Science,” and the event featured unique discussions and workshops across different stakeholders from both academics and the life sciences industry, including manufacturers, regulatory leaders and health economists, to consider the latest challenges and opportunities being addressed by health economics and outcomes research. Topics included Joint Clinical Assessments (JCAs), access to innovative therapies, environmental…

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