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Developing Effective Global Value Dossiers 

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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Rise with the Waves: UK – Now and Beyond – Four Policy Trends That May Shape Pharma’s Future 

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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Japan Pricing Policy Reform 2024

Published May 17, 2024

Executive Summary The Central Social Insurance Medical Council, the key Japanese reimbursement policy panel known as Chuikyo, introduced the 2024 drug pricing reform in April 2024. Some key features of the reform plan include: The creation of premiums for incentivizing the early introduction of new innovative therapies in Japan The establishment of post-listing price adjustment scheme by average foreign price for specific imported drugs at the time of price revision The simplification of the price maintenance premium (PMP) system so…

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RWD + PMR = Tethering Demand Forecasts to Reality

Published April 30, 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: France – Accelerating Pricing and Market Access: Two Policies Shaping Pharma’s Future

Published April 22, 2024

Executive Summary The latest publication of new reimbursement regulations in the French Social Security Financing Act (PLFSS 2024), coupled with the recent approval of HEMGENIX® through the direct access scheme in France this past December, underline continued efforts in France to innovate its healthcare system. The 2024 PLFSS emphasizes: Drug access and cost containment, with a higher payback trigger aimed at reducing the government’s payback collections Temporary reimbursement to ensure continuous treatment of patients with medicines benefitting from the early…

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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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