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Japan’s Latest Drug Pricing Policy Updates: Key Changes and Expected Impact

September 7, 2022 Executive Summary A series of new drug pricing reforms came into effect in Japan in April 2022, to encourage innovation and ensure the transparency and predictability of drug pricing in the futureThese include updates to the cost-accounting pricing methodology, an expansion of the scope of the Price Maintenance Premium (PMP), an update to the spillover rule for drug re-pricing and an addition of a new “specific use” premium. Further details are outlined in the graphic below. Summary…

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Inflation Reduction Act of 2022: No Room for Negotiation

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…

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Mapping the Unknown: Measuring Cell and Gene Therapy Adoption Using Real-World Evidence

August 9, 2022 It’s been 10 years since the first pediatric patient was treated with chimeric antigen receptor T-cell (CAR-T) therapy for her acute lymphoblastic leukemia. At the time, the approach to engineer immune cells was a novel, ground-breaking concept. In the subsequent decade, research into this space had continued to advance. Equally importantly, the patient has remained cancer-free, serving as one of the most visible examples of the impact this type of therapeutic may have for patients with complex…

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The Humira Case: Exploring the Blockbuster Ahead of United States Biosimilar Launch

Summary Up to nine biosimilar versions of Humira (adalimumab) are expected to launch in 2023 in the United States, following settlements between AbbVie and their respective manufacturersIn contrast, biosimilar versions of adalimumab have been available in most countries outside the U.S. since 2018, resulting in high pricing disparities between immunology and inflammatory treatments between the U.S. and other markets Trinity’s Take Adalimumab biosimilar competition in Europe, as well as policy and payer pressure, has exerted downward pricing pressure for branded…

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Trinity’s ISPOR Annual 2022 Presentation Schedule

Email: to discuss one of our presentations listed below. Virtual Issue Panel: Tuesday, May 17 | 4:30 pm EDT IP14: The Challenges of Bringing Cell & Gene Therapies to Emerging Markets A panel of experts from different markets share their experiences and perspectives about the challenges associated with the access and funding of cell and gene therapies, given the issues associated with their upfront costs and potential long term clinical benefits. Moderator: Valeria Boers-Trilles, MPhil – Director Panelists:Guvenc Kockaya,…

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Pharmaceutical Innovation: Italy’s AIFA Algorithm for Assessing New Products

April 8, 2022 The Assessment Process of Innovativeness of a New Medicine in Italy In April 2017, AIFA (Agenzia Italiana del Farmaco, Italian Medicines Agency) released an upgraded algorithm to assess and evaluate the level of innovativeness of new drugs seeking reimbursement from the EUR one billion innovative medicine fund made available by the Italian MoH (Ministero della Salute, Ministry of Health). The algorithm introduced in 2017 provides a multi-dimensional approach: innovativeness will be judged by AIFA’s CTS (Commissione Tecnico-Scientifica,…

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France Pilots Opportunity to Increase Speed to Reimbursement for Select Innovative Products

March 29, 2022 Executive Summary French president Emmanuel Macron announced a two-year trial that will allow pharmaceutical products that receive an ‘Amélioration du Service Médical Rendu’ (ASMR) rating of IV or better to get reimbursement immediately after the evaluation by the Transparency Committee (TC)In these cases, price negotiations will start while the new therapies are already on the marketThis new reform started in January 2022 as part of a two-year pilot project and is expected to significantly reduce the average…

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How Effective is ANVISA’s Rare Diseases Expedited Approval Pathway [RDC 205]?

March 18, 2022 Key Takeaways An analysis was conducted of all the orphan therapies registered by the FDA and ANVISA before and after 2018 to effectively evaluate approval times once the RDC 205 pathway was implemented. The main takeaways from the analysis can be found below:​ ​The difference between FDA and ANVISA time to approval for orphan drugs is four times shorter after the implementation of the RDC 205 / 2017 pathway​The RDC 2015 pathway regulated the deadlines for the…

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EU Adopts Regulation on Pan-European Health Technology Assessment

February 18, 2022 Executive Summary A new pan-European Health Technology Assessment (HTA) regulation that will redefine the processes for the evaluation of new medicines in the EU entered into force in January 2022Although it will not become fully active until 2025, the new regulation will require EU member states to give “due consideration” to joint clinical assessment (JCA) reports and provide feedback to the European CommissionThese new JCAs will only focus on the clinical domain of HTAs and thus they…

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Key Changes to Health Technology Assessments (HTAs) in the UK

February 02, 2022 The National Institute for Health and Care Excellence (NICE) will mark the start of 2022 by implementing changes to health technology assessments (HTAs), demonstrating adaptability of regulatory bodies as medical technologies continue to evolve. The final HTA changes aim to provide earlier and more equitable access to treatments as well as display increased flexibility in the evaluation of new health technologies. As part of NICE’s plan to modernize healthcare, the changes will apply to both digital therapeutics…

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