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

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…

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The German Financial Stabilization of Statutory Health Insurance System Act

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 As of October 2022, the act was adopted by the Bundestag (German Federal Parliament). The act is expected to be implemented by January 2023 The new Statutory Health Stabilization Act includes several measures with significant impact in the commercial opportunity for pharmaceutical products Key Policy Updates…

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Brazil’s Latest Updates to Drug Coverage in the Private Sector: Anticipated Impact and Implications

October 14, 2022 Executive Summary The “ANS rol” defines the minimum mandatory coverage of services (diagnostics, procedures, and treatments) in the private sector. While private providers could opt to provide coverage beyond this list, in practice, the “ANS rol” has traditionally been seen as the maximum coverage that would be provided with anything beyond the “ANS Rol” being typically rejected Law 14.454/2022 published in September 2022 establishes that the “ANS Rol” will dictate the minimum coverage that private payers need…

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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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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 market This new reform started in January 2022 as part of a two-year pilot project and is expected to significantly reduce…

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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…

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