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

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…

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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

March 02, 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…

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

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…

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Key Takeaways from the ISPOR Europe 2022 Conference

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,…

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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 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…

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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 in 2022 and the 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 future These 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.…

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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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