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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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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As the market becomes increasingly crowded and budget constraints continue in China, downward pricing pressure to secure National Reimbursement Drug List (NRDL) inclusion remains the top challenge for multinational pharma companies in this market. However, the significant uptake post-NRDL inclusion and broad access offer substantial opportunities for innovative products with clinical differentiation.
In this white paper, Trinity Life Sciences explores the highlights of the 2021 NRDL negotiation; including trends within the oncology, rare disease and chronic disease therapeutic areas…
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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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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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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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Now Available On Demand:
What do pharmaceutical manufacturers need to know to successfully navigate the market access landscape in China through the latest NRDL update?
The access landscape in China is rapidly evolving with important implications for novel medicines. The most recent update of China’s National Reimbursement Drug List (NRDL) in 2021 focused on the expansion of new and high-cost innovative therapies and highlighted the improving access environment for these drugs.
In this webinar, Trinity Life Sciences’ Value, Access and…
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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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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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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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