International Archives

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Beyond the Price Tag: Understanding Colombia’s New Pricing Policy

November 7, 2023

In August 2023, the Colombian government published a new pricing policy outlining that the list price of new medicines in Colombia will be established based on their therapeutic value category, resulting from an assessment conducted by the Instituto de Evaluation Tecnológica...

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

March 10, 2023

Executive summary Highlight 1: Increased presence of multinational corporations in newly listed products from the 2022 NRDL negotiations The 2022 NRDL negotiations finished immediately before the week-long Chinese New Year holidays in January 2023, adding 83 novel non-traditional Chinese medicines...

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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: Introduction & History of the Regular Price Revisions in Japan For over two decades, Japan has maintained a biennial re-pricing approach in which drug prices are surveyed through wholesaler offices and healthcare institutions to capture the product discrepancy...

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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...

From the ISPOR lobby - Welcome to ISPOR Europe 2022

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The German Financial Stabilization of Statutory Health Insurance System Act

October 31, 2022

Executive Summary: Key Policy Updates AMNOG Rebate Negotiations AMNOG* rebate negotiations will be modified to give the GKV-SV increased powers in the pricing negotiations. HIGH P&MA IMPACT: The new negotiation framework increases the threshold of added benefit required for therapies...

Pill with Germany flag on background and medical particles

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

October 14, 2022

Executive Summary Introduction Agência Nacional de Saúde Suplementar (ANS) is the Brazilian regulatory agency linked to the Ministry of Health that oversees the private healthcare sector and insurance companies within the country. Key responsibilities of ANS include defining the legislation...

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Japan’s Latest Drug Pricing Policy Updates: Key Changes in 2022 and the Expected Impact

September 6, 2022

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...

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

March 29, 2022

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 [...]

Blonde woman wearing a mask looking at a red pill

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

March 18, 2022

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 [...]

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EU Adopts Regulation on Pan-European Health Technology Assessment

February 18, 2022

Pan-European HTA will enter into force in January 2022 and finally become active in 2025. This comes almost four years after the European Commission’s original proposal, and at a time where urgency for European HTA processes is growing [...]

Medical professional interacting with Health Technology

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

February 2, 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...

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Bypassing NICE: Manufacturers are Looking Towards NHS England to Support Early Access

December 6, 2021

There has been a trend in manufacturers opting to bypass the NICE appraisal process and have struck deals with NHS England directly to support market access for their novel therapies.