Blog
Published 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, Technical and Scientific…
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Blog
Published 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 the average time…
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Blog
Published 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 2022
Although 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 Commission
These new JCAs will only focus on the clinical domain of HTAs and thus they will…
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Blog
Published 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 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 as well as…
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Blog
Published December 6, 2021
Executive Summary
The National Institute for Health and Care Excellence (NICE) is the major reimbursement body and pathway to achieving market access in England, although products that have not been evaluated by NICE or have received a negative NICE outcome can still achieve local access through CCGs (Clinical Commissioning Groups)
In 2017, NHS England announced deals facilitating patient access to two innovative treatments (KADCYLA and STRENSIQ). KADCYLA’s previous negative NICE recommendation in HER2+ breast cancer and strong patient advocacy from…
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Blog
Published November 2, 2021
Executive Summary
In March 2020, the FDA amended its classification of add-on insulin products, changing the approval pathway from that of a chemical drug follow-on to a biosimilar and more closely aligning with the EMA’s longstanding biosimilar insulin approval pathway
The FDA approved the Semglee Pen (insulin glargine) as the first product through the new biosimilar insulin approval pathway in July 2021; the Semglee was priced as almost three times less costly in the USA than the previously approved biosimilar…
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Blog
Published September 30, 2021
Written by Caspar Kengeter and Manon Ricard…
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Blog
Published June 2, 2021
Executive Summary
The Medical Fund Bill would increase drug spending up to 4% of the total healthcare spending in Poland
The reimbursement applications can be reviewed as quickly as 180 days, reducing the typical time-to-market of two – three years
The criteria for “innovativeness” that need to be met for inclusion on the list are still not fully fleshed out to date
Only four of the 12 candidates on the list have been approved by the Health Minister to secure reimbursement…
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Briefs
Highlights from Trinity’s Recent Research Focused on European HCP
The COVID-19 pandemic continues to have an unprecedented impact on our lives and is disrupting businesses as it spreads worldwide.
As the EU5 countries comprise some of the most important pharmaceutical markets, and with Italy, Spain and France includes countries which have been impacted significantly from COVID-19, Trinity aimed to understand the impact on HCP engagement with Market Research.
Publication access form…
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White Papers
By 2022 Europe is forecast to account for 20% of a global US$1.2 trillion pharmaceutical market. For executives from emerging biopharmaceutical companies planning to develop and commercialize their assets in Europe, the views of biopharmaceutical investors are critical, as investors provide the necessary investments. Additionally, investors who have analyzed numerous biopharmaceutical companies will have valuable experience on what drives commercial success.
In this paper, we aim to understand the views of both investors and biopharmaceutical companies, specifically on the investments…
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