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EU Adopts Regulation on Pan-European Health Technology Assessment

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

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

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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Insulin Approval Pathways USA vs. EU

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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Poland’s Medical Fund Bill to Improve Access to Oncology Drugs

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

COVID-19 Briefing Series: European HCP Perspectives

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

Spending Wisely in Europe

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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