Home / Intelligence / Blog

Search

Blog

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

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…

Read Now

Blog

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

Published 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 the regulatory and…

Read Now

Blog

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…

Read Now

Blog

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…

Read Now

Blog

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…

Read Now

Blog

Global Evidence Requirements to Launch a Digital Health Technology

Published November 12, 2021

Executive Summary Given the growing number of digital health technologies available, there is a wide range of frameworks that outline key requirements to support decision-makers with the value assessment of digital health solutions Understanding how requirements differ based on the country and organization that develops the framework is key to prepare the successful global launch of a digital health technology Clinical evidence that demonstrates an improvement in the state of health or quality of life should be taken into consideration…

Read Now

Blog

Are Current Reimbursement Options for Opioid Use Disorder DTx Causing a Barrier to Widespread Adoption in the USA?

Published November 9, 2021

In 2020, Trinity assessed three applications developed to treat Opioid Use Disorders (OUD) (e.g., reSET-O, Connections, DynamiCare) through the lens of ICER conducting a cost-effectiveness evaluation. Only a year later, several more health tech startups have adopted a preventative outlook and seek to address chronic pain with digital health tools (e.g., phone applications). A key focal point is the current public health issue faced by the US with ~2.1 million Americans diagnosed with OUD. These applications, including Clearing, Curable, Remedee Labs, Swing Therapeutics…

Read Now

Blog

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…

Read Now

Blog

Cell and Gene Therapy Landscape: Challenges and Opportunities for Biotech and Investors

Published October 19, 2021

Executive Summary The American Society of Cell & Gene Therapy (ASCGT) wrapped up their 2021 conference earlier this year, which covered a range of topics, from new scientific advances to the evolving pricing and market access dynamics surrounding cell and gene therapies (CGT). Trinity had the opportunity to attend the conference, which brought together stakeholders from across the CGT landscape to discuss some of the challenges and opportunities within the space today. In this post we will cover the most…

Read Now

Blog

Assessing the Value of Non-Curative Cell and Gene Therapies

Published October 6, 2021

Executive Summary Given the majority of cell and gene therapies to date have offered the potential of a cure, pricing and access considerations are likely to differ for non-curative agents that are entering this space Although non-curative cell and gene therapies have demonstrated clinical efficacy (e.g., for multiple myeloma and wet age-related macular degeneration), manufacturers will need to communicate additional value offerings of these therapies to payers in order to avoid pushback and enhance access potential, such as: Robust evidence…

Read Now

Sign up for the latest intelligence

By signing up, you are agreeing to our Privacy Policy.

By submitting this form, creating an account, and/or using our website (or using our Services) you agree to our Privacy Policy. Information provided by you is stored in our database and may be used for sending you additional information about Trinity (including Trinity’s partners and affiliates) and our products and services. Such information may be transferred for this purpose to Trinity and affiliates in other countries. If you would like to opt out in the future, please email _compliance@trinitylifesciences.com.