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EU Adopts Regulation on Pan-European Health Technology Assessment

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…

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

February 02, 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…

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

December 07, 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…

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Global Evidence Requirements to Launch a Digital Health Technology

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 solutionsUnderstanding 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 technologyClinical evidence that demonstrates an improvement in the state of health or quality of life should be taken into…

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

November 09, 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…

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Insulin Approval Pathways USA vs. EU

November 02, 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 pathwayThe 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…

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

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…

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Assessing the Value of Non-Curative Cell and Gene Therapies

October 06, 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 spaceAlthough 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…

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AI-Based Software Paige Prostate is Granted FDA Approval Through the De Novo Regulatory Pathway

September 27, 2021 Paige Prostate is the first artificial intelligence (AI)-based software designed to identify areas of concern (i.e., high likelihood of containing cancer) on a prostate biopsy image so they can be flagged for further review by a pathologist. The program is intended to be used as an adjunct tool to the review of digital scanner slide images from prostate biopsies. The program was reviewed through the De Novo pathway, a regulatory pathway for low-to-moderate risk novel devices. The FDA…

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