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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 patient…

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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…

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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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Aducanumab Approval: Impact on Payers, Trials, and Trust

October 27, 2021 Executive Summary Aducanumab was approved for the treatment of Alzheimer’s disease by the FDA despite the Peripheral and Central Nervous System Drugs Advisory Committee’s vote against recommending the drug according to insufficient evidence in slowing cognitive declineSeveral payers have expressed hesitancy to cover aducanumab given perceived inadequate demonstration of clinical benefit combined with a high expected budget impact attributed to the large patient population and steep 56,000 per year price tagExperts are concerned that the aducanumab approval…

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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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Part II: Non-Traditional Players Attempting Entry into the Healthcare Sector

September 22, 2021 Executive Summary In June 2021, Walmart announced it is partnering with Novo Nordisk to produce its own private label insulin, ReliOn, at a discount to Novo Nordisk’s currently available fast-acting insulinThrough this partnership, Americans with a high-deductible health plan (HDHP) or without insurance can save up to 75% and purchase the insulin at their local WalmartNovo Nordisk’s key competitors, Eli Lilly and Sanofi are likely to respond with a similar partnership or price-cut for their insulin to…

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