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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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Part I: Non-Traditional Players Attempting Entry Into the Healthcare Sector

September 08, 2021 Executive Summary The healthcare sector is becoming increasingly attractive, and despite the risk of an expensive failed venture, non-traditional players have and will likely continue to take their chances to enter the fieldWhile the market has been profitable for some players such as Fujifilm and Nestlé, others have had a challenging time competing in this uniquely complex market (e.g., Kodak and Heaven) Trinity’s take: Non-traditional players that have been successful in tapping into the healthcare sector seem to…

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Exploring the Impact of COVID-Driven Trends on the US Healthcare Landscape

September 01, 2021 Executive Summary The COVID-19 pandemic has called into question many elements of the US healthcare system across key stakeholders, resulting in changes across patients, providers, payers, researchers, and manufacturersThe pandemic has required many healthcare providers and patients to provide telemedicine options, which for many specialties has proved to be an effective way to dispense and receive careFor payers at the national level, CMS has implemented reimbursable telehealth codes for all medical services that may be provided remotely,…

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Verily to Acquire SignalPath, Expanding the Company’s Clinical Research Capabilities

August 30, 2021 Verily recently announced its first major acquisition, a software platform known as SignalPath. SignalPath’s flagship software, TrialPath, digitizes and modulates individual protocols in a clinical trial, from budgeting to tracking point-of-care communication. The acquisition would fold SignalPath into Baseline, Verily’s clinical research platform designed to improve clinical trial execution, help research manage their clinical trials, and explore flexible study options for decentralized and hybrids trials as well as novel ways to capture real-world data (i.e., generated by novel sensors…

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What Market Access Opportunities Exist for Rare Disease Products in China? An Analysis of Rare Disease Product Inclusion in the 2020 NRDL

August 19, 2021 Executive Summary While 7 additional rare disease drugs were included on the 2020 NRDL in China, this development comes amid a backdrop of rare disease policy development signaling a move towards multi-channel funding mechanism to support more widespread patient access and maintain sustainability of the NRDLAs such, manufacturers cannot solely rely on NRDL inclusion for their rare disease product market access strategy in China and should consider alternative funding opportunities outside of the NRDL (e.g., provincial critical…

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What Market Access Opportunities Exist for Oncology Products in China? An Analysis of Oncology Product Inclusion in the 2020 NRDL

August 16, 2021 Executive Summary Recent updates in the National Drug Reimbursement List (NRDL) have increasingly focused on the expansion of oncology products and highlighted the improving market access environment for innovative oncology therapies in ChinaThis effort first came under the spotlight in 2018 as the National Health Security Administration (NHSA) announced the inclusion of 17 novel oncology agents on the NRDL with discounts averaging ~60%. Subsequent NRDL updates saw comparable levels of price discounts and selection of products targeting…

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CMS Hospital Pricing Transparency: One Price Fits All?

August 02, 2021 Executive Summary: A CMS regulation from the Trump Administration requiring hospitals to post lists containing the list price, negotiated private payer prices, and self-pay rates for up to 300 shoppable services took effect in January 2021 but is still widely ignored by hospitalsA lack of enforcement coupled with minor penalties decreases the efficacy of the requirement, resulting in low incentive for hospitals to comply with the ruleThe data posted by compliant hospitals shows large variation in pricing…

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Is the Pricing Discount for Chinese NRDL Inclusion Worth it? NRDL Commercial Impact Assessment

July 06, 2021 Executive Summary The Chinese National Reimbursement Drug List (NRDL) is managed and negotiated by the National Healthcare Security Administration (NHSA) and drugs listed on the NRDL are reimbursed by the public insurance Since 2017, on average, a significant price discount of 44-61% was required for products to achieve a positive listing on the NRDL Based on average 2018 sales data, products included on the 2017 NRDL were able to achieve an increase in sales revenue (188%) despite…

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

June 02, 2021 Executive Summary The Medical Fund Bill would increase drug spending up to 4% of the total healthcare spending in PolandThe reimbursement applications can be reviewed as quickly as 180 days, reducing the typical time-to-market of two – three yearsThe criteria for “innovativeness” that need to be met for inclusion on the list are still not fully fleshed out to dateOnly four of the 12 candidates on the list have been approved by the Health Minister to secure reimbursement…

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