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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 insuranceSince 2017, on average, a significant price discount of 44-61% was required for products to achieve a positive listing on the NRDLBased on average 2018 sales data, products included on the 2017 NRDL were able to achieve an increase in sales revenue (188%) despite the steep…

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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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Novel Combinations: Double the Trouble

May 25, 2021 Executive Summary Branded novel combinations are increasingly entering the oncology market but bring a unique set of challenges to gain access and pricing successDynamics beyond demonstrating synergistic efficacy should be taken into consideration to optimize combination price / access outcomes Trinity’s Take: In this article, Trinity uses select combination case studies to highlight the key elements to consider when thinking through price / access strategy for a novel combination Evaluation of the Novel Combinations Landscape The pursuit of…

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The Future of Cell Therapy: What’s Next?

November 03, 2020 Executive Summary Cell-based therapies are emerging as a promising strategy for cancer and are generating a lot of interest both academically and industriallyTo date, cell therapies have been approved in the US by the Food and Drug Administration (FDA) with them showing a lot of promise in a limited number of solid tumors although they have not yet progressed to FDA approvalThere have been multiple challenges involved when trying to successfully commercialize the products, but the landscape…

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