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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

Published 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 NRDL As 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 illness budgets,…

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

Published 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 China This 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 the most…

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CMS Hospital Pricing Transparency: One Price Fits All?

Published August 2, 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 hospitals A lack of enforcement coupled with minor penalties decreases the efficacy of the requirement, resulting in low incentive for hospitals to comply with the rule The data posted by compliant hospitals shows large variation in pricing for…

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

Published July 6, 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 the steep average…

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

Published June 2, 2021

Executive Summary The Medical Fund Bill would increase drug spending up to 4% of the total healthcare spending in Poland The reimbursement applications can be reviewed as quickly as 180 days, reducing the typical time-to-market of two – three years The criteria for “innovativeness” that need to be met for inclusion on the list are still not fully fleshed out to date Only 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

Published 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 success Dynamics 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 a successful…

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The Future of Cell Therapy: What’s Next?

Published November 3, 2020

Executive Summary Cell-based therapies are emerging as a promising strategy for cancer and are generating a lot of interest both academically and industrially To 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 approval There have been multiple challenges involved when trying to successfully commercialize the products, but the landscape looks…

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