APAC Archives

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NRDL 2024: Rare Diseases Deep Dive

July 1, 2025

China’s pharmaceutical landscape is not only vast in scale but also rapidly evolving with an emphasis on balancing access with affordability. This year’s NRDL update stands out. The introduction of the value rating system continues to raise the bar for clinical...

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Early China Launch of PIASKY® in the Fight Against PNH

September 25, 2024

In February 2024, the National Medical Products Administration (NMPA), China’s drug regulator, granted priority review approval to Roche’s PIASKY (crovalimab), an injectable C5 inhibitor for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). PNH is a rare genetic blood disorder in which...

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Japan Pricing Policy Reform 2024

May 17, 2024

Executive Summary The Central Social Insurance Medical Council, the key Japanese reimbursement policy panel known as Chuikyo, introduced the 2024 drug pricing reform in April 2024. Some key features of the reform plan include: The reform outlines a suite of measures aimed at...

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Highlights of the 2022 National Reimbursement Drug List (NRDL) Negotiation Outcome

March 10, 2023

Executive summary Highlight 1: Increased presence of multinational corporations in newly listed products from the 2022 NRDL negotiations The 2022 NRDL negotiations finished immediately before the week-long Chinese New Year holidays in January 2023, adding 83 novel non-traditional Chinese medicines...

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Japan’s Latest Drug Pricing Policy Updates: Off-Year Revision and Other Anticipated Changes in 2023

February 27, 2023

Executive Summary: Introduction & History of the Regular Price Revisions in Japan For over two decades, Japan has maintained a biennial re-pricing approach in which drug prices are surveyed through wholesaler offices and healthcare institutions to capture the product discrepancy...

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Japan’s Latest Drug Pricing Policy Updates: Key Changes in 2022 and the Expected Impact

September 6, 2022

A series of new drug pricing reforms came into effect in Japan in April 2022, to encourage innovation and ensure the transparency and predictability of drug pricing in the future. These include updates to the cost-accounting pricing methodology, an expansion of...

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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 Trinity’s Take: Due to the rapidly evolving rare disease policy environment in China, manufacturers should prepare to take a flexible approach to their rare disease product market access strategy. This would include considering alternative funding opportunities outside of the...

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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 Trinity’s Take: While the NRDL presents increasing reimbursement opportunities for oncology products in China, pricing restrictions will remain as a key challenge. In order to defend pricing in NRDL negotiations, manufacturers should consider targeting indications with high unmet needs...

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

July 6, 2021

Executive Summary Trinity’s Take: Based on the short-term follow up sales data, the increase in average sales revenue and volume growth offset the average price discount for the majority of NRDL listed products in 2017, which justifies the steep price cut...

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2019 NRDL: Insights for Future Pricing Negotiations in China

June 2, 2020

China’s 2019 National Reimbursement Drug List (NRDL) update offers manufacturers key learnings and insights for future NRDL negotiations, particularly with respect to the negotiation tactics used in different disease areas; although in most disease areas the comparative negotiation rule was employed...