Access Barrier or Opportunity? Evolving Trends in NRDL Listings in China

Author(s)

Macaulay R1, Leong KW2
1Precision Advisors, London, UK, 2Precision Advisors, London, LON, UK

OBJECTIVES: The National Reimbursement Drug List (NRDL, established in 2000), in which included medicines are reimbursed by public insurance, is the main route to market access in China. Since 2017, NRDL’s scope has been expanded to cover innovative patented drugs and has been updated in 4 consecutive years. Since 2020, manufacturers can submit applications for formal review. Currently governed by the National Healthcare Security Administration (NHSA), negotiation rules state that manufacturers can provide two tender prices, and the process automatically terminates if the second price exceeds NHSA’s base price by 15%. This research evaluates trends in NRDL outcomes over time.

METHODS: NRDL listings (2017–2021) were identified and key information extracted (31-Dec-2021).

RESULTS: The total number of medicines included in the NRDL increased by 11%, from 2571(2017) to 2860(2021). An average of 161 new medicines were added per year (range: 74[2021]–375[2017]), 51% of which were ‘Western’ medicines (i.e. non-traditional Chinese medicines). Negotiation success rates for new medicines was 77% (range: 59%[2019]–94%[2018]). However, the average price cut negotiated was 55% and has risen from 44% in 2017 to 62% in 2021. Further, the proportion of negotiated medicines developed by multinational manufacturers dropped from 61% in 2017 to 43% in 2021.

CONCLUSIONS: Since 2017, the NRDL has provided a route for public reimbursement of innovative patented drugs in the very large market represented by China. However, the trends over time are for increasingly steeper price cuts being demanded alongside an increasing focus on domestically-manufactured medicines. Pursuing NRDL public reimbursement poses significant questions for multi-national pharmaceutical companies in terms of the discounts required, volume/revenue potential, and launch sequencing considerations. To optimize access to the Chinese market, manufacturers should closely monitor evolving NRDL trends and the domestic landscape, validate price-access trade-offs, and be prepared with a tailored negotiation strategy.

Conference/Value in Health Info

2022-05, ISPOR 2022, Washington, DC, USA

Code

HTA11

Topic

Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes, Pricing Policy & Schemes, Reimbursement & Access Policy

Disease

No Additional Disease & Conditions/Specialized Treatment Areas

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