Broad Success for Chinese Pilot Project to Negotiate National Formulary Approval for Innovative Medicines

Lawrenceville, NJ, USA—August 22, 2018—Value in Health Regional Issues, a MEDLINE®-indexed journal of ISPOR (the professional society for health economics and outcomes research), announced today the publication of an article highlighting the positive results of a pilot project launched by the Chinese central government. The project intended to negotiate approval on the China National Formulary for innovative medicines that had been previously unapproved because of their relatively high cost. The report, Recent Pricing Negotiations on Innovative Medicines Pilot in China: Experiences, Implications, and Suggestions, was published online in the Asia-focused issue of Value in Health Regional Issues.

The pilot, conducted between March and July 2017, showcased numerous leading-edge features including a working definition of innovative medicines and opportunities to submit dossiers on a drug’s clinical and economic information. In all, agreements (including both approved indications and prices) were successfully reached between China’s government and the pharmaceutical companies for 36 of the 44 medicines on the initial list. These 36 medicines treat important disease states such as hematology, cardiology, oncology, immunology, neurology, and Chinese traditional medicines for cancer therapy.

The authors make 6 recommendations critical to China National Formulary future developments, including enhancing criteria and process for evaluations, standardizing the dossier format, specifying data requirements, refining pricing calculation, and cultivating evaluation professional development.

“This pilot of negotiations for innovative drugs has been successful, resulting in the inclusion of innovative medicines in the China National Formulary, thus benefiting patients in China,” said author Jiu-Hong Wu, PhD, PharmD, 306 Hospital of PLA, Beijing, China. “The positive outcomes suggest a promising direction for future development. However, there are other key issues to consider for improvement of patient access under the China National Formulary. More pilots can be expected before the evaluation system becomes finalized.”



ISPOR, the professional society for health economics and outcomes research (HEOR), is an international, multistakeholder, nonprofit dedicated to advancing HEOR excellence to improve decision making for health globally. The Society is the leading source for scientific conferences, peer-reviewed and MEDLINE®-indexed publications, good practices guidance, education, collaboration, and tools/resources in the field.
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Value in Health Regional Issues (ISSN 2212-1099) is a peer-reviewed, MEDLINE®-indexed journal of ISPOR. It is an online journal that publishes articles that focus on health-related topics that impact the health policies and populations in the following regions: 1) Asia; 2) Central and Eastern Europe, Western Asia, and Africa; and 3) Latin America.
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