Xi'an Janssen Leads with Most New Products in China's Latest National Reimbursement Drug List Negotiations

On November 28, the National Healthcare Security Administration officially announced the list of drugs approved through the 2019 medical insurance negotiations. Among the 150 drugs subject to negotiation, 70 newly added drugs were successfully included, with an average price reduction of 60.7%. For drugs up for contract renewal, 27 were successfully negotiated, with an average price reduction of 26.4%. Following this round of adjustments, the 2019 "National Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance Drug Catalog" includes a total of 2,709 drugs. Compared with the 2017 edition, 218 drugs were added, 154 were removed, resulting in a net increase of 64 drugs.

Imported and Innovative Drugs Become "Hot"

This negotiation marks the largest-ever drug formulary access negotiation since the establishment of the National Healthcare Security Administration.

In terms of the key disease areas involved, the drugs successfully negotiated in this round cover more than 10 clinical therapeutic fields, including cancer, rare diseases, hepatitis, diabetes, multidrug-resistant tuberculosis, rheumatology and immunology, cardiovascular and cerebrovascular diseases, and digestive disorders. This negotiation will significantly enhance the coverage for major diseases, helping more Chinese patients greatly improve their access to and affordability of innovative medicines.

In terms of selected companies, among multinational pharmaceutical firms, Xian Janssen and its subsidiary Actelion, as well as Novartis (with two renewals), each had seven products successfully shortlisted, making them the biggest winners in this round of national medical insurance negotiations. Roche had five drugs selected; AstraZeneca and Gilead each had four drugs selected; Sanofi and Bayer each had three products selected. Among domestic pharmaceutical companies, Hengrui Medicine had three products selected, making it the local enterprise with the highest number of inclusions.

Notably, all seven products from Xian Janssen (bedaquiline fumarate tablets, infliximab for injection, canagliflozin tablets, bosentan tablets, selexipag tablets, macitentan tablets, and miglustat capsules) are newly added varieties, making it the enterprise with the highest number of new products. Among these, bosentan tablets, selexipag tablets, macitentan tablets, and miglustat capsules are all medications for rare diseases.

Bosentan, developed by Actelion, a subsidiary of Janssen, is a specific and competitive dual endothelin receptor antagonist. It reduces pulmonary and systemic vascular resistance, thereby increasing cardiac output without increasing heart rate, and improving exercise capacity and hemodynamic parameters in patients with idiopathic pulmonary arterial hypertension (PAH). PAH is a chronic, life-threatening, progressively malignant rare disease. On October 9 this year, the National Health Commission and other authorities issued the "First Batch of Encouraged Generic Drug List," which included two PAH treatment drugs—treprostinil injection and bosentan tablets. Bosentan tablets were part of the 2017 medical insurance negotiations but ultimately failed to reach an agreement; this time, it can be said that they finally achieved their goal.

A New Round of Pharmaceutical Competition Is About to Begin

In addition to several globally renowned “premium drugs” being offered at “affordable prices,” another noteworthy aspect of the successfully negotiated medications is that they are predominantly newly launched in recent years and possess high clinical value, with many having been newly introduced in 2018.

I still remember that in March 2017, the former China Food and Drug Administration (CFDA) website released the "Decision on Adjusting Certain Matters Concerning the Registration and Administration of Imported Drugs (Draft for Comments)." This 467-word draft caused a significant stir. In just over two years, China has continuously narrowed the gap between domestic and international launch times for imported and innovative drugs.

It is reported that Xian Janssen launched 22 new products and indications over the past 22 months, with most of the seven new products included in the recent reimbursement list through negotiation being among them. Meanwhile, Sintilimab, a PD-1 inhibitor from Innovent Biologics, which is the only oncology immunotherapy drug included in the National Reimbursement Drug List this time, was officially approved on December 27, 2018, and launched in February this year, entering the national reimbursement list in less than a year.

For pharmaceutical companies, negotiating inclusion in the National Reimbursement Drug List (NRDL) represents only one component of market access. Subsequent steps include tendering and procurement, online listing for procurement, hospital formulary inclusion, marketing, and sales follow-up. Under the broader concept of “market access,” true access is achieved only when a comprehensive, end-to-end process successfully delivers newly approved products to patients.

Industry experts believe that, bolstered by the dual policy support of accelerated regulatory review and approval alongside national medical insurance coverage, pharmaceutical companies are better positioned to expedite the market launch of innovative drugs, enhance drug accessibility, and benefit a broader population of patients in China. Looking ahead, with the implementation of the results from the recent medical insurance negotiations and the overall adjustments to the 2019 National Reimbursement Drug List (NRDL), coupled with the gradual phase-out of local medical insurance formularies, pharmaceutical companies will face a new round of significant restructuring, heralding the onset of healthy, competitive acceleration.

Appendix: List of 97 Drugs Successfully Negotiated