Nearly 60 days have passed since the launch of the first edition of the Commercial Insurance Innovative Drug List. How can rare disease medications reach the lives of ordinary patients?

Source: Times Finance
Author: Zhang Yuqi

Image source: TuChong Creative

In recent years, as rare diseases have garnered increasing social attention, addressing the challenges faced by patients in diagnosis, treatment, and medication access has become a key focus of China’s healthcare reform.

February 28th marks the 19th International Rare Disease Day, with the theme still being “More than you can imagine.” Over the past decade, through joint efforts by the government, pharmaceutical companies, medical institutions, patient groups, and public welfare organizations, more and more rare disease patients have been recognized, and China’s rare disease diagnosis and treatment system has been continuously improving. However, similar to many high-value drugs, the issue of payment for rare disease medications remains prominent.

The introduction of the first commercial health insurance innovative drug list (hereafter referred to as the “Commercial Insurance Innovation Drug List”) may open new pathways for medication access for rare disease patients. This list officially took effect on January 1st of this year, including a total of 19 drugs. Besides the highly discussed star anti-cancer CAR-T cell therapy, it also covers various treatments for rare diseases, including neuroblastoma and Gaucher’s disease.

But this is just one step toward improving access to high-value rare disease drugs. Truly bridging the “last mile” of medication access and establishing an efficient, sustainable保障 mechanism remains a significant challenge.

Jin Chunlin, Director of the Shanghai Center for Health and Development Research, told Times Finance that the Commercial Insurance Innovation Drug List can help address medication issues for rare diseases, but ultimately, it still requires joint solutions through social insurance or other diversified payment methods. Rare diseases are low-probability events, and the list is fundamentally a commercial activity; there are inherent differences in alignment between the two.

Huang Ming, former Standing Committee member of the Shanghai CPPCC and former Executive Deputy Director of the CPPCC Proposal Committee, told Times Finance that for multi-party payment to truly take effect, a stable and lasting制度 is needed. “For example, at the pre-approval stage, the government should implement direct policies for rare diseases, such as accelerating drug approval or creating special channels for rare disease treatments; at the implementation level, the government should introduce encouraging policies, such as urging enterprises and industry public welfare organizations to take on more roles in the rare disease保障 system. At the enterprise level, besides providing drugs and devices, they should cooperate with relevant industry departments and government to conduct statistics and整理 work, further exploring multi-party payment models,” she said.

Nearly 60 days after the implementation of the Commercial Insurance Drug List

In 2025, the national medical insurance negotiations (referred to as “National Negotiations”) first proposed adding a commercial insurance innovative drug list, providing new options for drugs with high innovation, significant clinical value, and substantial patient benefits that, due to exceeding the scope of “basic coverage,” could not be included in the basic catalog.

On February 20th, the National Healthcare Security Administration (NHSA) official WeChat announced that the dual catalog of medical insurance and commercial insurance has been fully implemented in Shandong Province. Particularly, the Commercial Insurance Innovation Drug List in Shandong strictly follows the NHSA’s “Three Exclusions” requirements: not included in self-pay indicators, not monitored as substitutes in centralized procurement, and not necessarily included in diagnosis-based payment scope, fully supporting clinical application. Currently, Shandong has included some commercial insurance innovative drugs, such as the CAR-T cell therapy drug Acalabrutinib, in its provincial customized commercial health insurance guidance list.

Li Shunping, Professor at Shanghai University of Public Health and Deputy Director of the Key Laboratory of Health Economics and Policy of the National Health Commission, told Times Finance that the Commercial Insurance Innovation Drug List recommends high-innovation, high-clinical-value drugs that benefit patients and are beyond basic medical insurance coverage for reference by commercial health insurance and mutual aid systems, forming a complementary connection with basic medical insurance. This can better发挥多元支付作用, reducing the medication burden on ordinary people.

Before the Spring Festival of the Year of the Horse, the NHSA conducted a survey on the nationwide implementation of the Commercial Insurance Innovation Drug List. As of January 11, 2026, 19 such drugs were available in 965 designated medical institutions nationwide, with 449 hospitals and 516 retail pharmacies. Among these 19 drugs, 16 have information on equipped institutions; for example, the injection of ipilimumab is available in more than 30 provinces, 7 drugs in over 20 provinces, and 12 drugs in over 10 provinces.

The NHSA stated that it will focus on varieties not yet equipped in designated medical institutions, strengthen monitoring, and督导 enterprises to ensure the rights and interests of insured patients.

Jin Chunlin told Times Finance that the implementation of the Commercial Insurance Innovation Drug List is still in its early stages, and many issues remain to be addressed. Especially since the list includes several rare disease drugs, which face obstacles due to high reimbursement costs and small usage volumes nationwide. The fact that this is the first implementation of such a list adds complexity. Currently, Shandong Province has a relatively good implementation, but it is impossible to require all medical institutions to include rare disease drugs, given the small patient population and potential issues like unused or expired drugs.

“Implementing the Commercial Insurance Innovation Drug List requires horizontal solutions, such as establishing several designated medical institutions within provinces or drug distribution platforms, which can facilitate implementation. Furthermore, when it comes to rare disease drugs, the number of hospitals or the volume of admissions should not be the sole criteria for assessing implementation, as this is not scientifically sound,” Jin Chunlin further explained to Times Finance.

How can multi-party payment for rare diseases cross the “last mile”

In recent years, the normalization of adjustments to the national medical insurance catalog has included many high-value rare disease drugs, significantly easing patients’ financial burdens. Additionally, payment support from惠民保 and other schemes has partially addressed the payment issues for high-value drugs for rare diseases.

Jin Chunlin told Times Finance that the Commercial Insurance Innovation Drug List can partly solve medication access issues for rare diseases, but it is not the only solution. For some patients with long-term or lifelong treatment costs, especially for rare diseases requiring ongoing medication, they still face the dilemma of “not being able to afford or access the drugs.”

China manages rare diseases through catalog lists, with relevant departments releasing the “First Batch of Rare Disease List” in 2018 and the “Second Batch of Rare Disease List” in 2023, covering a total of 207 rare diseases. By the end of 2025, the number of rare disease drugs included in the national medical insurance catalog reached 136, covering 69 rare disease conditions.

However, many patients still face the dual difficulties of expensive and inaccessible medication. On one hand, some treatments are not yet included in the national insurance catalog and remain costly; on the other hand, some diseases still have no available treatments.

According to the “China Rare Disease Industry Trend Observation Report,” currently, 58 rare diseases with 65 drugs are not covered by insurance, including 33 rare diseases whose entire treatment drugs (statistically 31) are not covered.

In response, Huang Ming told Times Finance, “In terms of rare disease payment, we have focused on expanding the establishment of dedicated救助基金 in recent years.” She believes that for multi-party payment to be sustainable and stable, there must be further efforts to establish dedicated救助基金 for rare diseases. First, relying solely on enterprises, charitable funds, or individual efforts, or a few government departments, cannot provide stable保障 for rare disease payments. Therefore, funding must be secured through clear and stable制度, which a dedicated fund can help achieve.

“Second, once funds are in place, how to use them effectively is crucial. For example, patients should be able to apply for funds at any time and place, and receive prompt assistance. The rare disease救助基金 should also establish ‘one-door’ or ‘one-window’ service agencies at the grassroots level, allowing patients to apply immediately and connect with the fund, ensuring the制度 is truly implemented,” Huang Ming further explained to Times Finance.

In fact, as early as 2013, Shanghai adopted a “multi-party sharing” model to provide solutions for high-value rare disease drugs. Later, Zhejiang and Jiangsu also established dedicated rare disease funds to support payment issues. However, nationwide, such local专项基金 are still limited.

According to media reports, Shanghai, as a pioneer of the “special保障模式,” supported rare disease patients through temporary procurement, corporate assistance, charitable funds, and pediatric hospitalization funds in 2013. But the Gaucher’s disease专项救助基金, for example, was based on a single hospital’s designated treatment, and this project may now face suspension.

This indicates that the implementation of rare disease专项基金 still faces obstacles.

Huang Guoying, Chairman of the Shanghai Rare Disease Prevention and Control Foundation, Vice Chairman of the Chinese Medical Association Rare Disease Branch, and President of the Chinese Medical Doctor Association Pediatrics Branch, told Times Finance, “In recent years, China has made some progress in rare disease救助, with some drugs included in the national insurance catalog, and high-value innovative drugs exploring other保障途径. Currently, the national level is still exploring mechanisms for保障 high-value rare disease drugs. But rare diseases are not only a medical diagnosis and treatment issue; they are also a deep social and民生问题. Ordinary people often cannot imagine the hardships faced by the rare disease community. This suffering is not limited to the patients’ own pain but also affects their families, relatives, and communities. Therefore, it requires joint efforts from multiple parties and多元支付 to effectively address these challenges.”