In the first half of this year, among the 38 approved innovative drugs in China, 31 were domestically developed, exceeding 80%.

As of the end of last year, China had a total of 4,751 innovative drugs under research, accounting for 33.7% of the global total.

While these achievements are encouraging, another issue has become prominent: once a drug is on the market, can it be purchased in hospitals? Are doctors willing to prescribe it? Can patients afford it?

On Tuesday of this week, the National Health Commission and three other departments jointly issued the Notice on Further Improving the Safe and Rational Deployment and Use of Innovative Drugs, aimed at resolving the practical bottlenecks of "difficulty in hospital admission, difficulty in prescribing, and difficulty in reimbursement" for innovative drugs.

So, to what extent can the new policy bridge the "last mile" of clinical implementation? Who will pay for innovative drugs — basic medical insurance or commercial insurance?

On Saturday of this week, the new version of the national medical insurance drug catalog was announced, with 51 of the 107 newly added drugs being Class 1 new drugs, setting another historic high.

Among them, a CAR-T injection originally priced at over one million yuan became the first CAR-T drug included in basic medical insurance.

On Thursday of this week, the National Medical Products Administration approved three Class 1 innovative drugs on the same day, two of which came from domestic pharmaceutical companies.

Among the 38 innovative drugs approved in the first half of this year, domestically developed innovative drugs also accounted for over 80%.

China's innovative drugs are also accelerating their overseas expansion. As of September this year, the total value of China's innovative drug outbound licensing transactions has exceeded 120 billion US dollars, a year-on-year increase of 36%.

Song Ruilin, Chief Expert of the China Pharmaceutical Innovation and Research Development Association, said: Through nearly a decade of effort, China has transformed from mainly buying projects from abroad to conduct research in China, to becoming a source of global pharmaceutical innovation projects, with everyone coming to China to buy projects.

China and the United States now differ by only about 3% to 4% in the number of global innovative drug R&D pipelines, but together they account for over 65%, meaning two-thirds of the world's R&D pipelines are in China and the United States.

On one hand, innovative drug R&D and market approval are accelerating; on the other hand, the general perception is that even after innovative drugs are approved and included in medical insurance, they are still unavailable in some hospitals.

This "temperature gap" means that innovative drug reform seems to have reached a moment where it must confront a series of core bottleneck issues.

Zhao Hong, National Committee Member of the Chinese People's Political Consultative Conference and Chief Physician at the Cancer Hospital of the Chinese Academy of Medical Sciences, said: During the 14th Five-Year Plan period, over 200 Class 1 new drugs were approved, along with approximately 270 medical devices.

Overall, the coverage rate of innovative drugs in tertiary hospitals is about 14%, and in key hospitals it can reach around 38%.

For a long time, even after innovative drugs enter medical insurance, they still need to go through multiple layers of review, including hospital pharmacy committee approval, before entering hospitals.

In addition, cost management and performance assessments also affect doctors' prescribing decisions.

On Tuesday of this week, the National Health Commission and three other departments jointly issued the Notice on Further Improving the Safe and Rational Deployment and Use of Innovative Drugs, proposing to directly address these institutional barriers from four aspects to accelerate the delivery of innovative drugs to patients.

For example, regarding the efficiency of pharmacy committee reviews, the notice requires that medical institutions at or above the secondary level improve the hospital admission process for innovative drugs, convene pharmacy meetings in a timely manner, and promptly include relevant innovative drugs in medication catalogs.

Beijing has gone further, requiring that once national medical insurance negotiated drugs and Class 1 innovative drugs are launched, hospitals can directly include them in procurement catalogs without convening drug selection meetings.

According to data from the Ministry of Industry and Information Technology, China's innovative drug market size exceeded 100 billion yuan in 2024.

The new goal is for the innovative drug industry to achieve an average annual growth rate of over 20% during the 15th Five-Year Plan period.

Against this backdrop, a contradiction is increasingly prominent: who will pay for expensive innovative drugs.

Overall, among China's innovative drug sales expenses, basic medical insurance covers 44%, commercial insurance covers only 7%, and the remaining 49% is paid out of pocket by patients or through other channels.

Compared to some developed countries, China's commercial insurance market has enormous room for growth.

On the same day the four departments issued the notice, the China Insurance Association also released the first version of the Recommended List of Commercial Health Insurance Drug Coverage, initially including 58 drugs and devices, of which 25 are Class 1 innovative drugs and 32 are drugs outside the basic medical insurance catalog.

The speed of innovative drug R&D and market launch is increasing, and the speed of medical insurance inclusion is also accelerating.

However, many patients find that even though innovative drugs are included in medical insurance, they cannot be purchased in hospitals.

Many pharmaceutical companies also say that even if innovative drugs enter medical insurance, entering hospitals still requires crossing several thresholds.

For example, the medical insurance catalog updates quickly, but each hospital's drug catalog is limited and cannot accommodate so many drugs, and replacing old drugs with new ones also requires a relatively long review period.

The most important point is that hospitals have limited total medical insurance budgets, and innovative drugs are generally expensive. Purchasing too many can easily lead to overspending, and who will bear responsibility for the overspending? Hospitals are naturally particularly cautious.

There are 149 innovative drugs included in the national medical insurance catalog, but only 4 Class 1 innovative drugs were introduced by the hospital — this was the reality faced by Chengdu Third People's Hospital in 2024.

Xu Min, Deputy Director of the Pharmacy Department at Chengdu Third People's Hospital, said: New drugs entering the hospital must go through the new drug selection process, but the new drug selection work may only be done once or twice a year.

Because our process is too long, or it happens to miss our new drug selection cycle, there is no way to admit it in time.

There is also the "one drug, two specifications" restriction, which may prevent entry into the hospital due to specification number limits.

There are also assessment indicators. Considering that innovative drugs have just been launched and are very expensive, concerns about patients' financial burden, and factors affecting the hospital's overall operations such as drug cost ratios, many hospitals adopt a relatively conservative attitude toward admitting innovative drugs.

These factors are all influences limiting the hospital admission of innovative drugs.

Related reforms in Sichuan Province were launched in 2024.

Medical institutions are required to convene pharmacy meetings within one week of drug listing and complete procurement and hospital admission within two months, greatly compressing the approval time.

At the same time, restrictions on the quantity of drugs used by medical institutions were abolished.

This week, the notice from the National Health Commission and three other departments also clearly states that health administrative departments at all levels shall not impose restrictions on the total number of drug varieties and specifications in medical institutions, and Class 1 new drugs in the basic medical insurance and commercial insurance catalogs shall not be counted toward the "one drug, two specifications" rule.

Zhao Hong said: Under "one drug, two specifications," for drugs with the same chemical name, hospitals in principle select the best among the best, allowing no more than two specifications or two brands of drugs to enter the regular drug storage for patient use.

Xu Min said: As innovative drug work continues to advance, from 2025 to 2026, we will have introduced 19 innovative drugs in total.

In the past, the use rate of essential drugs and drug prices were important content in public hospital performance assessments and monitoring, and to a certain extent influenced hospitals' and doctors' medication choices.

In response, the notice proposes that Class 1 new drugs in the basic medical insurance and commercial insurance catalogs will no longer be included in the scope of relevant performance monitoring for public hospitals.

Experts believe that the clinical use of innovative drugs still requires further resolution of the impact brought by medical insurance payment methods.

Under the DRG/DIP payment reform based on disease categories, some cases using innovative drugs may face the problem of actual medical costs exceeding payment standards.

In response, medical insurance departments have a special case single-review mechanism. For cases using new drugs, new technologies, or with complex conditions that are truly unsuitable for payment according to disease category standards, hospitals can independently apply, and after expert review, payment can be made on a fee-for-service basis or payment standards can be adjusted.

However, in actual implementation, this mechanism still faces some obstacles.

In response, the notice proposes that medical insurance departments should simplify procedures and optimize processes, organizing experts to review special case single-review cases on a quarterly or monthly basis, so that this mechanism can truly play its role.

In the view of many industry insiders, China's innovative drugs have shifted from a supply problem to a payment problem.

Simply put, drugs can be manufactured, but who will pay for them?

A relevant official from the National Healthcare Security Administration once provided this set of data: currently, among innovative drug sales expenses, basic medical insurance covers 44%, commercial insurance covers 7%, and nearly half of the remainder must be paid out of pocket by patients or resolved through other channels.

Medical insurance carries nearly half, but medical insurance protects "basic" needs, and there is not much room for increase.

Beyond medical insurance, patients paying out of pocket account for the other half, while commercial insurance is only a small fraction. This is also why many ordinary people still hesitate when facing sky-high priced innovative drugs.

Next, the reform approach becomes very clear: money will not come from nowhere. To make innovative drugs affordable for more people, commercial insurance must develop quickly and well.

On Saturday of this week, the new version of the national medical insurance drug catalog and the commercial health insurance innovative drug catalog were released.

Among the 12 new drugs added to the new commercial insurance innovative drug catalog is the world's first CAR-T cell therapy product targeting solid tumors, developed by a pharmaceutical company in Shanghai.

When this drug was launched in June this year, it attracted attention due to its pricing of 990,000 yuan per person. Being selected for the commercial insurance innovative drug catalog just five months after launch provides a more realistic path for patients to access cutting-edge therapies through commercial insurance.

What impact will inclusion in the commercial insurance catalog have?

This drug for treating relapsed or refractory multiple myeloma was initially priced at 1.15 million yuan. Last year, it was included in the first national commercial insurance innovative drug catalog. Over the past year, through cooperation with insurance companies, a certain degree of price reduction has been achieved.

This week, this drug was also included in the first version of the "Commercial Insurance Drug Recommendation List" released by the China Insurance Association.

Li Zonghai, founder of CARsgen Therapeutics and doctoral supervisor at Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine, said: In fact, some patients, because the product has been included in million-yuan medical insurance, basically do not need to pay such expenses themselves.

If included in Huimin Insurance, paying 30% to 35% of the cost means reducing at least about 300,000 yuan.

So after this inclusion, especially after inclusion by the China Insurance Association, it will better promote more insurance projects to be implemented.

The "Commercial Insurance Drug Recommendation List" released by the China Insurance Association this week covers 58 drugs and devices. During the compilation process, 22 participating experts reviewed four dimensions: clinical need, innovation, effectiveness, and safety. At the same time, 54 insurance companies were organized to vote, with the aim of more efficiently meeting consumers' diverse and quality medication needs.

With multiple measures working together, the commercial insurance innovative drug catalog and the commercial insurance drug recommendation list are only the first step. For innovative drugs to truly be embedded in insurance products and transformed into accessible protection for patients, insurance companies still need to develop products and expand markets.

For example, drawing on foreign experience, reforming enterprise group supplementary medical insurance is an important breakthrough for solving the current dilemma.

A new batch of innovative drugs has obtained "admission tickets" to medical insurance and commercial insurance.

From approval and market launch to entering catalogs is certainly a key step. Next, whether they can quickly enter hospital pharmacies, enter doctors' prescriptions, and finally reach patients tests the speed and effectiveness of a series of reforms.