Summary of Key Points
The National Healthcare Security Administration recently reported on the implementation of the “Special Case Exceptional Approval” program in all provinces across the country for 2025: A total of over 2.43 million cases were submitted from 32 provinces, with 85% being approved, and healthcare insurance paid out a total of 61.2 billion yuan (of which an additional 26.3 billion yuan was paid, accounting for 40%). Shanghai led the nation with an approval rate of 99% and an average additional payment per case of 29,800 yuan. Provinces such as Guangdong and Tianjin also had approval rates exceeding 95%. The “Special Case Exceptional Approval” program serves as a “green channel” for the use of innovative drugs and medical devices, but other healthcare support policies are also in place in various regions. In the future, the state plans to continue improving this mechanism.
Detailed Analysis
#### 1. What is the “Special Case Exceptional Approval,” and why is it so important for innovative drugs?
Simply put, the “Special Case Exceptional Approval” allows healthcare insurance to provide reimbursement for patients using new drugs or technologies. Normally, healthcare insurance reimburses based on disease categories (for example, colds are grouped together with a fixed amount of reimbursement). However, some cases involving newly launched innovative drugs or advanced technologies have much higher costs than regular cases, and the standard reimbursement amounts are insufficient. In such cases, hospitals can apply for “Special Case Exceptional Approval,” and if approved by experts, the healthcare insurance will cover an additional portion of the cost.
For hospitals and doctors: There is no fear of incurring fines due to excessive costs from using new drugs, encouraging them to boldly try new technologies. For innovative drug companies: If hospitals are willing to use their products, the market is secured, which motivates more research and development efforts. Therefore, this mechanism directly affects the speed at which innovative drugs can be introduced into clinical practice.
#### 2. How did Shanghai achieve an approval rate of 99%? What are the reasons behind this?
Shanghai has a high number of innovative drugs and complex, severe cases, so one might expect more intense competition for “Special Case Exceptional Approval.” However, the high approval rate (nearly 100%) can be attributed to two factors:
- High quality of applications: Shanghai’s hospitals have strict management, ensuring that only genuine cases requiring new drugs are submitted, and they communicate thoroughly with the healthcare insurance department in advance to understand the criteria for approval.
- Multiple support options: In addition to the “Special Case Exceptional Approval,” Shanghai offers other forms of healthcare support (such as separate payments or preferential reimbursement), so many innovative drug cases do not rely solely on this mechanism, resulting in a higher approval rate.
The average additional payment per case in Shanghai (29,800 yuan) indicates that the healthcare insurance provides substantial financial support for the use of these drugs.
#### 3. Variations in provincial performance: Which regions are more supportive of innovative drugs?
Based on the report data, the levels of support vary among provinces:
- High approval rates: Shanghai (99%), Guangdong, Tianjin, Guizhou, Shanxi (all with approval rates over 95%) – these regions either have lenient review processes or high-quality applications, indicating a strong willingness to accommodate innovative drugs.
- Large number of applications: Sichuan (396,000 cases, 16% of the national total), Guangxi, Henan, and other populous provinces – with more patients and complex cases, there is a higher demand for “Special Case Exceptional Approval.”
- High average additional payments per case: Hainan (32,300 yuan), Zhejiang (30,400 yuan), Beijing (21,100 yuan) – although these regions did not submit the largest number of applications, they provide more financial support per approved case.
#### 4. What additional measures are in place if “Special Case Exceptional Approval” is insufficient?
While the “Special Case Exceptional Approval” serves as a backup policy, it does not cover all needs, so other measures have been introduced:
- Hainan: Allows for “excluded payments” for biological innovative drugs, meaning certain costs are not included in the standard reimbursement categories and are reimbursed separately.
- Zhejiang: Offers an additional 10% bonus to hospitals using nationally negotiated drugs (equivalent to extra reimbursement) at the end of the year; also has a dynamic support system for innovative drug technologies.
- Beijing: Exploring new fee items for innovative medical devices to encourage hospitals to adopt these technologies.
These policies, combined with the “Special Case Exceptional Approval,” create a more comprehensive support system.
#### 5. How will the “Special Case Exceptional Approval” program be improved in the future?
The National Healthcare Security Administration plans to further optimize the mechanism:
- Encourage hospitals to apply more boldly to increase the number of approved innovative drug cases.
- Regularly make the approval process transparent.
- As healthcare insurance reimbursement categories are upgraded (from version 2.0 to 3.0), the classification will be more aligned with clinical realities, and compensation for complex surgeries will become more reasonable, requiring adjustments to the “Special Case Exceptional Approval” standards as well.
The industry believes that the “Special Case Exceptional Approval” is a temporary measure, and in the future, more stable and regular incentives are needed to build confidence among hospitals and companies.
In summary, the “Special Case Exceptional Approval” program serves as an indicator of the support environment for innovative drugs across different regions. The experiences of Shanghai and other provinces show that while providing a pathway for these drugs is essential, additional policies are necessary to ensure their effective integration into clinical practice and benefit patients.