Summary of Key Points
The application process for the 2026 national medical insurance catalog began on June 1st, with the online submission deadline set for June 10th. This year's changes include four major new aspects: the introduction of pre-submissions, additional conditions for submitting drugs not included in the catalog, the inclusion of key drugs that were previously removed, and adjustments to the dosage calculation parameters. Although the application period has been advanced, to minimize the impact on companies, the "approval deadline" has been extended to June 10th (and will be fixed as the release date of the new plan from next year). At the same time, the catalog for commercial insurance innovative drugs has also been updated, with a focus on supporting "genuine innovation and differentiated innovation," and the compliance requirements have become stricter.
Detailed Explanation
#### 1. Application Period: Special Relaxation This Year, Fixed Rule Next Year
The start of this year's medical insurance catalog application was earlier than in previous years, but companies expressed concerns about the tight preparation time. As a result, the Medical Insurance Bureau has moved the deadline for "drug approval or completion of technical review" from the plan release date (May 31st) to June 10th (the end of the application period). However, this is a temporary measure; starting from 2027, the deadline will be fixed on the day the plan is released.
In simple terms: Companies can take advantage of this year's extended period, but next year, they need to prepare even earlier, as they must confirm whether their drugs meet the requirements immediately upon the release of the new plan and cannot wait until the application period is about to end to submit additional materials.
#### 2. First-time Introduction of Pre-submissions: An Opportunity for Innovative Drugs to Get Ahead
In the past, applications for medical insurance could only be made after obtaining the drug registration approval. This year, pre-submissions are allowed for the first time. If a drug has completed its technical review by June 10th (meaning the regulatory authorities have deemed it technically acceptable, with only the final approval document missing), the company can submit the application materials in advance and provide the approval document and instructions by July 3rd. If approved, the drug can be included in this year's adjustment.
Benefits: Innovative drugs no longer need to wait for the approval document before entering the medical insurance process, allowing them to be available to patients more quickly. However, if the technical review is not completed by June 10th, even if approval is granted by July 3rd, the application will not be accepted.
#### 3. Additional Channels for Drugs Not Included in the Catalog
Three new conditions have been added this year to provide companies with more opportunities:
- Transfer from Commercial Insurance to Medical Insurance: Drugs listed in the commercial insurance innovative drug catalog can now be applied for inclusion in the basic medical insurance. For example, high-value innovative drugs that are initially expensive and used in commercial insurance can be included in the basic medical insurance after accumulating clinical data and reducing costs, fulfilling the promise of coordination between the two systems.
- Extended Application Period for Conditionally Approved Drugs: Conditionally approved drugs (e.g., urgently needed drugs that are temporarily available with subsequent evidence requirements) can apply for an additional three years, extending the total application period to up to eight years (five years of regular approval plus three years of extension). This gives companies more time to gather clinical evidence without rushing the application process.
- Reintroduction of Previously Removed Drugs: For drugs that were previously removed from the catalog due to negotiation, if another company produces a generic version, they can apply for inclusion.
In simple terms: Companies now have multiple options to get their drugs included in the medical insurance catalog, rather than being stuck with just one method.
#### 4. Removal of Drugs from the Catalog
This year, specific criteria have been added to identify drugs that may be removed from the catalog. Drugs with unclear instructions regarding contraindications, side effects, or precautions in their Chinese-language manuals, which have not been updated within the specified time frame, will be prioritized for removal.
Don't Worry: The Medical Insurance Bureau has stated that it will consider the traditional significance of these drugs and patients' medication habits when making decisions, avoiding arbitrary adjustments. Companies need to promptly update their manuals to maintain their eligibility for medical insurance.
#### 5. Dosage Calculation: More Accurate Costing
The parameters for calculating drug costs based on body weight have been updated. The standard adult weight has been increased from 60 kg to 65 kg, and the body surface area has been changed from approximately 1.5 m² to 1.68 m².
Reason: The average national weight has increased, and using the old parameters could result in under-reimbursed costs for heavier patients. The new calculations are more accurate and align with the methods used in other regions, preventing companies from miscalculating the cost of drugs.
Overall Direction
The main goal of this year's medical insurance catalog adjustment is to achieve steady progress while making improvements. On one hand, more flexible application options (such as pre-submissions and extended application periods) are provided to support truly innovative drugs with clinical value. On the other hand, compliance requirements have been tightened (e.g., requiring complete manuals), ensuring that medical insurance funds are used effectively. For patients, this means access to innovative drugs will be faster in the future. For companies, it emphasizes the importance of providing solid clinical evidence and complying with regulations.