Summary of Key Points
The process for innovative drugs to be included in national medical insurance negotiations (referred to as "national talks") and subsequently introduced into hospitals is becoming increasingly smoother. Most drugs approved through these negotiations can quickly enter clinical use within 12-18 months, which not only reduces patient costs but also improves access to treatment and optimizes the allocation of hospital resources. However, there are still several critical issues that need to be addressed: some newly approved drugs are hesitant to be used by doctors due to a lack of clinical evidence; the mismatch between combination therapy for tumors and medical insurance payment policies; and the pressure on hospitals from medical insurance cost control and performance evaluations.
1. Accelerated Introduction of Negotiated Drugs into Hospitals: Savings for Patients, Higher Efficiency for Hospitals
In the past, it was difficult for innovative drugs to be introduced into hospitals. Now, within two months of the new medical insurance catalog being implemented in most provinces, a "pharmacy committee" is convened to decide which drugs can be included. Drugs approved through national talks with clear clinical benefits can be widely used in hospitals within 12-18 months, directly driving an increase in pharmaceutical company revenues.
For Patients: For example, the drug Yiruoqi monoclonal antibody, which cost 80,000-100,000 yuan per year before the negotiation, now only costs a few thousand yuan out of pocket after insurance reimbursement. Patient Zhang Jian saw a 90% reduction in skin lesions after just two injections. Lung cancer patients using Yiwuxi monoclonal antibody do not need chemotherapy and only need to receive an injection every 3-4 weeks; patients from other provinces can also continue treatment locally, significantly reducing their financial burden compared to hospitalization.
For Hospitals: The use of Yiwuxi monoclonal antibody as a monotherapy that replaces chemotherapy frees up more hospital beds, increasing bed turnover rates. Additionally, the separate payment policy for outpatient services helps reduce hospitals' cost pressures.
2. New Challenges: The Real Effectiveness of Some Innovative Drugs Still Needs to Be Proven in Practice
Many new drugs are included in medical insurance as soon as they are released, some even with conditional approval (released first and then evidence provided later), leaving doctors unsure about their use in real-world scenarios:
- Hesitation to Use for Special Patients: Children, the elderly, and patients with multiple underlying conditions were often excluded from clinical trials before the drugs were approved, so doctors are unsure of the drug's effectiveness and side effects on these groups.
- Difficulties in Interdisciplinary Treatment: For instance, patients with psoriasis who also have hypertension may face difficulties when seeking treatment from cardiologists, as cardiologists may not be familiar with dermatological biologics.
Solutions include multidisciplinary consultations (MDTs) and real-world studies. MDTs involve doctors from different departments working together to develop treatment plans for patients, while collecting data that can both validate the drug's effectiveness and provide a basis for medical insurance decisions and hospital evaluations.
3. How to Address Hospitals' Concerns about Medical Insurance Cost Control and Performance Evaluations?
Hospitals are reluctant to use negotiated drugs due to concerns about their effectiveness and medical insurance evaluations:
- Drug Expense Proportion: The proportion of drug costs in total hospital expenses cannot be too high, as this can affect performance evaluations.
- DRG/DIP (Disease-Based Payment): Hospitals must not spend more on treating the same disease; otherwise, they have to cover the difference out of their own pockets.
To address these concerns, both the national and local governments have introduced policies:
- The state has explicitly exempted negotiated drugs from drug expense proportion and DRG evaluations.
- Provinces like Zhejiang have provided additional incentives, such as adding 10% more performance points at the end of the year based on the amount spent on using negotiated drugs in hospital settings, effectively providing subsidies to hospitals.
4. Difficulty in Reimbursement for Combination Therapies? Medical Insurance Has Provided Clear Guidelines
Combination therapy is becoming common in cancer treatment, but there are often discrepancies between medical insurance payment policies and clinical practices. For example, if a doctor uses drug A in combination with drug B, and drug B's instructions do not mention its use for that condition, will it be reimbursed by insurance?
The latest guidelines from the medical insurance department are as follows:
- The drug instruction manual is the authoritative source. If a combination therapy has been approved (e.g., a combination of A and B), it will be reimbursed, even if drug B's instructions do not list that indication.
- However, if one of the drugs is not part of the medical insurance catalog or has specific payment restrictions, it will not be reimbursed.
In summary, while the barriers to the introduction of negotiated drugs into hospitals are being overcome, additional efforts are needed to ensure that innovative drugs truly benefit patients by addressing issues such as insufficient clinical evidence, performance evaluation pressures, and reimbursement for combination therapies. The key approach is to use real-world research to support evidence, policy exemptions to reduce hospital burdens, and clear rules to resolve payment discrepancies—all with the ultimate goal of ensuring patients can access and afford high-quality medications.