Interpretation of the "Negotiated Drug Renewal Rules" by the National Medical Insurance Administration: Further support for drug innovation under the premise of "basic insurance"

2023-07-25

Recently, the National Medical Insurance Administration has adjusted and improved the "Negotiated Drug Renewal Rules" and interpreted the "Renewal Rules". With the normalization of medical insurance drug negotiations, the number of renewal varieties is increasing, and the renewal frequency of some exclusive varieties continues to increase. In order to make the negotiation of successful varieties more scientific, standardized, and reasonable, the National Medical Insurance Administration has organized in-depth research and argumentation. Based on extensive solicitation of opinions from various parties, ideas have been formed for further improving the renewal rules. The negotiation of medical insurance is not a random bargaining of "the lower the price, the better". The National Medical Insurance Bureau stated that whether entering or renewing a contract, it must comply with the positioning of basic medical insurance as "basic insurance". On this basis, the rules should be continuously optimized and improved. The medical insurance negotiation is a market-oriented mechanism that integrates the medication needs of 1.35 billion insured individuals and engages in a "quantity for price" exchange with enterprises. On the premise of not exceeding the affordability of the medical insurance fund and the vast number of insured individuals, medical insurance negotiations are based on a comprehensive and scientific evaluation of the clinical value of drugs and negotiations with enterprises, and are not arbitrary bargaining of "the lower the price, the better". The improvement of the renewal rules is completely consistent with the overall direction of strategic purchase and value purchase. The "Renewal Rules" must comprehensively consider the impact on the fund, patients, and the drug itself, cover the life cycle of the drug, provide stable expectations for enterprises and society, and take into account different situations such as initial renewal and multiple renewals, striving to achieve a win-win situation for patients, medical insurance, and pharmaceutical enterprises. This adjustment is generally beneficial for maintaining the safety of the fund, stabilizing and even reasonably improving the level of patient protection. By improving the renewal rules, the expectations of enterprises have been stabilized, which will further stimulate the enthusiasm of enterprises to apply for inclusion in the catalog and add indications for the varieties in the catalog. The level of medication guarantee for patients will be maintained and improved. At the same time, according to the new rules, the risk of successfully negotiated varieties being excluded from the catalog solely due to fund expenditure exceeding budget is reduced, and more cost-effective negotiation drugs can continue to be retained in the catalog, which is conducive to reducing fund expenditure risk and individual patient burden. The adjustment to include negotiated drugs that have reached 8 years in the regular catalog management mainly involves three aspects: firstly, the establishment of payment standard adjustment rules that basically cover the entire life cycle of drugs. From international experience, it usually takes about 8-10 years for a drug to reach its peak from launch to sales. Thanks to the promotion of dynamic adjustment mechanisms, the process in the Chinese market has accelerated. Based on this, the "Renewal Rules" propose to include negotiated drugs that have reached 8 years in the regular directory management; For negotiated drugs that have not reached 8 years, and varieties with a continuous agreement period of 4 years or more that are easily renewed or have new indications that trigger a price reduction, the reduction will be halved. The above adjustments are conducive to stabilizing enterprise expectations, reducing the pressure of price reductions in the later stage, and reducing the possibility of contract renewal failure. The second is to further demonstrate support for innovation. In order to further reflect the support for "true innovation", it is added that for Class 1 chemical drugs, Class 1 therapeutic biological agents, Class 1 and Class 3 traditional Chinese patent medicines and simple preparations approved according to the current registration management measures, when the renewal triggers the price reduction mechanism, we can apply for renewal in the form of renegotiation. We will organize experts to calculate and negotiate according to the procedures

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