Recently, the National Health Insurance Administration said in response to the proposal of the CPPCC members that in recent years, the drugs included in the medical insurance catalogue are mainly new drugs approved within 5 years, such as the 108 new negotiated bidding drugs added to the medical insurance drug catalogue in 2022, 105 of which were listed after January 1, 2017, accounting for 97%.
According to the National Health Insurance Administration, China has accelerated the pace of medical insurance negotiations, and the waiting time for new drugs to be included in the medical insurance catalog has been shortened from an average of nearly 5 years in the past to less than 2 years, and some new drugs have been included in the medical insurance catalog in only half a year. Medicare spending on new drugs increased from 59 in 20194.9 billion yuan, an increase to 481 in 20228.9 billion yuan, an increase of 71 times.
In addition, China has also established and improved the "dual channel" guarantee mechanism for negotiating drugs, negotiating drugs with patients through two channels of hospitals and retail pharmacies, and implementing the same reimbursement policy, with an additional 15 in the country in two years50,000 designated retail pharmacies negotiate drugs, which greatly alleviates the bottleneck of "drugs can enter medical insurance, but cannot enter hospitals".
Letter from the National Health Security Administration on the reply to the proposal No. 02468 (No. 214 of the medical and health category) of the first meeting of the 14th National Committee of the Chinese People's Political Consultative Conference.
Medical Insurance Letter No. 2023 No. 187.
Member Ding Lieming:
Your "Proposal on Enhancing Core Competitiveness and Promoting the High-quality Development of China's Biomedical Industry" has been received. After consulting with the National Health Commission, the State Administration of Taxation, the China Securities Regulatory Commission, and the National Immigration Administration, the reply is as follows:
1. The National Health Insurance Administration has always supported the inclusion of innovative drugs in medical insurance.
Since its establishment, the National Health Insurance Administration has adhered to the positioning of "guaranteeing the basics" and promoted the high-quality development of the pharmaceutical industry under the premise of openness and fairness.
The first is to insist on encouraging innovation, and establish a medical insurance access and negotiation renewal mechanism with new drugs as the main body. Innovativeness is an important part of the catalogue access review. At the same time, the renewal rules were optimized to stabilize corporate expectations. In recent years, the drugs included in the catalogue are mainly new drugs approved within 5 years, such as 105 of the 108 new negotiated and competitive drugs added to the 2022 medical insurance drug catalogue are listed after January 1, 2017, accounting for 97%. The second is to adhere to the principle of benefiting the people and accelerate the pace of medical insurance negotiations. The waiting time for new drugs to be included in the medical insurance catalogue has been shortened from an average of nearly 5 years in the past to less than 2 years, and some new drugs have been included in the medical insurance catalogue in only half a year after they are launched. Medicare spending on new drugs increased from 59 in 20194.9 billion yuan, an increase to 481 in 20228.9 billion yuan, an increase of 71 times. The third is to actively improve accessibility and expand the sales channels of negotiated drugs. Establish and improve the "dual channel" guarantee mechanism for negotiating drugs, negotiate drugs with patients through two channels of hospitals and retail pharmacies, and implement the same reimbursement policy, with an increase of 15 in the country in two years50,000 designated retail pharmacies negotiate drugs, which greatly alleviates the bottleneck of "drugs can enter medical insurance, but cannot enter hospitals".
It should be emphasized that supporting innovation must be based on the premise of "maintaining the basics". In the previous catalogue adjustment work, we firmly grasped the positioning of "guaranteeing the basics", did our best and did what we could, and built the improvement of the level of drug security on the basis of sustainable economic and financial growth, without departing from reality and beyond the stage. Supporting innovation must be premised on the premise of "patient benefit". In recent years, we have adhered to the "value purchase", and determined the best level around the benefits brought by drugs to patients, so that the cost performance of newly approved drugs has been significantly improved. With the advancement of the negotiation work, we have established a set of index systems in line with China's actual situation, realized the leap from "subjective to objective" and "from qualitative to quantitative" in drug evaluation, and made the measurement of innovation more accurate and scientific, which has been widely approved by all parties.
Overall, the adjustment of the medical insurance drug catalog in the past five years has better served the majority of the insured people, and patients have used innovative drugs with better efficacy with more reasonable results, which has also prompted China's pharmaceutical industry to embark on a high-quality development path of emphasizing innovation and strengthening research and development.
2. Do your best and do what you can, and scientifically form a negotiated drug payment standard.
At present, the formation of negotiated drug payment standards has the following points: First, pay attention to fairness and inclusiveness, and adhere to the principle of "guaranteeing the basics". In the adjustment of the national medical insurance drug list, the selection of drugs and the determination of payment standards should adhere to the principle of "guaranteeing the basics", and give full play to the main guarantee role of basic medical insurance in a fair and inclusive manner. Second, the determination of the payment standard for negotiated drugs follows the principles of marketization and science. In the review of the catalogue adjustment and the calculation of the negotiated reserve price, the opinions of experts and enterprises were widely solicited, and the expert review index system and scoring rules were improved, so as to promote the adjustment of the drug catalogue from subjective to objective. Optimize the calculation rules of pharmacoeconomics and medical insurance** to improve the scientific results. On the other hand, the company's best is proposed by the enterprise after comprehensively evaluating the market environment of a specific drug, and whether the negotiation can be successful depends on whether there is an intersection between the bottom line of the medical insurance party and the enterprise side, and follows the market-oriented mechanism. Third, from the actual situation, most of the drugs have reached the expected sales target. Relying on the world's most populous drug market, all drugs whose clinical value has been recognized have achieved an increase in sales volume and a rapid increase in sales amount after being included in the catalog, achieving the goal of "exchanging price for volume".
The Interim Measures for the Administration of Drug Use in Basic Medical Insurance stipulates that, in principle, the validity period of the negotiated drug agreement is two years. Considering that the time for newly launched drugs to enter the market is short, the change in sales volume is incompatible. From the perspective of considering safety, we inspect the use of drugs every 2 years, and adjust the payment standards according to the actual sales of drugs. According to the current version of the Rules for Negotiating Drug Renewal, exclusive drugs that have not adjusted the payment standard and payment scope for two consecutive agreement periods can be included in the management of the regular drug list. The inclusion of 8-year-old negotiated drugs in the regular catalogue management is conducive to stabilizing corporate expectations, reducing the pressure of price reduction in the later stage, and reducing the possibility of failure in contract renewal.
3. Financial investment support.
The China Securities Regulatory Commission (CSRC) actively supports the issuance, listing and refinancing of qualified biopharmaceutical enterprises. On the premise of adhering to the principle of quality first and balance between investment and financing, we will scientifically and reasonably maintain the normalization of new share issuance, report and review the refinancing registration review immediately, and issue it immediately after the review, continuously improve the review efficiency, optimize the review process, shorten the review cycle, and actively support qualified biopharmaceutical enterprises to raise funds through initial offerings and refinancing.
The China Securities Regulatory Commission supports qualified biomedical enterprises to be listed on the Beijing Stock Exchange and ** for financing. Diversification of listing criteria. The Beijing Stock Exchange has set four sets of listing standards, covering companies at different stages of development, profitability levels, industry types and business models. The issuance and registration review mechanism is transparent and efficient. The average review time for the issuance and listing of the Beijing Stock Exchange is about 170 days, and the financing function is effectively played. We will continue to optimize market-oriented mechanisms such as issuance, mergers and acquisitions to meet the financing needs of innovative biopharmaceutical companies. In terms of financing varieties, the Beijing Stock Exchange and ** have formed a relatively rich equity financing tool such as ordinary shares, preferred shares, and convertible bonds; In terms of issuance methods, public offerings, directional issuances, authorized issuances, shelf issuances, and self-run issuances are allowed, forming an on-demand, small-amount, and multiple continuous financing mechanism to reduce the financing costs of enterprises.
The China Securities Regulatory Commission (CSRC) supports listed biopharmaceutical companies to continuously improve their industrial chain through mergers and acquisitions, steadily promotes the full implementation of the restructuring registration system on a pilot basis, and continuously enriches the transaction mechanism and payment tools for mergers and acquisitions. In addition, we will support private equity venture capital** to invest in key areas such as biomedicine, focus on major national strategic deployments, focus on "bottleneck" fields, and accurately support key scientific and technological innovation fields such as medicine and biology, computers, and semiconductors.
In the next step, we will continue to do our best and do what we can, continue to improve and optimize the adjustment mechanism of the medical insurance drug list, strengthen communication with relevant departments under the premise of "ensuring the basics", form a policy synergy, ensure that innovative drugs enter clinical application as soon as possible, and strive to better support the development of pharmaceutical innovation.
Thank you for your concern and support for medical security work.
National Health Security Administration.
November 1, 2023.