After the adjustment of the national medical insurance catalogue in 2023, relevant supporting documents are also in full swing. In the two drafts just released, the National Medical Insurance Bureau has made new regulations on the negotiation of drug renewal rules. Under the favorable stimulus, the share prices of many innovative pharmaceutical companies in China have risen.
On July 4th, the National Health Insurance Bureau issued two documents, namely, Contract Renewal Rules for Negotiated Drugs (Draft for Comment, 2023) (hereinafter referred to as Contract Renewal Rules) and Bidding Rules for Non-exclusive Drugs (Draft for Comment), which are important supporting documents for the drug list management of national basic medical insurance, industrial injury insurance and maternity insurance in 2023.
Zhao Heng, founder of Latitude Health, a medical strategy consulting company, told CBN that from the current exposure draft, the update of the drug list negotiation rules is relatively beneficial to pharmaceutical companies, mainly because the decline in drug prices has slowed down, which will help the single product not fall too sharply after heavy volume. However, as the overall decline is still linked to the actual expenditure of the medical insurance fund, the overall benefits are limited.
Three kinds of drugs are included in the routine catalogue management.
The "Renewal Rules" proposes that drugs that meet one of the following conditions can be included in the routine catalogue management: first, they are non-exclusive drugs; Second, the drugs negotiated in the catalogue in 2019, and the exclusive drugs whose payment standards and payment scope have not been adjusted for two consecutive agreement cycles; The third is to negotiate drugs that have entered the catalogue and have been continuously included in the "drugs negotiated during the agreement period" for more than 8 years.
Compared with the relevant documents in 2022, the category of "drugs more than 8 years old" has been added. The specific rule is that the drugs negotiated in the 2017 version of the catalogue will be calculated from 2018, and the drugs negotiated in the 2018 version will be calculated from 2019, and 2019 and beyond will be calculated according to the year of implementation of the catalogue.
Zhao Heng believes that drugs that have been negotiated into the catalogue and continuously included in the "drugs negotiated during the agreement period" for more than 8 years have entered the regular catalogue, which means that drugs that have been listed for a long time may no longer need to be negotiated after more than 8 years. Of course, if there are new indications or sudden sharp growth, they will still be transferred to the negotiation part.
Hu Shanlian, a senior medical insurance policy research expert and professor at Fudan University School of Public Health, told CBN that the above-mentioned "drugs over 8 years old" category has simplified the management process as much as possible from a long-term perspective and reduced the burden on enterprises and medical insurance departments as much as possible.
The Contract Renewal Rules divides the contract renewal rules of negotiated drugs (including drugs with contract renewal) into three categories, including simple contract renewal and renegotiation, in addition to being included in the routine catalogue management.
The condition of simple renewal is that the agreement will expire on December 31, 2023, and drugs that meet the following conditions can be simply renewed, and the renewal period is 2 years, including exclusive drugs; The actual expenditure of the fund during the agreement period does not exceed 200% of the fund expenditure budget (the estimated value of the enterprise, the same below); The increase of fund expenditure budget in the next two years is reasonable. The core gradient price reduction rule of simple renewal has not changed, but the reference standard requirements for gradient price reduction starting in 2025 will change dynamically.
According to the "Renewal Rules", the expenditure budget of the medical insurance fund will no longer be calculated according to 65% of the sales amount from the renewal in 2025, but will be calculated according to the drug expenses included in the medical insurance payment scope. Considering the change of reference standard, the amount of medical insurance payment node is also increased accordingly.
Zhao Heng said that in terms of the link between the decline and the actual expenditure of the medical insurance fund, the adjustment standard for the decline exceeded 200 million yuan, 1 billion yuan, 2 billion yuan and 4 billion yuan from the original fund expenditure, and it was correspondingly increased to 300 million yuan, 1.5 billion yuan, 3 billion yuan and 6 billion yuan from 2025. This is relatively good for pharmaceutical companies. After all, the adjustment amount has increased, which is conducive to single products with a sales amount that is not particularly high.
Zhao Heng also said that the new rules of this negotiation are more friendly to products listed in the medium and long term. For varieties that have been continuously listed in the "drugs under negotiation during the agreement period" for more than 4 years, the reduction of payment standard is halved on the basis of the calculated value of products within 4 years, which is beneficial to products that have been listed for more than 4 years, which means that the price decline of products listed in the medium and long term is slowed down.
The "Renewal Rules" propose that drugs that meet the following conditions can be included in the scope of renegotiation: including exclusive drugs; Drugs that do not meet the conditions for inclusion in the routine catalogue management and simple contract renewal; Drugs that the enterprise applies for renegotiation and meet the requirements.
Zhao Heng believes that in 2022, drugs with increased indications through renegotiation or supplementary agreement will be deducted from the last decline when calculating the decline of renewal this year. This means that the decline of renegotiated products at the time of renewal will also slow down.
The final price of drugs depends on many reasons, such as cost, value, market competition, commercial agreement, government price control and so on.
Looking forward to the next step, Hu Shanlian believes that multi-indication pricing is a new problem at present, and it is also the most difficult problem how to determine the price reduction in drug price negotiations. Therefore, on the one hand, enterprises have the right to decide freely, and ask for price increase or price decrease according to the results of expanding indications in clinical trials; On the other hand, the medical insurance department can renew the contract by "selective evaluation" according to more valuable indications. In terms of methods, it can use the weighted pricing of the proportion of people with various indications to calculate a single new price.
Another document published by the National Medical Insurance Bureau, Bidding Rules for Non-exclusive Drugs (Draft for Comment), puts forward that the conditions for non-exclusive drugs to participate in the bidding are that, after expert review, it is recommended to add non-exclusive drugs to the medical insurance drug list, except for drugs selected in centralized procurement of drugs organized by the state and drugs priced by the government.
In terms of payment standard, if the drug is included in the medical insurance catalogue through bidding, the lowest price quoted by each enterprise shall be taken as the payment standard for the generic drug. If the quotation of the enterprise is lower than 70% of the willingness to pay for medical insurance, 70% of the willingness to pay for medical insurance will be used as the payment standard for the drug.
Hu Shanlian said that the document emphasized the response and feedback from the policy level on the bidding of "non-exclusive drugs". "Including the procedure, how to conduct expert review, submit information, expert calculation and enterprise bidding; Further, if enterprises encounter special circumstances such as great differences in specifications and different specifications of different enterprises, medical insurance can organize experts to study and put forward treatment opinions and fully communicate with enterprises, which is very important for promoting enterprise development. "
Hu Shanlian also mentioned that the document once again emphasized two aspects: ensuring pricing and ensuring supply. For example, "enterprises participating in the bidding must ensure the market supply, and they must not cut off the supply without reasonable reasons" and "there will be no illegal acts in the bidding process", all of which are measures to make full use of the market mechanism to put the national negotiation rules into practice.
New changes in the sixth round of medical insurance catalogue negotiations
Prior to this, on June 29th, the National Medical Insurance Bureau announced the "Work Plan for Adjusting the Drug List of National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance in 2023", which is the sixth consecutive year since the establishment of the Medical Insurance Bureau. According to the established timetable, this year’s work procedure is still divided into five stages: preparation, declaration, expert review, negotiation and announcement of results. The declaration was officially launched on July 1, and the negotiations were completed and the results were announced in November.
According to the above plan, the adjustment range of the drug list in 2023 is from January 1, 2018 to June 30, 2023, and the indications or functional indications of new generic drugs approved by the State Drug Administration have undergone major changes, and drugs that have obtained drug approval documents for this change, and drugs included in the National Essential Drugs List (2018 Edition), etc. Among them, there are no restrictions on the approval time for drugs included in the Catalogue of Drugs to Encourage Imitation, drugs included in the List of Drugs to Encourage Research and Development for Children, and drugs for the treatment of rare diseases. In addition, some detailed rules such as enterprise reporting process and content will also be adjusted.
According to the National Medical Insurance Bureau, on the basis of previous years’ experience, this year’s catalogue adjustment plan has been slightly adjusted. According to the rules, the time requirements for drug approval and modification of indications have been postponed. In terms of evaluation methods, the evaluation indicators have been further improved, and factors such as clinical needs and patients’ benefits have been comprehensively considered to evaluate the value of drugs more accurately, so as to better achieve the goal of "value purchase" and strengthen the supervision of corporate behavior.
This year’s catalog negotiations will continue to tilt towards innovative drugs. According to the data of the National Medical Insurance Bureau, the waiting time for new drugs listed in China to be included in the medical insurance catalogue has been shortened from the average of nearly five years in the past to less than two years. The expenditure of medical insurance on new drugs increased from 5.949 billion yuan in 2019 to 48.189 billion yuan in 2022, an increase of 7.1 times.
In recent years, medical insurance negotiations have promoted a large number of exclusive varieties of anticancer drugs and drugs for rare diseases to be included in medical insurance at appropriate prices, and the catalogue has been adjusted for five consecutive years, superimposed and included in the medical insurance reimbursement of drugs, which has reduced the burden on patients by more than 500 billion yuan.
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