Text: Hu Xiangyun
Edited by Hai Ruojing
354 billion yuan.
On December 13, the results of the new version of the 2023 National Medical Insurance Catalogue were officially announced. At the press conference in the morning, Huang Xinyu, director of the Department of Pharmaceutical Service Management of the National Health Insurance Administration, said that as of the end of October this year, the amount of expenditure negotiated by the medical insurance fund for the catalogue agreement period has reached 244.7 billion yuan, driving the income of related drugs to 354 billion yuan.
If the figure of "354 billion" is not intuitive enough, let's compare: until 2022, there are only about 30 pharmaceutical companies in China with an annual revenue of more than 10 billion yuan, and the peak net profit in the history of Hengrui Pharmaceutical, the "first brother of medicine", is more than 6 billion yuan. After the announcement of the catalog, a domestic pharmaceutical company that has successfully negotiated told 36Kr that judging from the results of revenue growth after the same type of products entered the national medical insurance catalog in previous years, they are still looking forward to the effect of this year's volume.
Overall, a total of 126 new drugs were added to the catalogue, and the success rate of negotiation/bidding for 143 products not included in the catalogue was 84.6%, the highest in the past three years, and the average decrease was 61.7%, which was basically the same as in previous years. In terms of variety, a number of blockbuster innovative drugs such as Hua Medicine's dolagliatin tablets, Betta Pharmaceutical's befacitinib, and Yifan Pharmaceutical's ibergostim α injection have been included. In addition, the National Health Insurance Administration mentioned that 15 high-value rare disease drugs for the treatment of Gaucher disease, myasthenia gravis and other diseases have been successfully negotiated.
"We have given a lot of policy preferences to the inclusion of innovative drugs in the medical insurance catalog, and established a support mechanism for innovative drugs covering the whole process of declaration, review, calculation, negotiation, etc. Huang Xinyu said.
In the context of the moderate reduction in negotiations, not only the price theory, but "more emphasis on the effect of spending money", the attitude of domestic innovative drugs embracing medical insurance is becoming more and more obvious, which is also the biggest signal released by the results of the adjustment of the medical insurance catalog. This is undoubtedly an important benefit for the innovative varieties that will be launched in the future.
It is reported that the new version of the National Medical Insurance Catalogue will be officially implemented on January 1, 2024.
The success rate of Class 1 new drugs was 92%, and 15 new rare disease drugs were included
At the press conference on the morning of the 13th, the announcement of two sets of figures attracted the attention of the audience: first, in the access link, 100% of the eligible innovative drugs passed the formal review; on the other hand, in the negotiation process, among the 25 innovative drugs outside the catalogue that participated in the negotiation this year (specifically referring to Class 1 chemical drugs, Class 1 therapeutic biological products, Class 1 and Class 3 Chinese patent medicines), 23 negotiations were successful, and the negotiation rate of 92% was 7.4% higher than the overall level, but the decline rate was 4.4% lower than the average rate.
"In the past, it was said that medical insurance negotiations were 'soul bargaining', but this year's attitude is generally mild, and the decline in innovative drugs is relatively small. In the process of communicating with relevant departments, we also felt that they also hoped to find a balance between enterprise costs, medical insurance payments, and patient benefits by supporting domestic innovation. A domestic business person who participated in the adjustment of the national medical insurance catalogue for the first time this year reviewed the negotiation process and said to 36 Krypton.
The attitude of domestic innovative drugs and medical insurance departments to "rush" to each other can also be glimpsed from the list of catalogs announced today. In terms of variety, Hua Medicine's dolagliatin tablets, Betta Pharmaceutical's befacitinib, Yifan Pharmaceutical's ibergrastim α injection and other blockbuster innovative drugs are all listed. Taking the hypoglycemic drug dolagliatin tablets highlighted by the National Health Insurance Bureau as an example, this is the first domestic self-developed oral hypoglycemic drug with a scope glucokinase target, and the indication included in the medical insurance catalog is type 2 diabetes, and the unit price of a 75mg dosage form is 5.39 yuan, about 150 yuan per box, which is about 64% lower than the previously disclosed pricing of 420 yuan per box.
In addition, the new version of the NRDL also includes 15 rare disease drugs, including STUXIMAB for injection from BeiGene, agamod from Zai Lab, and ozanimod from Bristol-Myers Squibb, involving 16 rare disease types that have "not been solved for many years and have a great social impact", such as Gaucher disease, myasthenia gravis, and multiple sclerosis.
Among them, the oral Gaucher disease drug Eglastat Tartrate Capsule, an oral Gaucher disease drug of Gloria Tiancheng, a domestic innovative enterprise, was successfully shortlisted, which is mainly used for adult patients with type I Gaucher disease (GD1). As the first imitation of this variety in China, the original research has not been able to enter China for a long time, and this product has attracted the attention of Gaucher disease patients before the negotiation. According to the data released by the National Health Insurance Administration, the price of one 84mg egernostat is 381 yuan, which is almost 1/10 of the price of foreign products with the same generic name, effectively filling the gap in the specific therapy of Gaucher disease in China.
According to Kailai Tiancheng's introduction to 36Kr, this product is the first imitation product in China, and the company has worked hard to reduce the relevant costs, superimposed on the policy guidance of the National Health Insurance Bureau to support rare diseases, and finally achieved a breakthrough in the field of Gaucher disease. After the reimbursement of this variety according to the medical insurance category B, the patient's self-payment has been pressed to the level of tens of thousands of yuan, coupled with the convenience of oral dosage form, compared with the imported injections with an annual treatment fee of more than one million yuan, the burden on patients has been greatly reduced.
This also means that the treatment of Gaucher disease in China is about to enter the threshold of 100,000 yuan, and the pricing and commercialization of follow-up products may change.
In addition, it is quite interesting that none of the new ADC varieties that attracted much attention during the "national talks" in November were included, including AstraZeneca/Daiichi Sankyo's trastuzumab (DS-8201), Gilead's gosatuzumab, Pfizer's ocaituzumab and Roche's vepotuzumab, all of which are overseas varieties.
Originally, the price competition of ADC products in the national medical insurance catalogue was quite fierce, and the annual treatment fee of Rongchang Biotech's domestic ADC vedicitumab had dropped to about 200,000 yuan, and the annual fee price of Roche's trastuzumab, which was included in the catalogue in 2022, was only 185,000 yuan.
In contrast, the prices of several overseas products that are not included in the product are quite high, such as the unit price of DS-8201 is 8,860 yuan, and the annual fee is 638,000 yuan. However, after being listed in China this year, the revenue of this star product in the two quarters was only about 24 million yuan, far less than market expectations. In the case of "low price" of medical insurance varieties, how out-of-catalog products represented by DS-8201 will compete for market share is worth paying attention to for a long time.
The renewal of the contract is almost not subject to price reduction, and the "price confidentiality" system is conducive to the export of innovative drugs
From the price point of view, another highlight of the 2023 version of the National Medical Insurance Catalogue is that almost no price has been reduced in the price of renewal products. According to the data released by the National Health Insurance Administration, among the 100 renewal products, seventy percent of the renewed drugs were renewed at the original price, 31 drugs needed to reduce their prices due to sales exceeding expectations, but the average reduction rate was only 6.7%, and only 1 product triggered the price reduction mechanism.
According to the previously released negotiation documents, the renewal rules are mainly for products that expire in December of the same year and the medical insurance reimbursement does not exceed 200% of the estimated value during the agreement period. Prior to the negotiations, the market expected a decline of between 0-11% and within 20% for renewal products that do not adjust and adjust the scope of payment. However, judging from the results, the degree of "easing" of the medical insurance sector is even higher than market expectations.
In recent years, under the rules of dynamic adjustment of the National Medical Insurance Catalog, the time from approval to entry of new drugs has been shortened from more than five years in the past to about one year now, and 80% of new drugs can enter the National Medical Insurance Catalog within two years of listing. At the moment when new drugs are concentrated in the medical insurance, the benefits of simplifying the renewal rules and continuing to reduce the decline can be roughly understood as the transformation of the marginal cost in the past into a fixed cost, that is, after the price is reduced once into the medical insurance, it is no longer necessary to go through the "soul bargaining" many times as before, and the attractiveness of the medical insurance system to high-value innovative products will also be strengthened.
One of the most intuitive data is that in 2023, the number of products that will be "approved in the current year and included in the catalogue" will reach 57.
In the understanding of the companies involved in the negotiation of innovative varieties, the health insurance department is now more concerned about the "effect" of the money spent: "This signal can also be seen in the increasingly strict pharmacoeconomic reporting materials. In reality, the quality of life of patients is transformed into numerical value through a series of complex models, and the medical insurance department and relevant drug experts calculate the price that meets their expectations. I can feel that for independent innovative products, the pressure exerted in the whole process is not so strong. ”
In addition, at the press conference, the National Health Insurance Administration mentioned that in order to support domestic innovative drugs to go overseas, this year's adjustment of the national medical insurance catalogue has learned from international practices, and the negotiated price confidentiality system has been implemented for some drugs in accordance with the wishes of enterprises. In the new version of the catalogue, a total of 230 negotiated drug prices are kept secret.
Before the start of this year's national medical insurance negotiations, 36Kr learned that some companies in the global market would actually be more worried about the impact of the price reduction rules implemented by the domestic policy side on the overseas pricing of products, but due to the fact that there are not many domestic innovative varieties that have successfully gone overseas, this kind of sentiment has not yet become the mainstream. However, in the eyes of other practitioners, the overseas market represented by the United States has not actually implemented the rules of the pricing power of the first country, and whether the domestic low price will not excessively affect overseas pricing.
Despite the differences of opinion, it can be seen that the health care department is indeed listening to the voices of many parties. The National Health Insurance Administration also mentioned that the "adjustment results" of the catalogue adjustment work are basically in line with expectations.
This time, according to the calculation of the National Health Insurance Administration, superimposed on the negotiation of price reduction and medical insurance reimbursement factors, it is expected that the overall burden on patients will be reduced by more than 40 billion yuan in the next two years.