In 2023, the dust settled on the adjustment of medical insurance catalogue, and innovative drugs for rare diseases were highly favored.

Figure worm creativity/Photo courtesy officers and soldiers/cartography

In 2023, the results of the medical insurance adjustment catalogue were officially released. This time, a total of 126 drugs were newly added to the national medical insurance drug catalogue. The average price reduction of drugs was 61.7%, and the negotiation success rate (84.6%) and price reduction were basically the same as those in 2022. On the evening of December 13, a number of listed companies quickly announced that their drugs were included.

With the continuous optimization of rules, medical insurance negotiation is no longer a "soul bargain", and the policy continues to tilt towards rare diseases and innovative drugs. The decline in the inclusion of innovative drugs in medical insurance is relatively moderate, and the success rate of negotiation is higher than the overall level. The decline in renewal is generally moderate, and most varieties have renewed their contracts at the original price.

Innovative drugs get "preference"

On the whole, 126 drugs were added to the new medical insurance catalogue, including 21 drugs for tumors, 17 drugs for COVID-19 and anti-infection, 15 drugs for chronic diseases such as diabetes, psychosis and rheumatism, 15 drugs for rare diseases and 59 drugs for other fields. At the same time, a drug that is about to be withdrawn from the market was transferred.

Medical insurance negotiations continue to tilt towards innovative drugs, and innovative drugs no longer "smell medical insurance bargaining". A total of 25 innovative drugs participated in this year’s medical insurance negotiations, and finally 23 were negotiated, with a success rate of 92%. Compared with the overall level, the success rate of innovative drug negotiation is 7.4% higher and the average decline rate is 4.4% lower.

It is reported that most of the drugs included in the catalogue through negotiation are newly listed and have high clinical value in recent years, and a large number of new mechanisms and new target drugs have been included in the catalogue. Through negotiations, the price of innovative drugs is more reasonable, the affordability of patients is greatly improved, and most of them have seen a rise in sales and income.

A total of 19 products of Hengrui Pharma, the "First Brother of Innovative Drugs", passed the medical insurance catalogue adjustment, among which 5 products were included in the catalogue for the first time, and the new indications of 5 innovative drugs were included in the new catalogue. So far, there are 103 products that have entered the national medical insurance drug list in Hengrui Pharma, among which 13 of the 15 innovative drugs that have been listed have been included in medical insurance.

Domestic innovative drugs were successfully included in medical insurance, and the A-share COVID-19 pharmaceutical sector rose sharply. On the evening of December 13th, Junshi Bio announced that its deuterium hydrobromide tablet (trade name "Mindevio []") was successfully included in the category B of the medical insurance catalogue through the national medical insurance negotiation. The indications of this drug for adult patients with mild to moderate novel coronavirus infection (COVID-19) were officially listed in the national medical insurance catalogue for the first time.

In addition to COVID-19, another innovative drug of Junshi Bio, Tereplizumab Injection (trade name "Tuoyi []"), has also passed the national medical insurance negotiation. The drug has three new indications, and all the six indications that have been approved for marketing in China are included in the national medical insurance catalogue. It is the only anti-PD-1 monoclonal antibody drug used to treat melanoma in the national medical insurance catalogue.

In addition, Eiberg Sting α injection of Yifan Pharmaceutical, Dogleetin tablets of Hualing Pharmaceutical, Iruak tablets of Qilu Pharmaceutical, Pemosartan injection of Hanson Pharmaceutical, Ennadistat tablets of Xinlitai, Befotinib of Beida Pharmaceutical and many other domestic innovative drugs have been successfully included in the new medical insurance catalogue.

On December 13th, Hualing Medicine -B announced that the company’s first commercial product, self-developed GKA Doglietine (Huatangning []), the world’s first new drug for diabetes, was included in the national medical insurance drug list. The drug is a GKA drug with a new mechanism and ectopic allosteric regulation, which is the first in the world and is used to treat type 2 diabetes.

Since the commercialization of Huatangning, it has contributed a lot of profits to Hualing Medicine, boosting the company’s revenue in the first half of this year by nearly three times compared with the same period of last year. At the end of November, Hualing Pharmaceutical also announced that it had received a milestone payment of 800 million yuan from Bayer for the Dogleetin business cooperation agreement, and the total milestone payment received reached 1.5 billion yuan. This time, when it is included in medical insurance, the price of Dogleetine is 5.39 yuan/tablet, and it is taken twice a day according to the approval, which means that the daily medication cost of patients is about 10.78 yuan.

Focus on the inclusion of rare disease drugs

After this adjustment, the total number of drugs in the medical insurance catalogue will increase to 3088, including 1698 kinds of western medicines and 1390 kinds of Chinese patent medicines, and the level of protection in the fields of chronic diseases, rare diseases and children’s medication will be further improved.

Rare drugs are still the focus of the adjustment of medical insurance catalogue in 2023. There is no time limit for listing the application conditions of rare drugs this year. Drugs listed in the catalogue of generic drugs encouraged by the state can apply for the medical insurance catalogue of that year, further broadening the access scope of rare drugs.

A total of 15 out-of-catalogue drugs for rare diseases were successfully negotiated and auctioned, covering 16 rare diseases and filling the gaps in drug protection for 10 diseases.

According to public information, these 15 drugs for rare diseases include Ai Jia Maud from Reding Medicine, Oz Maud from BMS, Iquzumab from AstraZeneca, Stouximab for Injection from Baekje Shenzhou, and Satterlee Zhuzumab from Roche, etc., and the fields involved include Gaucher’s disease, myasthenia gravis and neuromyelitis optica pedigree diseases.

On December 13th, Zaiding Pharmaceutical rose by more than 6%. According to the company’s announcement, Aijiamode α injection (trade name: "Weiweijia []") was included in the national medical insurance drug list. Wei Weijia is used to treat adult patients with generalized myasthenia gravis ("gMG") with positive acetylcholine receptor antibody. Myasthenia gravis is a chronic autoimmune disease, which often leads to human weakness and possibly life-threatening myasthenia. There are about 170,000 gMG patients in China. The drug was commercialized in China in September this year.

However, in the CAR-T therapy of "Millions of Anticancer Drugs", Fosun Kate’s Akirense Injection and Yaoming Junuo’s Ruiji Orense Injection, which have been receiving much attention, have passed the formal review, but they still have no medical insurance this year.

Generally realize the original price renewal.

In the new contract renewal rules, if the continuous agreement expires for 4 years but has not reached 8 years, the decline will be halved, which means that the decline in contract renewal will be more moderate. In addition, in the contract renewal stage, the rules continue to tilt towards innovative drugs, allowing innovative drugs to apply for renegotiation on price decline, which is also expected to narrow the decline after expert calculation, thus giving new drug companies the expectation of stable prices.

From the results, 70% of innovative drugs have achieved the original price renewal. Among the 100 renewed drugs, 18 drugs added new indications, and only one triggered the price reduction mechanism, which means that 17 drugs added new indications at the original price.

Rongchang Bio’s vidicon has successfully renewed its contract in the highly competitive ADC field in the innovative drug track. In the field of PD-1, the renewal of four PD-1 multi-indications in the medical insurance catalogue has been completed, and all indications have been included in the medical insurance catalogue.

On the evening of December 13th, Zejing Pharmaceutical announced that the indications of a new drug, Donafenib Toluene Sulfonate Tablets (trade name: "Zepusheng []"), which was independently developed for patients with unresectable hepatocellular carcinoma who had not received systemic treatment in the past, continued to be included in the national medical insurance catalogue through national medical insurance negotiations, and the scope of indications for patients with advanced, locally advanced or metastatic differentiated thyroid cancer was added.

Haichen Pharmaceutical announced that the company successfully renewed the contract of Landirol Hydrochloride for Injection and was included in the national medical insurance catalogue. The drug was included in the national medical insurance catalogue through negotiation in December 2021. This renewal was successful, and the payment standard and scope of medical insurance were consistent with the previous edition. The company said that this will help stabilize marketing and sales, and will not have a significant impact on the company’s performance.

Chipscreen announced that its chidamide film (Epsa []) was successfully renewed. The drug is mainly used for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who have received systemic chemotherapy at least once before. According to the announcement of Chipscreen, the payment standard of medical insurance after renewal is 322.42 yuan (5mg/ tablet), which is 6% lower than the previous payment standard of medical insurance.