The price of “life-saving drugs” for leukemia patients is limited, and the state strictly guards against inflated prices of drugs in shortage

On October 19, the Anhui Provincial Pharmaceutical Centralized Purchasing Platform issued a rare price rectification notice, the price of a product of Sichuan Meida Kang Huakang Pharmaceutical Co., Ltd. was directly limited. .

Health and Knowledge Bureau learned that the price-restricted drug is a variety in the “National Drug Shortage List”: Mitoxantrone Hydrochloride Sodium Chloride Injection (100ml:5mg). This is a tumor drug, known as a “life-saving drug” for patients with acute leukemia. According to the data of the State Food and Drug Administration, there is only one company in the country, Midakang Huakang.

Anhui documents show that, according to the “Letter from the National Medical Insurance Administration on Checking and Disposing of Abnormal Prices and Delivery of Shortaged Drugs in July 2022”, as well as the relevant disposal of the Provincial Medical Insurance Bureau, Meida Kang Huakang’s unified provincial purchase price limit for the above-mentioned drugs is 1,586 yuan/bottle.

This statement shows that the National Health Insurance Administration has noticed the abnormal price of the drug. The price may be directly limited because of its special status as an “exclusive shortage drug”.

Meidakang Huakang Pharmaceutical Co., Ltd. replied: It is communicating with the relevant departments on this matter, and there is no other comment.

01 High API prices

As a national-level shortage drug, Mitoxantrone Hydrochloride Sodium Chloride Injection was actually very cheap before.

According to the “Health Times” report, In 2017, when mitoxantrone hydrochloride sodium chloride was not included in the national medical insurance, the online price in Sichuan was 39.28 yuan, After entering the national medical insurance in 2019, the demand has increased greatly, and there has even been a phenomenon of supply interruption.

Health Knowledge Bureau has learned that the reason why the mitoxantrone hydrochloride sodium chloride injection has been in short supply is mainly because the supply of the raw material mitoxantrone has been unstable for a long time. Originally, there were 16 domestic related injection products, but by 2019, many of them had been discontinued. Sichuan Shenghe and Shandong Luoxin had discontinued production of related products for two or three years.

However, Mitoxantrone Hydrochloride Sodium Chloride Injection is a commonly used drug for the treatment of many types of cancer. In order to reduce the cost of domestic anti-cancer treatment, the Ministry of Finance also reduced the import tax rate of Mitonequinone Hydrochloride APIs to zero in 2018, but the incentive effect was not significant.

In order to adjust supply and demand, in 2019, the State Office put forward requirements for ensuring supply and stabilizing prices of drugs in short supply: enterprises can make independent quotations on the provincial procurement platform, directly link to the Internet, and medical institutions can purchase independently. At the end of 2020, mitoxantrone injection was classified as one of the 6 clinically necessary and irreplaceable national shortage drugs by the National Health Commission.

This series of policies has given a rather rigid “basis” for the price increase of mitoxantrone hydrochloride and sodium chloride injection.

After a short period of labor suspension, Midakang Huakang Pharmaceutical’s mitoxantrone hydrochloride and sodium chloride injection resumed production in November 2021, and Jiangsu immediately gave 1,380 yuan The listed price is more than 35 times higher than the price in 2017.

Judging from the price limit notice in Anhui, the online price of this drug in Anhui is 200 yuan higher than that in Jiangsu.

Even so, Meidakang Huakang may still have some “little actions” in actual sales, and if it exceeds the maximum price, it will attract the “National Medical Insurance Bureau” Price anomaly verification” investigation.

The Health Knowledge Bureau found that another drug, calcium gluconate injection, produced by Meidakang Huakang Pharmaceutical Co., Ltd., also had a substantial premium. According to a report by China Business News in 2020, the related preparations of Meidakang Huakang and three other companies may be underwritten by the same “national general agent”, which is suspected of monopolizing the market.

02 Monitoring the big net open

Because it is a national-level shortage drug, even if the price is abnormal, the local medical insurance department can only implement a price-limited sales strategy, in order to maintain the rational use of drugs for patients.

Actually, similar price anomalies are rare. In August 2019, the State Council mentioned at a policy briefing that among the more than 3,200 commonly used drugs monitored by the state, the prices of most of the drugs decreased or remained the same, and the individual varieties with larger increases were mostly drugs in shortage.

In order to avoid unreasonable price increases, the National Medical Insurance Administration monitors the market prices of these drugs on a monthly basis. This time, the mitoxantrone hydrochloride sodium chloride of Meidakang Huakang was discovered during routine monitoring in July.

Price monitoring and management is a routine practice in the health care sector. The “14th Five-Year Plan for National Medical Insurance” mentioned: Implement the national medical price monitoring project… curb the inflated prices of drugs and medical consumables, take into account the reasonable profits of enterprises, and promote the high-quality development of the pharmaceutical industry.

In recent years, national centralized procurement has squeezed out the price of drugs to the greatest extent possible, but there are also problems of inflated prices outside centralized procurement. Therefore, the normalization of drugs such as shortage drugs is implemented. Integrated monitoring and early warning has become a must.

At present, each province requires the price linkage of “the lowest price in the country”, and has adopted price linkage monitoring for the varieties of hanging nets, prompting enterprises to give the most favorable and reasonable prices. Liaoning and other provinces have announced information on active price reductions for tens of thousands of varieties. The network in Shanghai is even larger, and even the varieties not covered by medical insurance are included in the “red, yellow and green” monitoring and evaluation mechanism.

Anyone who refuses to lower the price will have to withdraw from the network.

In February of this year, Hunan Province conducted price corrections and limited price listings for 10 varieties of 340 products, including the gastrointestinal drug famotidine and the cardiovascular and cerebrovascular drug ligustrazine. Among them, 17 products continued to be listed after price reduction, and all 323 products that did not respond or refused to reduce prices were withdrawn from the network. Hunan also emphasized that after that, the scope of random inspections will continue to expand and will continue to be carried out.

Shortage drugs enjoy some price flexibility, but they should not be reckless. The mandatory price limit of Meida Kang Huakang this time is a shock to the mountains. It is not difficult to see the determination of the medical insurance department to limit the price of drugs.

The big network of drug price monitoring is being rolled out, and it will be more and more difficult for companies to escape.

Writing | Li Ao

Editing|Jiang Yun Jia Ting

Operation | Jia Saixuan

Illustration|Visual China

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