More than half of the company's star varieties are expected to be shortlisted in the 2019 medical insurance drug price negotiation process

2019/11/14 08:49:29 Source: China Securities Journal 2019/11/14 08:49:29

On November 13, as of the press release of the China Securities Journal, a new round of medical insurance drug access negotiations organized by the State Medical Insurance Bureau was still underway. This is another major event that the pharmaceutical industry and investors have paid attention to since this year's national gathering.

On November 13, as of the press release of the China Securities Journal, a new round of medical insurance drug access negotiations organized by the State Medical Insurance Bureau was still underway. This is another major event that the pharmaceutical industry and investors have paid attention to since this year's national gathering. The negotiation access part involved a total of 150 varieties and more than 70 companies participated.

Earlier, a new version of the national health insurance routine catalog was released. This is the first comprehensive adjustment of the medical insurance catalog after the establishment of the National Medical Insurance Bureau, and it is also a comprehensive review since the first edition of the catalog was used in 2000.

150 varieties of "Short Fighters"

A person in charge of the National Medical Insurance Bureau told the China Securities Journal that it has become an international practice to negotiate pricing with pharmaceutical production and operation enterprises for high-priced special drugs such as patent drugs and exclusive production drugs. Since 2017, several documents have been issued at the national level, and exploration of medical insurance drug negotiations has begun.

The new version of the medical insurance catalog is divided into two parts: regular access and negotiated access. Compared with the adjustment of the regular access part, the negotiation access part has attracted much market attention. Negotiation access is mainly for high-priced drugs that are exclusive or protected by patent terms. After the negotiation is successful, the drugs will be included in the national medical insurance category B list.

In August this year, the latest edition of the medical insurance catalog was announced, and 128 drugs were included in the planned access scope. Except for 7 drugs that have abandoned negotiations, 121 drugs have entered the list of negotiations.

Adding to the renewal negotiations of 31 varieties successfully negotiated in the negotiations organized by the Ministry of Human Resources and Social Security in 2017 (5 of the 36 successfully negotiated varieties withdrew), there were about 150 drugs in this negotiation. Most of these medicines are innovative medicines, which have high clinical value, but are expensive, or patent exclusive products that have a relatively large impact on the medical insurance fund. The treatment field mainly involves major diseases such as cancer, rare diseases, such as hepatitis C, hepatitis B, hypertension, and diabetes.

Entering the medical insurance catalog has a significant effect on product volume, and has spawned dozens of varieties with sales of more than one billion yuan. Taking the anticancer drug Herceptin (trastuzumab) as an example, the price of the national medical insurance negotiations in 2017 decreased by 65%, and the sales volume increased by 259% in 2018.

According to sources from the National Medical Insurance Bureau, the medical insurance access negotiations were conducted by disease type. On the 11th, liver disease drugs were negotiated. On the afternoon of the 12th, glucose-lowering and tumor drugs were negotiated. On the 13th, the highly anticipated star anticancer drug PD-1 was negotiated. There are two negotiations in the morning and afternoon each day, and about 20 pharmaceutical companies each.

The negotiation method is a combination of competitive bidding and price comparison. Bidding negotiations do not set a minimum price, allowing companies to quote their own prices, and the lowest quotation is selected. However, most varieties adopt the method of price comparison negotiation, that is, the National Medical Insurance Bureau determines the lowest price first, and the enterprise reports twice, and the two quotes that exceed the lowest price by 15% will be out.

China Securities Journal reporter was informed that there has been a 90% reduction in the price of glucose-lowering drugs, but the negotiations have not yet been successful, and it is the new flagship product of A-share and one company. This shows from the side that hypoglycemic drugs that want to be included in the medical insurance list must be significantly reduced in price.

According to industry insiders, from the experience of the two negotiations in 2017 and 2018, the negotiations are mainly based on the following principles: selection of negotiated varieties based on clinical needs; evaluation of payment standards based on the value of therapeutic effects; and support by "big data" Expert think tanks make decisions; international experience is used as a reference, and quantitative evaluation methods are introduced.

How to negotiate the price

In the past 20 years, as the single largest buyer in the domestic pharmaceutical market, medical insurance has determined 70% of the domestic pharmaceutical market. However, Medicare had not previously been responsible for drug procurement and negotiation, and had no bargaining power. After the National Medical Insurance Bureau was listed on May 31, 2018, two moves were made. The national negotiations on anticancer drugs and the organization of "4 + 7" national volume purchases were intended to exchange low prices for quantity and expel inefficient drugs for high quality drugs.

Preparations for the current round of medical insurance negotiations began in August. After the National Medical Insurance Bureau announced on August 20 the 128 varieties to be negotiated, it immediately convened a production meeting on the 31st to discuss the willingness of the enterprises to negotiate.

At the beginning of September, the National Medical Insurance Bureau convened clinical experts to classify the varieties to be negotiated according to different mechanisms of action, and compared them with similar products to determine the scoring rules for innovative drugs. The total score was 15 points, which were carried out from the dimensions of clinical efficacy and patient benefits. Scoring. Judging from the scoring situation, the scores of most varieties are around 10. This shows that the overall level of drug innovation is not high.

At the end of September, the National Medical Insurance Bureau began to receive materials from companies interested in negotiating, including the market price of the product, the price of donated drugs, sales data, basic drug data, indications, and analysis of the impact on the health insurance fund budget, The most important thing is that the company intends to pay the price.

The National Medical Insurance Bureau is very cautious about how to determine the lowest price. To this end, it has referred to the expert opinions of two different measurement methods.

At the end of September, the National Medical Insurance Bureau convened 39 experts in pharmacoeconomics calculations to discuss. Except for one team leader and two deputy team leaders among the 39 experts, the remaining 36 experts were assigned 4 varieties each, and pharmacoeconomics calculations were performed, and each category calculated a reasonable negotiated price.

On October 17, the National Medical Insurance Bureau convened 11 measurement experts from all over the country. They are also experts in the measurement and management of medical insurance funds in various regions. They have more practical experience. They mainly focus on the indications of each variety and pay attention to the number of people participating in the insurance and Changes in fund influence, and then calculate the negotiated price of each product.

At the end of October, the measurement expert will write a product analysis report of about 5,000 words for each measured variety. The National Medical Insurance Bureau finally gave an intermediate price based on the different negotiated prices calculated by the two groups of experts.

Several large varieties are expected to be shortlisted

Judging from the current situation, the major varieties of many large pharmaceutical companies are expected to be shortlisted, such as Zhengda Tianqing, Livzon Group, Hengrui Medicine.

In May 2018, Zhengda Tianqing Anlotinib was officially approved by the National Drug Administration (NMPA) for use in locally advanced or metastatic non-small cell lung cancer that has progressed or relapsed after receiving at least two types of systemic chemotherapy. Treatment of patients. Anlotinib is the company's first innovative small molecule drug developed in accordance with international research and development processes and standards, and is expected to enter the medical insurance catalog again.

Lizhu Group's esomeprazole has obvious advantages compared with previous gastric medicines. First, it has stronger activity to inhibit gastric acid; second, there is no individual difference in patients with different metabolic types; third, there are fewer toxic side effects. This breed is also expected to enter the medical insurance catalog.

Roche has two models, namely Ansa (Aletinib), a targeted drug for the treatment of ALK-positive non-small cell lung cancer, and Pergizumab, an innovative targeted drug for breast cancer. It is a breast cancer drug Aiboxin, a rheumatoid drug Shangjie and a biological DMARD drug Enli for treating rheumatoid arthritis and ankylosing spondylitis.

It is worth noting that Xiu Meile took the initiative to reduce prices in response to this medical insurance negotiation. Developed by AbbVie, it has ranked first in the world ’s best-selling drug list for seven consecutive years since its launch in 2002, and its global sales in 2018 reached US $ 20.485 billion. Although it was named "Yaowang", its penetration rate in the Chinese market is not high. This may have something to do with its high price and fewer approved indications. Since the beginning of this year, Xiu Mei Le has dropped from 7,600 yuan to 3,160 yuan each, a decrease of nearly 60%. Many people in the industry believe that the price cut of Xiu Mei Le is to enter the national medical insurance directory.

(Article source: China Securities Journal)

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