The "War Of Kings" In The Negotiation Of National Health Insurance: Will The Six Market Of Hepatitis C Drugs Enter Into Two And The Blue Ocean Market Will Change?

In 2019, the national health insurance drug negotiation came to an end, and the relevant drug market will usher in a new pattern next year.

On the one hand, the state health insurance agency has sharply cut prices, while the other side is foreign pharmaceutical companies frequently showing the "lowest price in the world". In the industry, the "medicine king" repaired Miller for many years until its bio similar drugs were listed. Finally, they entered medical insurance. The four eligible PD-1 drugs were finally accepted by the "domestic" letter Dili monoclonal antibody, but PD-1/L1's "sharp edge" in the field of medical insurance has not yet been released.

In contrast, judging from the variety, form and performance of various pharmaceutical companies, the negotiation of new hepatitis C drugs is regarded as the "battle of kings".

According to the national health insurance agency, the negotiations are directed against hepatitis C direct antiviral drugs (DAA), and "innovative competitive negotiation is adopted." A total of 6 drugs were involved in the negotiations in 4 enterprises. Eventually, three medicines of gilid and Mercedes entered health insurance, and the average price of drugs dropped by an average of more than 85%. The cost of each course fell from 10 thousand yuan to 50 thousand yuan earlier.

"The negotiation of hepatitis C medicine has lasted for more than two hours, and it should be the longest variety in the negotiations, usually a product is half an hour." In December 9th, Luo Yongqing, general manager of gilid's scientific global vice president and general manager of China, told the economic report in twenty-first Century, "I believe this is the result of the National Health Insurance Bureau's interest. The government has great desire to facilitate the two sides to reach an agreement. The negotiation process is very scientific, rigorous, fair, just and open. I participated in similar negotiations a long time ago, but this negotiation shows that the government has made great efforts. "

As the hepatitis C drug is a "cure" market, as the cure rate of patients increases, the market shrinks year by year.

The medical insurance negotiations "explicitly only allow 2 full course of treatment of the lowest cost of drugs into the directory, and promised not to include 2 new drugs in the same year." And local medical insurance at all levels "shall not transfer the negotiated drugs out of the catalogue or adjust the scope of payment limits, and uniformly implement the standard of payment negotiated".

As a big country of hepatitis, the "big cake" of hepatitis C medicine in the Chinese market needs a new method.

Mutual bright base price

The national health insurance negotiations involved 150 drugs, 119 new drugs have 70 successful negotiations, including 52 western medicine and 18 proprietary Chinese medicines, the average price decline of 60.7%. The average dosage of three kinds of HCV was over 85%, and the average rate of treatment for cancer and diabetes was about 65%. Of the 31 renewals, 27 were successfully negotiated and the average price fell by 26.4%.

The first dose of oral medicine that can cure hepatitis C is entered. Before adjusting, there was only one interferon treatment plan in the medical insurance directory. The treatment lasted for 1 years and the cure rate was only about 50%. After adjustment, the DAA class HCV drug use time is about 12 weeks, 98% cure rate, all oral.

The hepatitis C medicine negotiations involved six kinds of drugs, four enterprises, namely, Gillie, Mercedes, Ai Bowei, three multinational pharmaceutical companies and Chinese enterprises Song Li pharmaceutical.

The result of the negotiations was gilding's Alfonso Bwevipatave (85%) and Xia Fanning (Lai di vsso phosphorus), and Mercedes's choice (Alba Vegh Larry Vee Pen) entered the national health insurance category B with an average decrease of about $2, and the agreement was valid from January 1, 2020 to December 31, 2021. AI Bo Wei and Song Li out.

CCTV then announced the "competitive" negotiation process at the time: four companies directly estimated the offer at the scene, and the price of each drug should be two to the decimal point. 20 minutes later, the company gave the final offer, and the negotiating group announced the offer under the supervision of the supervision group. According to the rule, if the company quoted price is within the medical insurance payment intention, the two will be selected according to the quoted price from low to high; if all of them are willing to pay, second rounds of quotation will be required.

For the negotiations, the national health insurance agency said, "in view of the obvious efficacy of the 6 hepatitis C drugs, the same treatment effect and the high price, it is difficult to guide the enterprises to reduce the price to a reasonable range by relying on the pharmacoeconomic calculation and conventional access negotiations. We creatively introduced the competitive negotiation method, and only allowed 2 drugs with the lowest cost of the whole course to enter the catalogue, and promised that they would not be included in the new drugs in the 2 years, and that the enterprises would be fully competitive. Through competitive negotiations, the quoted price of enterprises has dropped sharply, and achieved the expected goal. "

From the perspective of enterprises, "for multinational companies, the prerequisite for successful negotiation is to get a base price approved by the headquarters, otherwise good negotiation skills will be useless. We did all kinds of considerations, plans, anticipation, analysis of various situations, and got headquarters recognition. Luo Yongqing said to the twenty-first Century economic report, "such recognition is not easy. China's negotiating price is lower than that of overseas or even surrounding markets. How can we persuade our headquarters?" First of all, the headquarters must have a corresponding concept, and then look at the number of patients in China, and how much volume will increase in the next 35 years, so that the volume of sales will not be much worse than expected.

In the 2019 national health insurance directory, only two direct antiviral drugs were approved for the treatment of hepatitis 1B gene in the scope of medical insurance. This represents the Chinese government's recognition of the value of the drug in the field of hepatitis C treatment. "

After the result of the announcement, the song came out of the "Star" biological innovation company listed on the new regulation of the HKEx. "The negotiation has not been successful due to the price limitation of the long-acting interferon in the scheme," he said in a statement. But still can not stop the cruelty of the market: after the announcement of the results of the negotiations, the price of the song Li fell sharply. In November, the 28 daily newspaper closed 3.42 Hong Kong dollars / share, a decrease of 25%. For local pharmaceutical companies that choose innovative ways, there are still many risks, such as racetrack, variety, timing and policy.

New commercial competition

Hepatitis C is a big market.

According to who data, it is estimated that 71 million people worldwide are infected with chronic hepatitis C virus (HCV). In 2016, about 399 thousand people died of hepatitis C, mainly due to cirrhosis and hepatocellular carcinoma (primary liver cancer).

Hepatitis C is the fourth most common infectious disease in China. At present, there are about 10 million infections. Hepatitis C virus has 6 genotypes and many subtypes.

According to the guideline of hepatitis C prevention and treatment issued by the society of Hepatology and Chinese society of infectious diseases of Chinese Medical Association in 2015, HCV1b and 2A genotypes are more common in China, 56.8% of them are 1b type, followed by type 2 (24.1%) and 3 type (9.1%), and 6 type is relatively less (6.3%), mainly in southern China.

In terms of treatment, different types of HCV have different therapeutic methods. At present, no effective preventive hepatitis C vaccine is available. Antiviral drugs can cure more than 95% of hepatitis C infected people, thereby reducing the risk of death from liver cancer and cirrhosis, but the diagnosis and treatment are very low.

In China, HCV genotype 1, 2, 3 and 6 cases account for 96% of all HCV cases, compared with less than 1% of patients currently receiving treatment.

Professor Wang Guiqiang, director of the Department of infectious diseases and liver disease center of No.1 Hospital of Peking University, has said that the treatment of HCV infection in China is still interferon plus ribavirin, and there are some cases of poor response rate, poor tolerance, long course of treatment and low safety.

Interferon (IFN) is a broad-spectrum antiviral agent that does not directly kill or inhibit the virus. It mainly produces antiviral proteins through cell surface receptors, thereby inhibiting viral replication.

However, the listing of sopophie tablets and other hepatitis C direct antiviral drugs (DAA) is a turning point in the treatment of HCV, which can be taken orally, with a shorter course of treatment and the majority of patients can be cured.

Between 2014 and 2015, the launch of a new generation of direct antiviral drugs has rapidly pulled the global market for hepatitis C drugs. The sales of Gillie, Ai Bowei, BMS, Johnson and Mercedes have expanded steadily during this period. In 2013, the global market for hepatitis C drugs was about $5 billion, rising to $14 billion 300 million in 2014 and rising to $28 billion 700 million in 2015.

One of the reasons is the high unit price. The price of the company's listing in the United States is as high as $84000 / course (12 weeks), which is equivalent to 1000 US dollars per tablet, 66000 USD / course in Germany, and 57000 US dollars / treatment course in Britain. In addition to the compulsory patent license granted by the India government, it sold about 10 US dollars per piece in India.

This also directly led to the huge risk of Chinese patients crossing the border for medical treatment. Luo Yongqing said, "black market drugs exist in the market, which means that many patients have risks. Some patients eat drugs that flow into China in informal ways, and there is resistance to hepatitis C virus mutations.

Lowering prices into health care to improve drug accessibility of patients, side curb illegal channels into the market of hepatitis C, should also be the medical insurance bureau and pharmaceutical companies to see the situation.

In 2017, DAA drugs were approved in China, marking the new era of hepatitis C treatment in China.

Although the curative effect is excellent, due to the high unit price of DAA drugs and the spread of black market drugs, the market of hepatitis C among multinational pharmaceutical companies in China is far from spreading. In addition, with the improvement of cure rate, the global hepatitis C drug market has been declining year by year, and the sales performance of various countries began to decline in 2016. According to the IQVIA MIDAS database, the global market for hepatitis C drugs (DAA) in 2018 was about $16 billion 600 million, which shrank by more than 40% compared to the peak of 2015. In 2019, this continued downward trend is still inevitable.

Gilead is a hepatitis C drug giant in the global market. It has a number of hepatitis C drug products portfolio, which has created multiple marketing myths. Evaluate Pharma predicts that Gilead will continue to dominate the antiviral market in 2024 due to HIV drugs, but the share of global sales of hepatitis C will decline from 55% in 2017 to 38.7% in 2024.

For gilid, whose R & D capability is greater than commercial capability, the national health insurance negotiations also provide a new commercial competition path for them.

"We have a small number of commercialized personnel. The European and American markets are very mature. 65% of the drugs in the United States are commercial insurance, and the approved drugs are introduced directly without negotiation. In the history of the pharmaceutical industry, only one of us sold us $ten billion in the first year of the launch of the product. Luo Yongqing said, "the Chinese market is very complex, diverse and uneven, so the form of national health insurance negotiation gives us the chance to do such a thing, which has nothing to do with commercialization capability. Gilead's commercial team in China has only more than 200 people. After all, unlike other old pharmaceutical factories in China for decades, we want to work in a new way.