The end of the era of "high gross profit" innovation into a breakthrough for pharmaceutical companies must choose

A reporter from the Economic Information Daily learned that the negotiation on the national health insurance access catalogue has come to an end a few days ago, and the results of the negotiations may be announced before the end of the year. In the past year, through measures such as volume procurement and medical insurance negotiations, the prices of drugs and high-value medicinal materials have dropped significantly, the burden on patients has been significantly reduced, and the accessibility of patients' medication has been greatly improved. Industry insiders said that with the reform of medical insurance control fees entering the deep water area, the era of unreasonable "high gross profit" in China's pharmaceutical market has come to an end, enterprises have accelerated their transformation, and innovative pharmaceutical equipment has become the direction of enterprises.

　In the game, more patients can afford good medicine.

"So-and-so medicine into the health insurance? Price? I have ovarian cancer, need this medicine, but can not afford." "Do you know how many cancer patients in the countryside give up treatment? My dad spent 100000 yuan in half a year, and I can hardly afford to eat." These are the messages under a certain medical public number, and they are also the reality faced by cancer patients at present.

At 7:00 p.m. on December 16, with the completion of the negotiation of the last drug for melanoma treatment, the three-day adjustment of the national medical insurance drug catalogue in 2020 completed the most intense negotiation link. According to the "List of Declared Drugs for the Adjustment of the National Medical Insurance Drug Catalogue in 2020" issued by the Health Insurance Bureau in September this year, a total of 751 varieties have passed the formal examination this year, involving cancer, mental illness, eye disease, pediatrics and other drug varieties.

This is the fifth time that the National Health Insurance Bureau has negotiated the national health insurance access catalogue. In order to allow patients to use new drugs and good drugs, it has become a normal operation to promote the reduction of drug costs through the "quantity for price" negotiation access.

In October 2015, my country organized the first national drug price negotiation pilot work, and identified 5 drugs for the treatment of hepatitis B and non-small cell lung cancer. After multiple rounds of negotiations, 3 drug negotiations were successful, with an average drop of 58% and a maximum drop of 67%.%. In 2017, 36 of the 44 negotiated drugs in the second round were successfully negotiated, including tumor-targeted drugs, cardiovascular drugs, and hemophilia and other major diseases, with an average drop of 44% and a drop of up to 70%.

Special negotiations on anticancer drugs were launched in 2018, and 17 drug negotiations were successful, covering more than 10 kinds of cancer treatment drugs, such as non-small cell lung cancer, chronic myeloid leukemia, childhood acute lymphoblastic leukemia, melanoma, renal cell carcinoma, colorectal cancer, etc., with an average decrease of 56.7 per cent and a maximum decrease of 71 per cent. In November 2019, 150 drugs were included in the scope of negotiations, of which 70 new drugs and 27 renewed products were successfully negotiated, covering clinical treatment areas such as cancer, rare diseases, hepatitis, diabetes, MDR-TB, rheumatic immunity, cardio-cerebrovascular, and digestion. The catalogue of new varieties, the average decline of 67%, the highest decline of 81%.

The results of this year's negotiations, the National Health Insurance Bureau has not yet officially announced. Judging from the previous market news, the price of PD-1/PD-L1 monoclonal antibody, the most concerned cancer immunotherapy drug, is expected to drop significantly. In the past, the cost of hundreds of thousands of dollars a year made many families "out of reach" for PD-1 ".

Another news shows that Hengrui medicine carilizumab, which has covered four indications, such as Hodgkin lymphoma, non-small cell lung cancer, esophageal cancer and hepatocellular carcinoma, is successfully negotiated as a tumor treatment drug with definite curative effect or with a price reduction of up to 80%. Previously, the annual treatment cost of a patient using karelizumab was nearly 120000 yuan. If he entered the medical insurance, the actual cost per patient per year was only 15000 yuan after the medical insurance reimbursement according to the reduced price, which was nearly half lower than the 29000 yuan of xindilizumab previously included in the medical insurance.

　　"Quantity for Price" Makes More People Dare to Treat Diseases

"The hypoglycemic drugs taken in the past have dropped from 65 yuan per box to less than 6 yuan per box now. The annual drug cost per person has dropped from 4680 yuan to nearly 10,000 yuan for two people to only 800 yuan. Yuan." There are two diabetic patients in Ms. Li's family in Shanxi who are taking hypoglycemic drugs, and the drop in drug prices has immediately reduced her financial burden.

In addition to medical insurance negotiations, the national centralized procurement of large varieties of chronic diseases and common diseases, high-value consumables inflated price level to the "freezing point".

On August 24, Shanghai United Procurement released the results of the third batch of national centralized belt procurement, 55 generic varieties successfully won the bid, the average price reduction of more than 70%, the highest drop of up to 98.7 percent.

Among them, metformin tablets and captopril for two chronic diseases quoted prices of less than 1.5 cents. Among olanzapine orally disintegrating tablets, Qilu Pharmaceuticals dropped all the way to 0.45 yuan/tablet from 10 yuan/tablet with the lowest bid price last year, a decrease of 95.5 percent. Connbe's finasteride tablets dropped from 1.88 yuan/tablet with the lowest bid price in 2018 to 0.17 yuan/tablet, a decrease of 90.76 percent.

According to the calculation of the State Medical Insurance Bureau, for the 112 varieties collected in three batches, the annual drug cost has been reduced from 65.9 billion yuan to 12 billion yuan according to the agreed purchase volume, saving 53.9 billion yuan. According to the reimbursement rate of 60%, it can save 21.6 billion yuan for patients and 32.3 billion yuan for medical insurance fund. Among them, the annual treatment cost of tenofovir disovir and entecavir for hepatitis B has been reduced from about 20000 yuan and 9000 yuan in 2015 to about 70 yuan.

As drug prices have fallen sharply, so has access to medication. According to statistics, there are nearly 30 million patients with chronic hepatitis B in my country, and the standard treatment rate is only 11%; there are about 0.245 billion patients with hypertension, and the blood pressure control rate is only 17%. After the sharp price reduction, the sales volume of hepatitis B drug entecavir increased from 68 million tablets to 0.207 billion tablets in 11 pilot cities, and the number of patients treated with the drug increased by nearly two times. Sales of hypertension drugs amlodipine, irbesartan and losartan generally doubled.

On November 5, the first round of centralized procurement of high-value medical consumables organized by the state in China was opened in Tianjin. The 10 products of 8 enterprises, including Yisheng Technology, Shanghai Minimally Invasive Medical and Lepu Medical, were selected. The price of coronary stent will drop from the previous average price of about 13000 yuan to about 700 yuan.

In China, about 1 million patients with coronary heart disease are implanted with cardiac stents every year. It is estimated that by 2021, the personal out-of-pocket expenses will be reduced to less than 2500 yuan.

　　The innovation ability of pharmaceutical enterprises is expected to be further enhanced

Industry insiders said that China's pharmaceutical industry is undergoing great changes. Under the influence of a series of pharmaceutical policies, such as consistency evaluation, volume procurement, adjustment of medical insurance catalogue, reform of registration system, drug marketing license holder system, and acceleration of new drug approval, the industrial structure has been accelerated to upgrade and optimize, the original pattern of drugs and consumables and the commercial value chain have been broken and reshaped, and enterprise transformation is inevitable.

The person also said that the current national collection and health insurance negotiations are pushing China's pharmaceutical market to gradually integrate with overseas, the future generic drug price reduction pressure will continue, high-value consumables collection has just begun, domestic innovative drugs into the health insurance release is worth looking forward.

Yang Song, chief analyst at Cinda Securities, also said that the health insurance negotiations give innovative drugs faster access opportunities and relatively moderate price cuts, and innovative drugs are still expected to be the direction of policy encouragement.

Under the guidance of the policy, the enterprise innovation consciousness is increasing. A company revealed at an internal meeting that its R & D investment will definitely not decrease in the next few years. Now is the time to transform and upgrade and roll out all innovative drugs, and we must not look back.

Xu Binghe, director of the National New Drug (Anti-tumor) Clinical Research Center of the Cancer Hospital of the Chinese Academy of Medical Sciences, said at the first China Industry Chain Innovation and Development Summit recently that the research and development of original new drugs in China is progressing rapidly, the research and development cycle is rapidly shortened, and the iterative progress is continuous. The number of CAR-T research has ranked first in the world, and more new cell therapy drugs will be launched in the near future.