Imatinib, the drug used to treat chronic myeloid leukemia in the movie "I am not a medicine god", was listed in 2001 at a unit price of 400 yuan / tablet, and the annual cost of patients at their own expense reached 300,000 yuan; by 2019, its price dropped to 9.8 yuan / tablet, and the annual cost of patients' self-payment was only 1500 yuan.
Why has imatinib fallen by 98% in 18 years? The price reduction caused by the "patent cliff" after the expiration of the original drug patent is only one of the reasons, and the real substantive price reduction of imatinib is after the 4+7 pilot collection in 2018.
Jiang Changsong, director of the Price Recruitment Office of the National Medical Security Research Institute, said at the press conference held on the 15th that since the State Medical Insurance Bureau organized the centralized procurement of drugs, the prices of the purchased varieties have been greatly reduced, and the average reduction of the selected products has exceeded 50%, bringing about the "patent cliff" that China is looking forward to.
According to the statistics of the price and procurement of the 9 commonly used drugs in the year before and after the implementation of the results of the collection and collection of 9 commonly used drugs, the "volume effect" and "price reduction effect" of the selected generic drugs were significant, and the prices of the unselected drugs fell with the movement. Under the same generic name, the original research drugs, the selected generic drugs and the unselected generic drugs have "dropped in three prices", and the burden of medication for the masses has been significantly reduced.
Procurement with quantity brings "patent cliff"
The "patent cliff" is a unique phenomenon in the pharmaceutical industry, which is a metaphor for the sharp decline in sales and profits of patented drugs brought about by the expiration of the patent protection period of pharmaceuticals. In foreign countries, the expiration of the patent protection period for drugs, generic drugs enter and occupy the market at lower prices, resulting in a sharp decline in the sales amount of patented drugs.
Jiang Changsong believes that before the collection and procurement in China, there was no "patent cliff" expected. Drugs that have passed the patent protection period still occupy a large market share, and the drugs have not been significantly reduced in price due to the expiration of the patent period. The sales amount of original drugs and generic drugs that have passed the patent protection period can still account for 65% of the national prescription drug market, and patients still buy drugs that have no patent protection at high prices.
Taking imatinib as an example, after the expiration of the original research patent in 2013, the price remained 200 yuan / piece, 12,000 yuan / box, and the patient's self-funded annual fee was 140,000 yuan. It was not until the 4+7 pilot collection in 2018 and entered the national medical insurance directory through negotiation that its price dropped to 14 yuan / piece, 834 yuan / box, and the annual cost of patients' self-payment fell to 2,000 yuan. In 2019, the 4+7 expansion collection continued to drop to 9.8 yuan / tablet, 586 yuan / box, and the annual cost of patients at their own expense was only 1500 yuan.
According to the statistics of more than 20 kinds of original research drugs selected in the first 5 batches of procurement, the highest price reduction in collection and procurement reached 92%, and the lowest reduction also reached 43%, and the price of drugs was significantly reduced.
Jiang Changsong said that since the National Medical Insurance Bureau organized the centralized procurement of drugs, the prices of the purchased varieties have been greatly reduced, and the average reduction of selected products has exceeded 50%, and the "patent cliff" has also emerged. For production enterprises and circulation enterprises, the collection and purification of the industry ecology, improve the scale of intensification, and force upgrading and innovation.
Generic drugs accelerate the replacement of original research drugs
The China Medical Insurance Research Association selected 9 kinds of drugs such as atorvastatin oral regular-release dosage form and amlodipine oral regular-release dosage form, according to the incomplete statistics of the national situation, compared the price and procurement volume of the year before and after the implementation of the collection results, and found that the "volume effect" and "price reduction effect" of the selected generic drugs were significant, and the price of the unselected drugs fell with the movement, and finally showed the trend of "two subtractions and one increase" and the price "three prices falling together".
Liu Wenxin, director of the Technical Standards Department of the China Medical Insurance Research Association, said that after one year of collection, the purchase volume of drugs showed "two subtractions and one increase", that is, the purchase volume of unselected original drugs was greatly reduced, and the "substitution effect" of selected generic drugs on the unselected original drugs was obvious; the purchase volume of unselected generic drugs fell higher, and the "substitution effect" of the selected generic drugs of "good quality and good price" on the unselected generic drugs was also obvious. The purchase volume of selected generic drugs has risen sharply, and the masses use the selected drugs with "high quality and good price".
The data shows that one year after the implementation of the collection results, the total annual procurement volume of the original research drugs that have not been selected has dropped by an average of 46% compared with the year before the implementation of the collection results. The total annual procurement volume of unselected generic drugs fell by 80.8%, 9 drugs fell by more than 70%, and 6 drugs fell by more than 80%. The total annual procurement volume of selected generic drugs increased by 265.2%,
In addition, the collection policy also promotes the optimization of the drug use structure. In terms of the proportion of the total annual procurement volume of the same generic drug in the national total procurement, the original research drug decreased from 28.9% in the year before the implementation to 12.7%.
Hu Xin, chief pharmacist of the Pharmacy Department of Beijing Hospital, said that the collection not only significantly reduces the cost of drugs for diabetes, hepatitis B and other diseases, but also greatly improves the accessibility of drugs and realizes the replacement of generic drugs for the original drugs.
Hu Xin also said that according to the efficacy and safety evaluation results of the data in the real diagnosis and treatment environment, there was no difference in clinical efficacy and safety between 14 selected generic drugs in 8 treatment areas such as hepatitis B, hypertension and tumors, which provided important evidence-based medical evidence for generic drugs to replace original research drugs.
Liu Wenxin said that after the collection of drugs, there has been a "three-valence decline" in the original research drugs, selected generic drugs and unselected generic drugs, and the burden of medication on the masses has been significantly reduced. In terms of common names, the average price of all nine drugs has been significantly reduced. The average decline in the nine drugs was 67.1%. Among them, the price decline of the selected generic drugs is the most significant. The effect of "exchanging price for volume" is obvious, and the average price of the 9 selected generic drugs has dropped by 82.4%. At the same time, the price of the original research drug fell with the movement.
According to the decline in the price of the selected generic drugs, the medical insurance departments in various places have jointly lowered the price of the corresponding non-selected original research drugs, or anchored the lowest price in the country, or anchored the Purchase Price in Shanghai, guiding the price of the original research drugs of the non-selected original research drugs to decline. The average reduction of the unselected original research drugs of the 9 drugs reached 12.9%. In addition, the price of unselected generic drugs fell with the trend. The average reduction rate of the 9 unselected generic drugs was 17.4%.
The study by the China Medical Insurance Research Association also shows that the price reduction effect in 2021 continues to be released, compared with the year after the implementation of the collection results, the average price of drugs in 2021 fell by 25.7%, of which the average decline of the selected drugs was 29.1%.
Secondly, the selected generic drugs continue to replace the original drugs that have not been selected and the generic drugs that have not been selected, and the effect of "generic drug substitution" has continued to strengthen. Compared with the year after the implementation of the collection results, the market share of selected generic drugs in 2021 further increased to 84.4%, an increase of 5.2 percentage points; the market share of original drugs further decreased to 11.7%, down 3.9 percentage points; the market share of selected generic drugs of each drug was more than 80%, and the market share of 3 drugs has reached more than 90%.
Wang Nannan, government affairs manager of the market access department of Zhejiang Jingxin Pharmaceutical Co., Ltd., believes that the clinical accessibility of selected products will be improved after the collection and procurement, and the total medical cost and medical insurance fund expenditure will be reduced. The collection and collection profoundly affects the development of enterprises, not only allowing enterprises to exert their scale advantages and return to the essence of manufacturing operations, but also promoting the transformation and upgrading of enterprise management strategies.