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2022 new rules on health care negotiations, bidding model no less than collection

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, the Medical Insurance Bureau announced the "2022 National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog Adjustment Work Plan" and related documents for public comments. Overall, the health care negotiation process and key policies are largely in line with last year, with conditions relaxed for children's and rare disease drugs on the basis of continued support for new coronavirus treatment drugs and innovative drugs. The three main changes to the new health care rules in 2022 are:

1. New non-exclusive drug bidding rules;

2. New rules for negotiating drug renewals;

3. Move the timeline of each phase of the health care negotiations forward by a month.

non-exclusive drug bidding rules: no less than volume procurement

non-exclusive drug bidding rule is completely new and does not mention specific health insurance payment standards in 2021, but only encourages provincial health insurance departments to adjust and specify payment standards according to the price level of generic drugs. This year, there are very specific rules:

1

the calculation of the medical insurance party organization, the willingness to pay for medical insurance is put forward as the entry threshold.

2

the reporting enterprise submits the quotation. As long as there is a company's offer is not higher than the willingness to pay for health insurance, the generic drug is included in the health insurance category B catalog, otherwise the generic drug is not included.

3

drug is included in the health insurance catalog through bidding, the lowest price quoted by each enterprise shall be taken as the payment standard for the generic drug.

4

drugs have multiple specifications, select the most commonly used clinical specifications for bidding. Payment standards for other specifications are determined in accordance with the differential price rule.

5

drug is included in the medical insurance catalogue through bidding, all enterprises participating in the quotation shall promise that the price of supplying the drug to the designated medical institutions of the national medical insurance shall not be higher than the quotation at the time of participating in the bidding within the validity period of the bidding.

6

bidding does not affect the inclusion of the drug's generic name in national centralized band procurement or government pricing. Where centralized procurement is selected or government-priced, the payment standard shall be determined in accordance with the relevant provisions.

7

bid results are valid for 2 years.

can be seen from the rules, as long as the enterprise to reach the medical insurance price, to low price theory, in the medical insurance cost control under the main theme, non-exclusive varieties in accordance with the generic drug pricing route, for the enterprise, may be a similar to the volume of procurement price fight situation. The new approach of bidding is not only a new way to access the medical insurance catalogue, but also a new way to establish the payment standard.

Negotiating renewal rules: Proportional adjustment rules are clearer

can be seen from the rules, as long as the enterprise to reach the medical insurance price, to low price theory, in the medical insurance cost control under the main theme, non-exclusive varieties in accordance with the generic drug pricing route, for the enterprise, may be a similar to the volume of procurement price fight situation. The new approach of bidding is not only a new way to access the medical insurance catalogue, but also a new way to establish the payment standard.

Figure 1. Negotiating drug renewal rules in 2022

ratio A is the ratio of the actual expenditure of the health insurance fund to the estimated value of the fund's budget impact, and ratio B is the higher of the budgeted value of the new health insurance payment range/the estimated value two years ago and the actual expenditure value of the previous two years. It can be simply understood as ratio A mainly measures the ratio of actual and estimated health insurance expenditures, the larger the value, the higher the risk of the health insurance fund deficit, and B is the ratio of new expenditures to estimated or actual expenditures, the larger the actual health insurance expenditures.

Therefore, the ratio A is used to determine the downward adjustment of the payment standard, so as to reasonably adjust the payment of the medical insurance fund and keep the income and expenditure of the medical insurance fund stable. For example, if the ratio A is 150 and the average annual actual expenditure of the medical insurance fund is less than 0.2 billion yuan, the payment standard will be reduced by 10 percent and the simple renewal process will be followed. The larger A, the higher the actual expenditure of the medical insurance fund, the larger the reduction. If the ratio A exceeds 200, it will need to be renegotiated.

from the variety point of view, according to statistics, there are nearly 170 drugs that meet the medical insurance documents, of which more than 100 products have not entered the medical insurance catalogue in 2021. Among them, there are not many newly approved varieties. Most of them are varieties that have not entered into negotiations before. PD1 that has attracted much attention include K-drug and O-drug, as well as several newly approved PD1 in China, such as Paianprimab of Zhengda Tianqing/Kangfang, Srullimab of Fuhong Hanlin and Sepalimab of Yuheng/Yao Ming. These products will face more severe competition this year. If more PD1 enter the medical insurance catalogue, it will also have a market impact on PD1 enterprises already in the medical insurance catalogue.

, judging from the policy trend in recent years, medical insurance fee control is the main theme, the reform of medical payment methods, the new rules of medical insurance catalog negotiation, and the purchase with quantity are all aimed at the price. For pharmaceutical enterprises, only by consolidating their own foundation, actively innovating and developing drugs with better clinical value can they maintain their advantage in the price competition. For upstream life science companies, how to improve their own technical level, improve product quality and cost performance, and meet the needs of pharmaceutical companies for cost control is also a long way to go.