The Policy Logic of Guangdong's 45 Product Centralized Procurement Renewal Plan

Title: The original intention of the country's centralized drug procurement is to promote the substitution of high-quality generic drugs for original drugs, save medical insurance funds, and reduce patient expenditures; and promote the revolution of China's pharmaceutical industry and achieve the goal of 2050 Made in China

In the policy and practice of drug bidding and procurement, Guangdong Province has always been in the forefront of the country

In a sense, the industry has already had an expectation of a wave of waves in the preparation of the Guangdong Province’s plan to renew the contract for the centralized procurement of 45 products this time

Guangdong Province really lived up to expectations

Relying on the provincial centralized drug procurement platform, learning from the state’s experience in organizing centralized drug procurement and use, adopting a cross-regional alliance approach, intensifying reforms and innovations in the scope of procurement of drugs, shortlisting standards, and centralized procurement forms-this is for the State Council’s "About In response to the “Notice on Several Policy Measures to Further Deepen the Reform of the Medical and Health System with the Centralized Procurement and Use of Medicines as a Breakthrough” (Guoyugaifa [2019] No.

The old method, we still use a few questions to sort out the core of this Guangdong drug procurement document and the ins and outs of the policy

Question 1.

Simply put: 1) Original drugs and generic drugs that have passed the consistency evaluation of the quality and efficacy of generic drugs-this is consistent with the national centralized procurement requirements; 2) generic drugs that have not passed the consistency evaluation, but the prerequisite is the same There are less than 3 products that have passed the consistency evaluation under the generic name and medical insurance formulations-this means that the country's surplus market for centralized procurement will be further included in standard management

Question 2.

This question is actually the opposite of the first question

1) Product qualification: If there are 3 generic drugs that have passed the consistency evaluation under the same generic name and medical insurance dosage form, the generic drugs that have not been evaluated will not be eligible for registration;

2) Enterprise qualification: the applicant enterprise is not included in the current "National Pharmaceutical Price and Procurement Untrustworthy Enterprise Risk Warning List"; the applicant enterprise should abide by the "Patent Law", "Anti-Unfair Competition Law" and other relevant laws and regulations, and undertake corresponding laws Responsibility

The above requirements for corporate qualifications are for the recent National Medical Insurance Administration's "Pharmaceutical Price and Recruitment Credit Evaluation Operation Specification (2020 Edition)" and "Pharmaceutical Price and Recruitment Credit Rating Discretionary Benchmark (2020 Edition)", as well as the National Medicines The Supervision Bureau’s response and implementation of policy documents such as "Implementation Measures for Early Resolution Mechanisms for Drug Patent Disputes (Trial)"

Question 3.

It should be noted that this medical institution's report needs to be clearly reported to the label

Question 4.

Although no price-limiting rules are clearly proposed, from the perspective of the rules for determining the selected price, there are basically the following two points: 1) Not higher than the national minimum price of this product; 2) Unreviewed products need to be lower than those of overrated products The lowest price in the country

In the price declaration, the company needs to quote the price of 2 steps.
The first step is the step price that corresponds to the first-year pre-purchasing volume of the company in the alliance area.
The second step price exceeds the first-year forecast of the company in the alliance area.
The cascade price corresponding to ?% of the purchase volume
.
The 2nd rung quotation theoretically needs to have at least a 2% decrease compared to the 1st rung.
If it is higher than the 1st rung quotation, it is an invalid quotation
.

It is very clear that: 1) If the product wants to win the bid, it is impossible to increase the price; 2) The price of the unreviewed product cannot be higher than the lowest price of the reviewed product-clearly set the price red line based on quality to avoid regulatory loopholes; 3) Gradient quotation 2 % Reduction requirement-This draws on the practice of Wuhan's volume procurement gradient quotation in 2019, and is also in line with the behavior model of Guangdong Province to continuously inquire about the national minimum price with its market share
.

Question 5: What are the winning rules?

The selection rules are more complicated, but in general: 1) The highest-priced product is out-as long as there are 3 companies in the same competition group, the company with the highest "comparable unit price" will definitely be eliminated; 2) Winning bids for multiple products-basis The "comparable unit price" ranges from low to high.
Group A will eliminate at least one company, and Group B will be shortlisted according to a certain percentage but not more than six
.

Take amlodipine as an example: 1) If the original research product Luohuoxi maintains the original strategy of not reducing the price and winning the bid in the country's volume procurement, it will become a non-selected product without any suspense; 2) The quotation of the generic drug cannot be selected.
It is higher than the previous selected price in the national volume purchase.
Taking Zhejiang Jingxin as an example, its quotation cannot be higher than the "4+7" selected price of 0.
15 yuan (5mg/tablet), and you need to ensure that you are not in Group A The unit with the highest comparable price
.

On the whole, the selection rules are similar to the national procurement rules
.
For products that hope to gain market share through the selection, we need to carefully consider the price reduction rate-further reduce the price on the basis of the selected price in the national volume procurement
.

Question 6.
How big is the margin market for volume purchases?

For the unselected products, the remaining problem is the allocation of the margin market
.
Reporting volume is the bidding and trading rules of the Guangdong platform for many years, and this matter is not unfamiliar
.
In the past, at the actual operational level, medical institutions could also decide what products to purchase by whether or not to report
.
However, the drug procurement documents this time made clear requirements-in the procurement year, the incremental use of medical institutions in principle will give priority to the use of selected products, and the use ratio should not be less than 80% of the incremental
.

Let's take amlodipine as an example
.
Assuming that the medical institution A does not report the volume at all, at the actual procurement level, 80% also need to apply the selected products, and only 20% of the share can be reserved for the unselected products
.
Assuming that the reported volume of medical institution B is 60% of the actual purchase volume, then of the remaining 40%, 32% need to use the selected products, and only 8% can be reserved for the unselected products
.

From the perspective of policy entry point, this is to further incorporate the margin market into the standard management, and its essence is the deepening of price-for-volume-further commitment to purchase volume to depress drug prices
.

Question 7.
What is the practical basis for the margin market to be further included in the standard management?

There are mainly two: One is the continuous increase of over-rated drugs; the other is the capital of over-rated generic drugs to obtain the capital of the original research drugs-in 2019, the Beijing Municipal Health Commission selected 14 from the "4+7" products A representative variety, commissioned 20 well-known medical institutions in Beijing to conduct real-world research on the clinical efficacy and safety of the selected products in the centralized collection based on their respective medical advantage projects and using data in the clinical real diagnosis and treatment environment
.

From the results of big data sorting, there is no significant statistical difference between the 14 selected generic drugs and the original drugs in the key efficacy evaluation indicators, and there is no significant statistical difference in the safety indicators
.
It is preliminarily confirmed that the 14 generic drugs that passed the consistency evaluation in this study are clinically equivalent
.