Two sides of the coin: in the face of "soul bargaining", how to stimulate local pharmaceutical innovation?

So far in 2020, the full vaccination of vaccines and the launch of new crown drugs have not prevented the continuous raging of the epidemic around the world.

In the face of fierce competition in the industry, it is also necessary to cross the medical insurance payment barrier that lies ahead

"Burning money" is one of the characteristics of biomedical research and development, and capital seeks profit.

"Burning money" is one of the characteristics of biomedical research and development.

During the two sessions this year, the topic of medical insurance continued to heat up, and CPPCC members from the medical and health field brought wonderful proposals one after another, offering suggestions for promoting the innovation and development of the local pharmaceutical industry

PART.

PART.

Optimize the negotiation system of the medical insurance catalogue

Support the local innovative drug industry

Support the local innovative drug industry

Zhu Tongyu, member of the National Committee of the Chinese People's Political Consultative Conference, vice chairman of the China Democratic League Shanghai Municipal Committee, and vice president of Shanghai Medical College of Fudan University, put forward the proposal of "Suggestions on Optimizing the Negotiation System of the Medical Insurance Catalogue and Supporting the Local Innovative Drug Industry"

First , there is a certain decline in the sales of some innovative drugs newly entered into medical insurance.

one

Second , the performance of newly listed innovative drugs was lower than market expectations, which greatly reduced the company's stock price, restricted the ability to refinance, and affected subsequent R&D investment;

Second

Third , the ultra-low prices of domestic innovative drugs in the local market will affect the pricing in overseas markets and put companies at a disadvantage in international competition

third

The following suggestions are made for this issue:

First , give preferential treatment to local innovative drug prices in the national medical insurance catalog negotiation

First

Second , for drugs with the same mechanism of action, latecomers to medical insurance and products already in the catalog should keep basically the same price, so as to form a fair competition environment with foreign-funded products;

second

Third , clarify the pricing rules for drugs with new indications, and refer to the price-volume agreement agreed in the first negotiation as the principle of price adjustment for renewals, so that drugs with new indications and renewed products enjoy non-discriminatory treatment

third

PART.

PART.

Establish new medical insurance access rules for new indications to support the development of local innovative drugs

Wu Depei, member of the National Committee of the Chinese People's Political Consultative Conference and director of the Department of Hematology of the First Affiliated Hospital of Soochow University, put forward the proposal "On Establishment of Medical Insurance Access Rules for New Indications to Support the Development of Local Innovative Drugs", pointing out three problems in the development of innovative drugs in China

First of all, the overall proportion of China's innovative drugs in the first decline and the subsequent decline in new indications is much higher than that in other countries

First of all, the overall proportion of China's innovative drugs in the first decline and the subsequent decline in new indications is much higher than that in other countries

The price of similar drugs in China is much lower than that of international similar drugs.
For example, the price of PD-1 monoclonal antibody Baizean in China is only 18.
07% of the international price in the main European market, and the annual treatment cost is the same in Germany, Japan, Switzerland and France.
9.
33%, 10.
72%, 9.
00%, 11.
57%
.

The price of similar medicines in my country is much lower than that of international similar medicines

In this era of highly information-based international reference prices in the global drug market, the price of China's domestic innovative drugs has hit the lowest price in the world.
Coupled with relatively open negotiated price information, Chinese companies will face challenges in pricing new drugs in major international markets
.

Secondly, the access to medical insurance for new indications in China lacks classified management and lacks an objective, predictable and actionable standard
.
All new indications are required to be included in formal negotiations, which will increase government administrative costs and corporate burdens to a certain extent
.
The uncertainty of the evaluation method increases the communication cost of the enterprise and the administrative risk of the government, and is also not conducive to the enterprise's early formulation and layout of R&D and commercialization plans
.
For example, for new indications with little room for decline, small number of patients, and little impact on funds, there is a lack of a price adjustment model that simplifies the process and does not require negotiation
.

Secondly, the access to medical insurance for new indications in China lacks classified management and lacks an objective, predictable and actionable standard
.

Third, China lacks an innovative access management model for medical insurance access for high-value breakthrough new indications
.
According to international practice, conditional approval of marketed drugs is characterized by a high degree of innovation, high price, uncertainty in clinical efficacy and the need for further proof
.
These characteristics often require medical insurance to conduct a more complex and longer-processed medical insurance evaluation for pricing and reimbursement decisions, resulting in delays in the timely use of new drugs by patients
.

Third, China lacks an innovative access management model for medical insurance access for high-value breakthrough new indications
.

In recent years, in order not to delay the use of new drugs by patients, and at the same time reduce the uncertainty and risk of medical insurance payment, governments around the world have adopted more flexible and innovative access methods, which have achieved good results
.
The main method is to reimburse first, and then make evaluation and reimbursement decisions based on real-world data after innovative drugs enter the market in the later stage
.
Some agreements are signed based on payment of efficacy, while others are based on financial risk sharing, such as signing agreements based on volume and price
.

Based on this, it is recommended to reform and simplify the access rules for new indications of drugs in the catalog, implement classified management, and actively explore the innovative model of "conditional reimbursement" for new indications
.

short term plan

short term plan

The inclusion of new indications involves drugs with a large unmet demand and a high degree of innovation.
If the company has higher expectations for pricing than the payment standard for the drug indication on the existing list, it is recommended to participate in the negotiation according to the complete process of the existing medical insurance negotiation.
, to reformulate payment standards
.

The newly added indications involve no major innovation, that is, moderate innovation, minor innovation or the same level of innovation.
If the company has the same or does not require a higher payment standard for the drug indication on the existing list, it is recommended to refer to the existing negotiated drugs.
renewal rules
.

Establishing a predictable, operable, and unified standard of reduction rules for enterprises is conducive to guiding enterprises to do a good job of measurement in advance, evaluate the reduction, and the impact on sales and profits, and make effective decisions
.

Medium and long term plan

Medium and long term plan

Countries adopting innovative medicines to pay for their efficacy and financial risk sharing have become the payment model for international new medicines to be included in medical insurance
.
With the increase in the number of drugs approved by the Chinese Food and Drug Administration with conditions, traditional pharmacoeconomic evaluation cannot make objective pricing and reimbursement decisions based on uncertain clinical data.
It is recommended to establish an innovative payment management model.
Indications are given a special and relatively flexible access channel, and a special access channel that considers "temporary reimbursement with conditions"
.

Pay-for-efficacy financial risk sharing model

PART.
0 3

PART.
0 3

Improve the medical price management mechanism and retain the spark of international competition in medical innovation

Improve the medical price management mechanism and retain the spark of international competition in medical innovation

Fang Laiying, member of the National Committee of the Chinese People's Political Consultative Conference and vice-chairman of the Chinese Hospital Association, pointed out that there are several problems in my country's drug price mechanism in the proposal on "Improving the Drug Price Governance Mechanism and Retaining the Spark of International Competition in Pharmaceutical Innovation":

1 The statistical caliber of "cost-price" is too narrow

1 The statistical caliber of "cost-price" is too narrow

In the budget impact analysis (BIA) calculation of the national medical insurance drug price negotiation, the costs associated with concomitant intervention measures such as the cost of linkage consumables, service facility costs, and follow-up costs are rarely considered, resulting in the cost advantage of innovative drugs (especially breakthrough therapies).
Not fully represented and there is a risk that the price will be significantly undervalued
.

2 Insufficient incentives for "price-R&D" innovation

2 Insufficient incentives for "price-R&D" innovation

Through the analysis of the data from 2011 to 2020, the research group of "Innovative Drug Price-R&D Correlation" found that the higher the profit of enterprises in the pharmaceutical industry, the more conducive it is to encourage enterprises in the industry to invest in R&D
.

At present, local innovative drugs are greatly affected by the "soul bargaining" of medical insurance access, and the continuously declining profit margin is expected to affect medium and long-term R&D investment and R&D intensity
.

3 The linkage between price policy and other pharmaceutical policies is limited

3 The linkage between price policy and other pharmaceutical policies is limited

After the price reduction of some innovative drugs, the conversion mechanism of "price-for-volume" is not smooth
.
The medical insurance departments of individual provinces and cities are limited by their ability to protect people and property, handling services, and informatization standardization support capabilities, and the innovative drugs in the catalog cannot be reimbursed locally in a timely, full, and convenient manner
.

For local innovative pharmaceutical companies that have fully benefited from the medical insurance access process, upstream scientific research policies, midstream industrial policies, and downstream financial policies have not been followed up synchronously, making it impossible for companies to enhance the "hematopoietic" function of sustainable development after "big blood loss".

.

In order to enhance the international innovation power of my country's pharmaceutical innovation, President Fang put forward the following suggestions:

In order to enhance the international innovation power of my country's pharmaceutical innovation, President Fang put forward the following suggestions:

1 Build a truth-oriented cost monitoring mechanism

1 Build a truth-oriented cost monitoring mechanism

In the traditional incremental cost-effectiveness ratio (ICER) calculation, ensure that the data caliber fits the real world and follows the laws of clinical medicine and the pharmaceutical industry, especially the full caliber of research and development costs, manufacturing costs, warehousing and logistics costs, and clinical support.
Costs, as well as the compliant doctor training/scientific research/conference costs passed on by the government and medical institutions to pharmaceutical companies, strictly prevent the underestimation of the comprehensive operating costs of innovative drug companies, which will lead to misjudgment of innovative drug pricing
.

2 Build an international-oriented price assessment mechanism

2 Build an international-oriented price assessment mechanism

It is necessary to break the pricing rule of "only the low price is taken", and bid farewell to the administrative price limit model of "do not talk about over 500,000, and do not enter over 300,000"
.
Based on the academic consensus of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the experience and lessons of price policy in major developed and developing countries, the maximum limit is raised year by year with the growth of China's gross domestic product (GDP) and the net income of urban and rural residents.
price, and gradually shift from "one size fits all" to "one drug, one policy" scientific value assessment
.

For major and difficult diseases such as rare diseases and end-stage diseases, the National Medical Insurance Bureau can conduct special negotiations separately to determine the payment thresholds that are different from common chronic diseases
.

3 Build a compensation-oriented policy linkage mechanism

3 Build a compensation-oriented policy linkage mechanism

In terms of negotiating the landing of drugs, it is recommended that the National Medical Insurance Bureau implement the "Promotion Project for Typical Cases of Medical Insurance Variety Landing", compile the "Guidelines for the Construction of National Medical Insurance Drug Landing Capability", and strongly support some leading provinces and cities to explore general outpatient coordination policies, outpatient chronic diseases/outpatient clinics The special disease model and the "dual-channel" model (also known as the "special drug policy") collect, select, and praise a number of pilot demonstration areas for the implementation of medical insurance drugs, and replicate and promote them nationwide
.

In terms of corporate incentives for negotiation, a price protection period of more than 3 years is set for Class 1.
1 new drugs that meet the "breakthrough therapy" conditions of the State Food and Drug Administration, during which centralized procurement, price negotiation and related package payments are exempted
.
Change the evaluation criteria of national major new drug creation projects and fiscal and taxation support policies from "only (patient) quantity theory" to "comprehensive value assessment" to avoid the exclusion of "niche" innovative drugs such as rare diseases and rare tumors
.
The securities regulatory authorities and the China Stock Exchange will not identify the universal and normalized price reduction policy of medical insurance as a "systemic risk" for listed innovative drug companies, and avoid setting improper restrictions on their additional issuance
.

PART.
0 4

PART.
0 4

Epilogue

Epilogue

In the blueprint for the development of the pharmaceutical industry in the "14th Five-Year Plan" for the development of the pharmaceutical industry, the basic principle of "adhering to innovation and leadership" is specially proposed, and innovation is regarded as the core task of promoting the high-quality development of the pharmaceutical industry.
The determination and will to promote the internationalization process of China's pharmaceutical industry and create a new engine for sustainable and healthy development through innovation
.

The development of new drugs is a long road full of thorns, and the construction of a multi-level medical security system is not achieved overnight.
In the process of continuous reform, adjustment and optimization, we will eventually explore a balanced development path with local characteristics
.