Based on the global perspective, based on China's practice, this paper discusses the evaluation of drug value and the formation of payment standards for medical insurance negotiations

In November 2020, China Medical Insurance magazine published an article on "Several Discussions on the Value Assessment and Payment Standards of Medicines in Health Insurance Negotiations", which is also the result of the "Research on Medical Insurance Negotiating Methods in the Context of Pharmaceutical Innovation" jointly with the Beijing Medical and Health Economic Research Association, Ai Kunwei Real World Research and RDPAC.
the three medical insurance drug negotiations from 2017 to 2019 are based on the exploration of China's national conditions and the current situation of medical insurance management, and have laid a practical foundation for perfecting the access mechanism of China's innovative drug and medical insurance.
The basic framework of the current drug negotiation mechanism has been formed, but there is still room for refinement in the details of the framework and key factors formed by the value assessment and payment criteria, the renewal negotiations and the adjustment of the payment standards for new adaptive drugs.
In March 2020, the three-party partnership launched the study, which lasted five months and combed through the experience of the international relatively mature health technology evaluation system in the United Kingdom, Germany, Canada, Australia, France, Japan, Taiwan and other countries and regions, and held three expert seminars, listened to many suggestions and discussed how to improve the details of the negotiations.
Research Main Results (Excerals of articles)1 The framework formed by the value assessment and payment criteria is based on international experience, multi-dimensional value evaluation of drugs and grading according to the results, and then the implementation of value-based grading price, the key is to achieve a quantitative measurement of drug value.
drug score by value can be divided into three categories: micro-value, medium value, significant or significant value.
value of drugs can be used to determine payment standards by reference to similar drugs already available in the medical insurance catalogue, and promote price competition for similar drugs.
for medium or significant/significant value drugs, payment standards should reflect the value they bring to patients, families and society, while stimulating pharmaceutical companies to innovate.
comprehensive evaluation and measurement of negotiated medicines, the payment criteria need not only reflect the value of the drugs themselves, but also take into account the balanced risks of health insurance funds and the development of the pharmaceutical industry.
, the health care sector determines the negotiated benchmark price based on factors such as the comprehensive value assessment results, the cost of medicines, international reference prices, and the impact of medicines on the health care budget.
clearly defined the method of estimation and consideration criteria for each determining factor, the process can be transparent and efficient.
it is also worth noting that innovative pharmaceutical product development cycle is long, each stage requires sustained investment of huge funds.
The study therefore recommends that, when adjusting the base price, a price protection may be provided for medicines of medium and significant or significant value, or even a certain premium range for drugs of significant or significant value.
of the consideration dimension 2.1 nuclear price reference selection principle reference formed by the payment standard is an element of the payment standard in the negotiation.
In the light of international experience, the selection of nuclear price references should follow the principle of "most similarity", with preferences for adaptation, efficacy, machinery, chemical structure, dosage forms, drugs with the most similar doses, and drugs with direct comparison results from head-to-head trials As a reference, traditional drugs in the mechanism of action and chemical structure and efficacy and innovative drugs have a certain gap, and innovative drug comparability is poor, so the time to market of nuclear price reference products need to be within a certain period of time, and generic drugs should not be used as a reference for nuclear prices.
2.2 International Reference Price Application Principles Most countries that use IRP internationally will work together with other methods to determine the payment criteria for medicines, using IRP as the basis for price adjustment.
For example, Japan uses IRP and references to compare nuclear prices to adjust prices for drugs calculated by costing methods and similar drug efficiency comparison methods;
practice, the application of international reference price needs to be considered: which countries and regions to choose, how to calculate the price standard, the scope of application of international reference price, etc.
2.3 Budget Impact Analysis Applying Principles Budget Impact Analysis is used to evaluate the impact of a new treatment drug on health finance or health care expenditures after it is incorporated into health insurance, emphasizing the affordability of health insurance funds.
Based on international experience, it is recommended in our practice: 1 Budget impact analysis is not suitable as a tool to limit reimbursement and patient access to innovative medicines, taking into account significant differences between different patients or diseases, it is not recommended to establish a clear threshold for budget impact2 Technically, budget impact analysis should follow clear operational and evaluation guidelines, regulate technical methods and data caliber 3 recommendations to take Innovative payment methods to improve drug affordability, especially for drugs with budgetary uncertainty, can reduce uncertainty by signing risk-sharing agreements between payer and enterprises 2.4 cost effect analysis application principle cost effect analysis is a drug economic method to measure the cost of drugs and produce out to determine whether drugs are economical.
results can be used to select cost-effective treatment options, promote clinical rational drug use, and control drug cost growth.
but CEA has limitations when it is used in health care negotiations for innovative drugs, and should be considered carefully when applying them.
Cost effectiveness analysis may limit or delay access to health insurance for innovative drugs for a related reason: First, the choice of reference products, some diseases of existing therapeutic drugs have usually been on the market for many years, after multiple rounds of price reductions and generic drugs, making the price of reference products very low.
Although the efficacy and safety of new drugs have improved significantly, due to the large price gap, the incremental cost-effectiveness ratio (Incremental cost effectiveness ratio, ICER) results are very high, it is difficult to fall within the threshold set by the payer;
the mere use of CEA results as a measure would limit the availability and payment of many innovative drugs.
3 renewal negotiations should maintain the original payment criteria if a number of conditions are met in accordance with international practice.
These conditions include: no significant change in the domestic market pattern of medicines, no significant changes in the prices of medicines in the original international reference market, no adjustment in the scope of payment or less impact on health insurance funds, no significant increase in the actual expenditure of health insurance funds during the agreement period than the budgetary impact submitted by enterprises before the negotiations, and significant or significant innovation in pharmaceuticals.
companies can be allowed to maintain their original payment standards if they have complementary long-term follow-up clinical trials, meta-analysis and real-world evidence to further demonstrate the clinical efficacy and safety of the drug during renewal negotiations.
4 Access to health insurance for new adaptations Is different due to differences in the clinical value of different adaptations of the same drug, as well as differences in the size and economy of the patient group, so many countries are exploring different payment standards for different adaptations under the concept of value payment, or better reflect The value of drugs in each adaptation, however, this kind of nuclear price mechanism is more cumbersome, it is necessary to develop the commodity name and medical insurance code for the different adaptations of the drug, and it is difficult to establish the whole process tracking management for patient qualification, prescription use, medical insurance reimbursement, etc.
how to make a single price reflect as much as possible the combined value of drugs in multiple adaptations is a key issue in the access of ADHD medicines to health care.
In the light of international experience, it is recommended that the payment criteria for ADHD drugs be set in a weighted and average manner, i.e., that the various adaptations of the drug be assessed against actual value and then weighted by the actual number of uses as the payment criteria for the drug.
5 risk-sharing mechanism with the accelerated access to health insurance after the launch of innovative drugs, more and more drugs have the uncertainty of efficacy and budget impact, which brings challenges to health insurance decision-making.
risk-sharing mechanism, as a new payment method that can be used in the access of innovative drugs, has been widely used worldwide to solve the "uncertainty" of new drugs in the process of access to health insurance.
on financial payments is focused on controlling budget shocks and reducing financial pressures on patients and health-care funds.
the data collection of the volume price protocol is relatively easy, and is considered to be a more operational risk-sharing method.
how to design the terms of the price agreement and the price reduction or repayment mechanism, and how to track the sales data accurately and timely, is the difficulty of the price agreement.
The relative complexity of efficacy-based payment protocols involves the measurement and analysis of efficacy data, requiring careful consideration of patient population, the setting of outcome indicators and measurement methods, as well as data tracking and payment implementation.
at the national level can choose to treat highly concentrated diseases for piloting, or allow local selection of suitable drugs to explore first.
6 Conclusion in China's innovative drug health insurance access, health technology assessment has received more and more attention and attention, and began to apply in the decision-making process, in the development process of China's health technology assessment, the international perspective can bring us a lot of inspiration, promote health insurance access policy can more reflect the value of drugs, respect innovation, but also maintain the sustainable development of health insurance funds.
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