Hu Shanlian, MD, Professor of Health Economics, School of Public Health, Fudan University, Shanghai, China
At present, there are many innovative payment mechanisms for innovative medical technologies or pharmaceutical products, such as the "annuity system" method of installment payment and the "risk sharing" payment mechanism. To improve the accessibility and affordability of new drugs for patients, balance the pressure of medical insurance funds and the innovation of the pharmaceutical industry, the reform of drug payment methods is imminent.
The flexible pricing model of the "risk sharing contract" provides a reference for the establishment of a value-based innovative drug evaluation system in China. However, due to the non-disclosure agreements and complexities of risk-sharing contracts, although they are rapidly developing globally and in the Asia Pacific region, their sustainability is still unclear.
This article mainly introduces the progress and implementation of the international "risk sharing contract” and discusses the possible problems in the implementation process.
Yang Shanshi and others from the Shanghai Health Development Research Center searched the PubMed and Web of Science databases from 2000 to 2021, using the risk sharing contract as the key word, and found that the number of reported documents showed an increasing trend year by year from 300 in 2000 to 1,600 in 2021. Among them, the top three countries with the most citations are the United States (3902), China (2707) and India (1479). Although China has not really implemented the reform of the medical insurance drug risk sharing contract payment system so far, the increase in the number of documents shows the degree of concern for the payment system reform.
The implementation of risk sharing contracts can solve the uncertainty of the clinical treatment effect and budget impact of new drugs, and the medical insurance department only needs to pay the cost of new drugs for patients who are successfully treated. Therefore, in general, this model improves treatment efficiency, provides a new reimbursement option for medical insurance payers, and promotes the rapid clinical use of new drugs.
Two Types of Contracts
There are two main types of risk sharing contracts. One type is a performance-based risk sharing contract, including three models: one is to decide whether to reimburse and compensate at the end according to the effect of real-world clinical treatment, which is mainly implemented in the United States, Australia, the Netherlands and other countries; the other is to contact by performance. The medical insurance department only pays and compensates patients who have curative effects; the third is to determine whether to adopt the conditional continuation of treatment mode according to the intermediate indicators and end-point indicators.
There is another type of cost-sharing contract, which is mainly implemented in Italy, Estonia, Sweden, Belgium, Hungary, and Portugal. There are four main types: the first is the maximum budget cap; the second is the cap on the service volume; the third is the volume price agreement to determine the price level according to the purchase volume; the fourth is the drug discount, which can be fixed discount or variable discount.
Implementation by Country
Given the complexity of implementing risk-sharing contracts, a holistic approach to research design, implementation, evaluation, and governance needs to be considered. Establishment of a multidisciplinary team and development of risk-sharing contract guidelines requires an objective, measurable clinical outcome measure. It is also necessary to plan a set of clinical data collection and analysis methods in advance to make decisions on the pricing and budget impact of new drugs in the future.
Given the complexity of implementing risk-sharing contracts, a holistic approach to research design, implementation, evaluation, and governance needs to be considered. Establishment of a multidisciplinary team and development of risk-sharing contract guidelines requires an objective, measurable clinical outcome measure. It is also necessary to plan a set of clinical data collection and analysis methods in advance to make decisions on the pricing and cost budget of new drugs in the future.
Carison and Garrison, two professors in the United States, used the PBRSA database of the University of Washington to analyze the implementation of risk sharing contracts in countries around the world from 1993 to 2016. A total of 437 projects were implemented, but only 42% of the projects were still in progress at that time, and they are divided into five types.
Italy has implemented risk-sharing contracts since June 2006. Three models have been implemented, namely, cost-sharing, risk-sharing (only partial compensation for patients with no therapeutic effect) and payment according to performance results, but in the end only 5% of the total drug fees are refunded. In the management, the cost of project implementation and maintenance, the time cost of the hospital, the consultation fee of the pharmacist, the need to establish a database of efficacy and safety, etc., so the total management cost is relatively high.
Guarga conducted a retrospective analysis of the status of 15 projects implementing risk sharing in the Catalonia region of Spain between 2016 and 2019 and found that only 10 projects were still under implementation. Diseases treated under the performance-linked compensation model include colorectal cancer, breast cancer, melanoma, and multiple sclerosis; diseases treated under the cost-sharing model include rare diseases such as lung cancer, melanoma, and multiple sclerosis.
It has been reported in the literature that the final success rate of different diseases according to the performance compensation model is different, breast cancer is as high as 94%, colorectal cancer is 72%, melanoma is 61%, multiple sclerosis is only 40%, and urothelial cell carcinoma has only a 13% success rate.
Among Asian countries, South Korea was the first one to legislate and implement risk-sharing contracts for 42 drugs in 2014, half of which (21) were capped on the total cost, and another 12 (28.6%) used cost refund for patients who did not respond to treatment (refund) mode. There are also 24 drugs that do not need to carry out cost-effectiveness analysis, the purpose is to improve the accessibility of new drugs to patients.
Risk-sharing contractual agreements have been widely used in the process of drug reimbursement for antineoplastic drugs and treatments for rare diseases as a major means of improving drug accessibility for patients. Although the compensation model of risk sharing contracts has not yet been formally implemented in the implementation of Chinese medical insurance, it is not impossible to carry out exploratory pilot projects in the future. It must be noted that the management cost of this payment method is relatively high, but it is also true that it can improve the accessibility of new drugs, which is conductive to promoting the implementation of new drug compensation.
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