New ideas for access to high-value innovative drug medical insurance under the multi-level guarantee framework

the | Ding Jinxi, Li Jiaming, Ren Yuqing China Pharmaceutical University, high-value innovative drug access difficulty continues to increase high-value innovative drugs usually refers to innovative drugs with high innovative value, can significantly extend survival time or improve the quality of life, but the treatment costs are high.
The population targeted by such drugs tends to have a large base and suffer from malignant tumors, autoimmune deficiencies and other serious diseases, with "heavy disease, good efficacy, high cost, large population" four characteristics.
china, high-value innovative drug medical insurance access is facing the problem of sustainable development.
1. Access needs are urgent for patients to incorporate high-value innovative drugs into basic health insurance.
patients with serious diseases such as malignant tumors and autoimmune diseases have a short life span and poor quality of life due to lack of effective treatment methods, while high-value innovative drugs can significantly improve the quality of life of patients and extend their lifespan.
take advanced non-small cell lung cancer as an example, the five-year survival rate of patients is less than 5%, while the first-line treatment of Paboliju monotherapy can improve the five-year survival rate to 23.2%.
high-value innovative drugs are often expensive to treat each year and are unaffordable for patients themselves.
Taking autoimmune disease treatment drugs as an example, according to the author, the eight immunologic preparations negotiated in 2020 (injection with Bellevu monoanti, sinimod tablets, hydrochloric acid fingomod capsules, injection with Vidley pearl monoanti, Ben Vimod The average annual treatment cost before admission is 106,000 yuan, which is 3.4 times the per capita disposable income (30733 yuan) in China in 2019.
2. As the health care negotiations continue to advance, the difficulty of access to high-value innovative drugs negotiations continues to increase, showing a "continuous decline in success rate" and "continuous decline" trend.
is that the success rate of negotiations is getting lower and lower.
according to official statistics, the overall success rate of negotiating drugs has fallen from 82% in 2017 to 73.46 percent in 2020, compared with less than 50 percent for only three of the seven PD-1/PD-L1 monodes that will be shortlisted for negotiations in 2020.
is a further increase in the decline in negotiations.
according to the author's statistics, the decline in negotiations on two types of high-value innovative drugs, anti-tumor drugs and immunologic agents, increased year by year from 46.76 percent and 30.59 percent in 2017 to 63.88 percent and 50.25 percent in 2019, respectively.
of high-value innovative drugs is difficult to analyze, first of all, because of its high cost, large population base, the basic health insurance fund structure has a major impact.
to the treatment of non-small cell lung cancer, for example, before the 2018 health care negotiations, the drug sales in the first three quarters of the year has reached 1.85 billion yuan, the impact on health insurance funds.
More importantly, such products usually have a greater risk of expenditure, that is, high-value innovative drugs into the health insurance after the demand-inducing effect (demand-inducing effect refers to the high-value innovative drugs into the health insurance, due to medical insurance reimbursement and price decline, further stimulate the demand for treatment, induce clinicians and patients to choose to use, resulting in the expansion of the treatment population.)
), resulting in a significant increase in the number of treatments and a rapid increase in sales, and an increase in fund spending that is likely to exceed the expectations of health care regulators.
For example, the sales of the eight anti-tumor drugs negotiated successfully in 2019 increased by an average of 209% compared to the second quarters of 2019 (data source milnet key city public hospitals chemicals - Chinese medicine terminal competition pattern).
8 anti-tumor drugs are: hydrochloric acid alethini capsules, pyrithione capsules, injectable retiquine, olapali tablets, Malay acid pyrithione tablets, patoju monoanti-injections, cyndili monoanti injections and reedcotini tablets.
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Therefore, in the absence of effective means of controlling the risk of the fund, in order to reduce the risk, the most concise way of health insurance is to negotiate to increase the decline, as far as possible to reduce the unit price, to achieve the goal of controlling the risk of the fund.
the short-term effects, negotiating significant price cuts not only effectively controls fund spending, but also increases the affordability of innovative drugs, providing good news for patients at large.
But from the perspective of long-term sustainable development, low prices make it difficult for enterprises to recover high research and development costs in the short term, and are not conducive to enterprises to maintain global market pricing strategies, thereby affecting the sustainability of innovation, resulting in the slow listing of high-value innovative drugs in China, and ultimately affecting the access of patients.
To PD-1 single resistance as an example, from the global price level, PD-1 single anti-health insurance pricing is higher, Navuliyu single-resistance and Pabli pearl single resistance in the United Kingdom, Germany, Canada, Japan, South Korea five countries annual treatment costs of about 650,000 yuan (price data sources in the United Kingdom, Germany, Canada, Japan and South Korea official website, and consider the exchange rate, tax rate factors into Chinese prices).
), while China's health care pricing is much lower than the international level, in 2019 the negotiation access of the letter Dili single anti-annual treatment costs 986,000 yuan, in 2020 negotiated access to the Karelli pearl monoanti, for the reilly pearl single anti-terrier treatment costs are lower.
2. The operability of the price-sharing agreement in China From the international experience, controlling the risk of high-value innovative drug funds, in addition to negotiating the reduction of unit price, is more the use of price-volume agreement (Price-volume Agreement, PVA) to control the risk of a sharp increase in sales after the inclusion of health insurance.
statistics, in 2013 the use of EU countries' price agreements has reached 39.2%.
the extraterritory implementation of the key price agreement refers to the access of medical insurance, the medical insurance department and enterprises through the budget impact analysis (BIA) measurement results, to determine the high-value innovative drugs of the health insurance fund expenditure ceiling as a risk point.
cost of medicines that exceed the risk point will be shared by the business.
cost-sharing methods are mainly the following two: First, enterprises to the health care sector refund.
example, in 2008, Taiwan's regional health insurance sector signed a volume-price agreement with enterprises, with an agreed risk point of T$200 million.
the actual fund expenditure exceeded the risk point, the company returned T$1.5247 million to the health care department.
, the health-care sector lowered the payment standard.
, for example, sweden's health-care sector signed a price agreement in 2016 for lynamamine (risk point confidentiality).
As of April 2017, the Swedish health insurance department calculated that the cumulative fund expenditure for that amine was 297,93 million kronor, exceeding the risk point, so it negotiated with the enterprise to reduce the standard of payment for the health insurance payment for that amine by 5% in the future.
, price agreements are a global trend to control the risk of access to high-value innovative drugs.
, can the volume price agreement be implemented in our country? From the extraterriter experience of China's implementation obstacles, how to deal with drug costs beyond the risk point is a key link in the implementation of the volume price agreement.
, under the existing medical insurance management system in China, there are certain obstacles to the implementation of the above two ways of sharing.
"Two lines of income and expenditure", enterprises can not directly refund medical insurance since 2018, the General Office of the Central Committee of the Communist Party of China, the General Office of the State Council issued the "national tax land tax collection and management system reform program", China's basic medical insurance fee financing has been handed over to the tax department unified collection, and the health insurance department is only responsible for the settlement and use of the health insurance fund, that is, "two lines of income and expenditure."
background, the health care sector itself does not have the capacity to charge fees, can not directly charge corporate refunds.
the same time, China's medical insurance directory development level and fund payment co-ordination level is not unified.
catalogue is the national health insurance sector, which has the right to enter into agreements with enterprises on access to and volume of health insurance, but the actual payer is the regional health insurance sector.
Therefore, if the national health insurance department for a high-value innovative drugs unified signed a volume price agreement, when the actual national sales of drugs accumulated above the expected sales ceiling, due to the co-ordination areas of the fund expenditure amount and proportion are not consistent, it is not possible to determine which co-ordination area should be returned excess costs.
adjustment of payment standards, resulting in unfair insurance benefits compared to corporate refund methods, adjustment of drug payment standards is easy to operate, but will lead to unstable payment price system.
Suppose a drug A maintains the original price if the fund expenditure does not exceed the risk point in the first payment standard adjustment cycle, the payment standard is lowered if the expenditure exceeds the risk point in the second cycle, and the payment standard returns to the original level of the payment point that does not exceed the risk point in the third cycle, which causes the payment standard to fluctuate up and down.
of drug payment standards will lead to two problems, one is that it may lead to confusion in the settlement of co-ordination areas, and the other is that it will lead to unfair payments between patients.
because patients settle their out-of-the-money expenses according to the Medicare payment standard, patients at different payment standard levels have different out-of-payment amounts at different times, leading to unfairness.
2020, the Cpc Central Committee and the State Council on Deepening the Reform of the Medical Security System put forward "promoting the development of the multi-level medical security system" and "accelerating the development of commercial health insurance".
The author suggests that the introduction of commercial health insurance can be explored in the volume price agreement, and basic medical insurance to form a multi-level security system, through the "risk sharing, co-payment, one-stop settlement" mechanism to play the implementation of the price agreement obstacles, for high-value innovative drug medical insurance access to provide a new model in China.
the establishment of a multi-level security system, sharing the fund risk high-value innovative drug fund actual expenditure exceeds the risk point, the basic medical insurance will no longer be paid, transferred to commercial insurance.
Operative process is as follows: the establishment of a three-level settlement system to build", drug patients, pharmaceutical institutions, medical insurance agencies, commercial insurance companies and pharmaceutical enterprises" five-way link of the Internet one-stop settlement system, the establishment of a "three-tier settlement system", is conducive to improve the convenience of patient settlement, reduce the burden of patient advance payment.
first-level settlement: drug patients and pharmaceutical institutions immediately settlement.
patients to buy drugs, according to the local health insurance reimbursement policy, only to the pharmaceutical institutions to settle personal out-of-the-money expenses, health insurance payments are paid by the pharmaceutical institutions in advance.
second-level settlement: pharmaceutical institutions and medical insurance business / commercial insurance companies monthly settlement.
When the cumulative fund expenditure of the drug does not exceed the risk point of the fund expenditure, the pharmaceutical institution shall settle with the medical insurance agency, and when the cumulative fund expenditure exceeds the risk point, the medical insurance agency shall stop the settlement and transfer it to the commercial insurance company and the pharmaceutical institution for settlement.
this is a key link in the three-tier settlement system.
third-level settlement: pharmaceutical institutions and pharmaceutical enterprises on a quarterly settlement.
pharmaceutical institutions receive the settlement fees of the medical insurance business/commercial insurance company, and settle the rebates with the pharmaceutical enterprises on a quarterly period.
in the second-level settlement system, how to divide and transform the payment responsibility of medical insurance and commercial insurance: First, establish a monitoring mechanism for the risk of fund expenditure, and monitor and judge whether the cumulative fund expenditure of drugs reaches the risk point agreed upon in the volume price agreement.
order to improve the efficiency of monitoring, an expenditure monitoring center and a fund expenditure reporting system can be established by variety for high-value innovative drugs signed by volume price agreement on the basis of the national medical insurance information management platform.
the medical institutions (medical institutions/social pharmacies) in the overall areas shall report the data on the amount of drug reimbursement to the National Monitoring Center in real time, and the monitoring centers shall summarize the data of each region to obtain the data on the cumulative expenditure of drugs throughout the country.
When the cumulative expenditure of the drug accumulation fund does not reach the risk point, the settlement port of the medical insurance organizations in each co-ordination area shall be open normally, and the payment expenses for medical insurance shall be settled by the basic medical insurance to the medical institutions, and when the cumulative expenditure exceeds the risk point, the monitoring center shall promptly feedback the medical insurance operating institutions in the co-ordination areas, close the settlement port of the basic medical insurance and no longer pay.
the original medical insurance payment part of the commercial health insurance to assume claims liability, and to the pharmaceutical institutions to pay.
design of new products, connecting multi-level protection of the new model at present, domestic commercial insurance companies have not yet developed for the volume price risk-sharing agreement of commercial insurance products.
combined with international experience and the development trend of China's commercial health insurance, the author suggests that we can explore the "exclusive insurance" designer insurance products.
exclusive insurance refers to the enterprise and commercial insurance companies in consultation, specifically for its production of high-value innovative drugs "tailor-made" a commercial insurance products.
insurance to the production enterprise as the insured, drug patients as the insured, and limit the conditions for claims.
First, a specific patient, the patient needs to use the product insured by the policyholder;
are indispensable to all three conditions mentioned above.
design of exclusive insurance, and China's existing commercial health insurance products there are certain differences, medical insurance management departments, commercial insurance companies, patients and pharmaceutical enterprises to participate in the joint design, in order to achieve the new goal of multi-level protection.
, the conclusion of high-value innovative drugs due to high prices, treatment population base, its fund expenditure risk is high.
this is the main reason for the "continued decline" and "increasing decline" in health care access negotiations.
long term, this will have a negative impact on the motivation of innovation and the accessability of innovative drugs.
suggested the design of new commercial health insurance products, the establishment of a multi-level security system, so as to implement the price agreement in China, commercial insurance and basic medical insurance to share the risk of drug overdress, in order to effectively improve the success rate of high-value innovative drug medical insurance access, under the premise of ensuring the sustainability of the fund, to meet the growing clinical new needs of patients.