Pay according to the curative effect, less than the expected maximum refund of 600,000, there is a new solution to the million CAR-T payment?

Text: Hu Xiangyun

Edited by Hai Ruojing

CAR-T has "cut in price".

On January 11, 36Kr learned from Fosun Kite that the company plans to cooperate with Chenxi Health, a subsidiary of Sinopharm, to launch a new payment method for CAR-T therapy, that is, "pay according to efficacy", and eligible patients will be refunded 50% of the reimbursement of the amount of the drug purchased at their own expense, up to 600,000 yuan, if they fail to achieve complete remission (CR) after purchasing the drug and infusing it back for 3 months for efficacy evaluation.

At present, a total of 4 domestic CAR-T drugs have been approved in China, respectively from Fosun Kite, WuXi Biologics, Junuo, IASO Biologics and Heyuan Biotech, with prices ranging from 999,000 yuan to 1.2 million yuan. Although CAR-T products are common in the claims list of various commercial insurance and urban Huimin Insurance, the difficulty of payment is still the top problem for its market expansion, due to the different payment standards and the high original price of the product.

The method of payment according to the curative effect is equivalent to digging a hole in the unshakable "million" threshold in the past. "The price paid by patients is adjusted according to different values, and at the same time, with the blessing of Huimin Insurance, the absolute value of the patient's out-of-pocket ratio is getting smaller and smaller. Fosun Kite explained.

Jin Chunlin, director of the Shanghai Health and Health Development Research Center, told 36Kr that the role of innovative payment methods is particularly important when the national medical insurance cannot pay for "sky-high drugs". Taking efficacy as the criterion is equivalent to a "gamble" between enterprises and patients, which can not only stimulate enterprises to continuously improve efficacy in product development, but also prevent "indiscriminate drug use" on the supply side.

Reducing the "absolute value" of out-of-pocket costs for patients

The first core of the treatment payment method is whether the "CR" is achieved.

According to Fosun Kite, according to the more than 13,000 cases of treatment after the world's first launch in 2017, the CR efficacy at 3 months of treatment has a "strong correlation" with indicators such as overall survival (OS) in the later stage, which can provide a reference for both doctors and patients to make next treatment decisions. The evaluation method is the internationally accepted Lugano performance standard.

Qi Yuanyuan, head of Fosun Kite's project, said that the biggest consideration is "the actual payment of Chinese patients", and it also combines the cost and pharmacoeconomic considerations of enterprises.

In addition, considering the increasingly developed financial products and continuous improvement of the ability of patient-funded expenses in the past two years, Fosun Kite and Chenxi Health have not yet considered providing a plan to provide patient installment payment.

The application of CAR-T therapy can be roughly divided into three steps: appropriate T cells are removed from the patient's body, genetically modified and cultured in vitro, and finally a large number of cultured CAR-T cells are infused back into the patient. According to the rules of the project, the patient's payment is divided into two stages, the first payment of 600,000 yuan for the first order, and the payment of 600,000 yuan for reinfusion after the completion of apheresis. After 3 months of the value-for-treatment plan, if a complete response (CR) is not achieved, the company will receive a refund of up to RMB 600,000. This payment plan according to the value of efficacy can be superimposed on other Huimin Insurance and commercial insurance.

Wang Zhengyu, deputy general manager of the Sinopharm Innovation Center, said for example, according to the plan, if the target of complete remission is not reached within 3 months, or if there is a curative effect but the efficacy does not reach such a good remission, half of the patient's self-paid drug purchase price will still be refunded. If the patient is completely self-paid, he will be refunded up to 600,000 yuan, and if the patient has participated in other insurance, such as the Shanghai medical supplementary insurance "Shanghai Huibao", which can pay 500,000 yuan, if the insurance pays 700,000 yuan, he will receive half of the refund, that is, 350,000 yuan.

It is worth mentioning that at the end of June last year, "Yikaida" added a new front-line indication, which was approved for the treatment of adult large B-cell lymphoma that failed to respond to first-line immunochemotherapy or recurred within 12 months after first-line immunochemotherapy. In the case of the expansion of the applicable group, how to allow more patients to "pay" for their own CAR-T may also be the reason why Fosun Kite promoted this treatment payment plan.

However, Fosun Kite did not respond positively to the approximate proportion of patients who participate in the value-for-treatment plan and need to be refunded if they do not meet the CR, and how many new patients are expected to be brought by this method, but mentioned that there are 80,000 new lymphoma patients in China every year, and more than 600 patients have used "Yikaida" in China so far. With the new batch of front-line indications, the expansion of the applicable patient scale, and the launch of new payment methods, "it is expected to benefit more patients".

Pay for efficacy, or conversely raise the standard of medication for doctors

In fact, the "efficacy insurance" approach is not the first of its kind in the medical industry. In 2017, Novartis had a pay-as-you-go pricing plan for its CAR-T product, Kymriah (priced at $475,000 at the time), but there has been no new development since then.

If the big pharma didn't do it at the beginning, would this method really effectively solve some of the problem of paying for high-priced drugs in China?

Qi Yuanyuan said frankly that globally, paying for high-value products according to the therapeutic value is a relatively common method, but it is not popular in China. First of all, there is no good database in China to support the calculation of drugs to pay according to the value of efficacy. The basis for the establishment of this method in CAR-T therapy lies in the individualized characteristics that can clearly observe the progress of each patient's efficacy and provide data support, and secondly, whether there are sufficient objective evaluation criteria for specific diseases.

"Taking lymphoma targeted by 'Yikaida' as an example, Lugano is a standard recognized by global experts, and its core lies in PET-CT scanning, unlike many diseases that can only judge disease remission through scales and blood tests. Therefore, the standardization of imaging tests for lymphoma makes it possible to implement the value of treatment payment. ”

Wang Pei, an associate professor at Fudan University's School of Public Health, believes that in terms of mechanism, CAR-T cell therapy is a "major mechanism innovation" compared with previous immunology and chemotherapy, and it is theoretically possible to achieve a complete cure. Therefore, in terms of data, as long as such a product is supported by data, the longer it takes to market, the more confident the company may be to try the pay-for-value model.

Jin Chunlin agrees with this innovative payment model. He introduced to 36Kr that according to the current hidden threshold of "500,000 do not enter, 300,000 do not talk", the market has gradually recognized that the hope of cell therapy represented by CAR-T or high-priced products such as rare disease drugs entering the national medical insurance is "relatively slim", and the importance of innovative payment methods is constantly highlighted.

"There are two main uncertainties about innovative drugs, namely the uncertainty of efficacy and the economic uncertainty caused by the indefinite number of patients. In this case, when faced with the issue of payment, the innovative payment method of pay-for-effect is equivalent to providing a kind of "bet". For example, if your CAR-T cells are effective, they will be paid for 1.2 million yuan, and if they are invalid, they will be refunded in half. This can reverse stimulate the enterprise to improve the efficacy, and at the same time, it can also prevent the doctor on the supply side from indiscriminately using drugs during treatment, which is a good way. Jin Chunlin explained.