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a new round of adjustments to the medical insurance catalogue is already underway.

recently, the national healthcare security administration officially announced the "list of drugs applied for the adjustment of the national basic medical insurance, work-related injury insurance and maternity insurance drug catalog in 2024 that passed the formal review". after review, a total of 445 drugs passed the formal review, of which 249 drugs were drugs outside the medical insurance catalog.

however, the fact that a drug has passed the formal review does not mean that it can then go directly to the medical insurance negotiation table.

the national medical insurance administration said that passing the formal review only means that the drug meets the corresponding application conditions and is qualified to participate in the next step of the review. only drugs that pass all the links such as review and negotiation can be finally included in the catalog.

among the drugs that have passed the formal review this time, there are both "new faces", that is, new drugs that were just approved for marketing in the first half of this year, and "old faces", that is, drugs that have previously failed in medical insurance negotiations. what do pharmaceutical companies expect from participating in medical insurance negotiations this time?

since 2017, medical insurance negotiations have become an important way to adjust the medical insurance drug catalog, and a dynamic adjustment mechanism has been adopted since 2020. in the past two years, the national medical insurance administration has optimized the rules for negotiation and renewal. in 2023, it was proposed that negotiated drugs that have been in the catalog for 8 years can be included in the regular catalog management, and the scope of renegotiation was refined. looking back at the drugs that participated in medical insurance negotiations in the past, they all faced a round of major price cuts, but it was also a process of seeking "price for volume". according to the compilation of the zhongkang industry research institute, from 2019 to 2023, the average annual decline in medical insurance negotiations has been above 56%.

zhang xiaolin, founder, chairman and ceo of digene pharmaceuticals, told the first financial reporter that two of the company's innovative drugs have been included in the formal review list. the company will actively promote the two commercial products to enter the medical insurance. if both are included in the medical insurance, it will greatly improve the accessibility of the drugs, accelerate the rapid sales of the two products, and also enhance the company's self-generating ability and realize the turnaround of losses into profits as soon as possible.

the two drugs involved in this case by digene pharmaceuticals (688192.sh) are suvotinib, a non-small cell lung cancer drug launched in august last year, and golixitinib, a lymphoma drug approved for marketing in june this year. as the world's first and only highly selective jak1 inhibitor in the field of lymphoma, golixitinib has broken the situation of no innovative drugs for relapsed and refractory peripheral t-cell lymphoma (ptcl) for ten years.

the semi-annual report shows that thanks to the increase in sales of its core product suvotinib, digene pharmaceuticals achieved a total operating income of 204 million yuan in the first half of this year.

"at present, before suvotinib and golixitinib are included in the medical insurance, product sales rely mainly on the self-paid market. self-paid products are mainly sold through dtp pharmacies outside the hospital." wu qingyi, deputy general manager and chief business officer of digene pharmaceuticals, said that the company hopes to include them in the medical insurance at a reasonable price through negotiations to achieve a win-win situation for patients, medical insurance funds, enterprises and other parties.

"we hope that medical insurance policies can encourage innovative drugs with real clinical value to enter the market as early as possible and obtain commercial returns to support r&d innovation," zhang xiaolin also said.

at the interim performance exchange meeting of kangfang biopharma (09926.hk), kangfang biopharma chairman xia yu said that the company's two bispecific antibody products will participate in medical insurance negotiations for the first time in the second half of the year, and look forward to a win-win result.

among the two bispecific antibody products involved in kangfang bio, one is also used for the treatment of non-small cell lung cancer, namely, ivoside, which is a new drug approved for marketing in the first half of this year.

car-t drugs are a typical example of drugs that have failed to pass the medical insurance negotiations many times in the past. take fosun pharma (600196.sh, 02196.hk)'s car-t drug akilencel injection as an example. it has also passed this formal review. this is the fourth time that the drug has tried to pass the medical insurance negotiations. the previous three times were restricted by the medical insurance negotiation rule of "no negotiation for 500,000 yuan, no entry for 300,000 yuan", and finally failed to get to the negotiation table.

it is worth mentioning that this year, along with akilenbine injection, there are three other car-t drugs on the list of drugs that have passed formal review.

for car-t products with treatment costs of millions of yuan, what are the chances of them being included in the medical insurance catalogue?

at the fosun healthcare interim performance exchange meeting, wu yifang, chairman of fosun pharma, responded to the media including caixin, saying: "i have been looking forward to the inclusion of car-t therapy in medical insurance for a long time, and i firmly believe that car-t therapy should be included in medical insurance. this product has indeed brought value to patients."

however, wu yifang also said that the company's car-t products have been on the market for four years, but the cost cannot be reduced at this stage. "if the price given by the medical insurance is to make the company lose money, this is unbearable for any company. at present, we still need to solve the problem of car-t products entering the medical insurance through innovative payment methods, and we also hope to have the opportunity to communicate."