The million-yuan expensive drugs "rejected" by the medical insurance have finally got the opportunity for commercial insurance negotiation.
Article by | Hu Xiangyun
Edited by | Hai Ruojing
Starting from October 30th, the annual National Medical Insurance Negotiation ("National Negotiation") is being held at the National People's Congress Conference Center in Beijing. The negotiation period is longer than in previous years, lasting about 4 - 5 days.
In the late autumn of Beijing, most representatives of pharmaceutical companies participating in the negotiation remained silent when questioned by the media outside the venue. "The confidentiality requirements within the negotiation are very strict." However, the occasional smiles on the representatives' faces often indicate a favorable negotiation outcome.
On the first day of the negotiation, the focus was mainly on generic drugs, such as anti - infective and anesthetic analgesic drugs. More attention - grabbing innovative drugs, represented by oncology drugs, are scheduled for today and tomorrow. Different from previous years, the biggest change in this year's medical insurance negotiation is the newly established "Commercial Insurance Innovative Drug Catalog".
36Kr has learned that the price negotiation for the Commercial Insurance Innovative Drug Catalog may start on November 1st.
The so - called Commercial Insurance Innovative Drug Catalog was initially known as the "Class C Medical Insurance". It is a catalog newly added by the National Healthcare Security Administration this year to ease the payment contradiction of high - priced new drugs. It mainly targets innovative drugs that are expensive and usually difficult to be included in the basic medical insurance catalog (commonly known as "Class A" and "Class B" medical insurance) as individuals have to pay out - of - pocket.
Similar to the adjustment of the basic medical insurance catalog, the confirmation of the Commercial Insurance Innovative Drug Catalog also goes through multiple stages, including enterprise application, formal review, expert evaluation, negotiation / bidding / price consultation, etc. In August, the National Healthcare Security Administration announced 121 application drugs that passed the formal review, mainly high - priced oncology drugs and drugs for rare diseases. The expert evaluation work ended at the end of September. After multiple rounds of voting by members from various parties, including clinical, insurance companies, universities, and third - party service institutions, less than 30 drugs remained in the "game".
The "price consultation" stage starting tomorrow is the key for these "pioneering" products to finally enter the first batch of the Commercial Insurance Innovative Drug Catalog.
It is understood that in previous years, the average price reduction of drugs in the "National Negotiation" that entered the basic medical insurance catalog was between 50% - 60%. However, since the impact of entering the Commercial Insurance Innovative Drug Catalog on drug sales volume is unknown, pharmaceutical companies may be less willing to make concessions.
"We think the price reduction will be lower than that in the 'National Negotiation', perhaps between 10% - 30%." an insurance practitioner mentioned.
Commercial insurance shows preference for "first - class new drugs",
Five CAR - T therapies are about to participate in price negotiation
Compared with the basic medical insurance catalog, there are more requirements for applying to the Commercial Insurance Innovative Drug Catalog. The drugs must be newly launched within 5 years or drugs for rare diseases, and information on being included in the people - friendly medical insurance or other commercial health insurance, such as price / discount and compensation information, must be provided.
It is worth mentioning that according to the regulations of the National Healthcare Security Administration, if a drug meets the requirements, it can apply for both the medical insurance and commercial insurance negotiations, following the order of "negotiating for the basic medical insurance first, then participating in the commercial insurance price consultation". This gives the products participating in the negotiation of the Commercial Insurance Innovative Drug Catalog another chance.
Therefore, a total of 79 new drugs applied for both the basic medical insurance catalog and the Commercial Insurance Innovative Drug Catalog this year.
A person who participated in the expert evaluation stage of the Commercial Insurance Innovative Drug Catalog previously said that the overall design concept and rules of this year's Commercial Insurance Innovative Drug Catalog are relatively open. Although the number of selected varieties is relatively small, the coverage of diseases is wide, including multiple types of tumors, metabolic diseases, and rare diseases.
"There is a preference for several types of products, such as first - class new drugs with high innovation, definite curative effects, and strong patient benefits, as well as products that have been included in local people - friendly medical insurance and commercial health insurance. I think there is an idea of not wanting patients to stop taking the drugs."
In terms of varieties, except for Ciltacabtagene Autoleucel of Legend Biotech, the other five approved CAR - T therapies that meet the regulations have applied for the Commercial Insurance Innovative Drug Catalog. Among them, the products of Heyuan Biotech, Reindeer Biotech, and Kaixing Life Science and Technology are "dual - applicants". In the expert evaluation stage, these five CAR - T therapies also "passed 100%" and are about to enter the "price negotiation" table.
Illustration of five CAR - T therapies applying for the Commercial Insurance Innovative Drug Catalog
It can be said that CAR - T is the most representative type of product in the "entangled past" between high - priced innovative drugs and the national medical insurance. Their annual treatment costs reach one million yuan. Even after maximizing various types of reimbursements, patients still have to pay out - of - pocket more than 350,000 yuan.
Previously, CAR - T products had tried multiple times to enter the basic medical insurance catalog, but all attempts failed. Under the potential framework of "not negotiating for drugs over 500,000 yuan and not including drugs over 300,000 yuan" in the basic medical insurance catalog, many high - priced innovative oncology drugs and drugs for rare diseases, represented by CAR - T, are difficult to be selected, resulting in difficulties in hospital admission and commercialization.
The Commercial Insurance Innovative Drug Catalog plan aims to give these "once - hopeless drugs a new hope".
It should be noted that this hope is not like the direct "trading price for volume" preferential treatment in the basic medical insurance catalog. It is more like an attempt of "trading price for policy".
First of all, the overall scale of commercial insurance in China is not large. Even for the people - friendly medical insurance strongly supported by government departments in the past two years, the current insured population basically remains at around 300 million. Some products once faced the risk of "excessive compensation". If new insurance products are designed with the Commercial Insurance Innovative Drug Catalog as the core, it is still difficult to predict how much the sales volume can increase.
Many interviewees believe that pharmaceutical companies are more interested in the policy "commitment" behind the Commercial Insurance Innovative Drug Catalog plan.
Previously, the National Healthcare Security Administration has clearly stated that it will provide "three exemptions" support for drugs included in the Commercial Insurance Innovative Drug Catalog, that is, they will not be included in the self - payment rate indicator of the basic medical insurance, not included in the detection of substitutable drugs selected in the centralized procurement, and the application cases of innovative drugs within the scope of relevant commercial insurance will not be included in the scope of disease - based payment.
This is equivalent to opening a gap in the current DRG/DIP (Diagnosis - Related Groups/ Disease - Based Score) policy that pharmaceutical companies are most concerned about, providing more space for the payment of high - priced innovative drugs.
"Hospital sales are attractive to many pharmaceutical companies, especially for surgical or inpatient drugs. First, under the current policies, the procurement of many off - hospital drugs is restricted. Second, even for off - hospital drug purchases, some are restricted by DRG assessment. Therefore, the industry pays high attention to this catalog, and many pharmaceutical companies have made the negotiation work for this catalog a key task in the second half of the year." At the 14th China Rare Disease Summit Forum recently, Yu Jingyi, the general manager of the pharmaceutical business department of Chenxi Health, explained to 36Kr. Chenxi Health is a health management and comprehensive patient service platform under Sinopharm Group and once assisted Fosun Kite's CAR - T to launch a "payment - by - efficacy plan".
Meanwhile, including "star products" like CAR - T is also what insurance companies expect. Because commercial insurance is essentially a supplementary health consumer product, and star products have an advertising effect, which helps to attract more insured people for insurance companies.
This can also be seen from the formal review list previously released by the National Healthcare Security Administration. Among the 121 drugs, many are popular varieties in the industrial investment field, including 8 PD - (L) 1 drugs, 3 ADC products from overseas companies, as well as nuclear drugs and influenza vaccines. In terms of indications, in addition to tumors, they also cover weight loss, autoimmune diseases, neurological diseases, etc.
Pharmaceutical companies: More concerned about how the catalog will be implemented and how strong the constraints are
The issue of innovative drug payment has been discussed for many years, and the industry has reached a consensus that the payment for high - priced drugs must rely on diversified means, that is, multiple subjects sharing the burden and multi - level protection.
"We hope people realize that drug pricing is not for individual patients but should be collective and shared by society." an enterprise person whose product passed the expert evaluation stage of the Commercial Insurance Innovative Drug Catalog mentioned.
At the National Medical Insurance Work Conference at the end of last year, the National Healthcare Security Administration mentioned the importance of developing commercial health insurance several times. In addition to the national medical insurance, different methods such as critical illness insurance, special funds, and charitable donations should also actively participate to provide possibilities for the payment of high - priced innovative drugs.
Now, this is also the reason why the Commercial Insurance Innovative Drug Catalog is highly anticipated. However, since it is still uncertain how the catalog will be implemented, pharmaceutical companies and insurance companies still have some concerns.
"Highly concerned about the list and waiting to see the result." the aforementioned insurance practitioner summarized.
People outside the industry often think that the disagreement lies in whether insurance companies are willing to "pay the bill", but this is not the case. "Commercial insurance companies as payers are willing to bear this part of the cost because they have already paid for a large number of innovative drugs in various products such as the people - friendly medical insurance, and it is unlikely that they will cut this budget in the future. Now, if the National Healthcare Security Administration is willing to provide price discounts, there is no problem from the perspective of claims cost control for them." Yu Jingyi said.
In contrast, designing an implementation plan that satisfies government departments such as the medical insurance and the financial regulatory authority, as well as executive institutions such as insurance companies, pharmaceutical companies, and hospitals, may be a greater challenge. For example, do insurance companies have the autonomy to choose which drugs to include in the catalog? Which government department will be responsible for the supervision during the implementation of the catalog? Pharmaceutical companies are willing to offer discounts, but to whom should the discounted money go? These details remain to be discussed.
The aforementioned expert who participated in the evaluation believes that during this process, the medical insurance department may hope that insurance companies can play a greater role. "They hope that 'commercial insurance can keep up with the development of innovative drugs more quickly'."
It is reported that in the operation of current commercial insurance products, they often "passively execute". For example, the design of compensation clauses is relatively straightforward, lacking pre - conditions and conditional settings.
"If this catalog can prompt commercial insurance to make more adjustments to the management system and product design around these products, such as setting its own medication path guidelines and requiring a certain test before compensating for a certain drug. While supporting the payment of innovative drugs, it can also move the commercial insurance checkpoint forward and promote the development of commercial insurance." the aforementioned expert who participated in the evaluation said.
On the other hand, this may also mean that the Commercial Insurance Innovative Drug Catalog can play a transitional and connecting role. For example, innovative drugs can first enter the commercial insurance catalog for a period of time to accumulate certain real - world data, and then be considered for inclusion in the Class B catalog of the basic medical insurance.