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The biggest benefit of the national health insurance negotiations at the end of this year may be the addition of new indications
.
On October 12, the National Health Insurance Bureau replied
to the proposal of Sun Piaoyang, deputy to the National People's Congress and chairman of Hengrui Pharmaceutical, and Wang Weidong, deputy to the National People's Congress and chairman of Remegen Biopharmaceutical, on "negotiating drug renewal".
The Health Bureau noted that the response highlighted the new "simple renewal" rule
in the national health insurance negotiations this year.
This is a new rule for health insurance price negotiation introduced this year to simplify the negotiation process and improve efficiency
.
The National Health Insurance Bureau replied that it mentioned:
After "fully considering the opinions and suggestions of relevant parties", the new indications have been included in the scope of consideration of simple renewal, which is "basically the same idea"
as the proposal made by the representative.
In other words, some new indications for drugs may not need to be renegotiated, but will be directly included in medical insurance
through the "simple renewal" rule.
For varieties with new indications, this means that the price reduction will not be too large, because according to the simplified renewal procedure, the reduction may be only 25%
at most.
For example, after negotiations for new indications for BeiGene's PD-1 tislelizumab in 2021, the price reduction reached 34%.
The Health Bureau learned that Hengrui Pharmaceutical, its core product PD-1 carrelizumab, and Remegen's ADC drug vedicitumab have all declared new indications and are about to sit at the final negotiating table
.
If all varieties add new indications, they can be included in the simple renewal procedure, which is undoubtedly a major benefit to relevant enterprises
.
The biggest advantage of simple contract renewal: less price reduction
The biggest advantage of simple contract renewal: less price reduction On September 6, the National Medical Insurance Administration announced the list
of drugs that passed the review of the adjustment form of the national medical insurance catalogue in 2022.
The list shows that a total of 145 products in the catalog have passed the review, of which 57 are non-renewal, mainly
for new indications.
Before this year, these new indications also needed to go through a negotiation process
if they also wanted to be included in Medicare payments.
China Medical Insurance, a subsidiary of the National Health Insurance Administration, said in July this year that if the new indications also follow the traditional negotiation process, not only will the price be reduced significantly", but also go through complex processes such as material submission, which will cause "certain pressure on government administrative resources and enterprises"
.
Simple renewal can effectively circumvent this shortcoming
.
According to the rules previously announced by the National Medical Insurance Bureau, although simple renewal products also need to reduce prices, the proportion is relatively relaxed
.
For products that do not adjust the scope of payment, the National Medical Insurance Bureau will calculate a ratio based on the actual medical insurance expenditure and the fund budget value before the product, and use this as a basis to adjust the drug price: if the actual medical insurance expenditure is less than 110% of the predicted value ratio, the price will not be adjusted; If the ratio is between 110% and 200%, the payment standard will be lowered by
5-15%.
For products that adjust the payment scope, such as products with new indications, the rules are the same as those for products that do not adjust, but the ratio range is different and the rules are more complicated
.
According to Guojin Securities' previous calculations, the price will be reduced by up to 25%
in the new adaptation.
, up to 25% price reduction
If the new indications can also enter the national medical insurance directory with a simple renewal procedure, it is naturally very attractive
to enterprises.
During the national medical insurance negotiations in 2021, BeiGene's PD-1 tislelizumab added three indications such as non-squamous non-small cell lung cancer, and the product was reduced from 2180 yuan per bottle to 1450 yuan, and the annual fee was reduced to about 46,000 yuan, a decrease of 34%.
After being included in the simplified renewal procedure, drugs can expand the scope of reimbursement and reduce prices, and companies are willing
.
Moreover, the simple renewal also saves a lot of trouble in declaration, and only needs to go through an expert review
.
Products that meet the conditions for simple renewal can be contracted after the relevant pharmacoeconomics and medical insurance management experts calculate the corresponding reduction in payment standards
.
According to the regulations of the National Medical Insurance Bureau, the validity period of the agreement for products included in the medical insurance catalogue through the simple renewal rule is also 2 years
.
A number of star innovative drugs are expected to participate
A number of star innovative drugs are expected to participate The proposal put forward by the two NPC deputies at this year's National People's Congress and the National People's
Congress is undoubtedly forward-looking.
According to the information released by the National Medical Insurance Bureau, the core products of Hengrui Pharmaceutical and Remegen have passed the formal review
for new indications this year.
Among them, Hengrui Pharmaceutical's carrelizumab has newly declared two indications for nasopharyngeal carcinoma, and Remegen's ADC vedicitumab has declared a new indication for urothelial carcinoma
.
These new indications are not large cancers such as lung cancer, and the number of patients that can be increased will not be very large, and if they want to face a large renegotiation of price reductions, the company may not be worth the loss
when declaring.
China Medical Insurance quoted Chen Yi, a professor at the Hospital Management Research Institute of Tsinghua University, as saying that the new simple renewal rules issued by the National Medical Insurance Bureau have brought more favorable medical insurance access
to "new indications with little impact on medical insurance funds and relatively small patient numbers.
" ”
The Health Bureau noted that in addition to these two products, a number of star innovative drugs in medical insurance have been declared for new indications
this year.
The PD-1 "three tigers" were naturally fully involved: BeiGene's tislelizumab, Junshi's trepilimab, and Innovent Biologics' sindilimab each declared 1 to 2 indications
.
In addition, AstraZeneca's anti-cancer drug olaparib, Roche's breast cancer drug pertuzumab and other well-known star products are listed
.
The National Medical Insurance Administration actively explained this year's medical insurance negotiation rules before the negotiations began, which may be related
to the current domestic new drug research and development situation.
New indications are an important trend
in the current research and development of innovative drugs.
According to China Medical Insurance, as of 2021, there are 16 monoclonal antibody products with 2 or more clinical stage indications in China, and nearly 90 oncology products, accounting for about
70%-80%.
Still taking Hengrui Pharmaceutical's PD-1 as an example, the company said that as of mid-April this year, more than
10 single-agent or combination clinical studies of carrelizumab are being carried out.
In this case, it is naturally very important
to improve the access to new indications for medicine in medical insurance.
On October 12, the National Medical Insurance Bureau replied to Deputy Wang Weidong that it will continue to improve the adjustment mechanism and drug evaluation methods of the medical insurance drug catalogue in the future to ensure that the direction of drug innovation is balanced with the drug needs of insured personnel and the affordability of medical insurance funds, and more "scientifically and rationally carry out the negotiation and access work of the catalogue"
.
