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"The weather was nice today and friendly to the business we came to negotiate
, hoping that the price reduction will be as mild as the weather
.
On January 5, 2023, a representative of a pharmaceutical company at the entrance of the National People's Congress Conference Center smiled heartily with those who traveled with him
.
.
”
The most lively thing in the innovative drug industry every year is the annual medical insurance negotiation work since the establishment of the Health Insurance Bureau in 2018
.
Last year, "normalized negotiations" was mentioned many times, but due to the epidemic and other reasons, the negotiations in 2022 have been delayed until the end of the solar calendar
.
Medical insurance is an important way for pharmaceutical companies to improve the accessibility of products, and it is also one of the important tools for the
state to protect people's livelihood and ensure medical treatment.
The medical insurance catalogue determines the competition pattern of similar varieties and even the same therapeutic field, and is also a vane
for the top level of medicine, an industry with strong "policy-oriented" attributes.
After the huge decline in the prosperity of the innovative drug industry in 2022, this year's medical insurance negotiations are particularly important
.
Although the confidentiality of this year's medical insurance negotiations was stricter than in previous years, from the feedback from negotiators on the first day, the negotiations also seemed to be a timely change from the huge price reduction in previous years
.
After the industry has suffered countless shocks in the past three years due to the pandemic, it is indeed necessary for policies to give various innovative pharmaceutical companies a certain amount of room
for relaxation.
-01-Medical insurance negotiation of all living beings
-01-Medical insurance negotiation of all living beingsToday is the first day
of negotiations on the 2022 National Medical Insurance Drug List.
In the morning, it was still cold and windy, but in the afternoon, it became brighter, and the representatives of the company were more lively
.
The medical insurance negotiation venue returned to the National People's Congress Conference Center, and representatives of enterprises, securities analysts, and media reporters who came to attend and understand the situation gathered at the entrance of the conference center and across the road
.
Before entering, the representatives of the enterprise looked relaxed, and three or five people gathered together to greet each other and wish
each other.
One enterprise representative joked that he had memorized all the information, while another said helplessly, "If you don't participate in the negotiations this year, next year it will become a multi-competition.
"
"
In addition, there are many representatives of enterprises who come to step on the spot, on the one hand, to understand the entry process, on the other hand, to inquire about the situation of
other companies.
But when talking about their own drugs, the communication between companies is also very vague, "It's hard to say"
.
.
When the doors of the conference center opened, the atmosphere began to change from
the beginning.
Each enterprise has 3-4 representatives to enter, and only after the personnel arrive can they sign in at the door, and the enterprises compete to sign in, because the order problem is slightly noisy, the security guards on the scene have to maintain order
first.
It is reported that more than 20 pharmaceutical companies
participating in the negotiations today include Corun, Baxter, Otsuka, Astellas, Simcere Pharmaceutical, Nanjing Haina, Zai Ding, and Chia Tai Tianqing.
After the appearance, most of the representatives of the enterprises had serious expressions and hurried
actions.
The car that picked them up had already taken up positions on both sides of the road and hurried to the entrance of
the conference center.
They were picked up in escorts by accompanying colleagues, with little communication and little response to questions from the media
.
In the morning session, there were five groups of negotiations, with the participation of more than 10 enterprises
.
At 8:30, the companies entered one after another, and the first company that finished the negotiation appeared at 9:57
.
The last one didn't play until 12:07, more than half an hour
later than expected at eleven-thirty.
Two representatives from Hunan pharmaceutical companies were obviously not well prepared, and after they appeared, they dragged their boxes along the road, waiting for the car to come and pick them up
.
One of the representatives said that we were participating in the negotiations for the first time, and the drugs involved were two classes of new drugs, and the negotiations were smooth, and the price reduction was acceptable
.
A representative of a Shanghai antibiotic company said that there were talks, but it was not very smooth
.
In addition, the representative of Colen, who appeared last in the morning, also generously said that it was quite smooth
.
In the afternoon, the business representatives were even more silent and could only speculate
from their emotional state.
Astellas representatives expressed their happiness that Astellas has three drugs on the preliminary review list, tacrolimus granules outside the catalog, and the renewal of mirabelon sustained-release tablets and enzalutamide softgels in the catalog
.
Haina Pharmaceutical's omeprazole sodium bicarbonate dry suspension entered the preliminary review list, but the company representative gave three answers: general, okay, very good
.
More business representatives were expressionless or smiling
.
After the first day of negotiations, some enterprise representatives booked tickets to leave Beijing, while some enterprise representatives said that they would come
back tomorrow.
Regardless of the outcome this year, "this is the annual meeting of pharmaceutical companies, and it will come
next year.
" ”
-02 - The rules of Medicare negotiations are gradually moderated
-02 - The rules of Medicare negotiations are gradually moderatedThis year's health insurance fund income and expenditure are more optimistic
than in the past two years.
Data show that from January to August 2022, the cumulative income of the national medical insurance fund was 1.
91 trillion yuan (+5.
7%), and the expenditure was 1.
51 trillion yuan (-1.
5%), and the decrease in expenditure was mainly due to the decrease in the
number of new crown vaccinations.
With the further expansion of the balance, coupled with the decline in the prosperity of the industry, the Health Insurance Bureau, as the main operator of medical reform, does need to loosen the mouth of "price reduction"
.
However, as early as this year, before the negotiations, medical insurance did release a lot of "good news" - the rule changes for medical insurance negotiations in 2022 also mainly focused on non-exclusive bidding units and "simple renewal" rules
.
The non-exclusive bidding unit involves not many varieties, it is expected that there are about 38 in total, but these drugs will face a cruel reality: whether they participate in the negotiation or not, the medical insurance payment will be reimbursed according to the lowest quotation of the enterprise price, and this rule is also attached to a detailed rule, such as the company's quotation is less than 70% of the medical insurance willingness to pay, and 70% of the medical insurance willingness to pay is used as the payment standard
for the drug.
for the drug.
This will test the company's ability to quote, but although there are voices in the industry that the company's bargaining situation is comparable to centralized procurement, but because the medical insurance department has formulated a 70% safety valve, the price reduction is not too outrageous
.
It is worth mentioning that the vothioxetine hydrobromide tablets declared by Lundbeck Pharmaceutical also participated in the bidding, vothioxetine hydrobromide tablets are the only new drugs for depression in recent years, which were previously expensive, but with the listing of generic drugs of domestic pharmaceutical companies such as Chia Tai Tianqing, Lundbeck's share is gradually threatened
.
Therefore, using medical insurance channels to stabilize market share in advance has also become the reason why
Lundbeck cannot be out this time.
One of the more interesting changes in negotiation rules for companies is the new "simple renewal" model
.
At present, the renewal method of negotiating pharmaceutical companies is divided into three modes: including conventional catalog management, simple renewal and renegotiation, simple renewal is good for innovative drug products, and there is no need to go through the negotiation process for drugs that expire in the current year, as long as they pass expert review and determine the payment standard, they can sign a contract, and some securities firms estimate that the average reduction is about
25%.
The media has previously sorted out the varieties that may be discussed through "simple renewal": AstraZeneca's goserelin acetate sustained-release implant, CSPC Enbipu Pharmaceutical's sodium chloride injection, butylphthalide soft capsules, Boehringer Ingelheim's alteplase for injection, and paclitaxel liposomes for injection of Luye Pharmaceutical
.
There is also a number of drugs with expanded potential indications: lenvatinib, anlotinib and additionally advanced, locally advanced or metastatic radioactive iodine refractory components
Chemical thyroid cancer (RAIR-DTC), visual impairment
caused by compacept addition to RVO.
Previously, after many products such as Cindilimab expanded their indications in medical insurance negotiations, although the volume continued, the unit price was very water-skiing, resulting in a situation
where profits were increased without income.
If the new indications of the company's renewal products can be directly "simply renewed" without negotiation, the reduction of
drugs can be controlled.
Considering that this year's negotiations are in January, the implementation may be March 1, and the current price of the drug company will be retained for two months
more than in previous years.
-03-The first stop for the commercialization of domestic innovative drugs
-03-The first stop for the commercialization of domestic innovative drugsIn addition to non-exclusive bidding products, exclusive products account for the main market, and among the 183 Western medicines participating in the medical insurance negotiations, exclusive products account for nearly 80%, and among these exclusive products, domestic innovative drugs have become the "fierce generals"
who are pinned on high hopes in the negotiations.
In the past few years since the launch of the medical insurance national talks, although the innovative drugs after high-cost research and development cannot "lie down and make money" like traditional pharmaceutical companies in the past, the National Health Insurance Administration's inclination towards innovative drugs in the access link is obvious, which means that innovative drug companies do not need to "race the horse" like traditional pharmaceutical companies at the sales level, although the growth rate is slow, but once it enters the medical insurance catalog, at least the livelihood of pharmaceutical companies can be
maintained.
Taking Cindilimab and vometinib, which entered medical insurance in 2019 and 2021, as examples, these products are rapidly increased after
entering medical insurance.
The PD-1 track where Cindilimab is located is the most competitive red sea in recent years, and in November 2019, when other PD-1s were still hesitating, Cindilimab became the only PD-1
to enter the new version of the national medical insurance catalogue that year.
After entering medical insurance, the volume of Cindilimab increased, according to the official data released by Cindilimab, the sales of Cindilimab in the first three quarters of 2021 were about 2.
17 billion yuan, and after tasting the sweetness, Cindilimab entered the medical insurance in December 2021, becoming the PD-1
with the most first-line indications in medical insurance that year.
to enter the new version of the national medical insurance catalogue that year.
Sales growth of vometinib follows the
same narrative.
Vometinib in 2021 3
In the first half of 2021, the sales of vometinib were about 120 million yuan, and in the first half of 2022, its sales have jumped to 300 million yuan, which is not bright at first glance, but the EGFR where vometinib is located
The T790M track is also a field of "rolling life and death", and the imported drug osimertinib also entered medical insurance earlier than vometinib, and the results of vometinib have been higher than industry expectations
.
If you don't enter medical insurance, you will basically die, and entering medical insurance may have an unexpected increase, and for innovative pharmaceutical companies, how to choose is very clear
.
.
In this year's medical insurance negotiations, 22 domestic innovative drugs, such as Akeso's dual antibody cardunigli, Henlius' PD-1 serplulimab, Corning Jerry/Sidi/Simcere Pharmaceutical's PD-L1 envolimab, and Ascentage's orebatinib, entered the medical insurance catalogue negotiations, these domestic innovative drugs are the first to participate in medical insurance negotiations, and registered innovative drugs that require new indications, such as vometinib, sindilimab, and teripulimab, can quickly increase the coverage of indications through "simple renewal" for the first time
。
Image: Source of domestic innovative drugs participating in medical insurance negotiations for the first time: China Merchants Securities
Whether pharmaceutical companies want it or not, the negotiation of the medical insurance catalogue has become the first stop
for the commercialization of domestic innovative drugs.
This has become an opportunity for many innovative pharmaceutical companies whose commercialization teams are not deep enough to rapidly increase the penetration rate of "dual channels" in hospital pharmacies and accessibility among patients.
However, for pharmaceutical companies, the dividend period of innovative drugs into medical insurance will not be maintained for too long, only the leader in similar drugs can seize the short window period to obtain volume, and the volume alone does not equal the increase in profits, how pharmaceutical companies to weigh in terms of volume, indication range, sales expenditure, etc.
, is still a complex knowledge, and changes every year
.
(Secret Cong Cong also contributed to this article)
