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Since China's medical insurance reform in 2016~2017, approved innovative drugs can enter the medical insurance system
faster.
Obtaining medical insurance reimbursement is very important for the development of innovative drugs, for enterprises, the important goal of new drug listing is to be included in the medical insurance reimbursement catalogue with as little price reduction as possible, especially during the patent period, medical insurance reimbursement in the early stage of new drug marketing can bring about the expansion
of sales as soon as possible.
However, with China's existing medical affordability, innovative drugs entering medical insurance do not seem to usher in the expected high returns
.
Through 6 rounds of national medical insurance negotiations, the negotiation standards, processes and rules have become clearer, and the reduction of uncertainty is conducive to enterprises to make new drug medical insurance access strategies
according to their own conditions according to the medical insurance negotiation rules.
Especially since the medical insurance drug catalogue was changed to the enterprise application system in 2020, enterprises have greater autonomy to decide whether to enter medical insurance
.
In view of a variety of factors, the proportion of innovative drugs abandoned/suspended from entering medical insurance has increased, and the analysis of pre-medical insurance information in 2022 shows that the proportion of innovative drugs that meet the negotiation conditions but are not on the formal review list reaches 52%.
In view of the recent media situation about the abandonment of medical insurance negotiations for innovative drugs, this paper analyzes the number, common characteristics and market performance of drugs that abandon negotiations through data
.
1.
Public health drugs are not necessarily necessary to enter medical insurance
Public health drugs are not necessarily necessary to enter medical insurance
Since 2003, China has implemented "four exemptions and one care" for HIV/AIDS prevention and treatment, which is a dual access, so HIV drugs have less room for bargaining in medical insurance negotiations
.
From 2019, the first imported HIV drugs passed medical insurance negotiations (Gilead Dejie Fukang), in 2020, only 2 domestic HIV drugs entered the negotiation (Frontier Bio Ekonin, Disanoji Weijiu), and in 2021, imported HIV drugs entered again (Gilead Bitovir, Addy Pharmaceuticals Ebond and GlaxoStopovitos).
Among the drugs that passed the formal review this year, Merck Sharp & Dohme Drastic, Baker Biotech Taidou and Real Bio were shortlisted
.
Six HIV drugs (Table 1) also did not appear on the formalities review list, and may not have intended to share the health insurance plate with the existing nine HIV drugs
.
Table 1.
HIV drugs not on the form review list
Source: GBI Analysis
GBI2.
Popular target drugs have more competition with indications
Popular target drugs have more competition with indications
After June 30, 2021, 7 more domestic PD-1/L1 preparations were approved in China, and the PD-1/L1 preparations in the domestic market were previously approved
The 4+4 pattern soared to 15.
It seems that imported PD-1/L1 was not intended to enter the medical insurance catalog from the beginning, so only domestic products were included in medical insurance
PD-1/L1 formulations are competing
.
In 2019~2021, only 4 domestic models are dividing medical insurance resources, and in 2022, there will theoretically be 10 PD-1 competing together
.
However, Akeso's Anico, Yuheng Pharmaceutical's Yuto, and CStone Pharmaceuticals' Zejiemei did not appear on the
formalities review list.
And it is revealed that the above three domestic preparations are actively abandoning entering medical insurance (that is, undeclared form review), possibly because similar preparations with similar indications have been covered by medical insurance and have formed sufficient competition
.
Some drugs, due to the small number of approved indications (small number of people and more drugs in the same indication), may not choose to enter medical insurance for the time being, and will consider entering
after being approved for larger indications.
3.
Conditional approval leads to caution in clinical use
Conditional approval leads to caution in clinical use
Conditionally approved indications are more cautious
when used because their clinical use is inadequate.
This may also lead to certain obstacles and difficulties
in entering medical insurance.
It is true that some conditionally approved drugs are innovative drugs on a global scale, or rare disease drugs urgently needed in China, which are difficult to imitate in a short period of time, so they do not necessarily need to be increased by entering medical insurance
.
4.
Domestic exclusive products
Domestic exclusive products
In essence, the higher the irreplaceability of a drug, the more bargaining power it has; The longer the patent period of drugs, the longer the period of theoretical market exclusivity, and the lower
the need for price reductions to enter medical insurance.
At present, most of these drugs are imported, including drugs introduced by domestic enterprises
.
However, domestic innovative drugs still tend to enter medical insurance according to the past situation, so although the price reduction is not necessarily large, they are still facing price reduction pressure
.
The products developed by pure local enterprises are only the new crown antibody of Tengsheng Bo Pharmaceutical, and the rabies drug
of North China Pharmaceutical.
The drugs introduced are all oncology drugs, because of their high prices, and many of them are domestic/global firsts when they are approved, which may not be highly motivated to enter medical insurance
.
5.
Long patent term for imported special drugs
Long patent term for imported special drugs
The situation of importing new drugs is more complicated
.
In the first few negotiations, some imported drugs still have a patent period of about 1 year, and similar imitations are about to appear on the market, so they choose to enter medical insurance
.
With the implementation of medical insurance in recent years, it is difficult for the state to talk about drugs entering the hospital, and the rapid increase in volume has become a theoretical value to some extent, and the enthusiasm of imported new drugs to enter medical insurance has also been reduced
.
Especially with the normalization of the procurement of mature products (the centralized procurement price and the medical insurance price are linked to take their low value), imported drugs are becoming more cautious
.
Exclusive imported products, imported products approved for marketing in many countries/considering international selling price strategies, orphan drug products, imported products that are urgently needed clinically in China, and imported products with a long patent period will not choose to enter medical insurance
.
summary
summaryOn the surface, eligible innovative drugs are choosing to enter medical insurance less and less, but in fact, it may be due to the following reasons: (1) the degree of innovation of innovative drugs is becoming more and more difficult to replace; (2) After medical insurance, the competition of similar drugs is serious, and profits are diverted; (3) Temporarily not the best period to enter medical insurance; (4) The company's strategic layout, etc
.
It is true that the more difficult it is to replace drugs in the short term, the more innovative they can be, and the more bargaining power
they have.
However, the homogeneous competition between medical insurance drugs is serious, resulting in the Health Insurance Bureau having greater bargaining power
.
To some extent, this also reflects that in just a few years of China's innovative drug reform, the relevant laws of drug supervision are still gradually improving, and in the early stage, it is more inclined to approve the listing of multiple drugs of the same kind
.
Therefore, for truly innovative drugs, they may not be able to give commercial returns
that meet their expectations.
At present, entering medical insurance is one of the important commercialization channels for innovative drugs, and although other diversified payment/commercialization channels are also indispensable, the development of supplementary insurance such as domestic commercial medical insurance is not perfect, and it only accounts for a small part
of the overall medical reimbursement system 。 Previously, GBI interviewed Mr.
Song Ruilin, Honorary President of the China Association for the Promotion of Medicine, who suggested: "There should also be differential treatment in medical insurance payment, and for those who can fully solve the urgent clinical needs, or fill the gap, and achieve effective substitution can bring important utility, you can consider changing the existing fixed proportion reimbursement system, according to the principle of 'doing your best and doing what you can', by appropriately adjusting the reimbursement ratio, not only to ensure the safety of the medical insurance fund, but also to allow innovative enterprises to profit and further continue to innovate
.
" ”
