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Recently, the official website of the National Medical Insurance Bureau posted the "Reply to Recommendation No.
4221 of the Fifth Session of the 13th National People's Congress", which replied to
the proposal put forward by representative Wu Wenfei on accelerating the inclusion of precision medical genetic testing for cancer into medical insurance.
4221 of the Fifth Session of the 13th National People's Congress", which replied to
the proposal put forward by representative Wu Wenfei on accelerating the inclusion of precision medical genetic testing for cancer into medical insurance.
The National Medical Insurance Bureau said in its reply that the current version of the national medical insurance drug catalogue contains a total of 2,860 kinds of Western medicines and proprietary Chinese medicines, of which about 30 are
targeted drugs.
In accordance with the relevant requirements of the drug label and the limited payment scope of medical insurance, genetic testing
is required to use specific targeted drugs.
targeted drugs.
In accordance with the relevant requirements of the drug label and the limited payment scope of medical insurance, genetic testing
is required to use specific targeted drugs.
At present, some regions have included some genetic testing projects in the scope of
medical insurance payment.
However, due to the short clinical application time, the technology is not very mature, as well as the high price and cost, the genetic testing industry needs to be further standardized, etc.
, most places have not included tumor genetic testing projects in medical insurance
.
In the next step, we will guide local governments to include safe, effective, affordable and clear fee standards into the local medical insurance payment scope
according to the procedures.
medical insurance payment.
However, due to the short clinical application time, the technology is not very mature, as well as the high price and cost, the genetic testing industry needs to be further standardized, etc.
, most places have not included tumor genetic testing projects in medical insurance
.
In the next step, we will guide local governments to include safe, effective, affordable and clear fee standards into the local medical insurance payment scope
according to the procedures.
In addition, whether tumor genetic testing projects will be included in the procurement with quantity, the National Medical Insurance Administration said: "Tumor genetic testing is a medical service project, and according to the current policy, the basic medical services provided by public medical institutions are subject to government guidance prices
.
" At present, we are guiding local governments to explore centralized procurement of diagnostic reagents in accordance with the principle of "separation of technology and consumption", promote the price of reagents to return to a reasonable level, and drive the price of related medical service items to decrease
.
”
.
" At present, we are guiding local governments to explore centralized procurement of diagnostic reagents in accordance with the principle of "separation of technology and consumption", promote the price of reagents to return to a reasonable level, and drive the price of related medical service items to decrease
.
”
According to Frost & Sullivan data, the domestic tumor high-throughput genetic testing market has increased from 700 million yuan in 2016 to 4.
1 billion yuan in 2021, with a compound annual growth rate of 41.
1%; It is expected that in 2025 and 2030, the market size will reach 14.
9 billion yuan and 49.
1 billion yuan
respectively.
1 billion yuan in 2021, with a compound annual growth rate of 41.
1%; It is expected that in 2025 and 2030, the market size will reach 14.
9 billion yuan and 49.
1 billion yuan
respectively.
Although the scale of the domestic tumor gene testing market is growing rapidly, it is also facing many difficulties
.
.
At present, the main business model of China's tumor high-throughput genetic testing industry is based on independent medical testing laboratories to provide medical testing services
.
In addition, many provinces do not have price items, and most of the cost of genetic testing is still relatively high, except for Beijing, other provinces in the country have not included genetic testing in medical insurance, and mature standards are urgently needed to standardize
.
.
In addition, many provinces do not have price items, and most of the cost of genetic testing is still relatively high, except for Beijing, other provinces in the country have not included genetic testing in medical insurance, and mature standards are urgently needed to standardize
.
The most promising development areas of the tumor high-throughput genetic testing industry are tumor companion diagnosis, tumor recurrence monitoring and early tumor screening and diagnosis
based on large panels.
However, domestic tumor NGS gene testing products generally have serious problems
of homogenization.
based on large panels.
However, domestic tumor NGS gene testing products generally have serious problems
of homogenization.
At present, 12 small panel kits have been approved, most of which focus on a few drugs accompanying NSCLC non-small cell lung cancer and CRC colorectal cancer, and target genes are concentrated on EGFR, ALK, ROS1, etc
.
At the same time, there are still a number of unlicensed enterprises providing services in the LDT model (according to incomplete statistics, the number of NGS enterprises in China will be more than 300 in 2020).
.
At the same time, there are still a number of unlicensed enterprises providing services in the LDT model (according to incomplete statistics, the number of NGS enterprises in China will be more than 300 in 2020).
The loosening of the medical insurance payment policy revealed by the National Medical Insurance Bureau is undoubtedly a shot in the arm for the tumor genetic testing market
.
With the two-way blessing of the market and policies, it is believed that the domestic tumor gene testing market is bound to usher in new opportunities
.
.
With the two-way blessing of the market and policies, it is believed that the domestic tumor gene testing market is bound to usher in new opportunities
.
Safe, effective, affordable and well-defined genetic testing programs are expected to be included in local medical insurance coverage according to procedures
Since the establishment of the National Medical Insurance Administration in 2018, it has established and improved the dynamic adjustment mechanism of the medical insurance drug catalog, carried out the adjustment of the medical insurance drug catalog for four consecutive years, and timely included eligible drugs into the medical insurance drug catalog
according to the procedures.
The current version of the national medical insurance drug catalogue contains a total of 2,860 kinds of Western medicines and proprietary Chinese medicines, including about 30 targeted
drugs.
according to the procedures.
The current version of the national medical insurance drug catalogue contains a total of 2,860 kinds of Western medicines and proprietary Chinese medicines, including about 30 targeted
drugs.
In accordance with the relevant requirements of the drug label and the limited payment scope of medical insurance, genetic testing
is required to use specific targeted drugs.
Taking crizotinib as an example, the medical insurance limits the scope of payment to "patients with locally advanced or metastatic non-small cell lung cancer who are limited to anaplastic lymphoma kinase (ALK)-positive or patients with advanced non-small cell lung cancer who are ROSI-positive", that is, they need to prove that the patient has ALK or ROS1 mutations through genetic testing, and the medical insurance fund will pay
.
is required to use specific targeted drugs.
Taking crizotinib as an example, the medical insurance limits the scope of payment to "patients with locally advanced or metastatic non-small cell lung cancer who are limited to anaplastic lymphoma kinase (ALK)-positive or patients with advanced non-small cell lung cancer who are ROSI-positive", that is, they need to prove that the patient has ALK or ROS1 mutations through genetic testing, and the medical insurance fund will pay
.
At present, the national level adopts exclusion regulations to determine the scope of medical service items that are not paid by basic medical insurance and partially paid, and does not exclude medical services related to genetic testing
.
.
The medical insurance departments of each province (autonomous region and municipality) determine the scope
of payment of medical service projects in their provinces according to the actual situation of medical technology development and the operation of medical insurance funds in their respective regions.
Due to the different levels of economic development and medical technology in different places, the specific projects included and the level of payment also have certain differences
.
of payment of medical service projects in their provinces according to the actual situation of medical technology development and the operation of medical insurance funds in their respective regions.
Due to the different levels of economic development and medical technology in different places, the specific projects included and the level of payment also have certain differences
.
From the perspective of local reality, some regions have included some genetic testing projects in the scope of
medical insurance payment.
However, due to the short clinical application time, the technology is not very mature, as well as the high price and cost, the genetic testing industry needs to be further standardized, etc.
, most places have not included tumor genetic testing projects in medical insurance
.
medical insurance payment.
However, due to the short clinical application time, the technology is not very mature, as well as the high price and cost, the genetic testing industry needs to be further standardized, etc.
, most places have not included tumor genetic testing projects in medical insurance
.
In the next step, we will pay close attention to the development of relevant medical technologies, and on the basis of strengthening industry management by the health department, guide local governments to incorporate safe, effective, affordable and clear charging standards into the scope of local medical insurance payment according to procedures, so as to better meet the needs of
the people.
the people.
Explore centralized procurement of diagnostic reagents
Tumor genetic testing is a medical service project, and according to the current policy, the basic medical services provided by public medical institutions are subject to government guidance prices
.
At present, we are guiding local governments to explore centralized procurement of diagnostic reagents in accordance with the principle of "separation of technology and consumption", promote the price of reagents to return to a reasonable level, and drive the price of related medical service items to decrease
.
.
At present, we are guiding local governments to explore centralized procurement of diagnostic reagents in accordance with the principle of "separation of technology and consumption", promote the price of reagents to return to a reasonable level, and drive the price of related medical service items to decrease
.
