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One of the biggest "blocking points" in tumor treatment, the cost of genetic testing, will soon be solved
.
On October 12, the National Health Insurance Administration issued the "Reply to Recommendation No.
4221 of the Fifth Session of the 13th National People's Congress", which clearly will guide local governments to include safe, effective, affordable and clear fee standards into the scope of
local medical insurance payment according to procedures.
Genetic testing is the premise of determining tumor gene mutations, and only by clearly knowing the type of mutation can targeted anticancer drugs play a role
.
However, a set of genetic testing is as little as three or four thousand, and more than tens of thousands of yuan, if the patient cannot find the corresponding mutation, even if he takes the "anti-cancer miracle drug", it may not work
.
But patients who want to be reimbursed by health insurance have to get tested
.
In 2018, the National Health Commission issued the "Guidelines for the Clinical Application of New Antitumor Drugs", which clarified that for drugs with clear targets, target detection can only be reimbursed
.
Many contradictions in tumor treatment focus on
genetic testing.
Spent money and did not get the desired result, it is difficult to judge if it is weak positive, and it is not effective to take medicine after detecting the target.
.
.
These have affected the smooth promotion
of genetic testing.
Especially at present, the most cutting-edge NGS testing technology companies are facing the dual pressure of high product costs and application scenarios that are not conducive to medical insurance payment, and many companies are sluggish in development
.
Can medical insurance pay for genetic testing to bring a glimmer of life to NGS sequencing companies?
01 Targeted drug partners, but not trusted
01 Targeted drug partners, but not trustedThe current status quo of tumor genetic testing is that while the advantages of targeted drugs have been recognized and gradually included in the national medical insurance drug list, the genetic testing combined with it still needs to be paid
by patients out of their own pockets.
On the online diagnosis and treatment platform "Good Doctor Online", one of the most frequently asked questions by lung cancer patients is "blind eating"
.
After the reform of the drug review system in 2015, a large number of anti-tumor drugs have been listed in China, many of which have been included in medical insurance
.
Taking the new version of the medical insurance catalogue in 2021 as an example, there are a total of 51 anti-tumor drugs and 44 targeted drugs
.
After negotiating the price reduction into medical insurance, a large number of targeted drugs have achieved a large volume, taking lung cancer with the most target drugs to be detected as an example, crizotinib, afatinib, osimertinib, ceritinib, gefitinib After being included in medical insurance in 2018, the price decreased by an average of 60%, but sales still doubled, of which crizotinib increased more than 4 times in 2019, with sales reaching 380 million
.
Anti-cancer drugs are cheaper, and the group of "blind eating" has expanded much
more than before.
more than before.
Many doctors do not recommend that patients use targeted drugs
directly without knowing the specific gene mutation.
Patients are looking forward to being able to cure the disease, and the "wrong" targeted drugs are actually incurable
.
But economically and psychologically, patients will have a little resistance
to target detection.
On many health websites, "whether to do genetic testing for lung cancer" often becomes a topic
.
The high price of genetic testing is one of
the reasons why many patients are turned away.
In recent years, the call for tumor genetic testing programs to be included in medical insurance has become more and more intense
.
In fact, the National Health Insurance Bureau has not excluded genetic testing from medical insurance reimbursement, and some places have included some genetic testing items in medical insurance
.
But most patients don't enjoy this benefit, and there is a reason for this
.
A chief physician of Peking Union Medical College Hospital once told the Health Bureau: The state generally has no standards for genetic testing, and many hospitals rely on third-party medical testing institutions, but the technology is uneven and the charging standards are different
.
In many areas, the conduct of testing items is comparable to underground joints: doctor's recommendation, institutional ordering, out-of-hospital testing
.
.
Due to its own objective limitations, most of the complex testing and analysis services that hospitals cannot carry out will be handed over to third-party testing institutions, that is, through LDT to carry out testing
.
But in the eyes of patients, the way the genetic testing business is carried out appears "informal", which exacerbates patients' distrust
of it.
Once a doctor-patient dispute occurs, LDT business often becomes the focus of
conflict.
conflict.
It is the cutting-edge NGS gene sequencing that requires a large number of LDT methods, and it is also the most concentrated business
at present.
02 New technologies are difficult to push, and the struggle continues
02 New technologies are difficult to push, and the struggle continuesBeijing has taken the lead in implementing medical insurance reimbursement for some genetic testing projects, but this does not include NGS technology
.
In June 2019, the Beijing Municipal Medical Insurance Bureau included tumor tissue deoxyribonucleic acid (DNA) sequencing into the scope of medical insurance reimbursement, implemented a government guidance price of 3,800 yuan, and implemented a comprehensive reform of medical consumption linkage, so that patients no longer need to run to a third-party testing institution to obtain genetic testing that meets clinical drug decisions within the hospital and enjoy medical insurance reimbursement
.
There are four main types of commonly used tumor genetic testing items, namely PCR
, FISH, IHC and NGS four technologies
.
PCR, FISH, and IHC are all mature traditional methods, which basically adopt the "one drug one diagnosis" model, that is, the detection
of a single biomarker is approved with the drug as the center.
According to the Global Times, Zhou Jun, deputy chief physician of the Department of Gastroenterology and Oncology of Peking University Cancer Hospital, introduced: At present, the tumor genetic testing projects reimbursed by Beijing medical insurance only include traditional technologies such as FISH and PCR, and the general cost of testing a gene does not exceed 500 yuan, even if it is packaged to test 10 genes, it is only 5,000 yuan
.
Obviously, these tests meet the standards
of the National Health Insurance Administration, which is "safe and effective, affordable and clear-cut".
Relatively speaking, the most accurate NGS technology is an area where many innovative genetic testing companies are clustered, but it is not easy
for this piece to get the "favor" of medical insurance.
On the one hand, NGS technology itself is more suitable for genetic testing at multiple sites, which is known in the industry as the "big panel"
.
Because multiple drug sites can be measured at a time, it is faster and more convenient
for patients.
With more and more drugs approved in clinical practice, NGS may be of greater use
.
However, the biggest problem with big panels is the high
cost.
The payment of medical insurance funds is limited, and the use of NGS for tumor genetic testing is somewhat overkill
.
cost.
In addition, the detection reagents based on NGS technology themselves are relatively difficult to be approved, and Genetron insiders introduced that it generally takes three or five years or even longer
for such products to be certified.
Many products cannot get licenses, and can only be tested by third-party testing, and hospitals at a given point provide testing support
.
.
The revenue of Shihe Gene's third-party testing service model reached 73% of total revenue, while Zhenhe Technology was as high as 84%.
The third-party testing model is not illegal at present, and Guangdong and other places actively support the pilot and encourage the use of third-party medical testing as a supplement
to public medical institutions.
In terms of specific implementation, how does third-party testing access medical insurance? Is it through a designated hospital, or directly connected to the medical insurance system? These are all inconclusive matters
.
Therefore, at present, many NGS testing companies are targeting non-therapeutic businesses
such as recurrence monitoring and early tumor screening.
The prospectus of Shihe Genomics predicted that the future market space of early screening and other businesses is expected to exceed the medication guidance business, and Zhenhe Technology has also made the same judgment
.
NGS companies shoulder the heavy responsibility of impacting the medical frontier, but in the short term, even if medical insurance provides targeted drug genetic testing support, it is difficult for the sun to shine on NGS companies
.
