Source of this article: Times Finance Author: Wen Ruonan
Following drugs and high-value consumables, tumor genetic testing projects will also usher in centralized procurement.
Recently, the National Medical Insurance Bureau stated in the “Reply to the Suggestion No. 4221 of the Fifth Session of the 13th National People’s Congress” that according to the requirements of the drug instructions and the limited payment scope of medical insurance, the use of specific targeted drugs requires genetic testing. At present, the national level adopts the exclusion law to stipulate the scope of medical service items that basic medical insurance does not pay and pays part of, and does not exclude the medical service items related to genetic testing. At present, some regions have included some genetic testing items into the scope of medical insurance payment. However, due to the short clinical application time, immature technology, high price and cost, and the need to further standardize the genetic testing industry, most places have not yet included tumor genetic testing items in medical insurance.
Therefore, the National Medical Insurance Bureau clearly stated that the next step will be to pay close attention to the development of relevant medical technologies, and on the basis of strengthening industry management by the health and health department, guide local governments to incorporate safe and effective genetic testing projects with appropriate costs and clear charging standards into local areas according to procedures. health insurance coverage.
In addition, the National Medical Insurance Administration also mentioned that tumor genetic testing is a medical service item. According to the current policy, the basic medical services provided by public medical institutions are subject to government-guided prices. At present, the National Medical Insurance Administration is guiding local governments to explore centralized procurement of diagnostic reagents in accordance with the principle of “separation of technology and consumption”, so as to promote the price of reagents to return to a reasonable level, and to drive down the prices of related medical service items.
Qian Yiming, a veteran of the genetic testing industry, analyzed Times Finance that because some tumor drugs have been included in centralized procurement and medical insurance negotiation, medical insurance reimbursement requires evidence of genetic testing, otherwise it will not be reported, which is a rigid requirement. Since these tumor drugs are included in the medical insurance, it is reasonable for the matching genetic testing items to be included in the medical insurance, both in terms of necessity and practical needs.
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In response to the specific scope of the tumor genetic testing items mentioned in the above reply, a relevant person from a leading domestic genetic testing company told Times Finance, “Because the National Medical Insurance Administration has not yet clearly defined the tumor genetic testing items in the reply, so It is not easy to speculate for the time being. With the gradual expansion of the centralized procurement boundary, it is also difficult for the company to predict.”
According to Times Finance, at present, the price of tumor genetic testing items on the market ranges from a few hundred yuan to tens of thousands of yuan, and charges are mainly based on the type of tumor and the number of genes performed. In addition, different regions and different types of hospitals have different costs.
“In recent years, precision therapy has become the main exploration direction of cancer treatment. Patients can greatly improve their survival rate through precise targeted therapy instead of traditional chemotherapy. The response from the National Medical Insurance Administration may be considered from the perspective of patients to reduce their economic burden.” Zhou Jun, an expert in pharmaceutical strategic marketing, analyzed Times Finance.
Catch the East Wind of Precision Treatment
Tumors can be classified into benign and malignant tumors, among which, malignant tumors, commonly known as cancers, have always been recognized as the number one killer of human beings. In recent years, the incidence and mortality of cancer have been increasing year by year. The latest cancer report in China released by the National Cancer Center in February 2022 shows that in 2016, there were 4.064 million new cancer cases in my country, that is, more than 10,000 new cases per day. , an average of 7 people are diagnosed with cancer every minute.
There are many ways to treat cancer, including traditional surgery, radiotherapy, chemotherapy, and interventional therapy. With the development of precision medicine, targeted therapy and immunotherapy are gradually applied to the treatment of cancer, especially for patients with advanced cancer.
Over the years, there has been a consensus in the medical community that tumors are ultimately a genetic disease, and many harmful genetic changes have accumulated in tumor cells, such as gene site changes, deletions, duplications, etc., resulting in cell growth and proliferation. Out of control, eventually lead to the occurrence of tumors.
Tumor gene detection, as the name suggests, is a technology that detects genes related to tumors. At present, the product directions of tumor gene testing in the market mainly include tumor susceptibility gene detection, hereditary tumor gene detection, tumor precision drug gene detection, tumor early screening gene detection, tumor prognosis prediction, efficacy evaluation, etc.
With the increase in the number of cancer cases in recent years, the precise treatment of targeted drugs has become an important direction for the medical community to explore. The genetic testing of tumor precision medicine is matched with it, which can identify harmful gene mutations for targeted medicine, and then assist patients with medication and related evaluation.
“Genetic testing is an inspection of targeted drugs for tumors. Without the assistance of genetic testing, it is almost impossible to use targeted drugs and determine their efficacy.” Xu Qiang, a domestic oncologist, told Times Finance.
In recent years, more and more companies have entered the field of tumor genetic testing, such as BGI (300676.SZ), Aide Bio (300685.SZ), Genetron Health (GTH.US), etc., and have successively launched tumors with different technical routes. Genetic testing projects, such as traditional FISH (fluorescence in situ hybridization), PCR (polymerase chain reaction), etc., as well as Next-Generation Sequencing (NGS, NGS, also known as “Next Generation Sequencing”), which can perform genetic testing in batches. Technology”, “High-throughput Sequencing Technology”).
According to the data of consulting agency Frost & Sullivan, the domestic tumor high-throughput genetic testing market scale has increased from 700 million yuan in 2016 to 4.1 billion yuan in 2021, with a compound annual growth rate of 41.1%. In 2030, the market size will reach 14.9 billion yuan and 49.1 billion yuan respectively.
How much is the price reduction space?
Before the National Medical Insurance Bureau released the signal that tumor genetic testing items were included in medical insurance and centralized collection, some regions in China have included tumor genetic testing items into medical insurance, such as Beijing and Shanghai.
According to media reports, in January 2022, Shanghai will include the Septin9 gene methylation test in the scope of medical insurance reimbursement. The fee is 780 yuan, and the medical insurance reimbursement ratio is 80%. In an interview with the Global Times, Zhou Jun, deputy chief physician of the Department of Gastrointestinal Oncology at Peking University Cancer Hospital, pointed out that at present, the tumor genetic testing projects reimbursed by Beijing medical insurance belong to the more mature traditional methods, including FISH (fluorescence in situ). Hybridization), PCR (polymerase chain reaction) and other technologies generally cost no more than 500 yuan to detect a gene. If a patient packs 10 genes to test, it will cost 5,000 yuan, and the reimbursement amount can reach 90%. In addition to traditional methods, there are second-generation sequencing technologies that can perform genetic testing in batches, and can measure hundreds of genes at a time, but the fee is higher, about 8,000 to 18,000 yuan.
However, according to Times Finance, the NGS project has not yet been included in the scope of medical insurance reimbursement.
“Tumor gene detection cannot be understood as an NGS project in a narrow sense or by default. For the detection of clear genes, FISH, QPCR and other technologies can be used, and the fees are lower. It is easier to collect the above-mentioned clear genes, and the methodology is simple, certified, Competitive projects start, not NGS, nor large panels (gene packages) that charge tens of thousands of yuan, or uncertified NGS products.” Qian Yiming told Times Finance.
According to statistics from the World Health Organization’s International Agency for Research on Cancer, the top ten most common cancers in China are lung cancer, colorectal cancer, gastric cancer, breast cancer, liver cancer, esophageal cancer, thyroid cancer, pancreatic cancer, prostate cancer and cervical cancer.
Zhou Jun pointed out to Times Finance and Economics that if the process of tumor genetic testing projects entering medical insurance is accelerated in the future, it will definitely target the types with high incidence, high cost or large patient groups, “In China, lung cancer, colorectal cancer, gastric cancer , adenocarcinoma, and lymphoid tumors all have a higher incidence, and the detection items of these cancer types will be more easily considered.”
Taking Shanghai as an example, the limited payment scope for Septin9 gene methylation detection is “limited to colorectal and colorectal cancer”.
Since 2018, my country has carried out seven batches of national centralized procurement. After the centralized procurement of traditional medicines and high-value consumables, the price has been halved. What will happen to the tumor genetic testing industry?
The relevant person from the above-mentioned leading genetic testing company said that for tumor genetic testing, speeding up the medical insurance process is beneficial to consumers first, and it is also beneficial to the industry, because after the inclusion of medical insurance, the entire market will be broader. . He also pointed out, “If tumor genetic testing technology is also included in centralized procurement, it may lead to a decrease in the unit price of related products or services, and the related gross profit of listed companies in the industry will also be compressed, which may be negative in the short term. However, Since the centralized procurement has not been implemented at present, the subsequent price compression cannot be predicted for the time being.”
“It is not easy to judge the room for the decline. It involves the scale of patients and similar competition. Considering that the current sales price contains too many sales expenses and squeezes the water, the decline can be expected.” Qian Yiming told Times Finance and Economics. .
Zhou Jun analyzed to Times Finance that if tumor genetic testing enters the scope of centralized procurement, there will definitely be a decline, but first, tumor genetic testing accounts for a small proportion of the overall medical insurance costs; second, tumor genetic testing is different from drugs, Consumables, it does not have a strong multi-vendor substitutable solution; again, patients are distributed in various regions, and diversity is presented. “To sum up the three points, there is still a long way to go before the tumor genetic testing project enters the centralized collection.” Zhou Jun said.
(At the request of the interviewee, Xu Qiang and Qian Yiming in the article are pseudonyms)