9month6Yesterday, the National Healthcare Security Administration2022The list of declared drugs that have passed the preliminary formal review for the adjustment of the national basic medical insurance, work-related injury insurance, and maternity insurance drug lists has been newly publicized.
Currently available344Which varieties have been included in the preliminary review list? Which ones are more interesting?2022What are the differences in annual healthcare negotiation compared to previous years? Frost & SullivanFrost & SullivanJiang Tengfei, Senior Consulting Director for Healthcare in Greater China at Frost & Sullivan (hereinafter referred to as 'Frost & Sullivan'), and Wang Siyi, Healthcare Analyst, were interviewed by Blue Whale Finance to jointly interpret the preliminary list of medical insurance drug catalogs.
Blue Whale Finance
9month6Yesterday, the National Healthcare Security Administration2022The list of declared drugs that have passed the preliminary formal review for the adjustment of the national basic medical insurance, work-related injury insurance, and maternity insurance drug lists has been newly publicized.
Upon review,344The passing rate of a drug after preliminary form review is70%Including Western medicines and proprietary Chinese medicines outside the catalog199Western medicines and Chinese patent medicines in the portfolio145one. And2021year474a medicine271Compared with the previous period, the number of drugs that have passed the preliminary form review and been declared for approval has increased to a certain extent. In terms of the approval rate, the proportion of drugs outside the catalogue is60%Proportion of drugs in the directory91%.
Added3modelPD-(L)1 inhibitorThe product has entered the preliminary review list.
According to the document requirements, the scope of this adjustment to the medical insurance catalog includes2017year1month1day after tomorrow2022year6month30During the period, new generic drugs approved for marketing by the national drug regulatory authorities, as well as drugs whose indications or functions and indications have undergone significant changes.
Judging from the adjustments to the medical insurance catalog in recent years, the proportion of innovative drugs included has been increasing year by year.PD-(L)1 inhibitorAs a representative of domestic innovative drugs, the competition is fierce, and price negotiations are worth paying attention to. Currently, there are already marketed products in China.PD-(L)1 inhibitormonoclonal antibody collection13Products, including9modelPD-1monoclonal antibody and4modelPD-L1monoclonal antibody, wherein4Model domesticPD-1They have been included in medical insurance, namely Sintilimab from Innovent Biologics, Camrelizumab from Hengrui Medicine, Tislelizumab from Junshi Biosciences, and Trileucelizumab from BeiGene.
Judging from the preliminary review list, there are3modelPD-(L)1 inhibitorNew products have entered the preliminary review list, including Sru Li Mab Injection of Fosun Pharma's Fosun Herceptin Immonobulin (FHI) and Envykine Mab Injection of CanSino Biologics.
Already enrolled in medical insurance4modelPD-1This year, several new indications have been added. Triferumab:1Lnasopharyngeal carcinoma,1 literEsophageal squamous cell carcinoma; Sintilimab: First-line for gastric cancer and first-line esophageal squamous cell carcinoma; Camrelizumab: First-line+Third-line nasopharyngeal carcinoma, esophageal cancer, squamous non-small cell lung cancerNSCLC); Tislelizumab: Non-small cell lung cancerNSCLCSecond-line or third-line treatment, previously treated microsatellite high instability typeMSI-H) or mismatch repair gene defect typedMMRTreatment of advanced solid tumors, esophageal squamous cell carcinomaESCCSecond-line treatment and nasopharyngeal carcinomaNPCFirst-line treatment, as well as first-line combination therapy with albumin-bound paclitaxel and carboplatin for squamous non-small cell lung cancerNSCLC).
Wang Siyi, an analyst from Frost & Sullivan's Healthcare Group in Greater China, pointed out that at present13modelPD-(L)1 inhibitorApproved in China52Indication: SinoCure Biologics, Hengrui Medicine Group Co., Ltd., Junshi Biosciences Inc., and BeiGene Biosciences Co., Ltd.4modelPD-1The approved indications for the product are as follows:4,8,5and9One, the indications included in medical insurance are as follows:4,4,3and5This year, in addition to paying attention to whether there will be newPD-(L)1 inhibitorIn addition to products included in medical insurance, you can also check those that were previously covered.4Will there be new indications included for this product?
WuXi AppTec GenomicsCAR-TThe therapy has entered the preliminary review list
Last year, during the medical insurance negotiation, Fosun Pharma's pricing reached120ten thousand yuanCAR-TThe therapy, axilelimab, has received much market attention but ultimately missed out on inclusion in the medical insurance catalog, with domestic products this yearCAR-TThe product already has two versions, namely Fosun Kite's axitinib injection (trade name: Yikaida) and WuXi AppTec's ruxolitinib injection.
However, judging from the preliminary review results, only Ruxience injection of WuXi AppTec's Juno Oncology Group Co., Ltd. has been included in the list, while Acalonase injection of Fosun Pharma's Kite Biologics Co., Ltd. has not made it to this year's medical insurance negotiation.
2022The year marked the first full year of commercialization of cell therapy in China. And the aforementioned twoCAR-TThe market performance of the therapy has also attracted considerable attention within the industry. According to the latest semi-annual report disclosed by WuXi AppTec,2022A total of77ZhangCAR-TTreatment prescription, revenue is about6600.7Ten thousand yuan. Based on this, the revenue from a single prescription is approximately86ten thousand.
However, the National Healthcare Security Administration has also pointed out that this year, some drugs with relatively high prices have passed the preliminary form review, indicating that they meet the application conditions and are eligible to proceed to the next stage. Whether these drugs can ultimately be included in the national healthcare insurance drug list requires a comprehensive and strict evaluation including economic factors. Exclusive drugs that pass the evaluation will undergo negotiations, while non-exclusive drugs will go through bidding. Only those that successfully negotiate or bid can be included in the list.
4modelADCAll drugs have entered the preliminary review list
ADCMedications have been one of the hot research directions in the field of anti-tumor therapy in recent years, this yearADCThe negotiation results of the drugs are also attracting attention. Last year, some were already launched domesticallyADCAmong the drugs, only Rongchang Biologics' vedicizumab has successfully negotiated a deal. Takeda's brevetuximab was shortlisted but failed negotiations, while Roche's enfuramtuzumab did not pass the preliminary review list.
Currently, there are a total of5modelADCThe drug has been approved for marketing.2021year6Month, Rongchang Biology'sADCDrug Veddioximab(RC48)Approved for listing, becoming the first domestic product to go publicADCNew drugs. In addition to this, it also includesSeagen/Takeda's Vebrutuximab(CD30 ADC)Roche's enfuramatumab(HER2 ADC)Pfizer's ogavilimab(CD22 ADC), as well as the recently approved cloud-based oncology treatment for lymphoma, GC014 (Trop2 ADC).
Judging from the preliminary review results, in addition to Yunding Xinyao's GS-TRIO (Trop2 ADC), the other fourADCThe medications have all been included in the list.
In addition, Jiang Tengfei, Senior Healthcare Industry Consultant at Frost & Sullivan Greater China, also pointed out,2022and2021annual averageBiotechThe year when innovative drug products are included in medical insurance marks an important “major exam&rquo;, and for local companiesBiotechThe inclusion of innovative drugs in medical insurance is conducive to their rapid scale-up, accelerating commercialization. At the same time, it alleviates patients' payment problems and improves their quality of life, which is of great significance.
"2022In [year], key concerns in the preliminary review listCAR-T,ADCmedications,PD-(L)1 inhibitorwait. Among Chinese innovative pharmaceutical companies, Yasheng Medicine'sBcr-AblInhibitors olaparib and Hengrui'sCDK4/6Inhibitor Darciplatin andARAntagonist Veruconazole, BeiDa PharmaceuticalALKThe inhibitor ensartinib is worthy of attention. ' Jiang Tengfei said, 'The annual medical insurance negotiations include a list1And directories2In addition to newly launched drugs, the expansion of indications also requires medical insurance negotiations. Rational price negotiation strategies and key choices will continue to challenge the wisdom and endurance of managers at leading domestic biotech companies.
The National Healthcare Security Administration pointed out that in accordance with the Interim Measures for the Administration of Essential Medicines and2022The 'Work Plan for the Adjustment of the National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug List in 2023' stipulates that the adjustment of the medical insurance drug list is divided into several stages: enterprise declaration, formal review, expert evaluation, negotiation and bidding. The formal review is just one of these stages. Passing the formal review indicates that the drug is eligible to proceed to the next stage of expert evaluation. Only by successfully completing all stages of the list adjustment can the drug ultimately be included in the national medical insurance drug list.
*This article is reprinted from Blue Whale Finance. Author: Tu Jun , Original title: 344The variety passes2022Preliminary review of the National Medical Insurance Drug ListPD-(L)1 inhibitor,CAR-Ttherapy,ADCWhat are the highlights of the drug? >>
Frost & Sullivan Insight & Extended Readings
QCurrently available:344Which varieties have been included in the preliminary review list? Which ones are more interesting?
A: The primary focus is on rare disease medication, which has appeared in this year's preliminary listVenetoclax/Aldurazyme/Idursulfase beta/Ofatumumab/Dimethyl Fumarate, focusing on fields such as digestion and metabolism, oncology, and autoimmunity.
at the same time,CAR-T, ADCThere are also several drugs in the field that have entered the preliminary review list, which is worth noting. TargetedHER2ofADCFor example, in the pharmaceutical field, last year Rongchang's product negotiations were successful, while Roche's products did not enter the preliminary review list. Takeda's vedolizumab was shortlisted but its negotiations failed due to extremely fierce competition.
In addition, pay attention to children's medications. They are included in this year's preliminary list11The treatment portfolio covers central nervous system diseases, immunological diseases, and more.
andPD-(L)1 inhibitorThe medical insurance access is also quite interesting,4Domestic leading enterprises all have2 - 4A new indication application. The products of Hengrui, BeiGene, Innovent Biologics, and Junshi Biologics all meet the conditions listed in the catalog2（2017year1month1day after tomorrow2022year6month30During the period, drugs whose indications or functions and indications have undergone significant changes, with the approval of national drug regulatory authorities, were included in the preliminary list for this medical insurance catalog adjustment. Competition for major indications is concentrated and fierce, especially for non-small cell lung cancer, esophageal squamous cell carcinoma, nasopharyngeal carcinoma, etc. Among the newly approved products, only sulimumab and enzolimab have entered the preliminary list, while pamukamab, siparlimab, and sugimicab3The product has not been included in the preliminary review list. And importPD-(L)1 inhibitorIt is reasonable that both have given up on medical insurance negotiations.
