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*Only for medical professionals to read for reference.
The new version of the drug catalog was officially launched in March 2021.
The National Medical Security Administration has officially announced the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2020)".
Compared with previous years, this medical insurance catalog has incorporated a variety of innovative drugs and rare disease drugs, which have benefited a wide range of Large therapeutic area.
Among them, the therapeutic drug Antaitan (deuterated tetrabenazine tablets) approved in May 2020 for the treatment of chorea related to Huntington’s disease (HD) and adult tardive dyskinesia (TD) successfully entered the medical insurance list.
Greatly improved the availability and affordability of drugs for the rare disease of HD.
Changing the clinical status of rare diseases HD is a rare autosomal dominant psychiatric disorder caused by the abnormal number of CAG repeats in exon 1 of the HTT gene.
The nerve cells in some areas of the patient’s brain gradually degenerate, leading to the face , Involuntary movement of the neck, trunk and limbs and cognitive impairment, abnormal mental behavior.
Epidemiological surveys show that HD is a rare disease.
The global incidence of HD is about 2.
7 cases per 100,000 people.
The incidence in European and American countries is relatively high, with 5.
7 cases per 100,000 people.
The incidence rate in Asia is relatively high.
Low, only 0.
4 cases per 100,000 people (1/25 million).
"Specific to the incidence in China, this data may not really explain the problem.
The incidence rate
of 1/2500 may be low.
" Professor Wu Zhiying, deputy dean of the Second Affiliated Hospital of Zhejiang University School of Medicine and director of the Neurology Research Center, believes Rare diseases have received less attention in China.
Many doctors do not fully understand the disease.
Patients and their families will also find this disease strange and lack of good treatment drugs.
As a result, many patients do not actually go to the hospital for treatment.
As experts said, the clinical treatment of HD is progressing very slowly, and there is a lack of breakthrough therapeutic drugs to delay disease progression.
In May 2020, Teva announced that its innovative drug, deuterium tetrabenazine tablets, has been approved by the National Food and Drug Administration (NMPA) for the treatment of HD-related chorea and adult TD.
This is the first approved listing in China HD treatment drugs, in addition, China is also the second country in the world to approve the drug after the United States.
Professor Wu Zhiying said that the entry of deuterium tetrabenazine into the Chinese market is a very milestone.
It not only enriches the clinical treatment options for doctors, but also brings hope for clinical treatment to patients.
“The country attaches great importance to the group of patients with rare diseases, and the ability to include this drug in medical insurance makes it easier for patients to afford it.
The clinical status and the distress situation of patients’ lives will be completely changed.
” Long-term safety of deuterium tetrabenazine has been greatly improved from the declaration.
To the rapid approval of listing, all highlight the extremely urgent clinical needs of HD.
In November 2018, deuterium tetrabenazine was included in the first batch of clinically urgently needed overseas new drugs announced by the country.
Thanks to the domestic medical regulatory reform and the continuous acceleration of the review of rare disease drugs, in March 2020, deuterium tetrabenazine The film was officially included in the priority review by the NMPA Drug Evaluation Center and quickly approved.
It is understood that deuterium tetrabenazine is a vesicle monoamine transporter 2 (VMAT2) inhibitor.
The drug is a derivative of tetrabenazine, in which the 6 H (hydrogen) of the two methoxy groups on the benzene ring Atom) is replaced by D (deuterium atom).
Professor Wu Zhiying further introduced the characteristics of deuterium tetrabenazine, pointing out that the incorporation of deuterium will reduce the rate of drug metabolism, reduce the frequency of administration, and significantly improve the safety and effectiveness of the drug.
"By improving the chemical molecular structure of deuterium tetrabenazine, it mainly acts on motor symptoms and acts on the dopamine receptor pathway.
In the past, some of the symptomatic drugs used to treat motor symptoms caused some mental symptoms.
The safety is better, and the benefits of long-term medication are very great.
"In a randomized, double-blind, placebo-controlled multicenter clinical trial involving 90 subjects with HD, the research data showed that: The average maximum total chorea score (TMC) improvement of patients in the benazine group was 4.
4, compared with 1.
9 in the placebo group; 33% of patients had a TMC score improvement of 6 points or more, and 2% in the placebo group. In addition, according to the Unified Huntington’s Disease Rating Scale (UHDRS) total exercise score (TMS), the average improvement in the deuterium tetrabenazine group was 7.
4 and that in the placebo group was 3.
4 [1].
Figure 1: Deuterium tetrabenazine significantly improved the TMC score of HD patients Figure 2: Deuterium tetrabenazine significantly improved the TMS score of HD patients According to the patient’s overall impression change scale, the treatment success rate of the deuterated tetrabenazine group was 51%.
20% in the placebo group; according to the total clinical efficacy scale, the treatment success rate in the deuterium tetrabenazine group was 42%, and the treatment success rate in the placebo group was 13%.
In terms of safety, the incidence of neuropsychiatric events in the deuterated tetrabenazine group was lower among patients who started treatment.
Figure 3: Deuterium tetrabenazine significantly improves the success rate of HD treatment.
It is not difficult to see that based on the unique mechanism of action of deuterated drugs and proven clinical trial data, deuterium tetrabenazine can reduce the frequency of medication and significantly improve HD patients The chorea symptoms, motor function, maintenance of the patient’s ability of daily life, and good safety.
The entry of deuterium tetrabenazine into the medical insurance catalog will surely provide a richer choice of drugs for the clinical treatment of HD in my country and also provide the possibility to improve the quality of life of patients.
References: [1] Samuel Frank, Claudia M Testa, David Stamler, et al.
Effect of Deutetrabenazine on Chorea Among Patients With Huntington Disease: A Randomized Clinical Tria[J].
JAMA.
2016; 316(1): 40-50 .
Expert profile Professor Wu Zhiying, winner of the National Outstanding Youth Fund, leader of the innovation team in key areas of the Ministry of Science and Technology, national candidate for the New Century Talent Project, and expert with special government allowances from the State Council.
Qiushi Distinguished Professor of Zhejiang University, Chief Physician, Deputy Dean of the Second Affiliated Hospital of Zhejiang University School of Medicine, Member of the Neurology Branch of the Chinese Medical Association, Head of the Neurogenetics Group, Vice Chairman of the Chinese Society of Neuroscience, Zhejiang Medicine Chairman-designate of the Society of Neurology, Deputy Chairman of the Rare Disease Branch of Zhejiang Medical Association.
Has undertaken 8 projects of the National Natural Science Foundation of China.
The corresponding author has published more than 100 SCI papers in well-known international journals of Nature Genetics, edited 1 English monograph (Inherited Neurological Disorders: Diagnosis and Case Study), and was invited to give more than 20 conference topics or special reports at international academic conferences.
He has successively won the 10th China Youth Science and Technology Award, the 9th China Young Female Scientist Award, the 1st China Outstanding Neurologist Academic Achievement Award, the 7th National Outstanding Scientific and Technological Worker, and the 8th National Health and Family Planning Outstanding Contribution Young and Middle-aged Expert, etc.
Honorary title.
The new version of the drug catalog was officially launched in March 2021.
The National Medical Security Administration has officially announced the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2020)".
Compared with previous years, this medical insurance catalog has incorporated a variety of innovative drugs and rare disease drugs, which have benefited a wide range of Large therapeutic area.
Among them, the therapeutic drug Antaitan (deuterated tetrabenazine tablets) approved in May 2020 for the treatment of chorea related to Huntington’s disease (HD) and adult tardive dyskinesia (TD) successfully entered the medical insurance list.
Greatly improved the availability and affordability of drugs for the rare disease of HD.
Changing the clinical status of rare diseases HD is a rare autosomal dominant psychiatric disorder caused by the abnormal number of CAG repeats in exon 1 of the HTT gene.
The nerve cells in some areas of the patient’s brain gradually degenerate, leading to the face , Involuntary movement of the neck, trunk and limbs and cognitive impairment, abnormal mental behavior.
Epidemiological surveys show that HD is a rare disease.
The global incidence of HD is about 2.
7 cases per 100,000 people.
The incidence in European and American countries is relatively high, with 5.
7 cases per 100,000 people.
The incidence rate in Asia is relatively high.
Low, only 0.
4 cases per 100,000 people (1/25 million).
"Specific to the incidence in China, this data may not really explain the problem.
The incidence rate
of 1/2500 may be low.
" Professor Wu Zhiying, deputy dean of the Second Affiliated Hospital of Zhejiang University School of Medicine and director of the Neurology Research Center, believes Rare diseases have received less attention in China.
Many doctors do not fully understand the disease.
Patients and their families will also find this disease strange and lack of good treatment drugs.
As a result, many patients do not actually go to the hospital for treatment.
As experts said, the clinical treatment of HD is progressing very slowly, and there is a lack of breakthrough therapeutic drugs to delay disease progression.
In May 2020, Teva announced that its innovative drug, deuterium tetrabenazine tablets, has been approved by the National Food and Drug Administration (NMPA) for the treatment of HD-related chorea and adult TD.
This is the first approved listing in China HD treatment drugs, in addition, China is also the second country in the world to approve the drug after the United States.
Professor Wu Zhiying said that the entry of deuterium tetrabenazine into the Chinese market is a very milestone.
It not only enriches the clinical treatment options for doctors, but also brings hope for clinical treatment to patients.
“The country attaches great importance to the group of patients with rare diseases, and the ability to include this drug in medical insurance makes it easier for patients to afford it.
The clinical status and the distress situation of patients’ lives will be completely changed.
” Long-term safety of deuterium tetrabenazine has been greatly improved from the declaration.
To the rapid approval of listing, all highlight the extremely urgent clinical needs of HD.
In November 2018, deuterium tetrabenazine was included in the first batch of clinically urgently needed overseas new drugs announced by the country.
Thanks to the domestic medical regulatory reform and the continuous acceleration of the review of rare disease drugs, in March 2020, deuterium tetrabenazine The film was officially included in the priority review by the NMPA Drug Evaluation Center and quickly approved.
It is understood that deuterium tetrabenazine is a vesicle monoamine transporter 2 (VMAT2) inhibitor.
The drug is a derivative of tetrabenazine, in which the 6 H (hydrogen) of the two methoxy groups on the benzene ring Atom) is replaced by D (deuterium atom).
Professor Wu Zhiying further introduced the characteristics of deuterium tetrabenazine, pointing out that the incorporation of deuterium will reduce the rate of drug metabolism, reduce the frequency of administration, and significantly improve the safety and effectiveness of the drug.
"By improving the chemical molecular structure of deuterium tetrabenazine, it mainly acts on motor symptoms and acts on the dopamine receptor pathway.
In the past, some of the symptomatic drugs used to treat motor symptoms caused some mental symptoms.
The safety is better, and the benefits of long-term medication are very great.
"In a randomized, double-blind, placebo-controlled multicenter clinical trial involving 90 subjects with HD, the research data showed that: The average maximum total chorea score (TMC) improvement of patients in the benazine group was 4.
4, compared with 1.
9 in the placebo group; 33% of patients had a TMC score improvement of 6 points or more, and 2% in the placebo group. In addition, according to the Unified Huntington’s Disease Rating Scale (UHDRS) total exercise score (TMS), the average improvement in the deuterium tetrabenazine group was 7.
4 and that in the placebo group was 3.
4 [1].
Figure 1: Deuterium tetrabenazine significantly improved the TMC score of HD patients Figure 2: Deuterium tetrabenazine significantly improved the TMS score of HD patients According to the patient’s overall impression change scale, the treatment success rate of the deuterated tetrabenazine group was 51%.
20% in the placebo group; according to the total clinical efficacy scale, the treatment success rate in the deuterium tetrabenazine group was 42%, and the treatment success rate in the placebo group was 13%.
In terms of safety, the incidence of neuropsychiatric events in the deuterated tetrabenazine group was lower among patients who started treatment.
Figure 3: Deuterium tetrabenazine significantly improves the success rate of HD treatment.
It is not difficult to see that based on the unique mechanism of action of deuterated drugs and proven clinical trial data, deuterium tetrabenazine can reduce the frequency of medication and significantly improve HD patients The chorea symptoms, motor function, maintenance of the patient’s ability of daily life, and good safety.
The entry of deuterium tetrabenazine into the medical insurance catalog will surely provide a richer choice of drugs for the clinical treatment of HD in my country and also provide the possibility to improve the quality of life of patients.
References: [1] Samuel Frank, Claudia M Testa, David Stamler, et al.
Effect of Deutetrabenazine on Chorea Among Patients With Huntington Disease: A Randomized Clinical Tria[J].
JAMA.
2016; 316(1): 40-50 .
Expert profile Professor Wu Zhiying, winner of the National Outstanding Youth Fund, leader of the innovation team in key areas of the Ministry of Science and Technology, national candidate for the New Century Talent Project, and expert with special government allowances from the State Council.
Qiushi Distinguished Professor of Zhejiang University, Chief Physician, Deputy Dean of the Second Affiliated Hospital of Zhejiang University School of Medicine, Member of the Neurology Branch of the Chinese Medical Association, Head of the Neurogenetics Group, Vice Chairman of the Chinese Society of Neuroscience, Zhejiang Medicine Chairman-designate of the Society of Neurology, Deputy Chairman of the Rare Disease Branch of Zhejiang Medical Association.
Has undertaken 8 projects of the National Natural Science Foundation of China.
The corresponding author has published more than 100 SCI papers in well-known international journals of Nature Genetics, edited 1 English monograph (Inherited Neurological Disorders: Diagnosis and Case Study), and was invited to give more than 20 conference topics or special reports at international academic conferences.
He has successively won the 10th China Youth Science and Technology Award, the 9th China Young Female Scientist Award, the 1st China Outstanding Neurologist Academic Achievement Award, the 7th National Outstanding Scientific and Technological Worker, and the 8th National Health and Family Planning Outstanding Contribution Young and Middle-aged Expert, etc.
Honorary title.
