Exploring the reasons why Zhong Nanshan suggested "Viagra" to enter health care

"This drug (Sidinafi, Viagra) we want to try to get it into health insurance."this is the view of Zhong Nanshan, a member of the Chinese Academy of Engineeringnot only Zhong Nanshan, December 7, held in Guangzhou, yang city pulmonary hypertension international forum (2019), including his many experts have said that from the point of view of the treatment of pulmonary hypertension, they support the "Viagra" drugs into health insurance, because it is effective, and relative to other imported targeted drugs, the price is relatively cheappulmonary hypertension, known as "cancer in cardiovascular disease", due to inadequate pulmonary circulation and lack of oxygen, lips blue-purple, patients also known as "blue lips" patients, can lead to heart failure, if not effective treatment, the average life of the patient is only 2.8 years, according to the news report, Zhong Nanshan introduced that the incidence of pulmonary hypertension of up to 1%, is a common disease, but among them isopathic pulmonary hypertension is a rare disease, conservatively estimated the number of such patients in China is 3-5 millionpulmonary hypertension patients spend an average of 20,000 to 200,000 yuan a year on drugs, patients generally can not afford to take drugs, and "Viagra" drugs are relatively cheap, a survey shows that more than half of pulmonary hypertension patients are using it to treat the disease, so Zhong Nanshan is fighting for "Viagra" drugs into health insurancethe dilemma, however, is that although the FDA approved Sidina non-for the treatment of pulmonary hypertension as early as 2005, in China, approved adaptation certificates are still a familiar use for Sidinanoneven, when patients go to the pharmacy to buy "life-saving medicine", it can be very embarrassinglittle girl who eats Viagrahas this short video on the Internet in September, an 8-year-old girl from Xuchang City, Henan Province, ran to the pharmacy and said she wanted to buy "West African land" (commonly known as Viagra), and a purchase was ten boxes of 500 yuan eachA slightly awkward scene, which has been playing out in recent yearsIn the face of other people's strange vision, Xiaoya mother can only endure tears again and again to explain - the daughter is a pulmonary hypertension patients, eating Viagra can save livespulmonary hypertension is about 1% of the global population, and the China Charity Federation estimates that there are about 12 million patients in Chinais mainly divided into isopathic (primary) pulmonary hypertension and secondary pulmonary hypertension, in which iacopulmonary hypertension temporarily can not identify a clear cause, in May 2018, the Health and Reform Commission and other five departments jointly formulated the "first batch of rare diseases" directory, ieropathic pulmonary hypertension ranked among them"The incidence of pulmonary hypertension is not high, but it is a malignant disease, young patients are the majority, once diagnosed, the average life expectancy is less than three years, than some malignant tumors are 'evil'Ge Junbo, a member of the Chinese Academy of Sciences, pointed outpatients are young and have a very low quality of lifeThe appearance of sound but limited mobility, daily walking for them is also a painful ordealdrugs for the disease, including the targeted drugs such as Angio, Vantavi, Remodulin, as well as the agency, Tadalavic and other drugs, a total of more than a dozen have been listedOne industry expert pointed out that the five-year survival rate of patients increased from 20 percent to 50 percent after the targeted drug of pulmonary hypertension was applied to the clinic"Maxi Tengtan, 29,980 yuan per month; Leo Si-yuan, 8,000 yuan per month; Anlishengtan, Possontan 5,385 yuan per month; injection of Remodulin, three or so per month, 10,000 yuan eachThere are also two or three drugs combined"Southern Weekend" has reported on the video of the girl Xiaoya, Xiaoya's mother these expensive life-saving drugs such as several JaneJing Zhicheng has pointed out that the treatment of severe pulmonary hypertension drug "subcutaneous injection of remodulin" an injection of about 10,000 yuan, each patient needs about 2 to 3 per monthTreatment light to moderate oral Anlisheng tablets, the monthly cost of treatment is about 3500 yuan to 6000 yuan, the patient's financial burden of medication"There are few cheap generic drugs to treat pulmonary hypertension, most of which rely on imports." "One industry source saidat the beginning, Xiaoya also ate imported medicineBut the expensive medical expenses almost hollowed out the little Ya family"Her father and i both work, hit a not hit two, hit two not hit four." "Under the lens, Xiaoya's mother broke down in tearsThe couple's monthly income is only 4,000 yuan, so far, medical expenses have reached more than 40 million yuansee sick friends rely on "Viagra" to delay the disease, helpless, had to let Xiaoya also eat a relatively cheap "Viagra" - 126 yuan per grain, a day need to drive to take three times a month, the monthly cost of medicine control at about 3000 yuan"Viagra" treatment pulmonary hypertension has been many years, because the dose is to treat ED and set, for patients with pulmonary hypertension, need to take a tablet of 4 to 5 servings to eat A survey of member patients conducted by the 's Center for Rare DiseaseCare found that 50.8 per cent of patients using Viagra-type drugs were used in the country Of these, 31.8 per cent were used, 5.9 per cent of Thevanaphand was used and 12.9 per cent were used by Hedarafi "Although Viagra is the cheapest of the three main target drugs, there are still many patients who can't afford it." Li Rong, executive director of Ai-visit, said small blue pills and white small pills the lungs of the human body is an important link in blood circulation, simplified, the body's blood cycle is repeated such a cycle process: low oxygen content of intravenous blood through the heart pump to reach the lungs, through the pulmonary artery to the pulmonary pulmonary network around the capillaries, gas exchange with the pulmonary bubble, carbon dioxide, oxygen, into oxygen-rich arterial blood, and then injected into the left atrium Such a cycle is called pulmonary circulation pulmonary hypertension disrupts the smooth progress of the cycle, when the pressure is too high, the pulmonary artery becomes narrow, and blood is difficult to circulate The result of inadequate pulmonary circulation is a decrease in blood oxygen content, which in turn results in blue lips and decreased endurance and to solve the problem of pulmonary hypertension, the core is to find a way to diastomy blood vessels, siding is not an avascular dilating agent treatment of pulmonary hypertension is not the original mission of Sidina, but the treatment of erectile dysfunction (ED) is not at the beginning of the development, Sidinawasi was the treatment of cardiovascular disease, after years of clinical trials, found that the results were not good As researchers prepare to declare a failure, they have accidentally discovered that it is effective in treating erectile dysfunction (ED), which has changed direction and launched a miracle drug In 1998, Sidinawaswas was approved for listing in the United States under the name Viagra Since then, "Little Blue Pill" has sold well around the world in 2005, the FDA approved the adaptation of Sidina's non-treatment of pulmonary hypertension, known as Revatio The two are different in terms of product name, tablet color (the color of the lung is white), the dose taken, the frequency of the dose, the composition of the accessory, etc the fda-approved adaptation certificate is intended for the population, only for adult treatment, not approved for use in children (1-17 years old) According to the notice disclosed on the FDA's official website, a long-term clinical pediatric trial showed that (1) children taking high doses of Revatio had a higher risk of death than children taking low doses of Revatio, and (2) low doses of Revatio did not effectively improve exercise Currently, only the European Drug Administration approved the application of Sidina in 2011 to children with pulmonary hypertension between the ages of 1 and 17 Far away in China, there are many small patients like Xiaoya, because they can not afford expensive special drugs, Sidinai has become their "life-saving medicine." sidinga has become a first-line treatment of PAH in China, and even this is clearly recorded in the China Lung Hypertension Diagnosis and Treatment Guidelines 2018 (hereinafter referred to as the Guide) In the drug specification, pulmonary hypertension appears in the "super-manual adaptation certificate" column, but also gives doctors the opportunity to use clinically "Viagra" into health care, what other dilemmas? pulmonary hypertension drugs have been called for years the family of a pulmonary hypertension patient who had hiked from Chengdu to Lhasa to advocate for the inclusion of pulmonary hypertension drugs in health insurance and to sign autographs from passers-by along On September 20th, a Tianjin resident complained about Posintina's health insurance on the People's Daily Online's "Leadership Message Board" there have been some advance explorations in the place As early as 2012, Qingdao and Shenyang will treat a certain variety of drugs to treat pulmonary hypertension into the scope of medical insurance payments, patients monthly out-of-pocket expenses by charity assistance of nearly 4000 yuan further reduced to about 1200 yuan August 2018, the first domestic imitation drug Anlisheng Tan tablets approved for the market Five provinces have now included it in the health insurance reimbursement list It is understood that if patients normally use the drug, through the "buy three give three" charity assistance, the monthly cost of patients in 1200 yuan to 2400 yuan, than the cost of taking the original medicine decreased by about two-thirds in addition, , in December 2018, the Inner Mongolia Autonomous Region Health Insurance Bureau officially followed, the pulmonary arterial hypertension into the basic medical insurance outpatient special slow disease protection scope, drugs including poshengtan tablets, anlithon tan tablets, quprosinneal injections, inhalation of iloprosin solution, will save patients nearly 40,000 yuan per year at the national level, four drugs for the treatment of pulmonary hypertension were included in the 2019 National Health Insurance Negotiating Drug List, released last month, including the Posson tablets, the Macitenstentan tablets and the Silupag tablets, as well as the Liocibos, which were developed jointly by Mercado and Bayer but there's no relatively cheap West Nidea A cardiologist at The Hospital of Sanjia believes that Viagra should be supported "In the clinical treatment of pulmonary hypertension, Viagra has been widely used but the biggest obstacle is that Sidinafi has not been approved for the adaptation of pulmonary hypertension in China add new adaptation certificates, which are equivalent to re-declaration of a new drug that requires clinical research and approval First, the time of at least 3 to 4 years, the second is the cost of at least tens of millions of yuan, coupled with this "minority disease" incidence, clinical trials are very difficult Jianwenjun in the database query, did not find Pfizer in China for the West Endanon application for pulmonary arterial hypertension adaptation certificate records, and the local generic drug company Yabang Epson Pharmaceuticals this year applied for and completed the study of the healthy human bioequivalence of sylph insyllades (20 mg), which is used to treat adult pulmonary hypertension, to improve motor capacity and delay the deterioration of the disease The reasons behind the failure of pulmonary hypertension to be included in the adaptation of West Africa's "Viagra" drugs have been complicated in China, Southern Reported over the weekend A doctor with knowledge of the drug revealed that in 2005, after the sale of the drug in the United States, the multinational drug companies that developed the drug had come up with the idea of listing the drug in the Chinese market, but at the time the Chinese medical community did not know much about this particular cardiovascular disease In addition, the addition of adaptation certificates requires pharmaceutical and clinical research in accordance with the Drug Registration Management Approach and relevant technical guidelines, and approved by the National Drug Administration With large clinical trials and low incidence of pulmonary arterial hypertension, the pharmaceutical companies are not strong lying in the face of uncertain expected profits this dilemma may be solved with the rise of real-world research In May this year, the Drug Review Center (CDE) released the Basic Considerations for Real World Evidence in Support of Drug Research and Development (Draft for Comments), which proposes that evidence obtained from real-world data analysis can support drug research and development in many forms, including pre-market clinical research and development and post-market evaluation In the case of rare disease synod synopsis, clinical trials have problems with the scarcity of cases and difficulties in recruiting, and on the other hand, in the choice of control groups, as rare diseases often have little or no alternative treatment Real-world data can be used as an external control of the experiment original title: Why Zhong Nanshan suggested "Viagra" into health care