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Which pharmaceutical enterprises will benefit from the expanded scope of medical insurance and drug reimbursement?
On May 13, the state health insurance administration and the ministry of finance issued a notice on doing a good job in providing basic medical care for urban and rural residents in 2019, which explicitly mentioned the need to establish and improve the mechanism for coordinating and paying outpatient medical insurance fees for urban and rural residents, with the focus on ensuring the common diseases and chronic diseases with heavy burden on the public. We will cover medical insurance reimbursement for outpatient medications such as hypertension and diabetes.
Meanwhile, sources close to the regulatory authorities told reporters that the second batch of "4+7" product catalog in 2019 is already on the agenda and will be released soon. Among them, antihypertensive drugs, hypoglycemic drugs and other drugs are the most important.
The diabetes drug market is growing rapidly
In recent years, the incidence of diabetes in China has been increasing rapidly. The number of people with diabetes in China has reached 114 million, with type 2 diabetes accounting for nearly 90 percent of the total, according to the national health and fitness commission.
The 2019 national health insurance directory adjustment plan was officially implemented, and the adjustment of the new health insurance directory is imminent. In this adjustment of the medical insurance directory, diabetes medication has become one of the priority categories.
The new national medical insurance catalogue contains 33 diabetes drugs, including 12 insulin drugs and 21 hypoglycemic drugs for type 2 diabetes.
In the field of diabetes, oral acarbose tablets, metformin tablets, reaglinide tablets and glimepirea tablets accounted for 15.3 billion yuan of the total amount of oral hypoglycemic drugs in public medical institutions in 2017, accounting for 70.69% of the total amount of oral hypoglycemic drugs, playing an important role in clinical drugs. Among them, acarbose accounted for half of oral hypoglycemic drugs.
According to the data of mineet, the market of acarbose drugs in Chinese public hospitals reached 7.4 billion yuan in 2017, with an increase of 18.79% year-on-year. It is a first-line hypoglycemic drug in the domestic clinical medication guidelines for diabetes, and has been included in the 2017 national medical insurance directory (category a) and 2018 national basic medicine directory.
The sales volume of bayer's acarbose tablet exceeded 4 billion yuan in 2017. East China medicine's acarbose tablet is not only the first copy in China, but also the first to pass the consistency evaluation. The average growth rate of sales in the last four years is about 30%.
Meanwhile, Beijing wansheng pharmaceutical, hainan rizhongtian pharmaceutical, qianjin pharmaceutical, xintai pharmaceutical (suzhou), haizheng pharmaceutical and other enterprises are also in the layout.
In addition to insulin and fixed dose compound preparations, currently, among the listed hypoglycemic drugs in China, biguanides, sulfonylureas, gleenes, alpha-glycosidase inhibitors and ddp-4 (dipeptidyl peptidase-4 inhibitors) have all been approved for consistency evaluation.
At present, metformin hydrochloride tablets have passed the consistency evaluation of manufacturers including guizhou tianan pharmaceutical, guangdong huanan pharmaceutical, Beijing sihuan pharmaceutical and shiyao group.
Metformin hydrochloride sustained release tablets have passed the consistency evaluation by deyuan pharmaceutical, Shanghai pharmaceutical, yuekang pharmaceutical and Shanghai xuantai pharmaceutical.
Dpp-4 generic drugs have been approved since 2019. Oxacon's xagliptin tablets 2.5mg and 5mg, and jiangsu haosen pharmaceutical and qilu pharmaceutical respectively approved viagliptin tablets 50mg are all new products approved in the first quarter of 2019.
Competition for hypertension drugs is fierce
According to the population number and structure, there are about 330 million hypertension patients in China. Of the 36 drugs in the second round of negotiations to be added to the medicare list in 2017, six are cardiovascular.
Omesartan ester is one of the most important antihypertensive drugs. Data show that in 2015, the global sales of daiichi sanhe's omethartan ester reached $1.847 billion, accounting for 25% of daiichi sanhe's total sales.
Ometasartan tablets approved in March this year will undoubtedly challenge the related market of daiichi sankyo.
Currently, as an antihypertensive drug, jiartan has passed the consistency evaluation of huahai pharmaceutical co., LTD., but due to the unresolved gene-toxic impurity event in 2018, it can only be re-marketed after the completion of the stability study.
As for amlodipine, a common hypertension drug, the sales volume in public medical institutions reached 5.689 billion yuan in 2017, according to data from mine.cn.
At present, many pharmaceutical enterprises under CRSC, jingxin pharmaceutical, huanghe pharmaceutical, yangzijiang pharmaceutical, suzhou dongrui pharmaceutical, chenxin pharmaceutical, yabao pharmaceutical and so on have passed the generic drug consistency evaluation.
Terrazosin hydrochloride tablets, which are used for the treatment of mild or moderate hypertension, sold more than 150 million yuan in public medical institutions in 2017. Abbott, the original research company, occupied more than 80% of the market share, and China resources secco, a subsidiary of China resources shuanghe, accounted for 12% of the sales share, which is the only enterprise that has passed the consistency evaluation.