Ranibizumab Achieves Full Reimbursement in China with All Four Approved Indications Included in National Medical Insurance

Shanghai, November 28, 2019 /PRNewswire/ -- The National Healthcare Security Administration released the Class B scope of the "National Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance Drug Catalog (2019 Edition)" (hereinafter referred to as the Drug Catalog). Among them, Novartis Pharmaceuticals' ophthalmic anti-vascular endothelial growth factor (anti-VEGF) drug ranibizumab (brand name: Lucentis^®) Three new indications were included in the National Reimbursement Drug List (Category B), for the treatment of diabetic macular edema (DME), macular edema secondary to retinal vein occlusion (RVO), and choroidal neovascularization (CNV).

Ranibizumab’s first approved indication in China, wet age-related macular degeneration (wAMD), was included in the National Reimbursement Drug List in 2017. With the addition of three new indications in this round, all currently approved indications for ranibizumab in China are now covered by the national reimbursement list, making it a domesticMaximumAnti-VEGF drugs whose indications are included in the National Reimbursement Drug List. Meanwhile, following this negotiation, ranibizumab has also become the current... for Chinese patients with macular edema secondary to retinal vein occlusion (RVO).UniqueAnti-VEGF drugs available within the scope of the National Reimbursement Drug List.

Ranibizumab isThe world’s first and China’s firstAnti-vascular endothelial growth factor (VEGF) drugs approved for ophthalmic use. Ranibizumab launched in the United StatesTime, which was named one of the Top Ten Scientific Breakthroughs of the Year by the U.S. journal Science，and received the "Galen Prize," which is hailed as the Nobel Prize of the pharmaceutical industry. After its launch in China, ranibizumab was successively approved for the treatment of wet age-related macular degeneration (wAMD), macular edema secondary to retinal vein occlusion (RVO), diabetic macular edema (DME), and choroidal neovascularization (CNV). It is currently the only drug in China withMaximumAnti-VEGF drugs for indications.

“In our past clinical experience, we often encounter many patients using ranibizumab who, due to different indications, are fortunate enough”Earthenjoying medical insurance prices, while others had to bear substantial medical expenses. Now that all indications are covered by medical insurance, every patient can enjoy equitable accessGround“Benefiting from the reforms to the medical insurance system is a tremendous boon for patients’ families. Meanwhile, we hope that such policies will be implemented in reimbursement regulations as soon as possible, thereby benefiting more patients at an earlier stage,” said Dai Hong, Director of the Department of Ophthalmology at Beijing Hospital.

China has a large population of patients with eye diseases, and fundus disorders such as wet age-related macular degeneration (wAMD), diabetic macular edema (DME), retinal vein occlusion (RVO), and choroidal neovascularization (CNV) have become leading causes of blindness among Chinese patients. Previously, the National Health Commission issued the “13th Five-Year” National Eye Health Plan (2016–2020), pointing out that China’s efforts in eye disease prevention and control are at a critical and opportune stage, requiring further practical measures to improve the eye health of the population. In this national medical insurance negotiation, ranibizumab actively responded to national policies by reducing its price to gain inclusion in the medical insurance catalog, which will further reduce avoidable blindness caused by fundus diseases.

Taking the newly added indication for diabetic macular edema (DME) as an example, there are currently approximately 110 million patients with diabetes in China, of whom about 23% have diabetic retinopathy (DR).^[1], which has also become one of the leading causes of visual impairment in the working-age population. Diabetic macular edema (DME) is a major complication of diabetic retinopathy (DR) and the primary cause of visual function impairment in patients with DR.^[2], as DR progresses, the incidence of DME gradually increases^[3]. In the 2017 updated AAO guidelines and multiple internationally published guidelines related to DME, it is clearly stated that anti-VEGF therapy is the first-line treatment option for DME.

RVO is known as “eye stroke” and is the second most common retinal vascular disease after DR.^[4]。RVOIt can cause complications such as macular edema, macular ischemia, and neovascularization. If not treated promptly, it may lead to vision loss or blindness. The situation in China is more severe: the average age of patients with retinal vein occlusion (RVO) is 52 years, at least 10 years younger than in other countries, which seriously affects the eye health of the working-age population.^[5]。Currently, international guidelines and consensus statements uniformly recommend anti-VEGF therapy as the first-line treatment for macular edema secondary to retinal vein occlusion (RVO). Following this negotiation, ranibizumab has also becomeCurrently the onlyAnti-VEGF Drugs Available Within the National Reimbursement Drug List (NRDL) Scope.

Fundus diseases severely impair patients' quality of life and impose a substantial economic burden. According to statistics, the average annual economic burden per person among individuals aged 50 and above with visual impairment in China is approximately RMB 60,000, and 51.69% of families with visually impaired members incur catastrophic health expenditures.^[6]. Taking retinal vein occlusion (RVO) as an example, the costs associated with RVO and its complications are substantial, imposing a disease burden of over RMB 40,000 per eye per year on patients.^[7], promoting patient acceptance of anti-VEGF therapy not only helps patients reduce treatment costs but also saves healthcare expenditures for the country.

References:

[1].  Xu, Y., et al., Prevalence and control of diabetes in Chinese adults. Jama, 2013. 310(9): p. 948-59.

[2]. Xu X, Lu Y. Chinese Journal of Ocular Fundus Diseases, 2018, 34(4):313-316

[3].  Lee R, et al. Eye Vis (Lond) 2015; 2: 17.

[4].  Wong TY, Scott IU. Clinical practice. Retinal-vein occlusion. N Engl J Med 2010; 363(22):2135- 2144

[5].  Rogers S et al,Ophthalmology. 2010 Feb;117(2):313-9.e1

[6].  Deramo et al. Arch Ophthalmol 2003;121:1297–302

[7]. Zhang Yabing, et al. Chinese Health Economics. 2015;34(1):63-65.