Novartis Announces Inclusion of Gilenya® and Mayzent® in China's 2020 National Reimbursement Drug List for Multiple Sclerosis Treatment

Shanghai, December 28, 2020 /PRNewswire/ -- Novartis China announced today that its disease-modifying therapy (DMT) drug Gilenya, used for the treatment of multiple sclerosis (MS),^®(Generic name: Fingolimod Hydrochloride Capsules) and Mayzent^®(Generic name: Siponimod Tablets) was included in the National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance (2020 Edition), significantly reducing the medical payment burden for patients with multiple sclerosis in China.

Fingolimod and siponimod are standard disease-modifying therapies (DMTs) for the relapsing phase of multiple sclerosis (MS). Growing evidence from real-world studies indicates that early initiation of high-efficacy DMT can effectively reduce disease relapses and delay disability progression.^[1]。

Fingolimod has been included in China’s first batch of clinically urgent drug lists. It is currently the only disease-modifying therapy (DMT) approved in China and globally for the treatment of multiple sclerosis (MS) in both adults and children aged 10 years and older. It works by intervening in peripheral inflammatory lesions, thereby reducing clinical relapses and the formation or enlargement of new lesions. Fingolimod has been marketed in 80 countries worldwide, with over 15 years of real-world experience benefiting more than 300,000 MS patients.^[2]。

Siponimod received priority review and approval for market launch from the National Medical Products Administration (NMPA) as a Class 1 new drug in May this year, achieving near-synchronous availability with the United States and the European Union. Siponimod is currently the first and only oral disease-modifying therapy (DMT) worldwide that not only exerts anti-inflammatory effects in both the peripheral and central nervous systems but also promotes remyelination and protects the central nervous system in patients with active relapsing multiple sclerosis (RMS), thereby delaying disability progression.^[3], which can delay the time to wheelchair dependence by 4.3 years, filling an unmet need in the treatment of progressive RMS^[4]。

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Multiple Sclerosis (MS) is a chronic inflammatory autoimmune disease in which the patient’s own immune system attacks the myelin sheath that protects nerves, leading to neurological impairment. Most patients experience their first symptoms between the ages of 20 and 40, making MS one of the most common causes of neurological disability among young and middle-aged adults. Multiple sclerosis was included in the First Batch of the Rare Disease Catalogue in 2018, and there are currently more than 30,000 diagnosed MS patients in China.^[5]。

85% of patients with multiple sclerosis have relapsing-remitting multiple sclerosis. If not effectively treated, as patients age and the disease progresses, remyelination and repair mechanisms weaken, potentially leading to irreversible neurodegeneration, gradually worsening disability, and cognitive decline.

According to statistics, 58% of patients with relapsing-remitting multiple sclerosis experience ≥1 relapse per year. Each relapse severely impacts patients’ daily lives and work, and the hospitalization costs incurred during relapses impose a substantial economic burden on families and society. The “2020 Social Survey Report on Patients with Multiple Sclerosis in China” further revealed that among the 656 surveyed MS patients, over 43% were unable to perform activities of daily living due to physical disability and required caregiving support, while as many as 88.5% experienced unemployment or school dropout as a result of the disease. In 2018, the average annual out-of-pocket medical expenditure exceeded RMB 46,000, accounting for more than 45% of household annual income, thereby surpassing the threshold for catastrophic health expenditure.^[6]。

Disease-modifying therapies (DMTs) are the standard-of-care treatments for relapsing multiple sclerosis, as recommended by domestic and international guidelines and consensus statements. Adherence to long-term, standardized treatment can effectively reduce relapses and delay disability progression. In Europe and the United States, DMT utilization rates have exceeded 86%, whereas in China, the current rate stands at only around 10%. Insufficient patient awareness of the disease and high treatment costs are the most significant factors limiting DMT adoption. Thanks to the national emphasis on rare diseases and continuously optimized medical insurance policies, two innovative drugs, fingolimod and siponimod, have been rapidly included in the National Reimbursement Drug List. This has bridged the “last mile” from drug approval to market availability, ensuring that patients can truly access and afford these medications, thereby making compassionate care attainable.

Since the list of drugs proposed for negotiation under the National Reimbursement Drug List (NRDL) was finalized in August this year, Fingolimod and Siponimod have ultimately been included in the NRDL after more than three months of selection and negotiations. Various cities and regions will gradually implement the negotiation results starting from 2021. It is anticipated that, with the implementation of the new NRDL, innovative drugs will benefit a greater number of patients with multiple sclerosis as soon as possible.

[1] Ontaneda, D., et al. Early highly effective versus escalation treatment approaches in relapsing multiple sclerosis. The Lancet Neurology. 2019; doi:10.1016/s1474-4422(19)30151-6

[2] Novartis data on file. PSUR 13

[3] National MS Society Brochure. Disease Modify Therapies for MS. http://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/Brochure-The-MS-Disease-Modifying-Medications.pdf

[4] Vermersch P,et,al. ECTRIMS 2019. September 11-13, 2019; Stockholm, Sweden. Abstract 158.

[5] Survival Report for Patients with Multiple Sclerosis (2018)https://health.qq.com/a/20190225/004129.htm

[6] “2020 Comprehensive Social Survey Report on Patients with Multiple Sclerosis in China”https://baijiahao.baidu.com/s?id=1686578378054544948&wfr=spider&for=pc