Breakthrough for NMOSD patients: AZ's Soliris now covered by health insurance

In a significant step forward for neuromyelitis optica spectrum disorder (NMOSD) patients, AstraZeneca's Soliris (ingredient: eculizumab) is now covered by national health insurance in Korea. 

NMOSD, which affects fewer than three people per 100,000, occurs more frequently in Asians and Black individuals and predominantly affects women over men. The median age of onset is in the 30s, a socially significant time when severe disabilities can occur. Unlike other autoimmune diseases, NMOSD can also appear in young children and in people as old as their late 80s.

At a press conference organized by AstraZeneca Korea on Tuesday, Professor Kim Ho-jin of the Department of Neurology at the National Cancer Center presented the importance of preventing NMOSD relapses and the significance of Soliris' reimbursement.

"Without proper treatment, NMOSD leads to about 50 percent of patients requiring wheelchairs within five years and to significant vision loss," Kim said. "Early diagnosis and effective treatment are crucial as while multiple sclerosis progresses slowly without frequent relapses, NMOSD erupts like a volcanic explosion right from the start, causing irreversible damage and permanent disability. Hence, the disease burden is overwhelmingly high."

Relapses often send most NMOSD patients to the emergency room, and the medical expenses of those who have experienced relapses are four times higher than those who have not, he added.

Kim stressed that the severity and frequency of NMOSD relapse not only lead to disability but also significantly impact the quality of life of the affected individuals.

In light of such a high drug burden, Kim showed high expectations for Soliris reimbursement for NMOSD.  

"Soliris is the first drug approved by the U.S. FDA and Korea's MFDS for treating NMOSD," explained Professor Kim. "The PREVENT trial confirmed Soliris' relapse-free rate of 98 percent at the 48-week mark, and further extension studies showed a remarkable 94.4 percent relapse-free rate over 197 weeks (3.7 years)."

For NMOSD patients who've lived in fear of relapses for years, news of Soliris' insurance coverage is truly welcoming news, Kim added.

However, Kim stressed strict eligibility criteria present challenges that necessitate ongoing efforts to improve accessibility.

Under the expanded reimbursement regulation, NMOSD patients 18 and older who are positive for anti-AQP-4 antibodies, with an Expanded Disability Status Scale (EDSS) score of seven or below at the time of treatment are eligible to receive benefits.

Also, eligible patients must have experienced at least two relapses within the past year or three within the past two years and they must have used either rituximab or satralizumab but have relapsed or experienced side effects at least after three months of treatment.

"To qualify under the current coverage criteria, patients must endure multiple relapses that significantly diminish the quality of life," Kim said. "There's also a limit for patients who were previously paying for rituximab out-of-pocket to minimize relapse risks."

It's essential to increase access to high-efficacy treatments like Soliris, considering the life quality of patients who suffer from repeated relapses, Kim added.