Will restrictions on oral SMA drug Evrysdi be lifted?

Will the restrictions set for reimbursed use of Evrysdi be lifted in Korea?

Roche applies for an improvement to the reimbursement standards…supported by relevant academic societies

Current standards allow reimbursement of up to 2 bottles per visit…attention is on HIRA’s review results

Whether the prescription restrictions set on the oral spinal muscular atrophy (SMA) treatment ‘Evrysdi’ may be lifted is gaining attention in Korea.

 

According to Dailypharm coverage, Roche Korea applied to expand the reimbursement of its SMA treatment Evrysdi (risdiplam), which is currently allowed up to 2 bottles per day, and the agenda is currently under review by the Korea Health Insurance Review and Assessment Service.

 

The need to expand Evrysdi’s reimbursement coverage has been continuously raised not only by the pharmaceutical company but also by prescribers on-site.

 

In fact, relevant academic societies and patient organizations have also submitted their statements to HIRA.

 

Spinraza is currently reimbursed for the treatment of 5q Spinal Muscular Atrophy in patients who received a genetic diagnosis of 5q SMN-1 deficiency or mutation that ▲ have 3 or fewer copies of SMN2 even before the onset of symptoms, and are less than 6 months old at the time of treatment initiation; or ▲ have SMA types 1-3 with clinical symptoms and signs related to SMA and are not on permanent ventilation.

 

However, the prescription volume restriction under the then-new reimbursement standards has resulted in unmet patient demand on-site.

 

According to the reimbursement standards, Evrysdi is prescribed on an in-patient basis and is allowed a maximum of 2 bottles per prescription for long-term use.

 

This is enough for adolescent and adult patients weighing 20kg or greater to take for about 3 weeks, which poses a challenge for patients with limited mobility and their caregivers to visit the hospital once every three weeks to refill their prescriptions.

 

In addition, additional visits to perform motor function assessments are required to continue receiving the medication, which may require more frequent visits than the reimbursement standards, increasing the burden on patients and their caregivers.

 

Oral medications have the advantage of being oral - therefore being easy to take - which can significantly reduce the burden of hospital visits.

 

However, it has been noted that the restriction set on the prescription volume may serve as a barrier for patients in need of oral medications.

 

Therefore, the industry’s eyes are focused on whether the reimbursement standards for Evrysdi may be improved this time.

 

Currently, Evrysdi is the only oral option available in the SMA space, with Biogen's Spinraza (nusinersen) and Novartis' Zolgensma (onasemnogene abeparvovec-xioi) being prescribed for SMA in Korea.