Oral SMA drug Evrysdi prescribed at tertiary hospitals

passes DC reviews at tertiary hospitals in Korea

Is in drug pricing negotiations with NHIS... final step to reimb

Attention rises on whether the first oral treatment option for SMA will be born in Korea

The oral spinal muscular atrophy (SMA) treatment ‘Evrysdi’ may now be prescribed at tertiary hospitals in Korea.

 

According to industry sources, Roche Korea’s SMA treatment Evrysdi (risdiplam) passed the drug committee (DC) reviews at the Big 5 tertiary hospitals in Korea - Samsung Medical Center, Seoul National University Hospital, Seoul, Asan Medical Center, Seoul St.Mary’s Hospital, and Sinchon Severance Hospital – and many other major medical institutions including the Gangnam Severance Hospital, Pusan National University Hospital at Yangsan, and Yongin Severance Hospital.

 

As Roche is currently in the final negotiation stage with the National Health Insurance Service for Evrysdi’s reimbursement, the industry believes Evrysdi’s reimbursement listing will quickly turn into prescriptions, if it is granted reimbursement.

 

Evrysdi was first approved in Korea in November 2020.

 

The company applied for the reimbursement listing of its drug in July 2022 but the agenda had long been pending at the Drug Reimbursement Standard Subcommittee stage after the committee deferred making decisions.

 

The agenda finally passed the Drug Reimbursement Standard Committee review in June this year.

 

Whether Evrysdi will be able to complete the reimbursement listing process until the end of this time and settle as an oral treatment option for SMA in Korea remains to be seen.

 

As the first oral option introduced in the field of SMA, Evrysdi has the advantage of allowing customized prescriptions for patients according to age and weight.

 

Currently, Biogen’s ‘Spinraza (nusinersen)’ and Novartis's Zolgensma (onasemnogene abeparvovec-xioi) are listed for reimbursement in Korea.

 

Meanwhile, Evrysdi’s efficacy has been demonstrated through the FIREFISH trial that was conducted on infants 2 months to 7 months of age, and the SUNFISH trial that was conducted on children and adults of 2 years to 25 years of age.

 

In the SUNFISH trial that was conducted on 180 Type 2 or 3 SMA patients, Evrysdi improved motor function at Month 12, as measured by the Motor Function Measure 32 (MFM-32) score from baseline.

 

Also, in the FIREFISH trial that was conducted on infants 2 to 7 months of age with Type 1 SMA, 88% of the patients that were administered Evrysdi for 2 years survived the 2 consecutive years without ventilator support.

 

Based on the Bailey Infant Development Test (BSID-III) that measures infant development and motor activity, 59% of the infants that were administered Evrysdi were able to sit without support for at least 5 seconds.

 

Also, 65% of the infants were able to control their necks for 1 year, 29% were able to turn on their buttocks, and 30% were able to stand with support.