[Newsmp] South Korea's national health insurance will cover Roche's oral Spinal Muscular Atrophy (SMA) treatment Evrysdi (ingredient: risdiplam) and its wet age-related macular degeneration (AMD) and diabetic macular edema (DME) treatment Vabysmo (ingredient: faricimab).

Bayer's hemophilia A treatment Jivi (ingredient: damoctocog alfa pegol) will also be newly covered, and coverage criteria for estradiol preparations, a hormone, will also be established.

Ivexproglycem Suspension (ingredient: diazoxide), an emergency-use drug, will be covered within the scope approved by the Minister of the Ministry of Food and Drug Safety.

Biogen's SMA treatment Spinraza (ingredient: nusinersen) will have its coverage expanded and will be added to the high-cost drug management program.

 

 

The Ministry of Health and Welfare announced an administrative notice of ‘Notice of the Review Results of a Healthcare Service Claim’ and began collecting opinions by September 25 for its implementation on the 1st of the next month.

According to the notification, Evrysdi is covered for patients with 5q SMA who have been diagnosed with deletions or mutations in the SMN1 gene.

The eligibility criteria for Evrysdi are as follows: Patients with 5q SMA who have a SMN2 gene copy number of 3 or less, even if symptoms have not yet manifested, and who start treatment before the age of 6 months. Patients with SMA who have Type 1-3 clinical symptoms and signs, and who are not using a permanent ventilator.

Despite the reimbursement of Evrysdi, replacement or combination therapy between SMA treatments is not covered by insurance.

However, if a patient is receiving Spinraza and shows improvement, and does not meet the discontinuation criteria, and the committee determines that there is a clinical reason to switch to Evrysdi, a single switch is approved.

In addition, the in-hospital prescription is the principle, but the maximum dose per prescription for long-term prescription is limited to 2 bottles for discharge and outpatient.

Spinraza, the first SMA treatment to be covered by insurance, was initially limited to patients who showed symptoms before the age of 3. However, the coverage scope will be expanded to include patients who meet the same criteria as Evrysdi.

Moreover, both drugs will be added to the high-cost drug management program. The management duration is one year, and eligible patients for management are those who are over 18 years old and have an HFMSE score of less than 5 points at their initial administration.

Vabysmo is reimbursed for wet age-related macular degeneration (AMD) and diabetic macular edema (DME).

For patients who are receiving Aflibercept (Eylea, Bayer) or Ranibizumab (Lucentis, Novartis) for neovascular age-related macular degeneration, if they switch to Vabysmo with an opinion attached, and if there is no therapeutic effect after 3 doses, subsequent doses are not covered by insurance.

Furthermore, for DME, a total of 14 doses are eligible for reimbursement, including Aflibercept and Ranibizumab.

Jivi, a drug used to treat hemophilia A, is covered by insurance for adult and adolescent (12 years of age or older) patients with hemophilia A who have a history of treatment (exposure for more than 150 days).

Preda (Dalim Biotech) and Progynova (Bayer) estradiol products are eligible for reimbursement not only within the approved indications such as menopausal disorders and postmenopausal osteoporosis prevention but also for hypogonadism, estrogen deficiency due to ovarian failure (in women over 11 years of age), and assisted reproductive techniques.

Ivexproglycem Suspension, which was introduced in an emergency at the request of the Korea Orphan & Essential Drug Center, is covered by insurance for the treatment of hypoglycemia caused by hyperinsulinemia associated with pancreatic islet cell tumor or pancreatic islet cell carcinoma that is inoperable in adults, and with leucine sensitivity, pancreatic islet hyperplasia, pancreatic extrapancreatic malignant tumors, pancreatic islet cell tumor, or pancreatic islet cell adenomatosis in infants and children. It can be used not only as a temporary measure before surgery but also in cases where hypoglycemia persists after surgery.