Vabysmo·Evrysdi will be reimbursed in October

New reimbursement for hemophilia drugs Zivi and estradiol

New reimbursement standards for Vabysmo, SMA treatment Evrysdi, and hemophilia A treatment Jivi (Damoctocog Alfa Pegol) will be established from the 1st of next month.

 

The scope of reimbursement for Spinraza, a cure for spinal muscular atrophy, will be expanded, and the reimbursement standard for the emergency introduction drug Ivexproglycem Suspension will be established within the range recognized by the Minister of Food and Drug Safety.

 

The Ministry of Health and Welfare recently announced some revisions to the details of the standards and methods for applying such nursing care benefits.

 

We plan to implement it from the 1st of next month after collecting opinions on the 25th.

 

◆Vabysmo=Vabysmo, an ophthalmic medication, is newly approved for neovascular (wet) age-related macular degeneration and diabetic macular edema.

 

If the medication is replaced with Vabysmo with an administration opinion attached, and the treatment effect does not appear after 3 administrations, subsequent administration will not be reimbursed.

 

In addition, for diabetic macular edema, reimbursement is recognized up to 14 times in total, including the number of administrations of Aflibercept and Ranibizumab.

 

◆Evrysdi=Evrysdi is newly reimbursed when administered to patients with 5q spinal muscular atrophy with a confirmed genetic diagnosis of deletion or mutation of the 5q SMN-1 gene.

 

▲If the SMN2 gene copy number is 3 or less even before the onset of symptoms and the start of treatment is less than 6 months old, or ▲Patients who have developed SMA-related clinical symptoms and signs and are Type 1 to Type 3 and are not using a permanent ventilator are eligible for the benefit.

 

Reimbursement is not recognized for replacement or co-administration between Evrysdi and spinal muscular atrophy treatment.

 

However, if improvement is confirmed during Spinraza administration and does not meet the discontinuation criteria, but the committee determines that there are clinical reasons for replacement with Evrysdi, one replacement administration is permitted.

 

In addition, in-hospital prescriptions are the principle, but for long-term prescriptions, the dosage per prescription is limited to 2 bottles for discharge and outpatient use.

 

◆Jivi = Hemophilia A treatment Jivi is approved for reimbursement when administered to adult and adolescent (age 12 or older) hemophilia A patients with a previous treatment history (exposure for more than 150 days).

 

The single administration dose (one serving) is 20-25 IU/kg.

 

However, in case of moderate or higher bleeding, up to 30 IU/kg is allowed depending on the doctor's medical judgment.

 

◆Spinraza = Spinraza's benefits range is expanded based on the same standards as Evrysdi.

 

Patients with 5q Spinal Muscular Atrophy (SMA) with a confirmed genetic diagnosis of deletion or mutation of the 5q SMN-1 gene are eligible for administration.

 

Eligibility for coverage is ▲ SMN2 gene copy number of 3 or less even before symptom onset and less than 6 months of age at the start of treatment, or ▲ Type 1 to Type 3 with SMA-related clinical symptoms and signs and not using a permanent respirator.

 

In addition, both Spinraza and Evrysdi will be added to the list of expensive drugs.

 

The management period is 1 year, and those eligible for management are those who are over 18 years old at the time of first administration and have an HFMSE score of less than 5 points.

 

◆Other= Ivexproglycem Suspension is within the scope recognized by the Minister of Food and Drug Safety, that is, inoperable pancreatic islet cell adenoma, pancreatic islet cell carcinoma, or extrapancreatic malignant tumor in adults, leucine sensitivity, pancreatic islet cell hyperplasia, extrapancreatic malignant tumor, and islet cell in infants and children.

 

Reimbursement is recognized for the treatment of hyperinsulinemia related to adenoma or pancreatic islet adenomatosis.

 

It can be used not only as a temporary measure before surgery but also when hypoglycemia persists after surgery.

 

Preda and Progynova, which are estradiol preparations, are approved for use not only within the scope of approval, such as prevention of menopausal disorders and postmenopausal osteoporosis, but also for hypoestrogenism (for women over 11 years of age) due to decreased gonadal function and ovarian dysfunction, and assisted reproductive technology.