New benefits for Epidiolex will be established from April

The MOHW announced the administration of amendments to the drug notification for Beovu·Atmeg Combigel·Xeljanz XR Tab

New standard for Epidiolex (a drug for refractory childhood epilepsy) will be established.

 

Democratic Party of Korea Rep.

 

Nam In-soon and others strongly pointed out the validity of health insurance benefits at last year's national audit.

 

Epidiolex costs about ₩1.64 million per bottle, and up to ₩40 million per year.

 

On the 17th, the MOHW announced an administrative notice of the amendment to the notification of details on the application standards and methods of medical care benefits.

 

It is scheduled to be implemented from April 1 after collecting opinions by the 24th.

 

In the revised bill, first, a new reimbursement standard for Cannabidiol (Epidiolex, CDB oil), a seizure treatment drug related to Lenox-Gasto Syndrome or Dravet Syndrome, will be established.

 

Administration methods, administration targets, and evaluation methods are prepared within the scope of the approval of the MFDS.

 

These patients were administered at a dose but did not show seizure reduction by more than 50% compared to the time of initial antiepileptic drug administration.

 

It is administered in combination with Clobazam, and if it cannot be administered due to contraindications or side effects to Clobazam, it can be administered alone.

 

Epidiolex is subject to the deliberation and resolution of the reimbursement list and benefit upper limit amount table of the Health Insurance Policy Deliberation Committee to be held in late March.

 

Epidiolex is a drug that Democratic Party of Korea Rep.

 

Nam In-soon repeatedly emphasized the validity and urgency of the benefit.

 

At last year's inspection of the state administration, she said, "Epidiolex, which is a rare among pediatric epilepsy patients, is effective for patients with Travet syndrome or Lennox-Gasto syndrome, and is a drug that burdens children and parents because it is expensive." She pointed out that "there is a need for rapid promotion of health insurance coverage." In addition to Epidiolex, as Atorvastatin, a treatment for dyslipidemia, and Atmeg Combigel, a combination of omega-3, are scheduled to be listed, a new reimbursement standard will be established by referring to differences in license requirements from existing drugs.

 

Atmeg Combigel is administered to complex dyslipidemia in which low-density lipoprotein cholesterol (LDL-C) levels are properly controlled with a single treatment of Atorvastatin 40 mg, but triglyceride (TG) levels are not controlled despite proper diet.

 

The triglyceride level is 1 when side effects are expected when using an existing similar alternative drug (Fibrate or Niacin series) when blood TG≥500 mg/dL, risk factors or diabetes, blood TG≥200 mg/dL.

 

4 capsules per day are accepted.

 

In addition, as the new vascular (wet) age-related macular degeneration drug Beovu Prefilled Syringe is scheduled to be listed, new standards such as administration targets and evaluation methods will be established.

 

According to the newly established standards, the subjects of administration are patients with submacular choroidal neovascularization due to age-related macular degeneration, and cases of scarring or severe atrophy are excluded from administration.

 

As for the administration method, if the treatment effect is not observed even after the initial three doses, subsequent administration is not recognized.

 

In the case of using only one of Eylea and Lucentis, if there is no therapeutic effect after 3 times of administration after replacing with Beovu, subsequent administration will not be recognized as a benefit.

 

From the 5th dose, if the corrected visual acuity is less than 0.1, no benefit is recognized.

 

Concomitant administration with Visudyne (Vertporfin) is not recognized.

 

The newly listed rheumatoid arthritis treatment Xeljanz XR Tab.

 

11mg (Tofacitinib) is admitted in accordance with the notification of the comparative drug reimbursement standard, but is revised in consideration of the difference in authorization.