Handok and JW’s new imported drugs reimbursed from July

to be listed for reimbursement next month

Fabhalta, a new oral drug for paroxysmal nocturnal hemoglobinuria

Ebglyss, a biological agent for severe atopic dermatitis

MOHW announces four new drugs to be listed for reimbursement in July

Tavalisse (JW Pharmaceutical) and Doptelet (Handok) will both be reimbursed for ITP from next month

In July, four new drugs, including an oral drug for paroxysmal nocturnal hemoglobinuria (PNH), a new biological agent for severe atopic dermatitis, and a new drug for immune thrombocytopenia (ITP), will be reimbursed by health insurance and be available with coverage for patients.

 

On the 19th, the MOHW announced the establishment of reimbursement standards for four new drugs, including Fabhalta Cap 200 mg (Iptacopan hydrochloride monohydrate, Novartis Korea), a new drug for the treatment of PNH.

 

The reimbursement will take effect on the 1st of next month.

 

In addition to Fabhalta Cap 200 mg, a treatment for severe atopic dermatitis, Ebglyss Autoinjector 250 mg (lebrikizumab-lbkz, Lilly Korea), ‘Doptelet Tab 20mg (avatrombopag maleate, Handok),’ and ‘Tavalisse Tab 100·150mg (fostamatinib sodium hydrate, JW Pharmaceutical).’ Fabhalta Cap 200 mg is an oral treatment for paroxysmal nocturnal hemoglobinuria and is expected to be more convenient than the injectable drugs that have been used until now.

 

In addition, its hemolysis control effect is expected to be better than existing C5 inhibitors (Soliris and Ultomiris).

 

PNH is a rare condition that affects about 1.5 people per 1 million worldwide.

 

Until now, Soliris (eculizumab) and Ultomiris (ravulizumab) have been the main C5 inhibitors used for PNH.

 

In November last year, Empaveli (pegcetacoplan, Handok), a subcutaneous injection that binds to C3 and C3b to inhibit the complement cascade, was also approved for reimbursement.

 

The reimbursement of the new oral drug Fabhalta is expected to improve access to treatment and offer better therapeutic effects.

 

Ebglyss Autoinjector 250 mg is reimbursed for adult (18 years of age or older) and adolescent (12 to 17 years of age, weighing 40 kg or more) patients with chronic severe atopic dermatitis whose symptoms have persisted for three years or more.

 

This drug is the third biological agent for atopic dermatitis, following Dupixent (dupilumab) and Adtralza (tralokinumab).

 

Ebglyss has demonstrated clinical efficacy and safety profiles through a Phase III clinical trial and is expected to become a first-line treatment option for atopic dermatitis patients in Korea.

 

Doptelet Tab and Tavalisse Tab will be reimbursed for the treatment of adult chronic immune thrombocytopenia (ITP) that is unresponsive to corticosteroids and immunoglobulin.

 

ITP is an autoimmune disease in which the immune system mistakes platelets for viruses and attacks them, causing platelet counts to fall below normal levels and increasing the risk of bleeding.

 

As a result, patients may experience easy bruising and frequent bleeding, which in severe cases can lead to cerebral hemorrhage or gastrointestinal bleeding.

 

According to the ITP Clinical Practice Guidelines issued by the Korean Society of Hematology, steroids and immunoglobulins are recommended as first-line treatments, while splenectomy or thrombopoietin-receptor agonists (TPO-RA) are recommended as second-line treatments for chronic ITP patients.

 

With rare disease drugs imported by domestic pharmaceutical companies such as Handok and JW Pharmaceutical now reimbursed, industry eyes are on how the drugs will be received in the market.