New reimbursement standards on Rinvoq and Remicade

Partially revised drug reimbursement standards by MOHW to come in effect from this month

Starting this month, the drug reimbursement would be granted on AbbVie Korea's rheumatoid arthritis treatment Rinvoq Sustained-release Tablet (upadacitinib) 15mg.

 

As a result, the reimbursement standards have been changed for drugs with other various substances available for a treatment switch, and the combination therapy with the drug would be included in the reimbursement standards.

 

Janssen Korea's Remicade (infliximab) injection, an immunosuppressant drug used in adult patients with Crohn's disease, has been newly indicated to treat intestinal Behçet's disease and received expanded coverage.

 

South Korea's Ministry of Health and Welfare's (MOHW) partially revised standards of the healthcare reimbursement (pharmaceuticals) has come in effect from Nov.

 

1.

 

◆New and revised standards on pharmaceuticals: As Rinvoq is newly listed from this month, a new reimbursement standard for upadacitinibs, including Rinvoq, was added.

 

An additional six months of reimbursed use would be permitted, if DAS28 score is decreases by 1.2 or more after six months of the use.

 

From then on, the score would be evaluated every six months and the continuous administration would be approved if the evaluation results from the first six months are maintained.

 

Due to the new reimbursement standard on the injection, the standards for other substance drugs eligible for switching have been added and changed.

 

Following are the drugs, including upadacitinib, to be applied with modified standards; Janssen Korea's rheumatoid arthritis treatment Simponi (golimumab) Prefilled Syringe Injection 50 mg, JW Pharmaceutical's Actemra (tocilizumab) Injection and Actemra Subcutaneous Injection 162 mg, Korea BMS' Orencia (abatacept) 250 mg and Orencia SubQ-Prefilled Syringe 125 mg, AbbVie Korea's Humira (adalimumab) Injection, Pfizer Pharmaceuticals Korea's Enbrel (etanercept) Injection, and Roche Korea's lymphoma treatment Mabthera (rituximab).

 

◆Newly listed Pencivir Cream: A new reimbursement standard was established to list a herpes simplex virus infection treatment Pencivir (penciclovir) Cream by Kolmar Korea.

 

According to the detailed criteria of the reimbursement, the healthcare benefit would be limited to the use within the approved indication of the drug (herpes simplex virus infection (herpes labialis)).

 

◆Additional changes on Remicade Injection: Among all infliximab drugs, immunosuppressant Remicade Injection by Janssen Korea was able to expand indication to treat intestinal Behcet's disease.

 

The coverage would be limited to the drugs with the indication.

 

As orally taken upadacitinib is newly listed, the reimbursement standard for the drug would add the name of the ingredient for a prescription switch.

 

The healthcare benefit on treating intestinal Behçet's disease is granted on patients older than 19 years of age, diagnosed with Behçet's disease, confirmed an intestinal ulcer via endoscopy, and not responsive to standard of care (SOC) (two or more drugs) or discontinued treatment due to adverse reaction.

 

Further sustained administration would be approved when the Behcet Disease Activity Score for Intestinal Behcet's Disease (DAIBD) is decreased by over 20 points within 14 weeks after the initial administration (administered three times).