'Xeljanz' reimbursed for juvenile idiopathic arthritis

Expanded scope has been confirmed, effective April…the first among JAK inhibitors

Pfizer provides various options, including syrup formulation

Product photo of Xeljanz

'Xeljanz' has become the first JAK inhibitor to be reimbursed for the treatment of juvenile idiopathic arthritis.

 

The Ministry of Health and Welfare (MOHW) has recently announced on the administrative notification board regarding the 'The Criteria and Scope of National Health Insurance (Pharmaceuticals)' that the reimbursement criteria for Pfizer Korea's Xeljanz (tofacitinib) will be expanded from April.

 

Xeljanz can be used to treat children (age 2 to 17) diagnosed with juvenile idiopathic arthritis according to the ILAR criteria (2001 revision), including ▲Polyarticular arthritis that affects five or more joints ▲Extended oligoarthritis ▲Psoriatic arthritis ▲Those who discontinued treatments due to inadequate response to one or more biological agent or side effects.

 

After 6 months of usage, an additional 6-month usage will be approved if an assessment indicates a decrease of over 30% in the number of inflammatory joints compared to the initial administration timepoint.

 

After that, the evaluation will be carried out every 6 months, and when the assessment result in the first 6 months is maintained, consistent administration will be approved.

 

This reimbursement approval is the first among the JAK inhibitors.

 

To date, 'Olumiant (baricitinib)' secured the same indication in September last year but is still non-reimbursed.

 

Similarly, 'Rinvoq (upadacitinib)' has not been domestically approved for treating idiopathic arthritis.

 

Following the patent expiration of Xeljanz, Pfizer has made efforts to increase product competitiveness by changing formulations in many ways.

 

In 2020, the company launched an extended-release formulation with fewer administrations for various arthritis treatments.

 

In 2023, Pfizer also launched a syrup formulation that is more convenient to administer to pediatric patients.

 

It is to be watched whether Xeljanz, with an opportunity to take the market share, prescription will increase in the idiopathic arthritis area.

 

Meanwhile, the efficacy of Xeljanz was demonstrated through the Phase 3 'JIA-I' trial.

 

The study compared the effectiveness and safety of the drug to a placebo in 225 patients aged 2 years and above and those aged 18 years and below.

 

In the study, Xeljanz tablet or syrup formulation (dosage depending on the weight range; 5 mg was administered less than twice a day) was administered for 18 weeks.

 

Patients (142 individuals) who reached the JIA ACR 30 (symptom improvement over 30%) were divided into Xeljanz and placebo groups.

 

The results at week 44 confirmed that the symptom worsening in the Xeljanz group (29%, 72 individuals) was significantly lower than those in the placebo group (53%, 70 individuals).

 

During the same period, the rate of reaching the JIA ACR30∙50∙70 (30∙50∙70% symptom improvement) was higher in the Xeljanz group.

 

Physical function measured by the Childhood Health Assessment Questionnaire (CHAQ) also confirmed significant improvement in the Xeljanz group (-0.11) compared to the placebo group (0.00).