Juvenile arthropathies (JIA and sJIA) Program in Pharmaceutical Benefits Scheme (PBS) 012-18051123

Juvenile arthropathies covers juvenile idiopathic arthritis (JIA) and systemic juvenile idiopathic arthritis (sJIA).

Listing dates:

• etanercept - 1 July 2003 (JIA)
• adalimumab - 1 November 2010
• tocilizumab i.v. formulation - 1 May 2012 (sJIA)
• tocilizumab i.v. formulation - 1 April 2014 (JIA)
• tocilizumab s.c. formulation - 1 August 2019 (JIA)
• tocilizumab s.c. formulation - 1 August 2020 (sJIA)
• tofacitinib - 1 December 2023 (JIA)

See Written Authority Required Drugs for more information.

Tocilizumab (Actemra®) is presented as:

• 80 mg per 4 mL intravenous solution
• 200 mg per 10 mL intravenous solution
• 400 mg per 20 mL intravenous solution
• 162mg/0.9mL injection (4x0.9mL) pen devices for subcutaneous administration
• 162mg/0.9mL injection (4x0.9mL) syringes for subcutaneous administration

Note:

• the most cost-effective combination of vials must be prescribed
• a separate authority prescription is required for each strength

JIA recommended doses:

• Intravenous dosing regimen:
• <30 kg is 10 mg per kg every 4 weeks
• ≥30 kg is 8 mg per kg every 4 weeks
• Subcutaneous dosing regimen:
• 162 mg once every 3 weeks for patients below 30 kg
• 162 mg once every 2 weeks for patients ≥ 30 kg

sJIA recommended doses:

• Intravenous dosing regimen:
• <30 kg is 12 mg per kg every 2 weeks
• ≥30 kg is 8 mg per kg every 2 weeks
• Subcutaneous dosing regimen:
• 162 mg once every 2 weeks for patients below 30 kg
• 162 mg once every week for patients ≥ 30 kg

When a patient qualifies for treatment, they will have a measured and defined level of disease activity:

• these levels become the patient’s baselines
• future applications for treatment must be measured against the baselines to determine a response or failure to current treatment
• a patient who fails treatment with one medicine may wish to use this flare of disease to set a new baseline for future treatment to measure against

JIA patients under 18 years are measured by the number of joints that are tender and swollen.

JIA patients over 18 years are measured by the number of joints that are tender and swollen and inflammatory and blood markers:

• erythrocyte sedimentation rate (ESR) and c-reactive protein (CRP) are blood markers that measure inflammation
• one of these markers must be elevated at baseline (or a reason why it is supressed)
• continuing treatment must be assessed against the markers provided at baseline

sJIA patients are either:

• polyarticular course disease and are monitored on affected joints, or
• refractory systemic disease and are monitored on the absence of fever, elevated CRP, or steroid treatment

sJIA vs JIA treatment

sJIA is a type of JIA.

Tocilizumab is listed for sJIA refractory and polyarticular patients (same restriction).

Tocilizumab was later listed for all JIA patients with different initial requirements. Both restrictions are still in effect.

Adults and JIA

A patient who starts JIA treatment before they turn 18 years is treated as a JIA <18 even when they become an adult.

Only a patient who starts treatment as an adult patient with onset before 18 years is treated as a JIA >18.

A sJIA patient must be under 18 years when they apply for initial treatment. If approved, they are eligible to continue treatment once they turn 18 years.

Treatment failures and breaks

A break in treatment cycles is measured:

• from the date of last approval for PBS-subsidised biological medicine treatment in the most recent cycle
• to the date of the first application for initial treatment with a biological medicine under the new treatment cycle

There is no limit to the number of treatment cycles.

See Treatment breaks and failures for full details.

Transfer enquiries about prescription arrangements to the PBS Complex Drugs Program team and choose the option relevant to the condition treated.