Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Severe active juvenile idiopathic arthritis

Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements

Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 January 2026; AND

Patient must have, prior to initiating treatment with this drug for this condition, demonstrated severe intolerance of, or toxicity due to, methotrexate; or

Patient must have, prior to initiating treatment with this drug for this condition, demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND

Patient must have demonstrated an adequate response to treatment with this drug; AND

Patient must not receive more than 24 weeks of treatment under this restriction; AND

Must be treated by a paediatric rheumatologist; or

Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND

Patient must be under 18 years of age, prior to commencement of this drug for this condition.

Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.

Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.

The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:

(a) an active joint count of at least 10 active (swollen and tender) joints; or

(b) an active joint count of at least 2, affecting the following joints: elbow, wrist, knee, ankle, shoulder, and hip; or

(c) active arthritis affecting the cervical spine or temporomandibular joint; or

(d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; or

(e) development/worsening of erosive disease due to active arthritis.

The assessment of response to prior treatment must be documented in the patient's medical records.

An adequate response to treatment is defined as:

(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or

(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or

(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or

(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or

(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.

The assessment of response to treatment must be documented in the patient's medical records.

The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.

The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:

(a) the date of assessment of severe active juvenile idiopathic arthritis; and

(b) details of prior treatment including dose and duration of treatment.

The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.

If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.