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

Enthesitis/spondylitis related 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, a diagnosis of enthesitis/spondylitis related juvenile idiopathic arthritis defined by at least one of the following: (i) peripheral arthritis and enthesitis, (ii) inflammatory sacroiliitis on Magnetic Resonance Imaging (MRI) plus at least 3 months of inflammatory back pain, (iii) arthritis or enthesitis plus at least 2 of: (a) sacroiliac joint tenderness, (b) inflammatory back pain, (c) presence of HLA-B27 antigen, (d) acute (symptomatic) anterior uveitis, (e) history of spondyloarthritis in a first-degree relative; AND

Patient must have, prior to initiating treatment with this drug for this condition, failed to achieve an adequate response for axial disease (sacroiliitis and/or spondylitis), following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) whilst completing an appropriate exercise program, for a total period of 3 months; or

Patient must have, prior to initiating treatment with this drug for this condition, failed to achieve an adequate response for peripheral disease (arthritis and/or enthesitis) following treatment with at least 2 NSAIDs, and either: (i) methotrexate at a dose of 15 mg per square metre (maximum 20 mg) weekly, (ii) sulfasalazine at a dose of 20 mg/kg (maximum 1 g) twice daily, whilst completing an appropriate exercise program, for a total period 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

Must be treated by a 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.

If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, details must be documented in the patient's medical records.

If treatment with methotrexate, sulfasalazine or NSAIDs is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records.

If intolerance to methotrexate, sulfasalazine or NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, details of the toxicity must be documented in the patient's medical records.

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

(a) a Juvenile Spondyloarthritis Disease Activity Index score greater than 2; or

(b) persistent symptoms of axial spondylitis or sacroiliitis with prior confirmatory Magnetic Resonance Imaging (MRI) assessed by a clinician experienced with juvenile spondyloarthropathy.

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

(1) details of prior treatment including dose and duration of treatment; and

(i) if applicable, a baseline Juvenile Spondyloarthritis Disease Activity Index score; or

(ii) if applicable, the current Juvenile Spondyloarthritis Disease Activity Index score; or

(iii) if applicable, details (name of the report provider, date of the report and unique identifying number/code that links report to the individual patient) of the MRI demonstrating inflammatory spondylitis or sacroiliitis; or

(iv) if applicable, details (name of the report provider, date of the report and unique identifying number/code that links report to the individual patient) demonstrating the presence of HLA-B27.

The Juvenile Spondyloarthritis Disease Activity Index score must be assessed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.

An adequate response is defined as an improvement from baseline in the Juvenile Spondyloarthritis Disease Activity Index score by at least 30% or an improvement in the persistent symptoms of axial spondylitis or sacroiliitis.

An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.

Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.

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 until 2 years have elapsed. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.