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

Enthesitis/spondylitis related juvenile idiopathic arthritis

Initial treatment

Patient must have 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 not have received PBS-subsidised treatment with a biological medicine for this condition; or

Patient must have had a break in treatment of at least 2 years from the most recently prescribed PBS-subsidised biological medicine for this condition; AND

Patient must have 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 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 not receive more than 16 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.

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, the baseline Juvenile Spondyloarthritis Disease Activity Index score; or

(ii) 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

(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) 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 assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of 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.

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

Enthesitis/spondylitis related juvenile idiopathic arthritis

Initial treatment - balance of supply

Patient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction to complete 16 weeks of treatment; AND

The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND

Must be treated by a paediatric rheumatologist; or

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