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

Systemic juvenile idiopathic arthritis

Continuing treatment in a patient weighing less than 30 kg

Patient must have previously received PBS-subsidised treatment with this drug for this condition; 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 rheumatologist; or

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

An adequate response to treatment is defined as:

(a) in a patient with polyarticular course disease:

(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or

(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:

- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or

- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).

(b) in a patient with refractory systemic symptoms:

(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or

(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or

(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.

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

Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application.

The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient's medical records.

The assessment of the patient's response to the most recent course of biological medicine 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 that most recent course of treatment in this treatment cycle.

The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.

If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.

A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.