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

Systemic juvenile idiopathic arthritis

Initial treatment - Initial 1 (new patient)

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

Patient must have polyarticular course disease which has failed to respond adequately to 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; or

Patient must have polyarticular course disease and have demonstrated severe intolerance of, or toxicity due to, methotrexate; or

Patient must have refractory systemic symptoms, demonstrated by an inability to decrease and maintain the dose of prednisolone (or equivalent) below 0.5 mg per kg per day following a minimum of 2 months of therapy; AND

Patient must not receive more than 16 weeks of treatment under this restriction; AND

Patient must be under 18 years of age; AND

Must be treated by a rheumatologist; or

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

The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy in a patient with polyarticular course disease and must be demonstrated in the patient at the time of the initial application:

(a) an active joint count of at least 20 active (swollen and tender) joints; or

(b) at least 4 active joints from the following list of major joints:

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

(ii) 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).

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

The following criteria indicate failure to achieve an adequate response to prior therapy in a patient with refractory systemic symptoms and must be demonstrated in the patient at the time of the initial application:

(a) an active joint count of at least 2 active joints; and

(b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or

(c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN).

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

The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.

The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.

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.

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

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

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 systemic juvenile idiopathic arthritis; and

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

The following reports must be documented in the patient's medical records where appropriate:

(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.

At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested.

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.

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

Systemic juvenile idiopathic arthritis

Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months)

Patient must have received prior PBS-subsidised treatment with this drug for this condition in the previous 12 months; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND

Patient must not receive more than 16 weeks of treatment under this restriction; AND

Patient must be under 18 years of age; 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.

At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested.

The following reports must be documented in the patient's medical records where appropriate:

(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.

An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to retrial or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.

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.

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.

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

Systemic juvenile idiopathic arthritis

Initial treatment - Initial 3 (recommencement of treatment after a break of more than 12 months)

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

Patient must have had a break in treatment of 12 months or more from this drug for this condition; AND

Patient must have polyarticular course disease and the condition must have at least one of: (a) an active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active joints from the following list of major joints: i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); (ii) 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); or

Patient must have refractory systemic symptoms and the condition must have (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN); AND

Patient must not receive more than 16 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; AND

Patient must be under 18 years of age.

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 systemic juvenile idiopathic arthritis.

The following reports must be documented in the patient's medical records where appropriate:

(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.

The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application.

At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested.

An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.

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.

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.

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

Systemic juvenile idiopathic arthritis

Balance of supply for Initial treatment - Initial 1 (new patient) or Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) or Initial 3 (recommencement of treatment after a break of more than 12 months)

Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) restriction to complete 16 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under Initial 3 (recommencement of treatment after a break of more than 12 months) restriction to complete 16 weeks treatment; AND

The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; AND

Must be treated by a rheumatologist; or

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