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

Severe active juvenile idiopathic arthritis

Initial treatment - Initial 1 (new patient)

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

Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; or

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

Patient must be under 18 years of age.

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 another DMARD 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 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.

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.

At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient. Up to a maximum of 3 repeats will be authorised.

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.

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

Severe active juvenile idiopathic arthritis

Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)

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 have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND

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

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

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.

At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient. Up to a maximum of 3 repeats will be authorised.

An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change 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 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.

A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. 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 approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.

If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

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

Severe active juvenile idiopathic arthritis

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

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 have previously received PBS-subsidised treatment with a biological medicine for this condition; AND

Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND

The condition must have either: (a) a total active joint count of at least 10 active (swollen and tender) joints; (b) at least 2 active major joints; (c) active arthritis affecting the cervical spine or temporomandibular joint; (d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; (e) development/worsening of erosive disease due to active arthritis; AND

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

Active major joints are defined as: elbow, wrist, knee, ankle, shoulder, and hip.

All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient's medical records.

Where the baseline active joint count is based on total active joints (i.e. more than 10 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active major joints, the response must be demonstrated on the total number of active major joints.

At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient. Up to a maximum of 3 repeats will be authorised.

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) the date of the last continuing prescription.

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 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.

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

Severe active juvenile idiopathic arthritis

Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) - balance of supply

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 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 (change or recommencement of treatment after a break in biological medicine 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 the Initial 3 (recommencement of treatment after a break in biological medicine 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 treatment available under the above restrictions.