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

Enthesitis/spondylitis related juvenile idiopathic arthritis

Continuing treatment

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 per continuing treatment course authorised 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.

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.

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.

A patient may re-trial this drug after a minimum of 2 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed, and the date of the first application submitted for approval.

Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.