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

High-risk neuroblastoma

Initial treatment

Patient must have high-risk neuroblastoma according to a validated risk classification system; AND

Patient must be in remission, with at least a partial response, at the end of multiagent, multimodality therapy for high-risk neuroblastoma; AND

The treatment must be initiated after completing previous therapy; AND

Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND

Must be treated in a hospital/cancer centre by either a: (i) paediatric oncologist, (ii) haematologist.

Prior to initiating treatment with this drug, a complete blood count, liver function tests and baseline hearing assessments should be performed and documented in the patient's medical records.

At the time of the authority application, the prescriber should request an appropriate quantity and number of repeats based on the patient's Body Surface Area (BSA), according to the dosing schedule in the TGA approved Product Information.

The following maximum quantity units and repeats may be authorised under this restriction (providing 3 months of therapy for each prescription).

Up to a maximum quantity of 100 units and 1 repeat for a BSA 0.25 m² to less than 0.5 m²;

Up to a maximum quantity of 200 units and 1 repeat for a BSA 0.5 m² to less than 0.75 m²;

Up to a maximum quantity of 200 units and 2 repeats for a BSA 0.75 m² to 1.5 m²;

Up to a maximum quantity of 300 units and 2 repeats for a BSA greater than 1.5 m².

Authority applications for initial treatment must be made in writing and must include:

(a) details of the proposed prescription; and

(b) a completed PBS authority application form, relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:

(i) details of prior multiagent, multimodality therapy for high-risk neuroblastoma [date of commencement and duration of therapy]; and

(ii) the patient's BSA measurement.