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

Newly diagnosed systemic light chain amyloidosis

Initial treatment from week 0 to week 24

The condition must have histological evidence consistent with a diagnosis of systemic light-chain amyloidosis; AND

The condition must be untreated with drug therapy, including this drug, irrespective of whether the diagnosis has been reclassified (i.e. the diagnosis changes between multiple myeloma/amyloidosis); AND

Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation; AND

Must be treated by a haematologist (this does not exclude treatment via a multidisciplinary team, but the PBS authority application must be sought by the treating haematologist); AND

Patient must be undergoing concomitant treatment limited to each of: (i) bortezomib, (ii) cyclophosphamide, (iii) dexamethasone, at certain weeks of treatment as outlined in the drug's approved Product Information.

The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include:

Details of the histological evidence supporting the diagnosis of systemic light chain amyloidosis, limited to: (i) the name of pathologist/pathology provider, (ii) the site of biopsy

If the application is submitted through HPOS form upload or mail, it must include:

(i) details of the proposed prescription; and

(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).