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

Active giant cell arteritis

Initial treatment

Must be treated by a rheumatologist, clinical immunologist or neurologist experienced in the management of giant cell arteritis; AND

Patient must have clinical symptoms of active giant cell arteritis in the absence of any other identifiable cause; AND

Patient must have an ESR equal to or greater than 30 mm/hour within the past 6 weeks; or

Patient must have a CRP equal to or greater than 10 mg/L within the past 6 weeks; or

Patient must have active giant cell arteritis confirmed by positive temporal artery biopsy or imaging; AND

Patient must have had a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis; AND

Patient must have had temporal artery biopsy revealing features of giant cell arteritis at diagnosis; or

Patient must have had evidence of large-vessel vasculitis by magnetic resonance (MR) or computed tomography (CT) angiography or PET/CT at diagnosis; or

Patient must have had evidence of positive temporal artery halo sign by ultrasound (US) at diagnosis; AND

The treatment must be in combination with a tapering course of corticosteroids; AND

The treatment must not exceed 52 weeks in total including initial and continuing applications; AND

Patient must be aged 50 years or older.

Clinical symptoms of giant cell arteritis at diagnosis include unequivocal cranial symptoms of giant cell arteritis (new onset localized headache, scalp tenderness, temporal artery tenderness or decreased pulsation, ischemia related vision loss, or otherwise unexplained mouth or jaw pain upon mastication); or symptoms of polymyalgia rheumatica, defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness.

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

(a) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has active giant cell arteritis including pathology reports outlining the patient's ESR or CRP levels within the last 6 weeks, or positive temporal artery biopsy or imaging; and

(b) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has been diagnosed with giant cell arteritis with a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis.

All reports must be documented in the patient's medical records.

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

(i) A completed authority prescription form; 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).