Age-related macular degeneration
Authority to supply aflibercept (Eylea®), ranibizumab (Lucentis®) and verteporfin (Visudyne®) for the treatment of subfoveal choroidal neovascularisation due to age-related macular degeneration, in eligible patients, through the Pharmaceutical Benefits Scheme (PBS) under Section 85 arrangements of the National Health Act 1953.
Restriction details
The Schedule of Pharmaceutical Benefits outlines restrictions for prescribing ranibizumab and verteporfin to patients.
View a full transcript of the Schedule restriction details
.
Initial treatment
Applications must be submitted in writing by the treating ophthalmologist. An initial application must be submitted for each eye.
Continuing treatment
After an application for initial treatment has been approved, applications for continuing treatment in the same eye may be made in writing or by calling 1800 700 270** (option 3) between 8.00 am to 5.00 pm Eastern Standard Time, Monday to Friday.
Item details
Dose
Aflibercept is supplied in a single-use vial or pre-filled syringe. Each vial and pre-filled syringe provides a usable amount to deliver a single dose of 50 µL solution for intravitreal injection containing 2 mg aflibercept. Treatment is initiated with one injection per month for three consecutive months, followed by one injection every two months.
Ranibizumab is available as a single use intravitreal injection (2.3mg / 0.23 ml). Treatment is given monthly.
Verteporfin is available as a single use powder for intravenous infusion (15mg—sterile). Patients should be re-evaluated every 3 months.
Applications for treatment
All applications for:
- verteporfin will be limited to one treatment only.
- Aflibercept and ranibizumab may be for the initial treatment and two repeats.
Where both eyes are being treated simultaneously, a quantity of two may be requested on the same prescription.
Maximum number of verteporfin treatments per eye
The maximum number of verteporfin treatments per eye is 15. This includes treatment administered under both the Medicare Benefits Schedule (MBS) Visudyne Program and the PBS. The number of MBS treatments already received must be supplied with the initial application.
Human Services must be notified if treatment with verteporfin is abandoned before completion of the laser activation step, but after infusion of verteporfin, so that it will not count towards the total.
You can notify Human Services by calling 1800 700 270** (option 3) between 8.00am to 5.00pm Eastern Standard Time, Monday to Friday.
Patient eligibility
Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive pharmaceutical benefits.
Test requirements
Verteporfin
A copy of the fluorescein angiogram which demonstrates the subfoveal choroidal neovascularisation is predominantly classic (greater than or equal to 50 per cent) must be provided with each initial application for the affected eye/s.
Patients must have a baseline visual acuity equal to or better than 6/60 (20/200).
Aflibercept and Ranibizumab
A copy of the fluorescein angiography diagnosing subfoveal choroidal neovascularisation must be provided with each initial application for the affected eye/s.
Where a fluorescein angiogram cannot be performed due to a contraindication, as listed in the Therapeutic Goods Administration approved product information, details of the contraindication must be provided. A copy of the report of an alternative method of diagnosis must be included in the application, for example, Optical Coherence Tomography (OCT) or red free photography.
Lodgement
All initial applications must be made in writing and sent to:
Department of Human Services
Prior written approval of specialised drugs
Reply paid 9826
Hobart TAS 7001
(No stamp required if posted in Australia)
Please make sure that all written applications for initial PBS authorisation include:
- a completed authority prescription form
- a completed subfoveal choroidal neovascularisation—PBS supporting information form
- a copy of the fluorescein angiogram, or OCT or red free photography reports where a fluorescein angiogram is contraindicated.
Emergency treatments only
To avoid delay in starting treatment, the initial application, angiogram report and a copy of the prescription may be faxed to Human Services on 1300 093 177*. Human Services will then contact the prescriber by phone. The original authority application form and angiogram must be posted to Human Services.
Application form for initial PBS subsidised treatment
Application form for initial PBS subsidised treatment [PDF, 235Kb]
(form 4187) Lodge this form for a patient starting initial PBS subsidised treatment for subfoveal choroidal neovascularisation due to age-related macular degeneration.
* Call charges apply.
** Call charges apply from mobile and pay phones only.
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Last updated: 30 November, 2012