Hereditary angioedema (HAE) Types 1 or 2 Program in Pharmaceutical Benefits Scheme (PBS) 012-21112939

This document outlines details of PBS-subsidised garadacimab and lanadelumab for patients with hereditary angioedema (HAE) Types 1 or 2.

For details on how to process a PBS Authority, see Processing Complex Authority Required Listings.

Restrictions	Authority level and section	PA assessment	Processing system	Prescriber type	Prescriber self-serve
Initial 1 New patient (commencing with no previous treatment with C1-INH for routine prophylaxis) PB325 form	Written Electronic S85: garadacimab lanadelumab	No	OPA	Must be treated by a: clinical immunologist specialist allergist	Yes
Initial 2 New patient (commencing from National Blood Authority - funded C1-INH) PB325 form	Written Electronic S85: garadacimab lanadelumab	No	OPA	Must be treated by a: clinical immunologist specialist allergist	Yes
Initial 3 (switching between PBS-subsidised garadacimab and lanadelumab) PB325 form	Written Electronic S85: garadacimab lanadelumab	No	OPA	Must be treated by a: clinical immunologist specialist allergist	Yes
Balance of supply (top-up) - initial	Telephone Electronic S85: garadacimab	No	OPA	Must be treated by a: clinical immunologist specialist allergist	Yes
Grandfather PB326 form	Written Electronic S85: garadacimab	No	OPA	Must be treated by, or in consultation with a: clinical immunologist specialist allergist	Yes
Continuing preventative treatment	Telephone Electronic S85: garadacimab lanadelumab	No	OPA	Must be treated by, or in consultation with a: clinical immunologist specialist allergist	Yes

Operational Information