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Paroxysmal nocturnal haemoglobinuria (PNH) Program in Pharmaceutical Benefits Scheme (PBS) 012-22022230

This document outlines details of PBS-subsidised eculizumab, pegcetacoplan and ravulizumab for patients with paroxysmal nocturnal haemoglobinuria (PNH).

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

On this page:

Paroxysmal nocturnal haemoglobinuria (PNH) C5 inhibitor - eculizumab and ravulizumab quick reference

Paroxysmal nocturnal haemoglobinuria (PNH) - pegcetacoplan quick reference

Paroxysmal nocturnal haemoglobinuria (PNH) C5 inhibitor - eculizumab and ravulizumab quick reference

Table 1

Restrictions

Authority level and section

PA assessment

Processing system

Prescriber type

Prescriber self-serve

Initial 1

induction

PB327 form

Written

Electronic

S100:

eculizumab

ravulizumab

No

OPA

Must be treated by a:

haematologist
non-specialist physician in consultation with a haematologist

Yes - delayed assessment due to DPMQ (cost)

Initial 2 - switching from LSDP-funded eculizumab -(induction dose)

PB327 form

Written

Electronic

S100:

ravulizumab

No

OPA

Must be treated by a:

haematologist
non-specialist physician in consultation with a haematologist

Yes - delayed assessment due to DPMQ (cost)

Return - from PBS-subsidised eculizumab -(induction doses)

PB327 form

Written

Electronic

S100:

ravulizumab

No

OPA

Must be treated by a:

haematologist
non-specialist physician in consultation with a haematologist

Yes - delayed assessment due to DPMQ (cost)

Return - from PBS-subsidised pegcetacoplan (induction doses)

PB327 form

Written

Electronic

S100:

ravulizumab

No

OPA

Must be treated by a:

haematologist
non-specialist physician in consultation with a haematologist

Yes - delayed assessment due to DPMQ (cost)

Initial switching from PBS -subsidised ravulizumab for pregnancy

PB327 form

Written

Electronic

S100:

eculizumab

No

OPA

Must be treated by a:

haematologist
non-specialist physician in consultation with a haematologist

Yes - delayed assessment due to DPMQ (cost)

Initial - switching from PBS-subsidised pegcetacoplan for pregnancy (induction doses)

PB327 form

Written

Electronic

S100:

eculizumab

No

OPA

Must be treated by a:

haematologist
non-specialist physician in consultation with a haematologist

Yes - delayed assessment due to DPMQ (cost)

Return - from PBS-subsidised pegcetacoplan (induction doses)

PB327 form

Written

Electronic

S100:

eculizumab

No

OPA

Must be treated by a:

haematologist
non-specialist physician in consultation with a haematologist

Yes - delayed assessment due to DPMQ (cost)

Balance of Supply (BOS) transition from non-PBS during induction

PB327 form

Written

Electronic

S100:

eculizumab

No

OPA

Must be treated by a:

haematologist
non-specialist physician in consultation with a haematologist

Yes - delayed assessment due to DPMQ (cost)

Grandfather - transition from non-PBS

PB329 form

Written

Electronic

S100:

eculizumab

ravulizumab

No

OPA

Must be treated by a:

haematologist
non-specialist physician in consultation with a haematologist

Yes - delayed assessment due to DPMQ (cost)

Grandfather - transition from LSDP-funded eculizumab

PB329 form

Written

Electronic

S100:

eculizumab

No

OPA

Must be treated by a:

haematologist
non-specialist physician in consultation with a haematologist

Yes - delayed assessment due to DPMQ (cost)

First continuing

or

Subsequent continuing

PB328 form

Written

Electronic

S100:

eculizumab

ravulizumab

No

OPA

Must be treated by a:

haematologist
non-specialist physician in consultation with a haematologist

Yes - delayed assessment due to DPMQ (cost)

Paroxysmal nocturnal haemoglobinuria (PNH) - pegcetacoplan quick reference

Table 2

Restrictions	Authority level and section	PA assessment	Processing system	Prescriber type	Prescriber self-serve
Initial PB343 form	Written Electronic S100: pegcetacoplan	No	OPA	Must be treated by a: haematologist non-specialist physician in consultation with a haematologist	Yes - delayed assessment due to DPMQ (cost)
Return PB344 form	Written Electronic S100: pegcetacoplan	No	OPA	Must be treated by a: haematologist non-specialist physician in consultation with a haematologist	Yes - delayed assessment due to DPMQ (cost)
First continuing or Subsequent continuing PB344 form	Written Electronic S100: pegcetacoplan	No	OPA	Must be treated by a: haematologist non-specialist physician in consultation with a haematologist	Yes - delayed assessment due to DPMQ (cost)