Disease index

paroxysmal nocturnal haemoglobinuria

Haematology · 2008–2025

9decisions
3medicines
3carried consumer input
89individual submissions

Every decision

MedicineMeetingOutcomeConsumer input
pegcetacoplan Treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who are either treatment-naïve to complement 5 inhibitors (C5is) or currently… May 2025 Recommended with restriction none received
ravulizumab Paediatric patients with paroxysmal nocturnal haemoglobinuria (PNH). Jul 2023 Recommended with restriction none received
pegcetacoplan Treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH) who have inadequate clinical response or are intolerant to C5 inhibitor treatment. Jul 2022 Recommended with restriction none received
pegcetacoplan Treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH) who have inadequate clinical response to C5 inhibitor treatment. Mar 2022 Not recommended 1 individuals PNH Support Association of Australia
ravulizumab Treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH). Jul 2021 Recommended with restriction 52 individuals PNH Support Association of Australia
ravulizumab Treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH). Jul 2020 Not recommended 36 individuals PNH Support Association of Australia
eculizumab Treatment of paroxysmal nocturnal haemoglobinuria (PNH) to reduce haemolysis in patients with classic PNH who meet specified eligibility criteria. Jul 2010 Recommended no section in document
eculizumab Treatment of paroxysmal nocturnal haemoglobinuria (PNH) to reduce haemolysis. Mar 2009 Recommended no section in document
eculizumab Treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH) to reduce haemolysis. Jul 2008 Not recommended no section in document

Who spoke

PNH Support Association of Australia

What the PBS pays

$188M in government benefit over 2024–25, across 3,741 services.

This is spend on the medicines considered for this condition, not spend on the disease. A medicine used for several conditions is counted in full under each, so figures across conditions add to more than national PBS expenditure.

MedicineGovernment benefit
ravulizumab $105.7M
Eculizumab $37.1M
eculizumab $37.1M
pegcetacoplan $8.4M

Appraised elsewhere

NICE, in England and Wales, has appraised 5 technologies for this condition, recommending 5 . A different committee, a different population and a different price: this is what has been looked at there, not a verdict on what happened here.

TechnologyAppraisalOutcomeDate
crovalimabCrovalimab for treating paroxysmal nocturnal haemoglobinuria in people 12 years and over TA1019 recommended 2024-11
danicopanDanicopan with ravulizumab or eculizumab for treating paroxysmal nocturnal haemoglobinuria TA1010 recommended restricted 2024-10
iptacopanIptacopan for treating paroxysmal nocturnal haemoglobinuria TA1000 recommended restricted 2024-09
pegcetacoplanPegcetacoplan for treating paroxysmal nocturnal haemoglobinuria TA778 recommended restricted 2022-03
ravulizumabRavulizumab for treating paroxysmal nocturnal haemoglobinuria TA698 recommended 2021-05

Registered, not subsidised

Medicines on the ARTG for this condition with no PBAC record at all. Registration and subsidy are separate decisions: a medicine can be legally available in Australia and never have been put to the committee.

MedicineOn the ARTG sinceRegistrations
danicopanVOYDEYA 50 + 100 mg film-coated tablets, composite bottle pack 2024 3

The ARTG export holds current registrations only, so the year is the earliest entry still on the register rather than a first-registration date. The condition here comes from the registered label, which is usually broader than the population a sponsor asks to have subsidised.

Conditions are classified by a language model from the indication text of each submission, so an individual label here can be wrong. Consumer input is read from the document's own consumer comments section: 3 of 6 decisions since 2014 carried some. Silence means no comment reached the committee through that facility, not that nobody was affected. More on how this was built.