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

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

PNH and listing dates

PNH is a rare acquired, life threatening disease of the blood that causes red blood cells to break apart.

Listing dates:

  • eculizumab - 1 March 2022
  • ravulizumab - 1 March 2022
  • pegcetacoplan - 1 December 2022

See Written Authority Required Drugs for more information

Treatment specifics

Complement 5 (C5) inhibitors are defined as eculizumab or ravulizumab.

Patients switching from a C5 inhibitor to pegcetacoplan, for the first four weeks:

  • pegcetacoplan is administered in addition to the patient’s current dose of C5 inhibitor treatment to minimise the risk of haemolysis with abrupt treatment discontinuation

After four weeks:

  • the patient should discontinue treatment with the C5 inhibitor before continuing on monotherapy with pegcetacoplan

Enquiries

Transfer enquiries about prescription arrangements to PBS Complex Drugs Programs, and choose the option relevant to the condition treated.

The Resources page contains:

  • application forms
  • contact details
  • item and restriction codes
  • the PBS schedule
  • Services Australia website link

Online Pharmaceutical Benefits Scheme (PBS) Authorities System (OPA System)

Process telephone Authority approval application

Processing and National Demand Allocation (PaNDA)

Processing Complex Authority Required Listings

Processing written authority approval requests

Written Authority Required Drugs