Peginterferon Alfa-2a
Chronic hepatitis B and C infections; also proposed for use in myeloproliferative neoplasms (essential thrombocythemia and polycythemia vera).
Decisions on record
- Meeting Nov 2017 Recommended Myeloproliferative neoplasms (MPN)
- Meeting Nov 2007 Recommended Immunomodulating drug no PSD
- Meeting Jul 2004 Recommended Used for the treatment of hepatitis C no PSD
Access path
- Nov 2005Recommended · restricted
Listing: Authority Required → Restricted
- Nov 2005Recommended · restricted
Listing: Authority Required → Restricted
- Nov 2017Recommended · restricted
Listing: Restricted → Unrestricted
- PBS listing · Unrestricted
From the public summary
5.1 The PBAC recommended the change in listing for peginterferon alfa-2a from Authority Required (STREAMLINED) and Authority Required to Unrestricted, on the basis of the proposed ''''''% price reduction and subsidisation cap.PSD · Nov 2017
5.2 The PBAC noted that the change in restriction level obviated the need for a section 100 community access listing for chronic hepatitis B as patients could access the drug for this use through either of the section 100 Highly Specialised Drugs Program listings or the general schedule listing.PSD · Nov 2017
4.2 The PBAC noted and welcomed the input from individuals (4) and organisations (1) via the Consumer Comments facility on the PBS website. The comments noted an unrestricted PBS listing for peginterferon alfa-2a will eliminate the current financial barrier when used for MPN. The PBAC noted Rare Cancers Australia supported the application based on the need for access to peginterferon alfa-2a as demonstrated by the MPN community.PSD · Nov 2017
Cost-effectiveness
Not modelled — this was a minor submission (change of authority level only) with no economic evaluation or ICER calculation.
The PBAC considered the number of patients with MPN to be overestimated but that the proposed subsidisation cap limited the financial risk to the Commonwealth associated with use in conditions other than MPN and chronic hepatitis B and C. PBAC · 2017
Decision context
PopulationPatients with chronic hepatitis B and C, and patients with myeloproliferative neoplasms (essential thrombocythemia and polycythemia vera) unable to be treated with hydroxyurea.
Risk sharingProposed subsidisation cap on PBS expenditure to limit financial risk to the Commonwealth associated with use in MPN and chronic hepatitis B and C.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2017 | Recommended · restricted | — | — | RCT |
| Nov 2005 | Recommended · restricted | lamivudine | $15k–45k | RCT · null |
| Nov 2005 | Recommended · restricted | lamivudine | $15k–45k | RCT |
Consumer voice
Four individuals and one organisation (Rare Cancers Australia) submitted consumer input supporting unrestricted PBS listing of peginterferon alfa-2a for MPN, noting it would eliminate current financial barriers and addressing demonstrated community need for access to the medication.
The comments noted an unrestricted PBS listing for peginterferon alfa-2a will eliminate the current financial barrier when used for MPN. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label broader than PBS population — PBAC recommends myeloproliferative neoplasms (essential thrombocythemia, polycythemia vera) beyond TGA-registered chronic hepatitis B and C indications.