Golimumab; Infliximab; Ustekinumab
Amendment to authority requirements for continuing treatment with golimumab, infliximab, and ustekinumab for all PBS-reimbursed indications (including severe chronic plaque psoriasis, ulcerative colitis, and other approved indications). The submission requested a change from complex written authority to telephone authority for second and subsequent continuing prescriptions.
From the public summary
7.1 The PBAC deferred the submission, noting that this matter would be considered in the context of the Post Market Review of PBS Authorities. The PBAC agreed that the points raised by the sponsor merited further exploration, but considered that addressing these in a consolidated fashion in the context of the Review would be the most efficient approach.PSD · Jul 2014
7.2 The PBAC noted that the current listings allow patients to switch to other agents for the same indication under specific circumstances. The PBAC foreshadowed that should it recommend changes such as those proposed in the submission, it considered that it would be appropriate for written applications to be required when switching to another agent. Outcome: DeferredPSD · Jul 2014
6.4 No formal economic analysis was presented in the submission.PSD · Jul 2014
6.2 The PBAC noted and welcomed the input from, health care professionals (1) and organisations (1) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of the proposed change including improve workload for prescribers, a simplification of the Authority process and reduced administrative burden for the Department of Human services.PSD · Jul 2014
Cost-effectiveness
No formal economic analysis was presented in the submission.
No clinical data were presented in the submission. PSD · 2014
Decision context
PopulationPatients who have already received initial and continuing therapy with golimumab, infliximab, or ustekinumab for PBS-reimbursed indications (including severe chronic plaque psoriasis, moderate to severe ulcerative colitis, and other registered indications).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2014 | Deferred | — | — | Other |
Consumer voice
Health care professionals and organisations submitted comments describing benefits of the proposed change, including improved workload for prescribers, simplification of the Authority process, and reduced administrative burden for the Department of Human Services.
health care professionals (1) and organisations (1) via the Consumer Comments facility on the PBS website Consumer comments · PSD