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Auranofin

Noted RheumatologyRestricted

Alternative capsule formulation of auranofin for patients with rheumatoid arthritis, particularly those with early or mild disease, or those with suboptimal response to methotrexate.

2
Submissions
1 resub
2016–17
On the record
—
ICER range
Not modelled
Cost basis

Decisions on record

3 decisions
  • Meeting Jul 2017 Noted Unrestricted benefit indicated for rheumatoid arthritis
  • Meeting Jul 2016 Recommended Rheumatoid arthritis
  • Meeting Mar 2012 Recommended Disease modifying anti-rheumatic drug (DMARD) no PSD

Access path

2 submissions · public record
  1. Jul 2016
    Recommended
  2. Jul 2017
    Recommended

    Listing: Unrestricted → Restricted

  3. PBS listing · Restricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
4.1 The PBAC recommended the temporary listing of a capsule form of auranofin on the PBS on the basis of clinical need.PSD · Jul 2017
4.2 The PBAC recommended that the new listing should be consistent with that for the currently listed auranofin product in terms of restriction, maximum quantities and repeats.PSD · Jul 2017
Consumer comments
3.6 The PBAC recalled the correspondence from the Australian Rheumatology Association (ARA), considered at the November 2016 PBAC meeting, sent in response to the PBAC’s request for advice regarding the ongoing PBS listing of auranofin tablets.PSD · Jul 2017

Cost-effectiveness

Not modelled; this is a minor submission for a formulation change (capsule replacing tablet) due to supply shortage.

Decision context

PopulationPatients with rheumatoid arthritis currently treated with or requiring auranofin, particularly those with early or mild disease or suboptimal response to methotrexate.

Submission history

2 entries
DecidedOutcomeComparatorICEREvidence
Jul 2017 Recommended — — Cost-minimisation
Jul 2016 Recommended — — Cost-minimisation

Similar precedents

By decision profile
Upadacitinib66%Infliximab66%Adalimumab65%Methotrexate65%Methotrexate (As Sodium)64%Abatacept64%Bimekizumab63%Golimumab63%

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to early/mild disease or methotrexate failure; TGA label covers all rheumatoid arthritis patients.