IpilimumabYervoy
Treatment of unresectable stage III or stage IV malignant melanoma as monotherapy or as the sole PBS-subsidised therapy for this condition.
Decisions on record
- Meeting Jul 2016 Recommended Metastatic melanoma
- Meeting Nov 2012 Recommended Melanoma
- Meeting Mar 2012 Not recommended As monotherapy, for the treatment of patients with unresectable or metastatic melanoma who have failed or are intolerant to prior therapy.
- Meeting Jul 2011 Not recommended Anti-cancer drug no PSD
Access path
- TGA registered · Yervoy
TGA label narrower than the PBS population
- 2011Not recommended
uncertain extent of clinical benefit, uncertain clinical place of therapy, high and uncertain cost-effectiveness ratio…
- Mar 2012Not recommended
uncertain extent of clinical benefit, uncertain clinical place in therapy, high and uncertain cost effectiveness…
- Mar 2012Not recommended
uncertain extent of clinical benefit, uncertain clinical place in therapy, high and uncertain cost-effectiveness…
- ↻ resubmittedNov 2012Recommended · restricted
ICER dropped $105,000 → $75,000 (-29%)
- Jul 2015Noted
Evidence: RCT → Registry
- Jul 2016Recommended · restricted
Evidence: Registry → Other
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the PBS restriction for ipilimumab for the treatment of unresectable stage III or stage IV malignant melanoma be amended to read “The treatment must be the sole PBS-subsidised therapy for this condition”, on the basis that it would remain as an Authority Required (STREAMLINED) listing only under special arrangements under Section 100 Efficient Funding of Chemotherapy.PSD · Jul 2016
6.2 The PBAC additionally recommended the removal of the grandfathering restriction for ipilimumab at this time.PSD · Jul 2016
Cost-effectiveness
Not applicable; minor submission requesting amendment to restriction wording only. No economic evaluation was undertaken.
The PBAC considered that the underestimation of both the incidence of adverse events (such as severe colitis), and the costs associated with treating such adverse events, would mean that the base case ICER for ipilimumab considered in November 2012 was underestimated. PBAC · 2015
Decision context
PopulationPatients with unresectable stage III or stage IV malignant melanoma for induction, re-induction, or completion of treatment, with no prior ipilimumab treatment for induction cases.
Risk sharingThe submission mentioned that nivolumab would be provided free-of-charge by the sponsor to enable a commitment to the TGA for a safety study of the combination. Additionally, the original positive recommendation in November 2012 included an 'Australian Outcomes Program' requiring the sponsor to rebate the cost of difference in performance between observed versus predicted benefits of ipilimumab.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2016 | Recommended · restricted | — | — | Other |
| Jul 2015 | Noted | — | — | Registry |
| Nov 2012 | Recommended · restricted | dacarbazine (DTIC) and fotemustine | $45k–75k | RCT · OS |
| Mar 2012 | Not recommended | dacarbazine (DTIC) and fotemustine | $45k–75k | RCT · OS |
| Mar 2012 | Not recommended | dacarbazine, fotemustine | $45k–105k | RCT · OS |
| 2011 | Not recommended | dacarbazine (DTIC) and fotemustine | $105k–200k | RCT · OS |
Consumer voice
One health professional submitted input via the Consumer Comments facility supporting the proposed change in restriction wording for ipilimumab.
The PBAC noted and welcomed the input from one health professional via the Consumer Comments facility on the PBS website, supporting the proposed change in restriction wording. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to unresectable stage III or IV melanoma and first-line treatment; TGA label includes all unresectable or metastatic melanoma without line-of-therapy restriction.