PomalidomidePomalidomide Sandoz
Treatment of multiple myeloma in patients requiring dose adjustments due to haematological toxicities. The submission was for the addition of 1 mg and 2 mg capsule strengths to support dose reductions and interruptions during treatment.
Decisions on record
- Meeting Jul 2023 Recommended Relapsed/refractory multiple myeloma (RRMM)
- Meeting Nov 2019 Recommended Multiple myeloma
- Meeting Jul 2019 Not recommended Multiple myeloma
- Meeting Nov 2017 Recommended Relapsed/refractory multiple myeloma (RRMM)
- Meeting Mar 2017 Not recommended Relapsed/refractory multiple myeloma (RRMM)
- Meeting Mar 2016 Not recommended Multiple myeloma
- Meeting Nov 2014 Recommended capsules, 3 mg and 4 mg; Pomalyst® Celgene Pty Ltd New listing (Minor submission) Myeloma To propose a re-specified base case and revised inputs to the economic model following the July 2014 PBAC consideration for the treatment in combination with dexamethasone, of patients with relapsed and/or refr
- Meeting Jul 2014 Not recommended Celgene Pty Ltd New listing (Major submission) Myeloma Section 100 (Highly Specialised Drug Program) Authority required listing for treatment in combination with dexamethasone, of patients with relapsed and/or refractory multiple myeloma who have received and failed prior treatment with both lenalid
Access path
- TGA registered · Pomalidomide Sandoz
TGA label narrower than the PBS population
- Jul 2014Not recommended
vs high dose dexamethasone (HDD)
- ↻ resubmittedNov 2014Recommended · restricted
Listing: Restricted → Authority Required
- Mar 2016Not recommended
Insufficient cost-effectiveness evidence in broader patient population; PBAC considered that a price reduction in the…
- Mar 2017Not recommended
Unknown cost-effectiveness, uncertain safety of pomalidomide in patients with prior severe intolerance to lenalidomide…
- ↻ resubmittedNov 2017Recommended
Comparator changed: High dose dexamethasone (HDD) or palliative care → high dose…
- Jul 2019Not recommended
Comparator changed: high dose dexamethasone (HDD) → carfilzomib in combination with…
- ↻ resubmittedNov 2019Recommended · restricted
Comparator changed: carfilzomib in combination with dexamethasone → carfilzomib in…
- Jul 2023Recommended
Comparator changed: carfilzomib in combination with dexamethasone (Cd) → Pomalyst…
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the listing of pomalidomide (Pomolide) 1 mg and 2 mg capsules under the same circumstances as the 3 mg and 4 mg capsule listings. The PBAC considered that the claim of non-inferior comparative effectiveness and non- inferior comparative safety of Pomolide to Pomalyst was reasonable.PSD · Jul 2023
6.2 The PBAC considered the lower strengths to be therapeutically relative to the higher strengths on a per mg basis.PSD · Jul 2023
5.6 As a Category 4 submission, the economic analysis had not been independently evaluated.PSD · Jul 2023
5.7 The submission presented a cost-minimisation analysis of Pomolide compared with Pomalyst.PSD · Jul 2023
5.4 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of Pomolide compared with Pomalyst.PSD · Jul 2023
5.5 The PBAC considered that the claim of non-inferior comparative effectiveness and non-inferior comparative safety of Pomolide to Pomalyst was reasonable.PSD · Jul 2023
5.2 The PBAC noted and welcomed the input from Rare Cancers Australia via the Consumer Comments facility on the PBS website. While the comments did not address the addition of the new strengths of pomalidomide, they described a range of benefits of pomalidomide treatment in general.PSD · Jul 2023
6.52 The PSCR stated that in order to address any residual uncertainty, the Sponsor would be willing to develop an indication specific Deed of Agreement and Risk Sharing Arrangement (RSA) for the use of pomalidomide in combination with bortezomib and dexamethasone.PSD · Jul 2019
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as drugs are therapeutically equivalent on a per mg basis
The PBAC noted that its recommendation was on a cost-minimisation basis and advised that, because pomalidomide 1 mg and 2 mg are not expected to provide improvement in efficacy and reduction of toxicity over pomalidomide 2 mg and 3 mg, the criteria prescribed by the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2022 for Pricing Pathway A were not met. PBAC · 2023
Decision context
PopulationAdults with multiple myeloma requiring dose adjustments (interruptions and reductions) due to haematological toxicities such as thrombocytopenia and neutropenia
Risk sharingPatients receiving pomalidomide under the PBS listing must be registered in the risk management program relevant for the brand being prescribed: Pomolide - Juno's Pregnancy Prevention Program; Pomalyst - i-access program; Pomalidomide Sandoz - Pregnancy Prevention Program
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2023 | Recommended | Pomalyst (pomalidomide 1 mg and higher strengths of pomalidomide) | — | Cost-minimisation · Cost-minimisation |
| Nov 2019 | Recommended · restricted | carfilzomib in combination with dexamethasone (Cd) | — | Meta-analysis · PFS |
| Jul 2019 | Not recommended | carfilzomib in combination with dexamethasone | — | RCT · PFS |
| Nov 2017 | Recommended | high dose dexamethasone (HDD) | $45k–75k | RCT · PFS |
| Mar 2017 | Not recommended | High dose dexamethasone (HDD) or palliative care | — | Single-arm |
| Mar 2016 | Not recommended | re-use of lenalidomide or bortezomib with adjusted scheduling | — | Single-arm · OS |
| Nov 2014 | Recommended · restricted | high dose dexamethasone (HDD) | $45k–75k | RCT · OS |
| Jul 2014 | Not recommended | high dose dexamethasone (HDD) | — | RCT · OS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| OPTIMISMM (MM-007) | Ph 3 | 559 | Progression Free Survival by Independent Response Adjudication Committee (IRAC) | completed |
Consumer voice
Rare Cancers Australia provided input describing benefits of pomalidomide treatment, including improved quality of life through oral administration reducing hospital visits, and its less burdensome nature compared to other chemotherapy regimens, while also noting challenges for long-term smokers.
the ability to take the drug orally which improved quality of life by reducing hospital visits for infusions Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted subsidy to patients requiring dose adjustments due to haematological toxicities; TGA label covers all multiple myeloma patients.