ElotuzumabEmpliciti
Treatment of relapsed or refractory multiple myeloma (RRMM) in combination with lenalidomide and dexamethasone, in patients who have received at least one prior therapy.
Decisions on record
- Meeting Jul 2021 Recommended Relapsed/refractory multiple myeloma
- Meeting Nov 2020 Not recommended Multiple myeloma
Access path
- TGA registered · Empliciti
TGA label narrower than the PBS population
- Nov 2020Not recommended
vs carfilzomib in combination with dexamethasone
- ↻ resubmittedJul 2021Recommended · restricted
Comparator changed: carfilzomib in combination with dexamethasone → carfilzomib and…
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended elotuzumab as a Section 100 (Efficient Funding of Chemotherapy) Authority Required listing for multiple myeloma that has progressed after at least one prior therapy, when administered in combination with lenalidomide 17PSD · Jul 2021
6.2 The PBAC noted the consumer comments which supported the listing of elotuzumab on the PBS for the treatment of RRMM.PSD · Jul 2021
5.9 In November 2020 the PBAC considered that the CMA between ELd and Cd was not appropriate as the claims of non-inferior efficacy and safety were not supported (paragraph 7.14, elotuzumab PSD, November 2020).PSD · Jul 2021
5.10 The November 2020 submission presented a CMA based on the cost per cycle. The resubmission presented a revised CMA based on the per patient costs over 12 cycles of ELd and Cd. In November 2020, the ESC considered that if the claim of non- inferiority was accepted, then the length of PFS, and thus the treatment durations applied in the CMA, should be similar.PSD · Jul 2021
non-inferior, safety profile compared with Cd. Source: Table 1.1.1 of the submission.PSD · Jul 2021
5.4 The resubmission did not present any additional efficacy or safety data.PSD · Jul 2021
5.2 The PBAC noted and welcomed the input from individuals (20) and organisations (4) via the Consumer Comments facility on the PBS website. The comments from individuals described the benefits of access to new treatment options and the impact 7PSD · Jul 2021
5.3 The PBAC noted the advice received from (i) Myeloma Australia, (ii) Myeloma Australia’s Medical and Scientific Advisory Group (MSAG), (iii) the Leukaemia Foundation and (iv) Rare Cancers Australia which supported the submission for elotuzumab and the need for alternative treatments for MM patients.PSD · Jul 2021
Cost-effectiveness
Cost-minimisation analysis presented; ICER not applicable as cost-minimisation model used.
The PBAC considered that the CMA was not appropriate as the claims of non-inferior efficacy and safety were not supported. PBAC · 2021
Decision context
PopulationPatients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy, treated with elotuzumab in combination with lenalidomide and dexamethasone.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2021 | Recommended · restricted | carfilzomib and dexamethasone (Cd) | — | Meta-analysis · OS |
| Nov 2020 | Not recommended | carfilzomib in combination with dexamethasone | — | RCT · OS |
Consumer voice
Consumers (20 individuals and 4 organisations) provided input via the PBS website consumer comments facility, describing benefits of access to new treatment options and their impact.
The comments from individuals described the benefits of access to new treatment options and the impact Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to relapsed or refractory disease and specifies later-line treatment; TGA label permits any patient with ≥1 prior therapy.