LenalidomideCIPLA LENALIDOMIDE
Treatment of newly diagnosed multiple myeloma (as monotherapy, doublet therapy, or triplet therapy), progressive multiple myeloma, relapsed/refractory multiple myeloma (including triple combination therapy with elotuzumab or carfilzomib), and myelodysplastic syndrome.
Decisions on record
- Meeting Nov 2023 Recommended Multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma
- Meeting Aug 2019 Recommended Multiple myeloma
- Meeting Jul 2019 Recommended Multiple myeloma (MM)
- Meeting Mar 2019 Not recommended Multiple Myeloma
- Meeting Mar 2019 Deferred Multiple myeloma
- Meeting Mar 2018 Not recommended Multiple myeloma
- Meeting Nov 2017 Recommended Relapsed/refractory multiple myeloma (RRMM)
- Meeting Jul 2016 Not recommended Relapsed or refractory mantle cell lymphoma
7 earlier decisions
- Mar 2016 Recommended Multiple myeloma
- Nov 2015 Deferred Multiple myeloma
- Mar 2014 Not recommended Revlimid® Celgene Pty Ltd Lenalidomide was TGA registered on 20 December 2007 and is currently indicated for the treatment of multiple myeloma patients whose disease has progressed after one therapy, in combination with dexamethasone and for the treatment of patients with transfusion dependent anaem no PSD
- Jul 2011 Not recommended For use in combination with dexamethasone in patients with multiple myeloma whose disease has progressed after one therapy. For treatment of patients with transfusion-dependent anaemia due to low or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality w
- Mar 2011 Not recommended Myelodysplastic syndrome
- Nov 2008 Recommended Multiple myeloma
- Mar 2008 Not recommended Multiple myeloma
Access path
- TGA registered · CIPLA LENALIDOMIDE
TGA label narrower than the PBS population
- Mar 2008Recommended
vs thalidomide (primary); bortezomib (secondary for…
- Nov 2008Recommended · restricted
Comparator changed: thalidomide (primary); bortezomib (secondary for…
- Mar 2011Not recommended
high and uncertain cost-effectiveness ratio, model highly sensitive to price of lenalidomide, pack usage, and utility…
- Jul 2011Not recommended
high and uncertain cost-effectiveness ratio, uncertainty in economic model due to lack of certainty with utilities, no…
- ↻ resubmittedMar 2013Recommended · restricted
ICER dropped $75,000 → $45,000 (-40%)
- Nov 2015Deferred
ICER rose $45,000 → $200,000 (+344%)
- Mar 2016Recommended · restricted
ICER dropped $200,000 → $105,000 (-48%)
- Jul 2016Not recommended
Comparator changed: thalidomide plus melphalan plus prednisone (or prednisolone) (MPT) →…
- ↻ resubmittedNov 2017Recommended
Evidence: RCT → Other
- Mar 2018Recommended · restricted
Evidence: Other → RCT
- Mar 2019Recommended · restricted
Comparator changed: best supportive care (BSC); secondary comparator thalidomide → mixed…
- Mar 2019Not recommended
Proposed increase to rebate for ND MM did not sufficiently address risk of use outside current PBS indications with…
- ↻ resubmittedJul 2019Recommended · restricted
Comparator changed: bortezomib → best supportive care (BSC) and thalidomide (mixed…
- Aug 2019Recommended · restricted
Comparator changed: best supportive care (BSC) and thalidomide (mixed comparator) →…
- Nov 2023Recommended
Comparator changed: lenalidomide and dexamethasone (Rd) → Revlimid (lenalidomide) 5 mg…
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the listing of a 20 mg strength of lenalidomide under the same circumstances as, and on a cost-minimisation basis to, lenalidomide 25 mg on a per mg basis, as it is the current least costly comparator per mg.PSD · Nov 2023
6.2 The PBAC considered that listing the 20 mg strength would provide clinicians greater flexibility in dose adjustment. It also considered that the estimated 4% uptake of the new strength was underestimated as it is likely that the 20 mg strength will be incorporated into clinical guidelines as a subsidised dosing option.PSD · Nov 2023
5.5 The submission presented a cost-minimisation analysis of Lenalide compared with Revlimid. The equi-effective doses were estimated as: • 1 mg of Lenalide = 1 mg of RevlimidPSD · Nov 2023
5.6 The cost-minimisation analysis was presented as a comparison of the drug ex- manufacturer price (EMP) and assumed no differences in the utilisation of other healthcare resources relating to the administration of the drugs and management of adverse events.PSD · Nov 2023
5.3 In its assessment of Lenalide 20 mg, the TGA determined that Lenalide was bioequivalent to Revlimid, and the submission has therefore claimed that it is non- inferior in terms of comparative effectiveness and safety to Revlimid 20 mg.PSD · Nov 2023
5.4 The PBAC considered that the claim of the non-inferior comparative effectiveness and safety of Lenalide to Revlimid was reasonable.PSD · Nov 2023
5.2 The PBAC noted and welcomed the input from Rare Cancers Australia (RCA) via the Consumer Comments facility on the PBS website. The comments described the benefits of lenalidomide over chemotherapies including the easier management of symptoms such as fatigue, and that it is an oral dose form which can be taken at home.PSD · Nov 2023
RCA stated that the option of dose adjustment offered by listing this new strength may reduce the degree to which patients experience the side effects of lenalidomide. The PBAC noted that this advice was supportive of the submission’s proposition.PSD · Nov 2023
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated.
The submission presented a cost-minimisation analysis of Lenalide compared with Revlimid. PSD · 2023
Decision context
PopulationPatients with newly diagnosed multiple myeloma (NDMM), progressive multiple myeloma, relapsed/refractory multiple myeloma (RRMM), and myelodysplastic syndrome requiring lenalidomide therapy in various treatment combinations (monotherapy, doublet, or triplet therapy).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2023 | Recommended | Revlimid (lenalidomide) 5 mg, 10 mg, 15 mg, and 25 mg strengths | — | Cost-minimisation · Cost-minimisation |
| Aug 2019 | Recommended · restricted | lenalidomide and dexamethasone (Rd) | — | RCT · PFS |
| Jul 2019 | Recommended · restricted | best supportive care (BSC) and thalidomide (mixed comparator) | $15k–45k | RCT · QALY |
| Mar 2019 | Recommended · restricted | mixed comparator of best supportive care (BSC) and thalidomide | — | RCT · OS |
| Mar 2019 | Not recommended | bortezomib | — | Cost-minimisation · Cost-minimisation |
| Mar 2018 | Recommended · restricted | best supportive care (BSC); secondary comparator thalidomide | — | RCT · OS |
| Nov 2017 | Recommended | — | — | Other |
| Jul 2016 | Not recommended | weighted mix of fludarabine, gemcitabine, chlorambucil, cytarabine or rituximab monotherapy | — | RCT · PFS |
| Mar 2016 | Recommended · restricted | thalidomide plus melphalan plus prednisone (or prednisolone) (MPT) | $75k–105k | RCT · Other |
| Nov 2015 | Deferred | thalidomide plus melphalan plus prednisone (MPT) | $105k–200k | RCT · PFS |
| Mar 2013 | Recommended · restricted | best supportive care | $15k–45k | RCT · Transfusion independence |
| Jul 2011 | Not recommended | placebo (best supportive care) | $45k–75k | — |
| Mar 2011 | Not recommended | best supportive care | $45k–75k | RCT · transfusion independence for ≥182 days (6 months) |
| Nov 2008 | Recommended · restricted | bortezomib | — | RCT · PFS |
| Mar 2008 | Recommended | thalidomide (primary); bortezomib (secondary for thalidomide-refractory patients) | $45k–105k | RCT · PFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| IFM2005-02 | Ph 3 | 614 | Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant resp… | completed |
Consumer voice
Rare Cancers Australia provided input supporting lenalidomide, highlighting benefits over chemotherapies including easier symptom management, oral administration, and potential for dose adjustment to reduce side effects.
the benefits of lenalidomide over chemotherapies including the easier management of symptoms such as fatigue, and that it is an oral dose form which can be taken at home Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts lenalidomide to multiple myeloma (newly diagnosed, progressive, relapsed/refractory) and MDS, excluding MCL from TGA label.