Lutropin AlfaLuveris
Stimulation of follicular development in women with severe luteinising hormone deficiency undergoing assisted reproductive technology.
Decisions on record
- Meeting Mar 2016 Recommended Assisted reproduction
- Meeting Mar 2015 Recommended Stimulation of follicular development
Access path
- TGA registered · Luveris
TGA label narrower than the PBS population
- Mar 2015Recommended · restricted
vs rFSH alone (recombinant follicle stimulating hormone)
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the listing of lutropin alfa for treatment of severe LH deficiency, on the basis that it should be available only under special arrangements under Section 100 (IVF/GIFT program) listing.PSD · Mar 2015
7.2 The PBAC is satisfied that lutropin alfa provides, for a small group of women who have inadequate levels of LH, a significant improvement in clinical pregnancies and potentially live births.PSD · Mar 2015
6.17 A stepped economic evaluation was presented in the submission. This was based on the Lehert 2014 meta-analysis, with a modelled evaluation of cost-effectiveness using clinical pregnancy as the outcome, and live births as a supplementary outcome. The ESC agreed that a cost-effectiveness analysis rather than a cost utility analysis was appropriate but considered live births to be the most relevant outcome.PSD · Mar 2015
Summary of model structure and rationale Component Summary Up to '''' treatment cycles in the model base case versus one cycle in meta- Time horizon analysis Outcomes Clinical pregnancies, live births Methods used to generate results Markov cohort expected value analysis Health states Start fresh cycle, live birth, discontinue IVF Cycle length Unspecified and variable Probability of OHSS, clinical pregnancy, live birth, miscarriage, discontinuation …PSD · Mar 2015
6.14 The submission described lutropin alfa (supplementary to rFSH therapy) as superior in terms of comparative effectiveness and superior in terms of comparative safety over rFSH alone, in poor responders. This may be reasonable for clinical pregnancy, but not for live births, given the non-statistically significant difference between treatment arms for live births, and the imputation of the data in the majority of the trials for poor responders.PSD · Mar 2015
6.15 The PBAC considered that the claim of superior comparative effectiveness was reasonable for clinical pregnancy but less certain for live birth.PSD · Mar 2015
6.2 The PBAC noted and welcomed the input from health care professionals (12) and organisations (1) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with lutropin alfa including affordable access to more options in IVF treatment.PSD · Mar 2015
6.4 The submission was based on a published meta-analysis of 40 studies comparing lutropin alfa + rFSH to rFSH alone (n=6,443), with a pre-specified sub-group analysis of ‘poor responders’ (14 studies; n=1,179), used in the submission to represent the eligible PBS population. The submission also included an appendix summarising studies of patients with hypogonadotropic hypogonadism.PSD · Mar 2015
Cost-effectiveness
Economic evaluation results are redacted (marked with ''' in the document). Step 2 base-case modelled evaluation for clinical pregnancy showed the intervention 'Dominates', but actual ICER values are commercially sensitive and not published in the PSD.
The ESC agreed that a cost-effectiveness analysis rather than a cost utility analysis was appropriate but considered live births to be the most relevant outcome. PSD · 2015
Decision context
PopulationWomen with severe LH deficiency, particularly poor responders to rFSH-only treatment, undergoing controlled ovarian stimulation in assisted reproductive technology (IVF/GIFT).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2015 | Recommended · restricted | rFSH alone (recombinant follicle stimulating hormone) | — | Meta-analysis · Live births |
Consumer voice
Healthcare professionals and organisations welcomed lutropin alfa as it provides affordable access to more IVF treatment options, with particular benefit noted for women with inadequate LH levels who may achieve pregnancy.
The comments described a range of benefits of treatment with lutropin alfa including affordable access to more options in IVF treatment. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to ART setting and poor responders to rFSH-only; TGA label permits any clinical use with severe LH/FSH deficiency.