Follitropin Alfa And Lutropin AlfaPergoveris solution for injection
Stimulation of follicular development in women with severe LH and FSH deficiency for assisted reproductive technology (IVF/GIFT) treatment.
Decision on record
- Meeting Mar 2012 Not recommended Fertility drug no PSD
Access path
- TGA registered · Pergoveris solution for injection
TGA label narrower than the PBS population
- Mar 2014Not recommended
inadequate clinical evidence of comparative effectiveness; no direct comparison of the fixed-dose combination with…
- ↻ resubmittedMar 2015Recommended
Comparator changed: follitropin alfa (rFSH) alone; human menopausal gonadotropin (hMG) as…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the listing of the fixed dose combination product follitropin alfa and lutropin alfa, 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 recommended the listing on a cost minimisation basis to the individual components.PSD · Mar 2015
6.15 The submission proposed that the price for the FDC product is equal to the sum of the prices of its individual components, Luveris (rLH) and Gonal-f (rFSH). The proposed price for rLH component as presented in the Luveris application was $'''''''''''''' for 75IU. The ex-manufacturer price for the smallest unit size of Gonal-f on the IVF/GIFT program is $'''''''''''''''' for 300IU.PSD · Mar 2015
6.16 The proposed price for the FDC product is the sum of its components at the relevant doses is $''''''''''''''''.PSD · Mar 2015
6.11 The clinical claim for supplementation of the rFSH regimen with rLH compared to no supplementation with rLH is superior efficacy and superior safety. These conclusions are based on the Lehert (2014) meta-analysis and are addressed in the major submission for Luveris.PSD · Mar 2015
6.12 The minor re-submission proposed that a demonstration of the efficacy and safety of the combination product based on the bioequivalence of the combination and its 4PSD · 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 Pergoveris including affordable access to more options in IVF treatment and less risk of dosing errors with the combination product than using two drugs separately, improving compliance and reducing anxiety.PSD · Mar 2015
6.3 The PBAC noted the advice received from ACCESS Australia’s National Infertility Network Ltd clarifying the likely use of Pergoveris in clinical practice. The PBAC specifically noted the advice that the use of Pergoveris may provide the possibility of achieving a pregnancy for a small group of women who have inadequate levels of LH and that some women in this small group for whom LH support is necessary, may in addition require a combination of FSH …PSD · Mar 2015
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Submission proposed pricing as sum of individual components with no additional PBS cost.
The PBAC recommended the listing on a cost minimisation basis to the individual components. PBAC · 2015
Decision context
PopulationWomen requiring both rFSH and rLH supplementation with severe LH deficiency for whom treatment with the fixed dose combination is appropriate after titration to the FSH and LH doses in the combination product after at least one cycle of treatment, undergoing assisted reproductive technology (IVF/GIFT).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2015 | Recommended | follitropin alfa (Gonal-f) and lutropin alfa (Luveris) as individual components | — | Meta-analysis · Clinical pregnancy rate |
| Mar 2014 | Not recommended | follitropin alfa (rFSH) alone; human menopausal gonadotropin (hMG) as secondary comparator | — | RCT · Composite |
Consumer voice
Health care professionals (12) and organisations (1) provided input describing benefits of Pergoveris treatment including affordable access to IVF options, reduced dosing errors with the combination product, and improved compliance. ACCESS Australia's National Infertility Network Ltd clarified that Pergoveris may benefit a small group of women with inadequate LH levels who require combined FSH and
The comments described a range of benefits of treatment with Pergoveris including affordable access to more options in IVF treatment and less risk of dosing errors with the combination product than using two drugs separately, improving compliance and reducing anxiety. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to IVF/GIFT treatment and requires prior titration, whereas TGA label has no treatment-setting or prior-treatment requirements.