Follitropin Alfa With Lutropin AlfaPergoveris solution for injection
Stimulation of follicular development in patients with severe LH deficiency undergoing assisted reproductive technology (IVF/GIFT) treatment.
Decision on record
- Meeting Nov 2024 Recommended Stimulation of follicular development
Access path
- TGA registered · Pergoveris solution for injection
TGA label narrower than the PBS population
- Nov 2018Recommended · restricted
- Nov 2024Recommended
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended the increase to the current maximum quantity for follitropin alfa (r-hFSH) 900 IU with lutropin alfa (r-hLH) 450 IU in a 1.44 mL multi-dose cartridge (Pergoveris) for the stimulation of follicular development from two to four per prescription.PSD · Nov 2024
5.2 The PBAC noted that the current maximum quantity of two provides a 12-day treatment at the recommended starting dose of 150 IU r-hFSH/75 IU r-hLH once daily, while most patients with severe LH deficiency require a higher daily dose to achieve the desired therapeutic outcome. The PBAC considered an increase in the maximum quantity to 4 pens reasonable, based on PBS 10% sample data showing that 10PSD · Nov 2024
4.9 The submission requested no change to the approved ex-manufacturer price (AEMP) of $887.56 for Pergoveris (900 IU/450 IU).PSD · Nov 2024
4.3 The PBAC noted and welcomed the input from health care professionals (3) via the Consumer Comments facility on the PBS website. The comments described the benefits of a combination treatment with follitropin alfa and lutropin alfa (Pergoveris) for patients who had a poor response to follitropin alfa therapy alone, including reduced injections and simplified treatment.PSD · Nov 2024
4.4 The submission stated that the maximum quantity of two provides a 12-day treatment at the recommended starting dose of 150 IU r-hFSH/75 IU r-hLH once daily, but most patients with severe LH deficiency would require a higher daily dose than 150 IU r- hFSH/75 IU r-hLH to achieve optimal results due to increased ovarian resistance and the need for more potent follicular stimulation.PSD · Nov 2024
Cost-effectiveness
No economic evaluation was performed; this is a minor submission requesting changes to quantity and clinical criteria for an already-listed medicine. Cost-minimisation only (administrative and financial burden reduction).
Decision context
PopulationWomen with severe LH deficiency undergoing assisted reproductive technology (IVF/GIFT treatment) who are considered appropriate for combination treatment with follitropin alfa 900 IU and lutropin alfa 450 IU.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended | separate follitropin alfa (r-hFSH) and lutropin alfa (r-hLH) therapies | — | Cost-minimisation · Cost-minimisation |
| Nov 2018 | Recommended · restricted | — | — | — |
Consumer voice
Three healthcare professionals provided comments via the PBS website describing benefits of Pergoveris combination treatment for patients with poor response to follitropin alfa alone, including reduced injections and simplified treatment. They also supported increasing the maximum quantity to reduce financial and treatment burdens.
The comments described the benefits of a combination treatment with follitropin alfa and lutropin alfa (Pergoveris) for patients who had a poor response to follitropin alfa therapy alone, including reduced injections and simplified treatment. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with severe LH deficiency, a specific subset not mentioned in the broad TGA registration.