Testosterone UndecanoateGONADRON
Testosterone replacement in primary and secondary male hypogonadism, including androgen deficiency in males with established pituitary or testicular disorders, males aged 40 years and older with confirmed androgen deficiency, and micropenis, pubertal induction, or constitutional delay of growth or puberty in males under 18 years.
Access path
- TGA registered · GONADRON
TGA label narrower than the PBS population
- Nov 2005Recommended
Evidence: RCT → Single-arm
- Nov 2005Recommended · restricted
Evidence: RCT → Single-arm
- PBS listing · Authority Required
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated.
The PBAC considered it appropriate that a modelled economic evaluation was not presented as the submission was based on a cost-minimisation approach. PBAC · 2005
Decision context
PopulationMales with primary and secondary hypogonadism, including those with established pituitary or testicular disorders, males 40 years and older with confirmed androgen deficiency, and males under 18 years with micropenis, pubertal induction, or constitutional delay of growth or puberty.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2005 | Recommended | testosterone implant | — | RCT |
| Nov 2005 | Recommended · restricted | testosterone implant | — | Single-arm |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to specific diagnostic criteria (testosterone <8 nmol/L or 8-15 with high LH) and age/disorder categories; TGA label is broader.