Nandrolone DecanoateDeca-Durabolin
Treatment of osteoporosis as monotherapy where other treatments have failed, are not tolerated, or are contraindicated, with specialist advice confirming it is the only suitable treatment option.
Decision on record
- Meeting Mar 2018 Not recommended Osteoporosis
Access path
- TGA registered · Deca-Durabolin
TGA label narrower than the PBS population
- Mar 2018Not recommended
no clinical need for a new form of nandrolone decanoate on the PBS for osteoporosis treatment, little clinical benefit…
From the public summary
6.1 The PBAC did not recommend the request of Authority Required listing of a new form of nandrolone decanoate on the basis that there was no clinical need for a new form of this drug on the PBS for the treatment of osteoporosis.PSD · Mar 2018
6.2 The PBAC noted that the advice received from the Royal Australian College of General Practitioners (RACGP) stated there is little benefit in the use of nandrolone decanoate for the treatment of osteoporosis. The RACGP also advised that general practitioners are unlikely to prescribe this drug without the support of another specialist (e.g. endocrinologists).PSD · Mar 2018
5.4 As a minor submission, there was no economic comparison presented.PSD · Mar 2018
Drug cost/patient/ year: $'''''''''''' (current), $'''''''''''' (requested)PSD · Mar 2018
5.2 The PBAC noted the advice received from the Royal Australian College of General Practitioners (RACGP) clarifying the likely use of nandrolone decanoate in clinical practice. The PBAC specifically noted the advice that there is little clinical benefit in the use of nandrolone decanoate for the treatment of osteoporosis.PSD · Mar 2018
Cost-effectiveness
Minor submission with no economic comparison presented
Decision context
PopulationPatients with osteoporosis where other treatments have failed, are not tolerated, or are contraindicated, requiring specialist confirmation that this is the only suitable treatment option
Why it was knocked back
- no clinical need for a new form of nandrolone decanoate on the PBS for osteoporosis treatment, little clinical benefit noted by RACGP, lack of clinical context in this setting
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2018 | Not recommended | nandrolone decanoate pre-filled syringe | — | Other |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to later-line use with failed/intolerant prior treatments and specialist confirmation; TGA label permits osteoporosis where oestrogen contraindicated without such restrictions.