Desmopressin AcetateDesmopressin ADVZ
Recommended EndocrinologyAuthority RequiredNot applicable line
Treatment of cranial diabetes insipidus and primary nocturnal enuresis.
1
Submissions
2025–25
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Nov 2025 Recommended Cranial diabetes insipidus and primary nocturnal enuresis
- Meeting Mar 2011 Recommended Nocturnal enuresis no PSD
- Meeting Nov 2008 Not recommended Synthetic pituitary hormone no PSD
- Meeting Jul 2008 Recommended Noctural enuresis no PSD
- Meeting Mar 2003 Recommended Drug that decreases urinary volume no PSD
- Meeting Mar 2003 Recommended Drug that decreases urinary volume no PSD
- Meeting Jun 2002 Recommended Nocturnal enuresis no PSD
Access path
- TGA registered · Desmopressin ADVZ
TGA label narrower than the PBS population
- Nov 2025Recommended
vs Minirin nasal spray
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
5.1 The PBAC recommended listing a new brand of desmopressin nasal spray (Desmomed) with a new pack size (50 actuations, 5 mL) for the treatment of cranial diabetes insipidus and primary nocturnal enuresis, under the same restrictions as the currently PBS-listed originator brand, Minirin® nasal spray (60 actuations, 6 mL).PSD · Nov 2025
5.2 The PBAC recommended that the new brand of desmopressin nasal spray (Desmomed, 50 actuations) be cost-minimised to Minirin nasal spray (60 actuations) on a per actuation (dose) basis.PSD · Nov 2025
Economic analysis
4.3 The submission presented an economic analysis for the new generic desmopressin nasal spray (Desmomed) compared to the currently PBS-listed Minirin nasal spray and the Section 19A brand (Desmopressin Nasal Spray USP (Apotex)), based on an equivalent price per pump pack rather than on a per actuation (dose) basis.PSD · Nov 2025
4.4 Table 1 provides a comparison of the price of desmopressin nasal sprays across the different brands. 3 OFFICIALPSD · Nov 2025
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. PBAC recommended cost-minimisation to Minirin nasal spray on a per actuation basis.
The PBAC noted that its recommendation was on a cost-minimisation basis and advised that, because Desmomed is not expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over Minirin nasal spray, or not expected to address a high and urgent unmet clinical need given the presence of an alternative therapy, the criteria prescribed by the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2022 for Pricing Pathway A were not met. PBAC · 2025
Cost-effectiveness accepted
Decision context
PopulationPatients with cranial diabetes insipidus or primary nocturnal enuresis (≥6 years of age for enuresis; those refractory to enuresis alarm or in whom alarm is contraindicated).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Recommended | Minirin nasal spray | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted enuresis to patients ≥6 years and those refractory to alarm or where alarm is contraindicated; omitted diagnostic test indication.