TeriparatideRitosa
Severe established osteoporosis in postmenopausal women and primary osteoporosis in men when other agents are considered unsuitable and when there is a high risk of fractures.
Decisions on record
- Meeting Jul 2025 Recommended Severe established osteoporosis
- Meeting Nov 2023 Recommended Osteoporosis
- Meeting Nov 2023 Recommended Osteoporosis
- Meeting Sep 2021 Recommended Osteoporosis no PSD
- Meeting Mar 2021 Recommended Severe established osteoporosis
- Meeting Mar 2012 Recommended Osteoporosis no PSD
- Meeting Jul 2009 Recommended Osteoporosis no PSD
- Meeting Nov 2008 Recommended Osteoporosis
1 earlier decision
- Jul 2007 Not recommended Treatment of osteoporosis in postmenopausal women and the treatment of primary osteoporosis in men when other agents are considered unsuitable and when there is a high risk of fracture. The maximal lifetime exposure to teriparatide for an individual patient is 18 months.
Access path
- TGA registered · Ritosa
TGA label narrower than the PBS population
- Jul 2005Not recommended
inappropriate comparator (placebo vs alendronate), uncertain clinical benefit against appropriate comparator, uncertain…
- Mar 2006Not recommended
Uncertain clinical benefit, uncertain and unacceptable cost-effectiveness, reliance on indirect comparison rather than…
- Mar 2006Not recommended
uncertain clinical benefit from indirect comparison and post-hoc sub-group analysis, uncertain and unacceptable…
- Sep 2006Not recommended
insufficient rigor in clinical trial data analysis, post-hoc subgroup analysis is a major deficiency with unclear and…
- ↻ resubmittedNov 2006—
Evidence: RCT → RCT | Registry
- Nov 2006Recommended
Evidence: RCT → RCT | Registry
- Jul 2007Not recommended
Lack of statistically significant clinical benefit for teriparatide over alendronate; uncertainty about incremental…
- Jul 2007Not recommended
No statistically significant clinical benefit over alendronate demonstrated, uncertainty about cost-effectiveness…
- ↻ resubmittedNov 2008Recommended · restricted
ICER dropped $45,000 → $15,000 (-67%)
- Mar 2021Recommended · restricted
Comparator changed: alendronate → Forteo
- Nov 2023Recommended
Comparator changed: Forteo → Terrosa PFC (teriparatide 250 microgram/mL injection, 2.4 mL…
- Nov 2023Recommended
Comparator changed: Forteo → Terrosa PFC (teriparatide 250 microgram/mL injection, 2.4 mL…
- Jul 2025Recommended
Comparator changed: Terrosa PFC (pre-filled cartridge) → Terrosa and Teriparatide Lupin
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the General Schedule Authority Required (STREAMLINED) listing of teriparatide injection 250 micrograms per mL, 2.4 mL in multi-dose pre- filled pen (Ritosa®) under the same circumstances as the current PBS-listed teriparatide injections 250 micrograms per mL, 2.4 mL in multi-dose pre-filled pens (Teriparatide Lupin® and Terrosa®).PSD · Jul 2025
6.2 The PBAC considered Teriparatide Lupin and Terrosa as the appropriatePSD · Jul 2025
5.10 The submission presented a cost-minimisation analysis of Ritosa compared with Terrosa and Teriparatide Lupin. The submission stated the equi-effective doses were Ritosa 20 µg once daily subcutaneous injection to Terrosa 20 µg once daily subcutaneous injection and Teriparatide Lupin 20 µg once daily subcutaneous injection.PSD · Jul 2025
5.11 The submission requested the same approved ex-manufacturer price and dispensed price for maximum quantity for Ritosa as that of Teriparatide Lupin and Terrosa.PSD · Jul 2025
5.6 The submission claimed non-inferior comparative effectiveness and safety of Ritosa compared to Terrosa and Teriparatide Lupin.PSD · Jul 2025
5.7 The submission did not provide a switching study between Ritosa, Terrosa and Teriparatide Lupin as there was no specific study available to determine the safety of switching between brands. 5 OFFICIALPSD · Jul 2025
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The PBAC noted that its recommendation was on a cost-minimisation basis and advised that, because Ritosa is not expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over Terrosa and Teriparatide Lupin, or 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
Decision context
PopulationPatients with severe established osteoporosis, as per existing PBS criteria for teriparatide (postmenopausal women and men with primary osteoporosis when other agents unsuitable and high fracture risk).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2025 | Recommended | Terrosa and Teriparatide Lupin | — | Cost-minimisation · Cost-minimisation |
| Nov 2023 | Recommended | Terrosa PFC (teriparatide 250 microgram/mL injection, 2.4 mL pre-filled cartridge) | — | Cost-minimisation · Cost-minimisation |
| Nov 2023 | Recommended | Terrosa PFC (pre-filled cartridge) | — | Cost-minimisation · Cost-minimisation |
| Mar 2021 | Recommended · restricted | Forteo | — | Single-arm · Biosimilarity |
| Nov 2008 | Recommended · restricted | alendronate | $15k | RCT · Vertebral fracture reduction |
| Jul 2007 | Not recommended | alendronate | $15k–45k | RCT · OS | PFS | DFS | ORR | QoL | Surrogate |
| Jul 2007 | Not recommended | alendronate | $15k–45k | RCT |
| Nov 2006 | — | alendronate | $15k–105k | RCT | Registry · QoL, BMD |
| Nov 2006 | Recommended | antiresorptive therapy (alendronate) | — | RCT |
| Sep 2006 | Not recommended | alendronate | — | RCT |
| Mar 2006 | Not recommended | alendronate | $15k–45k | RCT · vertebral fracture |
| Mar 2006 | Not recommended | alendronate | $15k–45k | RCT |
| Jul 2005 | Not recommended | alendronate | — | RCT · Vertebral fracture reduction |
Consumer voice
A consumer highlighted significant affordability challenges for individuals requiring medicines for rare diseases not on the PBS, specifically noting that teriparatide is required but unaffordable.
teriparatide is required, but unaffordable Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to 'severe established osteoporosis' whereas TGA label includes all 'osteoporosis' without severity qualifier.