Risedronate SodiumActonel
Primary prevention of fractures in patients with osteoporosis aged less than 70 years with a BMD T-score of -2.5 or less, without a history of minimal trauma fracture.
Decisions on record
- Meeting Mar 2011 Recommended Osteoporosis no PSD
- Meeting Jul 2010 Not recommended Treatment of osteoporosis; Treatment of glucocorticoid-induced osteoporosis; Preservation of bone mineral density in patients on long term corticosteroid therapy.
- Meeting Mar 2009 Recommended Anti-resorptive agent no PSD
- Meeting Jul 2008 Recommended Osteoporosis
- Meeting Mar 2008 Recommended Osteoporosis no PSD
- Meeting Sep 2002 Recommended Treatment for osteoporosis (once weekly presentation) no PSD
- Meeting Dec 2001 Recommended Re-submission requests listing in patients who have already sustained a fracture. Original submission proposed listing as prevention before fracture had occurred. no PSD
Access path
- TGA registered · Actonel
TGA label narrower than the PBS population
- Jul 2006Not recommended
uncertain benefit in non-vertebral fracture and hip fracture in target subgroup (aged 75+ years, BMD ≤-3.0, no…
- Jul 2006Not recommended
uncertain benefit in non-vertebral fracture and hip fracture in the clinically relevant subgroup (patients without…
- ↻ resubmittedMar 2007Recommended · restricted
Comparator changed: placebo or 'watchful waiting' (patient monitoring and standard…
- Jul 2008Recommended · restricted
Comparator changed: alendronate → placebo
- Jul 2010Recommended
Comparator changed: placebo → alendronate
- Jul 2010Noted
Comparator changed: placebo → alendronate
- Mar 2013Recommended · restricted
Comparator changed: alendronate sodium → alendronate
- Mar 2023Not recommended
Comparator changed: alendronate → placebo or 'watchful waiting' (patient monitoring and…
From the public summary
7.1 The PBAC deferred making a recommendation to amend the current age restriction 34PSD · Mar 2023
7.2 The PBAC noted that while input from specialist medical organisations including the Australian and New Zealand Bone and Mineral Society, the Endocrine Society of Australia, and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists supported amending the lower age restriction of the current risedronate listing they did not support the total removal of an age restriction (see paragraph 6.2).PSD · Mar 2023
6.49 The economic evaluation was based on early initiation of treatment with risedronate EC in eligible patients aged less than 70 years, versus delayed treatment with standard of care therapies (predominantly denosumab) in patients who fracture or reach the age of 70 years.PSD · Mar 2023
Treatment effect estimates for standard of care were based on estimated treatment effects for alendronate, denosumab, risedronate and zoledronic acid. Individual treatment effects were derived from published results of an indirect comparison of alendronate (FIT-CFA) and denosumab (FREEDOM) placebo-controlled trials in subgroups with BMD T-scores <-2.5 who are without fracture (denosumab PSD, March 2012 PBAC meeting).PSD · Mar 2023
6.38 The submission described risedronate EC as superior in terms of efficacy and non- inferior in terms of safety compared to placebo.PSD · Mar 2023
6.39 The clinical evidence included in the submission was based on the risedronate 5 mg daily immediate release formulation only, however, the supportive data suggests non- inferiority in terms of efficacy between the risedronate EC once weekly and risedronate 5 mg immediate release formulations which is consistent with prior PBAC considerations of various risedronate formulations.PSD · Mar 2023
• The ANZBMS advised it was open to expanded PBS criteria for risedronate for patients aged 50 years and over at increased risk of fracture, however was not supportive of expanding the listing to patients aged under 50 years, due to the lack of clear evidence of benefit and risk of adverse events.PSD · Mar 2023
• The ESA advised it was of the view that removing the age restriction entirely would create a risk of inappropriate use of risedronate in premenopausal women or younger individuals without specialist consideration, which may lead to adverse outcomes. Instead, ESA was supportive of amending the age restriction, such as subsidising therapy in patients over the age of 50 with low BMD T-scores and at risk of fracture.PSD · Mar 2023
Cost-effectiveness
Document appears truncated; economic model details not fully available in provided text.
The PBAC considered the estimated financial saving to the PBS were highly uncertain due to assumptions regarding utilisation, distribution of scripts across formulations, potential for switching between monotherapy/combination therapy, patient co-payments and the uncertain overall weighted price of risedronate. PBAC · 2013
Decision context
PopulationPatients aged less than 70 years with osteoporosis (BMD T-score of -2.5 or less) without a history of minimal trauma fracture
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2023 | Not recommended | placebo or 'watchful waiting' (patient monitoring and standard management with calcium and vitamin D) | — | RCT · Fracture prevention |
| Mar 2013 | Recommended · restricted | alendronate | — | Meta-analysis · Fracture risk reduction |
| Jul 2010 | Recommended | alendronate | — | RCT, registry, cost-minimisation · OS, PFS, DFS, ORR, QoL, Surrogate |
| Jul 2010 | Noted | alendronate sodium | — | Meta-analysis |
| Jul 2008 | Recommended · restricted | placebo | $15k–45k | RCT · null |
| Mar 2007 | Recommended · restricted | alendronate | — | RCT, Meta-analysis · OS | PFS | DFS | ORR | QoL | Surrogate |
| Jul 2006 | Not recommended | placebo or 'watchful waiting' (patient monitoring and standard management with calcium and vitamin D) | $15k–45k | RCT |
| Jul 2006 | Not recommended | placebo or 'watchful waiting' (patient monitoring and standard management with calcium and vitamin D) | $15k–45k | RCT · fracture_incidence |
Consumer voice
Specialist medical organisations and a consumer organisation provided input on expanded PBS criteria for risedronate. While most medical bodies supported amendments to age restrictions with caution about premenopausal women, Healthy Bones Australia advocated for broader access to reduce fracture burden.
The ANZBMS advised it was open to expanded PBS criteria for risedronate for patients aged 50 years and over at increased risk of fracture, however was not supportive of expanding the listing to patients aged under 50 years, due to the lack of clear evidence of benefit and risk of adverse events. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to age <70 years, BMD T-score ≤-2.5, and no prior minimal trauma fracture; TGA label is broader.