Strontium Ranelate
Treatment of severe established osteoporosis in patients unable to use other osteoporosis medications and without cardiovascular contraindications.
Decisions on record
- Meeting Nov 2015 Recommended Osteoporosis
- Meeting Jul 2015 Recommended Osteoporosis
- Meeting Nov 2012 Recommended Osteoporosis no PSD
- Meeting Jul 2012 Recommended Osteoporosis
- Meeting Jul 2007 Recommended Osteoporosis
- Meeting Mar 2007 Deferred To treat osteoporosis no PSD
- Meeting Nov 2006 Not recommended Treatment for osteoporosis
Access path
- Jul 2005Recommended · restricted
vs alendronate
- Nov 2006Not recommended
uncertain clinical benefit (weak evidence of superiority to placebo in high-risk subgroup; marginal hip fracture…
- Nov 2006Not recommended
uncertain clinical benefit, uncertain and unacceptable cost effectiveness, weak evidentiary basis for superiority to…
- ↻ resubmittedJul 2007Recommended · restricted
Comparator changed: placebo (primary); alendronate (secondary) → alendronate
- Jul 2007Recommended · restricted
Comparator changed: placebo (primary); alendronate (secondary) → alendronate
- Jul 2012Recommended · restricted
Comparator changed: alendronate → alendronate alone
- Jul 2014Recommended
Comparator changed: alendronate alone → alendronate
- Jul 2015Recommended
Comparator changed: alendronate → best supportive care
- Nov 2015Not recommended
Sponsor's offered price did not achieve the cost-effectiveness threshold of <$15,000–$45,000/QALY set by PBAC in July…
From the public summary
4.1 The PBAC considered the sponsor’s submission of 9 September 2015.PSD · Nov 2015
4.2 The PBAC noted that the sponsor’s submission offered a cumulative ''''''''''% price reduction consistent with the July 2015 Pre-PBAC Response, in addition to the 5% reduction occurring 1 April 2016. The Committee noted that after accounting for both reductions the ICER remained significantly higher than the original ICER of $15,000/QALY - $45,000/QALY which formed the basis for the PBAC’s listing recommendation in July 2015.PSD · Nov 2015
6.34 The submission presented a modelled economic analysis assessing the cost-effectiveness of strontium versus best supportive care for patients with severe established osteoporosis at high risk of fracture who are unable to use other osteoporosis medications (i.e. last-line treatment). The PSCR argued that the economic analysis was clearly relevant for this subgroup of patients.PSD · Jul 2015
6.35 No economic analysis was presented for patients using strontium ranelate as a ‘second-line’ treatment (i.e. patients with other treatment options). The submission claimed that strontium ranelate is inferior to denosumab and patients who can use denosumab should use denosumab in preference to strontium ranelate.PSD · Jul 2015
6.30 The submission described strontium ranelate as superior in terms of efficacy and inferior in terms of safety compared to placebo. This claim may be reasonable.PSD · Jul 2015
However, the ESC noted that strontium ranelate is associated with relatively small 14PSD · Jul 2015
6.2 The PBAC noted and welcomed the input from health care professionals (6) and an organisation (1) via the Consumer Comments facility on the PBS website. The comments supported the retention of strontium ranelate on the PBS for patients with osteoporosis, without cardiovascular contraindications, who are unable to use other available treatments due to intolerance or concern about adverse events.PSD · Jul 2015
Cost-effectiveness
PBAC set threshold of <$15,000–$45,000/QALY for listing. Sponsor's offered price resulted in ICER significantly higher than this threshold. Specific ICER values in submission are redacted (marked with '''''').
The PBAC reaffirmed its previous advice of July 2015 that the continued listing of strontium on the PBS, for the treatment of severe established osteoporosis in patients unable to use other osteoporosis medications and without cardiovascular contraindications, be based on the condition that the price is reduced such that the ICER would be less than $15,000/QALY - $45,000/QALY. PBAC · 2015
Decision context
PopulationPatients with severe established osteoporosis unable to use other osteoporosis medications and without cardiovascular contraindications
Why it was knocked back
- Sponsor's offered price did not achieve the cost-effectiveness threshold of <$15,000–$45,000/QALY set by PBAC in July 2015; no new evidence provided to support an ICER greater than this threshold
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2015 | Not recommended | other osteoporosis medications | $15k–45k | Other · Other |
| Jul 2015 | Recommended | best supportive care | — | RCT · Fracture |
| Jul 2014 | Recommended | alendronate | — | Other |
| Jul 2012 | Recommended · restricted | alendronate alone | — | RCT · BMD |
| Jul 2007 | Recommended · restricted | alendronate | — | RCT · Non-vertebral fractures, Vertebral fractures |
| Jul 2007 | Recommended · restricted | alendronate | — | RCT |
| Nov 2006 | Not recommended | placebo (primary comparator); alendronate (secondary reference comparator) | $15k–45k | RCT · QALY |
| Nov 2006 | Not recommended | placebo (primary); alendronate (secondary) | $15k–45k | RCT · peripheral fracture incidence |
| Jul 2005 | Recommended · restricted | alendronate | — | RCT · Vertebral fracture |
Consumer voice
Healthcare professionals and Osteoporosis Australia supported retention of strontium ranelate on the PBS for osteoporosis patients unable to use other treatments due to intolerance or adverse event concerns, noting its continuing clinical role and alternative mode of administration.
The comments supported the retention of strontium ranelate on the PBS for patients with osteoporosis, without cardiovascular contraindications, who are unable to use other available treatments due to intolerance or concern about adverse events. Consumer comments · PSD