From 1 August 2016, strontium ranelate 2 g (Protos) will be deleted from the list of drugs subsidised on the PBS for the treatment of severe established osteoporosis.1
Reasons leading to PBS deletion
In April 2014 the Therapeutic Goods Administration issued a safety alert that resulted in a revised indication restricting strontium to patients who were intolerant of, or had contraindications to, other treatments for osteoporosis.2
The change in indication was due to safety concerns around the risk of cardiovascular events and venous thrombosis associated with strontium.2,3 The Product Information (PI) and Consumer Medicines Information for strontium were also updated to include a black box warning to highlight the restricted indication.
Consequently the Pharmaceutical Benefits Advisory Committee amended the PBS listing to reflect strontium as a second-line option for patients with severe osteoporosis, on the basis that the cost-effectiveness of strontium will require reassessment in the revised patient population.3
More information about these PI changes and PBS restrictions for strontium ranelate can be found in the April 2014 NPS MedicineWise news article Strontium ranelate: black box warning added to Product Information and the December 2014 NPS RADAR brief item Black-box warning for strontium ranelate (Protos) added to Product Information.
In July 2015 the PBAC found that a price reduction was warranted for strontium to be cost-effective in the revised patient population.4 The sponsor of strontium was unable to agree to the new price and, as a result, strontium will be removed from the PBS.5
While no other strontium ranelate formulations are available on the PBS, there are alternative management and treatment strategies that may be implemented for some patients stopping strontium. Refer to the NPS MedicineWise website for a decision pathway diagram of PBS listed treatments.
Considerations for patients on strontium
Review patient management of osteoporosis and refer to current practice guidelines.6
If appropriate, transition patients to other PBS-subsidised treatment options for established osteoporosis, such as bisphosphonates, denosumab, teriparatide, raloxifene or calcitriol (refer to the PBS website for PBS criteria).7,8
Should patients remain on strontium, advise that treatment will be available through a non-PBS (private) script or a public hospital setting.5
- Department of Health. Summary of Changes. 2016. (Accessed .)
- Therapeutic Goods Administration. Strontium ranelate (Protos) and risk of adverse events. 2014. (Accessed 18 May 2016.)
- Department of Health. Strontium Ranelate Public Summary Document July 2014. (Accessed 9 May 2016.)
- Department of Health. Strontium Ranelate Public Summary Document July 2015.
- Department of Health. Strontium Ranelate Public Summary Document. November 2015. (Accessed 10 May 2016.)
- Servier Laboratories. Protos Product Information 2014. (Accessed 10 May 2016.)
- Australian Medicines Handbook. Australian Medicines Handbook (online). 2015. (Accessed 9 May 2016.)
- Department of Health. The Pharmaceutical Benefits Scheme. 2016. (Accessed 10 May 2016.)