Cinacalcet was relisted on the PBS on 1 February 2020.
From 1 August 2015, calcimimetic therapy cinacalcet will be deleted from the list of drugs subsidised on the PBS .1 This decision was made after a reassessment of its cost-effectiveness by the Pharmaceutical Benefits Advisory Committee and not due to efficacy or safety issues.1
This re-assessment was a requirement at the time of listing, before ongoing data from the EVOLVE trial became available.2 The EVOLVE study was a randomised controlled trial comparing the effect of cinacalcet to placebo in 3883 patients with secondary hyperparathyroidism on dialysis.3, 4
Cinacalcet did not demonstrate a statistically significant difference from placebo in the primary endpoint – time-to-death or non-fatal cardiovascular event – and the PBAC concluded that the only benefit of cinacalcet was a reduction in the need for parathyroidectomy.3, 4
The price reduction was considered unacceptable by the sponsor.1 Cinacalcet will remain available in Australia by private prescription and also via a special access program.1
Cinacalcet is currently a nephrologist-initiated PBS Authority required (streamlined) listing for initiation or maintenance therapy of patients with chronic kidney disease (CKD) on dialysis with sustained secondary hyperparathyroidism.5
Secondary hyperparathyroidism is progressive in patients with CKD and if left untreated can result in high turnover bone disease with serious consequences.6 Cinacalcet works by reducing parathyroid hormone levels and simultaneously reduces serum calcium and phosphorus levels.7
While there are no other cinacalcet formulations available on the PBS, there are alternative management and treatment strategies that may be implemented for patients stopping cinacalcet.1
Sponsor aid during transitionary phase
A group of senior nephrologists has developed recommendations for alternative management and treatment in patients stopping cinacalcet – see 'What to expect in patients stopping cinacalcet' and 'Considerations for patients stopping cinacalcet' below for this advice.
The sponsor has created a special access program, protocol and process for patients most in need or when alternative options are inappropriate.1
What to expect in patients stopping cinacalcet
Pathology changes:
- a rising parathyroid hormone (PTH) level8
- a rise in serum calcium level8
- a possible rise in serum phosphate level.8
Possible problems from stopping cinacalcet:
- if PTH level rises after cinacalcet is stopped, bone turnover is likely to rise, increasing the risk of hyperparathyroid bone disease (osteitis fibrosa). This rise also depends on the effect of other medicines8
- patients may require a total or subtotal parathyroidectomy8
- hypercalcaemia and hyperphosphataemia may result from increasing calcitriol dose; subsequently phosphate binder doses may need to be increased. Oral therapy alone may not control increases in serum phosphate level.8
Considerations for patients stopping cinacalcet
Consider alternative treatments: use of longer or more dialysis; calcitriol and/or parathyroidectomy may need to be considered.8
Review frequency of pathology testing: frequency of testing should be determined by the patient's nephrologist – in most cases the usual frequency of blood testing is sufficient.8
Use non-calcium-containing phosphate binders: in patients starting or increasing calcitriol, control of serum calcium may be problematic; use of non-calcium-containing phosphate binders such as sevelamer, lanthanum, magnesium-based or iron-based therapies may be preferable to starting or increasing calcium-based treatments.8
Dialysate calcium concentrations > 1.25 mmol/L are likely to result in a positive calcium balance and are not recommended to suppress PTH.8 Lowering dialysate calcium level may be useful in the event of hypercalcaemia but will also tend to increase serum PTH values.8 In general, do not use bisphosphonates or calcitonin routinely to reduce serum calcium level.8
Taper dose slowly for patients on high-dose cinacalcet: patients on higher doses of cinacalcet may be more challenging to manage – consider reducing the cinacalcet dose slowly in patients before stopping it.8
What to tell your patients
Encourage patients taking cinacalcet to discuss treatment options with their nephrologist before 1 August.
For questions and further information call the sponsor's medical information department on 1800 803 638.1
References
- The Society of Hospital Pharmacists of Australia. Manufacturers alerts. 20 February 2015. [Online PDF] (accessed 5 March 2015).
- Australian Government Department of Health Pharmaceutical Benefits Scheme. Public summary document Cinacalcet tablets, 30 mg, 60 mg and 90 mg, Sensipar. November 2007. [PBS] (accessed 11 March 2015).
- Australian Government Department of Health Pharmaceutical Benefits Scheme. Public summary document Cinacalcet tablets, 30 mg, 60 mg and 90 mg, Sensipar. November 2013. [PBS] (accessed 11 March 2015).
- EVOLVE Trial Investigators, Chertow GM, Block GA, et al. Effect of cinacalcet on cardiovascular disease in patients undergoing dialysis. N Engl J Med 2012;367:2482–94. [PubMed]
- Australian Government Department of Health, Pharmaceutical Benefits Scheme. Cinacalcet. March 2015. [PBS] (accessed 5 March 2015).
- Martin KJ, Gonzalez EA. Metabolic bone disease in chronic kidney disease. J Am Soc Nephrol 2007;18:875–85. [PubMed]
- Amgen Australia Pty Ltd. Sensipar Registered Product Information. January 2005. [TGA] (accessed 5 March 2015).
- Elder G, Hawley C, Holt S, et al. Withdrawal of cinacalcet (Sensipar): Suggestions for clinical care. March 2015.Information provided by Amgen Australia Pty Ltd, March 2015.