PBAC's latest decision on Cinacalcet: Recommended with restriction (2019). Considered for Treatment of secondary hyperparathyroidism in patients with chronic kidney disease receiving dialysis who have not responded to conventional therapy.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
3
first 2013
Submissions
3
2013 → 2019
Eligible population
Adults with chronic kidney disease on dialysis with sustained secondary hyperparathyroidism not responding to conventional therapy; iPTH at least 50 pmol/L, or iPTH 15–50 pmol/L with serum calcium ≥2.6 mmol/L.
Therapy area
Endocrinology
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Mortality and cardiovascular morbidity (composite outcome); reduction in parathyroidectomy
Pivotal trial size
3,883 patients
Key trials
EVOLVE
Comparator
placebo (add-on to standard medical management)
Economic model
Cost-minimisation
ICER note
No ICER calculated for this minor submission. Historical EVOLVE trial data from 2013 showed ICERs exceeding $15,000–$45,000 per QALY; this 2019 submission is for re-listing of an existing drug and does not present a new economic model.
ICER (historical)
$45k/QALY–$75k/QALY across 2 submissions (2013–2014) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Risk sharing
Risk-sharing arrangement in place — Risk-sharing arrangement (RSA) was recommended at the November 2007 PBAC meeting for Sensipar, requiring the Sponsor to provide ongoing data on efficacy and cost-effectiveness. The current submission requests the same listing as the previous Sensipar brand.
Submission history
Nov 2013: Not recommended · Restricted — ICER $200k/QALY
Mar 2014: Not recommended · Restricted — ICER $75k/QALY
Jul 2019: Recommended with restriction · Restricted