PBAC's latest decision on Paricalcitol: Not recommended (2011). Considered for Treatment of secondary hyperparathyroidism in patients with chronic kidney disease where treatment with calcitriol is not appropriate.
PBAC outcome
Not recommended
2011
ICER (AUD/QALY)
$45k/QALY
$15k/QALY–$45k/QALY · across 2 submissions
Submissions
4
first 2007
Submissions
4
2007 → 2011
Eligible population
patients with chronic kidney disease (CKD) who are not receiving dialysis for the proposed restriction –‘…where treatment with calcitriol is not appropriate’
Therapy area
Endocrinology
Evidence base
RCT
Primary endpoint
surrogate outcome: two consecutive decreases from baseline iPTH levels of 30% or greater
Key trials
Coyne D et al, Abboud H et al, Agarwal R et al, Ross EA et al
Comparator
placebo
Economic model
CUA
ICER note
Base case ICER was <$15,000. In sensitivity analysis with mortality risks equalised for Stages 3 and 4 CKD and cost reductions removed, ICER was between $15,000–$45,000 per QALY. A further scenario setting all-cause and cardiovascular mortality risks equal yielded ICER >$200,000 per QALY.
ICER basis
Range aggregates 2 submissions (2008–2011) — not a single base case.
Why PBAC said no
Reasons cited in the latest PSD: Uncertain clinical benefit (surrogate primary outcome of iPTH reduction not demonstrated to translate to final outcomes such as fractures, cardiovascular events or mortality); uncertain cost-effectiveness (modelled survival benefit relies on undemonstrated causal link between iPTH control and mortality reduction, with implausibly large survival gains); key concern is inappropriate use of relative risks from observational cohort studies not demonstrating that controlling iPTH reduces clinical event risk; insufficient evidence that paricalcitol prevents hypercalcaemia compared to calcitriol in the proposed population; short trial duration (12–24 weeks) with surrogate outcomes only
Submission history
Jul 2007: Not recommended
Mar 2008: Not recommended · Authority Required — ICER $200k/QALY