Paricalcitol

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.

The PBAC considered that it is unacceptable to use relative risks taken from selected observational studies (that do not demonstrate that controlling iPTH levels leads to reductions in risk of assessed events) and then apply these relative risks to changes in iPTH levels in the pivotal trial population. It is highly unlikely that the total relative risk reduction associated with differing iPTH levels is 100% attributable to changes in iPTH alone. PBAC · 2011

Populationpatients with chronic kidney disease (CKD) who are not receiving dialysis for the proposed restriction –‘…where treatment with calcitriol is not appropriate’

• 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

Label narrower than PBS population — PBAC restricts to dialysis patients only (stages 4-5) with specific iPTH and biochemical thresholds; TGA includes all stages 3-5 CKD without biochemical criteria.