PBAC's latest decision on Cinacalcet hydrochloride: Not recommended (2009). Considered for For the treatment of severe primary hyperparathyroidism and persistent or recurrent hypercalcaemia following resection of parathyroid carcinoma.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
$200k/QALY
$45k/QALY–$200k/QALY · across 3 submissions
Submissions
4
first 2005
Submissions
4
2005 → 2009
Eligible population
patients with severe primary hyperparathyroidism (defined as two consecutive readings of serum calcium > 2.85 mmol/L) and persistent or recurrent hypercalcaemia following resection of parathyroid carcinoma
Therapy area
Endocrinology
Evidence base
RCT, Single-arm
Primary endpoint
serum calcium reduction
Key trials
Trial 120, Study 204
Comparator
placebo and standard medical management
Economic model
CUA
ICER note
ICER range varies by population: severe PHPT $45,000–75,000 per QALY; parathyroid carcinoma $105,000–200,000 per QALY. If average increase of mortality risk is used, ICERs become >$200,000/QALY.
ICER basis
Range aggregates 3 submissions (2005–2009) — not a single base case.
Why PBAC said no
Reasons cited in the latest PSD: lack of durability of hypocalcaemic effect, no clinical outcome data (fractures, myocardial infarction, death), no difference in quality of life compared to placebo, high and uncertain cost-effectiveness ratios, uncertainty regarding extrapolation of survival benefit from maximum 4-year observation to 35-year model duration, small study populations
Submission history
Nov 2005: Not recommended · Authority Required — ICER $45k/QALY
Jul 2006: Not recommended · Restricted — ICER $45k/QALY
Nov 2007: Recommended · Authority Required
Jul 2009: Not recommended · Authority Required — ICER $200k/QALY