Cinacalcet HydrochlorideAKM CINACALCET
For the treatment of severe primary hyperparathyroidism and persistent or recurrent hypercalcaemia following resection of parathyroid carcinoma.
Decisions on record
- Meeting Nov 2010 Recommended Chronic kidney disease no PSD
- Meeting Jul 2009 Not recommended Hyperparathyroidism Hypercalcaemia
Access path
- TGA registered · AKM CINACALCET
TGA label narrower than the PBS population
- Nov 2005Not recommended
uncertain extent of clinical benefit (surrogate outcomes only, no demonstrated impact on bone fractures, cardiovascular…
- Nov 2005Not recommended
uncertain clinical benefit (biochemical surrogate outcomes only, no demonstrated impact on bone disease or quality of…
- Jul 2006Not recommended
uncertain clinical benefit from post hoc analysis of safety data (not primary endpoints), uncertain mortality hazard…
- ↻ resubmittedNov 2007Recommended
Comparator changed: placebo for add-on to standard care involving dietary modification…
- Nov 2007Recommended · restricted
Comparator changed: placebo for add-on to standard care involving dietary modification…
- Jul 2009Not recommended
lack of durability of hypocalcaemic effect, no clinical outcome data (fractures, myocardial infarction, death), no…
Cost-effectiveness
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.
The PBAC noted the incremental base case cost-effectiveness ratios for the severe PHPT and the parathyroid cancer population were high, in the range $45,000 – 75,000 per QALY and $105,000 – 200,000 per QALY, respectively. PBAC · 2009
Decision context
Populationpatients 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
Why it was knocked back
- 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
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2009 | Not recommended | placebo and standard medical management | $45k–200k | RCT, Single-arm · serum calcium reduction |
| Nov 2007 | Recommended | placebo plus standard medical management | — | RCT · other |
| Nov 2007 | Recommended · restricted | placebo plus standard medical management | $15k–45k | RCT |
| Jul 2006 | Not recommended | placebo for add-on to standard care involving dietary modification, vitamin D products in association with calcium-based | $15k–45k | RCT |
| Nov 2005 | Not recommended | placebo for add-on to standard medical management involving dietary modification, vitamin D products in association with | $15k–45k | RCT · OS | PFS | DFS | ORR | QoL | Surrogate |
| Nov 2005 | Not recommended | placebo for add-on to standard medical management | $15k–45k | RCT · iPTH response |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe primary hyperparathyroidism (calcium >2.85 mmol/L) and post-resection carcinoma; excludes secondary hyperparathyroidism and untreated parathyroid carcinoma.