CinacalcetAKM CINACALCET
Treatment of secondary hyperparathyroidism in patients with chronic kidney disease receiving dialysis who have not responded to conventional therapy.
Decisions on record
- Meeting Jul 2019 Recommended Chronic kidney disease (CKD)
- Meeting Nov 2013 Noted 30 mg, 60 mg and 90 mg, tablet Senisipar® Amgen Australia Pty Ltd Major submission Secondary hyperparathyroidism in patients with end stage renal disease To provide the results of the EVOLVE trial and consider the impact of the results on the cost-effectiveness of cinacalcet in the treatment of seco
- Meeting Nov 2007 Recommended Chronic kidney disease
Access path
- TGA registered · AKM CINACALCET
TGA label narrower than the PBS population
- Nov 2013Recommended
vs placebo plus standard medical management
- Mar 2014Not recommended
ICER ($45,000–$75,000 per QALY) remains higher than original threshold ($15,000–$45,000); price reduction insufficient…
- ↻ resubmittedJul 2019Recommended · restricted
Comparator changed: placebo → placebo (add-on to standard medical management)
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended the listing of cinacalcet for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) receiving dialysis, on the basis that it should be available only through special arrangements under the Section 100 Highly Specialised Drugs Program for initial and continuing treatment and the Section 85 General Schedule for continuing treatment.PSD · Jul 2019
7.2 The PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost-effectiveness of cinacalcet would be acceptable if it were 11PSD · Jul 2019
6.12 No economic analysis was presented in the submission as this was a minor submission.PSD · Jul 2019
6.13 The submission noted that it had no knowledge of the effective PBS price for Sensipar prior to it being delisted in August 2015 given the SPA that was applied. Therefore, the 8PSD · Jul 2019
6.10 The submission claimed that Pharmacor Cinacalcet provides equivalent effectiveness and safety to the previously listed brand, Sensipar. The PBAC noted that TGA considered the two brands to be bioequivalent.PSD · Jul 2019
6.11 Therefore, based on the bioequivalence statement, the PBAC considered that the claims of non-inferior comparative effectiveness and safety were reasonable.PSD · Jul 2019
6.4 As noted in November 2013, the EVOLVE trial was an international, randomised, double-blind trial comparing the effects of cinacalcet and placebo on mortality and cardiovascular morbidity in dialysis patients with SHPT (n=3,883) (cinacalcet PSD November 2013).PSD · Jul 2019
6.7 Additionally, the Pre-PBAC response noted that in the pre-specified subgroup analyses, there was a significant effect on the primary composite outcome seen in older patients aged ≥65 years (relative hazard 0.74; 95%CI 0.63, 0.86 (p-interaction = 0.01). The Pre-PBAC response claimed that since patients in this age group were likely to be unsuitable for parathyroidectomy and that cinacalcet would be the likely treatment option for SHPT.PSD · Jul 2019
Cost-effectiveness
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.
The PBAC noted that, even were it to accept that age is a treatment effect modifier to the extent proposed in the submission, the resulting ICERs were both between $45,000 and $75,000 per QALY gained in patients aged less than 65 years (including the proposed price reduction for that population), and for patients aged 65 years and over. PBAC · 2014
Decision context
PopulationAdults 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.
Risk sharingRisk-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
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2019 | Recommended · restricted | placebo (add-on to standard medical management) | — | RCT · Mortality and cardiovascular morbidity (composite outcome); reduction in parathyroidectomy |
| Mar 2014 | Not recommended | placebo | $45k–75k | RCT · Surrogate |
| Nov 2013 | Recommended | placebo plus standard medical management | $200k | RCT · OS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| EVOLVE | Ph 3 | 3,883 | Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitaliz… | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with prior treatment failure and specific iPTH/calcium thresholds; TGA label has no such treatment-refractory requirement.