IvabradineAPO-IVABRADINE
Chronic heart failure in symptomatic patients (NYHA classes II or III) with reduced left ventricular ejection fraction (≤35%) and elevated resting heart rate (≥77 bpm) on optimal standard heart failure treatment.
Decisions on record
- Meeting Mar 2015 Recommended Chronic heart failure
- Meeting Nov 2012 Not recommended Treatment of chronic stable angina due to atherosclerotic coronary artery disease in patients with normal sinus rhythm, who are unable to tolerate or have a contraindication to the use of beta-blockers, OR in combination with atenolol 50 mg once daily when heart rate is at or above 60 beats per minu no PSD
- Meeting Jul 2012 Deferred Heart failure
- Meeting Nov 2011 Not recommended Heart failure
- Meeting Jul 2008 Not recommended Treatment of chronic stable angina due to atherosclerotic coronary artery disease in patients with normal sinus rhythm who are unable to tolerate or have a contraindication to the use of beta blockers.
- Meeting Nov 2007 Not recommended Angina (heart pain due to lack of oxygen reaching the heart)
Access path
- TGA registered · APO-IVABRADINE
- Nov 2011Not recommended
high uncertainty around clinical evidence, applicability of SHIfT trial to Australian setting (dominated by Eastern…
- ↻ resubmittedJul 2012Recommended
ICER rose $45,000 → $200,000 (+344%)
- Jul 2012Deferred
ICER rose $45,000 → $200,000 (+344%)
- Mar 2015Recommended · restricted
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended amending the listing of ivabradine from Authority Required to Authority Required (Streamlined).PSD · Mar 2015
6.2 The PBAC also recommended a change to the restriction wording to include echocardiography as an alternative diagnostic test to electrocardiogram (ECG). The PBAC considered that echocardiography is regularly used in clinical practice, and that the change was therefore appropriate.PSD · Mar 2015
5.3 As a minor submission, no economic comparison was presented.PSD · Mar 2015
Cost-effectiveness
Minor submission; no economic comparison presented.
As a minor submission, no economic comparison was presented. PSD · 2015
Decision context
PopulationAdults with chronic heart failure, NYHA classes II or III, in sinus rhythm, with left ventricular ejection fraction ≤35%, resting heart rate ≥77 bpm, receiving optimal standard chronic heart failure treatment including maximum tolerated dose beta-blocker.
Risk sharingRisk share agreement (RSA) in place; expenditure estimated at 39% below first year RSA threshold.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2015 | Recommended · restricted | — | — | RCT |
| Jul 2012 | Recommended | placebo (standard medical management) | $15k–200k | RCT · OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other | null |
| Jul 2012 | Deferred | placebo (standard medical management) | — | RCT · CV_death_or_HF_hospitalisation |
| Nov 2011 | Not recommended | placebo (standard medical management) | $15k–45k | RCT · OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other | null |