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Aliskiren

Not recommended CardiovascularNot applicableNot applicable line

Treatment of hypertension in patients where an agent acting on the renin-angiotensin system is considered clinically indicated.

2
Submissions
2010–10
On the record
—
ICER range
Cost-min
Cost basis

Decision on record

1 decision
  • Meeting Jul 2010 Not recommended Antihypertensive

Access path

2 submissions · public record
  1. Jul 2010
    Not recommended

    no reduction in cardiovascular mortality and morbidity demonstrated (unlike ACE inhibitors and AIIRAs), no additional…

  2. Jul 2010
    Not recommended

    No reduction in cardiovascular mortality and morbidity demonstrated unlike ACE inhibitors and AIIRAs; no long-term…

RecommendedDeferredNot recommended

Cost-effectiveness

Cost minimisation analysis only; no ICER calculated

The submission presented a cost minimisation analysis. PSD · 2010
Surrogate endpoint

Decision context

PopulationPatients with hypertension where an agent acting on the renin-angiotensin system is clinically indicated; included trials in severe hypertension, systolic hypertension in elderly (age >65), and diabetes populations

Why it was knocked back

  • No reduction in cardiovascular mortality and morbidity demonstrated unlike ACE inhibitors and AIIRAs; no long-term safety data; safety issues (diarrhoea, peripheral oedema, hyperkalemia) requiring Risk Management Plans; uncertain clinical need; uncertain cost effectiveness; uptake assumptions underestimated

Submission history

2 entries
DecidedOutcomeComparatorICEREvidence
Jul 2010 Not recommended irbesartan (main); valsartan, ramipril, lisinopril (secondary); PBAC considered should include mix of all PBS-subsidised — RCT
Jul 2010 Not recommended irbesartan (main); valsartan, ramipril, lisinopril (secondary); PBAC considered should include a mix of all PBS-subsidis — RCT

Similar precedents

By decision profile
Losartan63%Ramipril With Felodipine61%Olmesartan Medoxomil60%Trandolapril With Verapamil59%Apixaban59%Lercanidipine With Enalapril59%Prucalopride58%Amlodipine Besylate With Valsartan58%

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to patients where RAS-acting agent is clinically indicated by prescriber; TGA label has no such clinical indication requirement.