← The record

Olmesartan Medoxomil With AmlodipineAKM OLMESARTAN AMLODIPINE

Recommended CardiovascularRestrictedNot applicable line

Hypertension in patients who are not adequately controlled with either angiotensin II receptor antagonist or dihydropyridine calcium channel blocker monotherapy.

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

Decision on record

1 decision
  • Meeting Jul 2010 Recommended Antihypertensive

Access path

2 submissions · public record
  1. TGA registered · AKM OLMESARTAN AMLODIPINE

    TGA label narrower than the PBS population

  2. Jul 2010
    Recommended · restricted

    Comparator changed: olmesartan medoxomil and amlodipine given concomitantly → olmesartan…

  3. Jul 2010
    Recommended · restricted

    Comparator changed: olmesartan medoxomil and amlodipine given concomitantly → olmesartan…

  4. PBS listing · Restricted
RecommendedDeferredNot recommended

Cost-effectiveness

Cost minimisation analysis; no ICER calculated by design.

The submission presented a cost minimisation analysis of olmesartan medoxomil plus amlodipine combination against the individual component products at the current price to pharmacist level. PSD · 2010
Economic model disputed

Decision context

PopulationHypertensive patients not adequately controlled with either olmesartan medoxomil or amlodipine monotherapy.

Submission history

2 entries
DecidedOutcomeComparatorICEREvidence
Jul 2010 Recommended · restricted olmesartan medoxomil and amlodipine given concomitantly RCT · DBP reduction
Jul 2010 Recommended · restricted olmesartan medoxomil and amlodipine as individual component products RCT · DBP

Similar precedents

By decision profile

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to patients inadequately controlled on prior monotherapy (ARB or CCB), a treatment-failure subset of the broad TGA hypertension label.