CurrentmhnPolicy CP.PMN.174

Clinical Policy: Perindopril/Amlodipine (Prestalia)

Defines medical necessity, initial and continuation approval criteria, dosing limits, contraindications, and authorization durations for perindopril/amlodipine (Prestalia) for commercial and Medicaid lines of business within Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyClinical Policy: Perindopril/Amlodipine (Prestalia)

Policy CodePolicy CP.PMN.174

Change TypeRevised; Clarified; Annual review

Effective DateDec 1, 2018

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Revised approval duration to 12 months or duration of request, whichever is less.

Added 1 tablet per day quantity limit for dosing requirement.

Annual reviews 2021-2025 noted no significant changes; references updated.

1Covered Indications (FDA)

14/10 mgMaximum Dose

1Tablet per day limit

3Tablet strengths available

Prestalia (perindopril/amlodipine) is a fixed-dose combination of an ACE inhibitor (perindopril) and a dihydropyridine calcium channel blocker (amlodipine). The policy coverage stance is covered_with_criteria for treatment of hypertension. This clinical policy (Policy Number: CP.PMN.174) is effective 12.01.18 and applies to Commercial and Medicaid lines of business. The policy defines initial and continued approval criteria, dosing limits (maximum 14 mg/10 mg per day and maximum 1 tablet per day), contraindications, and approval duration (up to 12 months or duration of request, whichever is less).

Quick Facts and Limits

Maximum daily dose14 mg/10 mg per day

Maximum tablets per day1 tablet per day

Tablet strengths available3.5/2.5 mg; 7/5 mg; 14/10 mg

Coverage stanceCovered with criteria

Approval durationUp to 12 months or duration of request, whichever is less

Initial Therapy Criteria

I. Initial Approval Criteria - Hypertension

Covered when ALL of the following are met:

ALL of the following

Diagnosis of hypertension
Provider must submit documentation (office chart notes, lab results or other clinical information)
ALL of the following
- Dose limits (both required)
  - Dose does not exceed 14 mg/10 mg per day<= 14 mg/10 mg per day
  - Dose does not exceed 1 tablet per day<= 1 tablet per day

Unproven / Not Authorized Indications

III. Diagnoses/Indications Not Authorized

Coverage is NOT authorized for:

Non-FDA approved indications, unless sufficient documentation of efficacy and safety per off-label use policy (CP.CPA.09 for commercial; CP.PMN.53 for Medicaid) or evidence of coverage documents

Provider Actions / Prior Authorization

Prior Authorization

Documentation required for prior authorization

Provider must submit documentation (office chart notes, lab results or other clinical information) supporting that member meets all approval criteria.

Examples: office chart notes; laboratory results; other relevant clinical information

Prior Authorization

Approval duration

Approvals granted for up to 12 months or duration of request, whichever is less.

Documentation Required

Justify combination vs individual components

Medical justification must support inability to use individual generic components concurrently to qualify for Prestalia.

Denial Risk

Non-FDA indications not covered without evidence

Requests for non-FDA approved indications will be denied unless documentation meets off-label policy criteria or evidence of coverage documents.

Documentation Required

Contraindications must be checked

Ensure member does not have contraindications including history of angioedema, hypersensitivity to ACE inhibitors or amlodipine, concomitant aliskiren in diabetes, concurrent/nearly concurrent neprilysin inhibitor (sacubitril); pregnancy requires immediate discontinuation.

Clinical Evidence & References

Evidence referenced in the brief includes the product Prescribing Information: Prestalia Prescribing Information; Symplmed; October 2019 (dailymed). The brief does not provide additional clinical trial metrics beyond this prescribing information reference.

Background & Definitions

Prestalia is a combination of perindopril (an angiotensin converting enzyme [ACE] inhibitor) and amlodipine (a dihydropyridine calcium channel blocker) indicated for treatment of hypertension in patients not adequately controlled with monotherapy or as initial therapy for patients likely to need multiple agents to achieve blood pressure goals. Available tablet strengths include 3.5 mg/2.5 mg, 7 mg/5 mg, and 14 mg/10 mg, with a maximum recommended dose of 14 mg/10 mg per day.

ACE: angiotensin converting enzyme

FDA: Food and Drug Administration

Revision History

10.18.21revised

Revised approval duration to 12 months or duration of request, whichever is less.

02.22revised

Revised approval duration to 12 months or duration of request, whichever is less (P&T approval).

07.12.22revised

Added 1 tablet per day quantity limit for dosing requirement (4Q 2022 annual review).

11.22revised

Added 1 tablet per day quantity limit for dosing requirement (P&T approval).

4Q 2021annual_review

4Q 2021 annual review: no significant changes; references reviewed and updated.

4Q 2023annual_review

4Q 2023 annual review: no significant changes; references reviewed and updated.

4Q 2024annual_review

4Q 2024 annual review: no significant changes; references reviewed and updated.

4Q 2025annual_reviewLatest

4Q 2025 annual review: no significant changes; references reviewed and updated.