CurrentAgency for Health Care AdministrationPolicy N/A

Amlodipine (Norliqva and Katerzia) Oral Solution/Suspension Coverage Criteria

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This policy governs prior authorization for Norliqva (amlodipine) oral solution and Katerzia (amlodipine) oral suspension for patients age 6 years or older with hypertension or specified coronary artery disease indications, subject to preferred-agent trial requirements and continuation criteria.

Policy Summary

PayerAgency for Health Care Administration

PolicyAmlodipine (Norliqva and Katerzia) Oral Solution/Suspension Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMarch 24, 2025

Next Review DateN/A

Key ActionDocument trial and failure of preferred calcium channel blockers, or explain why preferred agents cannot be tried.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsAuthorization length

≥6 yearsMinimum age

NorliqvaPreferred formulation

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CurrentAgency for Health Care AdministrationPolicy N/A

Amlodipine (Norliqva and Katerzia) Oral Solution/Suspension Coverage Criteria

Customize your policy alerts

Sign up for all Agency for Health Care Administration policy alerts

Know when Agency for Health Care Administration releases new policies or updates existing guidance.

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Policy Summary

PayerAgency for Health Care Administration

PolicyAmlodipine (Norliqva and Katerzia) Oral Solution/Suspension Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMarch 24, 2025

Next Review DateN/A

Key ActionDocument trial and failure of preferred calcium channel blockers, or explain why preferred agents cannot be tried.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsAuthorization length

≥6 yearsMinimum age

NorliqvaPreferred formulation

KaterziaNon-preferred formulation

2Covered disease categories

Coverage Criteria

Initial Therapy Criteria

Initial therapy is covered when all applicable criteria are met.

Initial therapy

Age: Patient must be at least 6 years of age.>= 6 years
Qualifying indication
- Hypertension: Patient has hypertension.
- Coronary artery disease
  - Chronic stable angina: Patient has chronic stable angina.
  - Vasospastic angina: Patient has vasospastic angina (Prinzmetal's or Variant Angina).
  - Angiographically documented coronary artery disease: Patient has angiographically documented coronary artery disease without heart failure or an ejection fraction <40%.Ejection fraction >= 40%
Preferred therapy history: Patient has a documented trial and failure of preferred calcium channel blockers OR the provider has documented why preferred agents cannot be tried.
Documentation required.
Katerzia-specific requirement: For Katerzia requests, the patient also has a documented trial and failure of Norliqva solution.
Applies only to Katerzia requests; documentation required.

Continuation Therapy Criteria

Continuation therapy is covered when all criteria are met.

Continuation therapy

Initial criteria met: Patient met the initial review criteria.
Clinical response: Documentation shows an improved clinical response.
Safety: Patient has not experienced any treatment-restricting adverse effects.
Dosing is appropriate as per labeling or is supported by compendia.

For coronary artery disease to qualify, documentation must show angiographically documented coronary artery disease without heart failure and without an ejection fraction below 40%. Other qualifying coronary artery disease presentations include chronic stable angina and vasospastic angina (Prinzmetal’s or variant angina).

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Clinical prior authorization is required for amlodipine oral solution/suspension products. Norliqva® (amlodipine) solution is preferred; Katerzia® (amlodipine) suspension is non-preferred. Authorizations may be issued for a maximum of 6 months.

Norliqva®: preferred agent.
Katerzia®: non-preferred agent.
Maximum authorization duration: 6 months.

Step Therapy

Preferred Calcium Channel Blocker Requirement

Before requesting either product, document a trial and failure of preferred calcium channel blockers. If preferred agents cannot be tried, document the clinical rationale for inability to use them.

Document the preferred calcium channel blocker(s) tried and failed.
Alternatively, provide a documented rationale explaining why preferred agents cannot be tried.

Clinical Background

Amlodipine is a calcium channel blocker available in liquid formulations for patients requiring treatment for hypertension or qualifying coronary artery disease, including chronic stable angina, vasospastic angina, or angiographically documented coronary artery disease without heart failure or an ejection fraction below 40%. The policy covers the Norliqva oral solution and Katerzia oral suspension subject to applicable authorization requirements.

Initial Therapy

Initial Therapy Criteria

Initial therapy requires all applicable criteria.

Initial amlodipine oral liquid therapy

Age: Patient must be at least 6 years of age.>= 6 years
Qualifying indication
- Hypertension: Patient has hypertension.
- Coronary artery disease
  - Chronic stable angina:

Continuation Therapy

Continuation Criteria

Continuation therapy requires all listed criteria.

Continuation therapy

Initial criteria met: Initial review criteria were met.
Clinical response: Improved clinical response is documented.
Safety: No treatment-restricting adverse effects have occurred.
Dosing is appropriate per labeling or supported by compendia.

Step-Therapy Requirements

Step	Requirement	Documentation / exception
1	Trial and failure of preferred calcium channel blockers is required.	Document the trial and failure, or document why preferred agents cannot be tried.

Step	Requirement	Documentation
2	For Katerzia requests, a prior trial and failure of preferred Norliqva solution is required.	Document the trial and failure of Norliqva solution.

Policy Summary

PayerAgency for Health Care Administration

PolicyAmlodipine (Norliqva and Katerzia) Oral Solution/Suspension Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMarch 24, 2025

Next Review DateN/A

Key ActionDocument trial and failure of preferred calcium channel blockers, or explain why preferred agents cannot be tried.

SourceLink

On This Page

Step Therapy

Katerzia Requires Norliqva Trial and Failure

Requests for Katerzia® require documented trial and failure of the preferred Norliqva® solution in addition to the other authorization criteria.

Document the Norliqva® solution trial.
Document failure or inadequate response to Norliqva® before requesting Katerzia®.

Documentation Required

Initial Request Documentation

Submit documentation supporting every initial review requirement with the request.

Patient age: 6 years or older.
Covered diagnosis: hypertension, or coronary artery disease documented as chronic stable angina, vasospastic angina (Prinzmetal's or variant angina), or angiographically documented coronary artery disease without heart failure or an ejection fraction below 40%.
Preferred calcium channel blocker trial and failure, or the documented rationale for why preferred agents cannot be tried.
For Katerzia® requests, documented trial and failure of Norliqva® solution.
Requested product, dosing, and other request details necessary to evaluate authorization.

Documentation Required

Continuation Documentation

For continuation, document that the initial approval criteria remain satisfied and that treatment continues to be clinically appropriate and tolerated.

Documentation that the initial authorization criteria were met.
Documentation of improved clinical response.
Confirmation that the patient has not experienced treatment-restricting adverse effects.
Documentation that dosing is appropriate according to labeling or supported by compendia.
Documentation of the ongoing need for treatment.

Denial Risk

Initial Criteria Not Met: Denial Risk

The initial request may be denied when required eligibility, diagnosis, preferred-agent, or product-specific criteria are not met or documented.

Patient is younger than 6 years of age.
No qualifying diagnosis is documented: hypertension or an eligible coronary artery disease indication.
Preferred calcium channel blocker trial and failure is not documented and no rationale explains why preferred agents cannot be tried.
For a Katerzia® request, trial and failure of Norliqva® solution is not documented.
Any other initial authorization requirement or supporting request detail is absent or not satisfied.

Denial Risk

Continuation Criteria Not Met: Denial Risk

Continuation authorization may be denied when the initial criteria, clinical benefit, tolerability, dosing appropriateness, or ongoing treatment need is not documented.

The initial approval criteria are not confirmed.
Improved clinical response is not documented.
Treatment-restricting adverse effects are present or tolerability is not established.
Dosing is not consistent with labeling and is not supported by compendia.
Ongoing treatment need is not documented.

Patient has chronic stable angina.

Vasospastic angina: Patient has vasospastic angina (Prinzmetal's or Variant Angina).

Angiographically documented coronary artery disease: Patient has angiographically documented coronary artery disease without heart failure or an ejection fraction <40%.Ejection fraction >= 40%

Preferred therapy history: Patient has a documented trial and failure of preferred calcium channel blockers OR the provider has documented why preferred agents cannot be tried.

Documentation required.

Katerzia-specific requirement: For Katerzia requests, the patient also has a documented trial and failure of Norliqva solution.

Applies only to Katerzia requests; documentation required.