KATERZIA (amlodipine) — Prior Authorization Criteria
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This policy establishes prior authorization requirements and coverage criteria for KATERZIA (amlodipine) for treatment of hypertension or angina in eligible Mississippi Division of Medicaid members, including pediatric patients age 6 and older.
No material clinical or coverage changes in this revision.
Coverage Criteria for KATERZIA (amlodipine)
inv-01: Initial Authorization
Covered when ALL of the following are met:
Each numbered requirement must be met.
inv-02: Re-Authorization
Covered when ALL of the following are met:
Both conditions required for renewal. Approval period: 1 year.
Coverage for KATERZIA (amlodipine) will be granted only when all required authorization criteria are met. Denial will result if the prescriber does not document the required prior therapy trials or if the requested dosing exceeds policy limits. Specifically, the request must include documentation of a minimum six‑month trial with inadequate response, intolerance, or contraindication to at least two different preferred long‑acting calcium channel blocker agents and a separate six‑month trial with inadequate response, intolerance, or contraindication to NORLIQVA (amlodipine). In addition, the prescribed dose must not exceed 10 mg per day for adults or 5 mg per day for pediatric patients. Requests lacking these documented prior trials or requesting doses above these thresholds will be denied.
Initial Authorization Details
inv-13: Initial Authorization
Initial authorization criteria specific to KATERZIA
Approval duration: 1 year. Provide documentation of prior trials and reasons for failure/intolerance/contraindication.
Re-Authorization / Continuation Requirements
inv-14: Re-Authorization
Re-authorization requirements for continued coverage
Approval period: 1 year. Monitor clinical response and adherence to dosing limits.
Step Therapy and Prior Trials
| Step | Required prior trials (minimum duration) | Failure criteria | Coverage |
|---|---|---|---|
| 1 | At least two different preferred long-acting calcium channel blocker agents — each trial ≥ 6 months | Inadequate response, intolerance, or contraindication to each agent | |
| 2 | NORLIQVA (amlodipine) — trial ≥ 6 months | Inadequate response, intolerance, or contraindication to NORLIQVA |
Provider Actions & Documentation Requirements
Prior authorization required for KATERZIA
Prior authorization is required for KATERZIA. Approval will be considered only when the policy’s coverage criteria are met, including minimum age per product labeling, a diagnosis of hypertension or angina, required prior trials (two preferred long-acting CCBs and NORLIQVA), and adherence to the specified dosing limits (≤10 mg/day adult; ≤5 mg/day pediatric).
Step therapy: required prior trials
Documented trials with inadequate response, intolerance, or contraindication to at least two different preferred long-acting calcium channel blockers and to NORLIQVA (amlodipine) are required before KATERZIA will be approved.
- Each required trial must be at least six months in duration.
- Reason for discontinuation (inadequate response, intolerance, or contraindication) must be documented.
Submit Universal PA Form and supporting clinical documentation
Submit the Universal PA Form along with supporting clinical documentation, including evidence of prior trials with preferred long-acting CCBs and NORLIQVA that documents trial duration and the reason for failure, intolerance, or contraindication.
- Include dates/duration of each prior trial.
- Document clinical rationale for inadequate response, intolerance, or contraindication.
Denial risk: missing required prior trials
Failure to document six-month trials with inadequate response, intolerance, or contraindication to at least two different preferred long-acting CCBs and to NORLIQVA will result in denial of the request.
- Both the two preferred long-acting CCB trials and the NORLIQVA trial must be documented for approval.
Dose limit exceeded — will be denied
Requests that exceed the policy maximum daily dose will be denied: adult doses over 10 mg per day or pediatric doses over 5 mg per day are not allowed.
- Prescribed dose must not exceed 10 mg/day for adults.
- Prescribed dose must not exceed 5 mg/day for pediatric patients.
Dosing Limits & Coding
Quantity Limits for KATERZIA
Definitions and Product Details
Background
KATERZIA is a long‑acting calcium channel blocker formulation of amlodipine used for treatment of hypertension and angina. The product is indicated for adults with angina and for treatment of hypertension in adults and in pediatric patients aged 6 years and older. Treatment and authorization decisions must consider labeled age limits and dosing; the policy enforces maximum daily dose thresholds of 10 mg/day for adults and 5 mg/day for pediatric patients.
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