Prior Authorization Criteria for SDAMLO (amlodipine)
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This document establishes prior authorization requirements and medical necessity criteria for SDAMLO (amlodipine) for Mississippi Division of Medicaid members, including initial and re-authorization rules and dosing limits.
No material clinical or coverage changes in this revision.
Coverage Criteria for SDAMLO (amlodipine)
Initial Authorization
Covered when ALL of the following are met
Re-Authorization
Covered when ALL of the following are met
Initial Therapy
Initial therapy
Initial therapy coverage requires:
Continuation / Re-Authorization Criteria
Continuation therapy
Re-Authorization criteria
Provider Actions and Requirements
Prior authorization required for SDAMLO (amlodipine)
Prior authorization is required for SDAMLO (amlodipine). When all initial authorization criteria are met (age per labeling; diagnosis of hypertension, angina, or coronary artery disease; required prior treatment trials; and dose within limits), approval may be granted for 1 year.
Required prior trials (step therapy)
Before SDAMLO will be approved, document trials showing inadequate response, intolerance, or contraindication to at least two different preferred long-acting calcium channel blockers and to NORLIQVA (amlodipine); each required trial must be for at least six months.
- ≥6-month trial with inadequate response/intolerance/contraindication to at least two different preferred long-acting CCB agents
- ≥6-month trial with inadequate response/intolerance/contraindication to NORLIQVA (amlodipine)
Required documentation for PA
Submit the Universal PA Form with supporting clinical documentation that demonstrates the patient’s diagnosis, age eligibility per product labeling, details of prior treatment trials (agents, durations, and reasons for failure/intolerance/contraindication), and the prescribed dose.
- Universal PA Form (completed)
- Clinical documentation of diagnosis and age per labeling
- Documentation of prior trials including agents, start/stop dates, and reason for failure/intolerance/contraindication
- Prescribed dose and evidence it does not exceed 10 mg/day (adult) or 5 mg/day (pediatric)
Triggers for PA denial
PA may be denied if required prior trials or supporting documentation are missing, or if the prescribed dose exceeds the policy limits.
- No documentation of ≥6-month trials of two preferred long-acting CCBs
- No documentation of a ≥6-month trial of NORLIQVA (amlodipine)
- Lack of clinical details showing inadequate response, intolerance, or contraindication for required agents
- Prescribed dose >10 mg/day for adults or >5 mg/day for pediatric patients
Dosing Limits & Coding
Step Therapy Requirements
| Step | Required trial | Duration | Failure criteria |
|---|---|---|---|
| 1 | Preferred long-acting calcium channel blocker — different agent (must be two separate agents total) | At least 6 months each | Inadequate response, intolerance, or contraindication |
| 2 | Preferred long-acting calcium channel blocker — different agent (second agent of two) | At least 6 months each | Inadequate response, intolerance, or contraindication |
| 3 | NORLIQVA (amlodipine) | At least 6 months | Inadequate response, intolerance, or contraindication |
Definitions
Background
SDAMLO (amlodipine) is a long‑acting calcium channel blocker indicated for the treatment of angina and coronary artery disease in adults, and for hypertension in adults and children aged 6 years and older. Prior authorization is required for SDAMLO; approval is contingent on documentation of diagnosis, age eligibility, prior treatment trials, and dose limits. (Submit the Universal PA Form and supporting clinical documentation.)
For dosing, adults are typically started at 5 mg orally once daily with a maximum recommended dose of 10 mg once daily. Small, fragile, elderly patients, or those with hepatic insufficiency may be started at 2.5 mg once daily. Pediatric dosing is 2.5 mg to 5 mg once daily, and doses above 5 mg/day have not been studied in pediatric patients.
SDAMLO is supplied as an oral powder for solution in 2.5 mg, 5 mg, and 10 mg strengths. Coverage under this policy requires demonstration of prior trials of other preferred long‑acting calcium channel blockers and NORLIQVA (amlodipine), and adherence to the policy’s dose limits for adults and pediatric patients.
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