CurrentmhnPolicy CP.PMN.176

Amlodipine/Atorvastatin (Caduet)

Coverage and medical necessity policy for the combination product amlodipine/atorvastatin (Caduet) for members under Centene-affiliated health plans (Commercial and Medicaid). Defines initial and continuation approval criteria, dosing limits, and excluded indications.

Policy Summary

Payermhn

PolicyAmlodipine/Atorvastatin (Caduet)

Policy CodePolicy CP.PMN.176

Change TypeNo material changes

Effective DateDec 1, 2018

Next Review DateJul 10, 2025

Key ActionSubmit documentation (office notes, labs or other clinical information) demonstrating the member meets all approval criteria including prior statin trial and dose limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard approval duration (Medicaid and Commercial)

80 mg/daymaximum atorvastatin dose allowed

1/daymaximum tablets per day

>=10 yrsminimum pediatric age listed

genericbrand/generic status

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Coverage and Medical Necessity Criteria

inv-01: Initial Approval Criteria - All FDA-Approved Indications

Covered when ALL of the following are met:

Initial approval requirements: 1) Diagnosis of one of the following: a) Hypertension; b) Chronic stable angina; c) Confirmed or suspected vasospastic (Prinzmetal's/variant) angina; d) Coronary artery disease documented by angiography and without heart failure or an ejection fraction < 40%. 2) Diagnosis of hyperlipidemia or another FDA‑approved indication for atorvastatin. 3) Member must instead use the individual components (atorvastatin and amlodipine) concurrently unless contraindicated to excipients or clinically significant adverse effects are experienced. 4) Failure to achieve NCEP goals after a trial of at least one generic formulary statin (e.g., lovastatin, pravastatin, simvastatin, atorvastatin), followed by ezetimibe/simvastatin (Vytorin) or rosuvastatin (Crestor), unless clinically significant adverse effects or contraindications exist. 5) Dose limits: atorvastatin ≤ 80 mg per day and ≤ 1 tablet per day.atorvastatin <=80 mg/day; tablet <=1/day

Provider must submit documentation supporting criteria

inv-02: Continuation (Renewal) Criteria - All FDA-Approved Indications

Covered when ALL of the following are met:

Continuation requirements: 1) Member currently receiving the medication via the Centene benefit or previously met initial approval criteria, or qualifies for continuity of care per state/product regulations. 2) Member is responding positively to therapy. 3) If a dose increase is requested, the new dose must not exceed atorvastatin 80 mg per day and 1 tablet per day.atorvastatin <=80 mg/day; tablet <=1/day

Approval duration: standard authorization periods per plan (e.g., 12 months)

inv-03: Other/Unlisted Indications

Consideration when requested use is not listed:

Other diagnoses/indications: 1) If the drug label changed within the last 6 months and the policy is not yet updated, follow the applicable formulary/no-coverage or nonformulary policy for the relevant line of business (see CP.CPA.190, CP.PMN.255, CP.PMN.16). 2) If the requested use is not listed in section III and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (CP.CPA.09 for commercial; CP.PMN.53 for Medicaid).

See referenced policies: CP.CPA.190; CP.PMN.255; CP.PMN.16; CP.CPA.09; CP.PMN.53.

Requests for uses that are non‑FDA approved indications and are not specifically addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy (see CP.CPA.09 for Commercial lines of business and CP.PMN.53 for Medicaid).

Caduet is contraindicated in members with acute liver disease or decompensated cirrhosis. Coverage is also excluded for individuals with known hypersensitivity to amlodipine, atorvastatin, or any excipients in Caduet.

Appendix C lists current contraindications and boxed warnings for Caduet; Appendix C was updated per the product labeling during a recent review. The update included revisions to contraindication language and the removal of pregnancy/lactation contraindications per the product information; see Appendix C for the full, current list of exclusionary conditions.

Use of Caduet for indications that are not FDA‑approved and are not described in this policy is not authorized (considered not medically necessary) unless the request is supported by sufficient clinical documentation and evidence following the applicable off‑label use policy.

Dosing and Quantity Limits

Maximum atorvastatin dose

Maximum atorvastatin dose80 mg per day

Context in approval criteriaInitial and continuation criteria specify atorvastatin dose must not exceed 80 mg/day

Document sourcePolicy initial approval criteria and continuation/renewal criteria

Maximum tablets per day

Maximum tablets per day1 tablet per day

Context in approval criteriaInitial and continuation criteria specify total tablets dispensed per day must not exceed 1

Dose limit applies to

Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must meet all initial approval criteria, including documented diagnosis for both the amlodipine and atorvastatin indications, evidence that the member will use the individual components concurrently (unless contraindicated), trial and failure of required step therapy agents, and dose limits. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria.

Affected products: amlodipine/atorvastatin (Caduet) combination
Dose limits: atorvastatin ≤ 80 mg/day; amlodipine/atorvastatin 1 tablet per day

Note

Prior Authorization and Approval Duration Notes

Approval durations have been administratively updated in prior reviews. Current standard authorization durations: 12 months for Medicaid; 12 months or duration of request for Commercial, unless otherwise specified by the Health Plan. The clinical policy effective date governs applicability; plan-level administrative policies and state/federal requirements may supersede policy provisions.

Clinical Background

Caduet is a fixed‑dose combination product that contains amlodipine, a dihydropyridine calcium channel blocker used for hypertension and angina, together with atorvastatin, an HMG‑CoA reductase inhibitor used for lipid lowering and cardiovascular risk reduction. The product provides an option for members who require concurrent therapy with both agents and is available in multiple tablet strengths, including combinations with up to atorvastatin 80 mg in the formulation lineup.

Key Definitions and Goals

Caduet

Product definitionCombination product of amlodipine and atorvastatin indicated when treatment with both agents is appropriate.

Amlodipine roleAmlodipine is a calcium channel blocker indicated for hypertension, chronic stable angina, vasospastic angina, and angiographically documented CAD

Atorvastatin roleAtorvastatin is an HMG-CoA reductase inhibitor indicated to reduce LDL-C and cardiovascular risk for multiple primary and secondary prevention indications

NCEP Goals

NCEP LDL goal for CHD or CHD risk equivalentsLDL < 100 mg/dL (10-year risk > 20%)

NCEP LDL goal for multiple (2+) risk factors and 10-year risk ≤ 20%LDL < 130 mg/dL