CurrentCignaPolicy IP0064

HMG-CoA Reductase Inhibitors (Statins) and Combination Products

Medical necessity and coverage criteria for statin drugs and statin/ezetimibe combination products for Cigna-administered health benefit plans, including conditions for formulary exceptions and reauthorization.

Policy Summary

PayerCigna

PolicyHMG-CoA Reductase Inhibitors (Statins) and Combination Products

Policy CodePolicy IP0064

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and document trial/failure, contraindication, intolerance, or formulation-exemption criteria as specified for the requested statin or combination product.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~15listed non-covered brand/generic products

Initial up to 12 monthsauthorization duration

Reauth up to 12 moreauthorization duration

Failure to 2–3 alternativescommon step/failure requirements

Product-Specific Coverage Criteria

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Altoprev (lovastatin ER) — Value/Advantage/Cigna Total Savings Drug List Plans

Altoprev is medically necessary when ALL of the following are met:

Altoprev main: 1) Documentation of failure, contraindication, or intolerance to lovastatin; AND 2) Failure, contraindication, or intolerance to TWO of the following: atorvastatin; fluvastatin/fluvastatin ER; pitavastatin; pravastatin; rosuvastatin.two alternatives

Value/Advantage/Cigna Total Savings Drug List Plans; step therapy may apply for other plans.

Atorvaliq (atorvastatin oral suspension)

Atorvaliq is considered medically necessary when ONE of the following is met:

Atorvaliq options: 1) Inability to swallow capsules and tablets; OR 2) BOTH of the following: A. Failure or intolerance to atorvastatin tablet; AND B. Failure, contraindication or intolerance to TWO of: fluvastatin/fluvastatin ER; lovastatin; pitavastatin; pravastatin; rosuvastatin; simvastatin.two alternatives

Applies to Standard/Performance/Value/Advantage/Cigna Total Savings Drug List Plans.

Atorvastatin/ezetimibe (Liptruzet generic)

Medically necessary when BOTH are met:

Atorvastatin/ezetimibe: 1) Documentation of failure, contraindication, or intolerance to ezetimibe; AND 2) Documentation of failure, contraindication, or intolerance to atorvastatin or rosuvastatin.both

Legacy Drug List Plans specify this for atorvastatin/ezetimibe (Liptruzet generic).

Crestor (rosuvastatin)

Crestor is medically necessary when BOTH of the following are met:

Crestor: Documentation of both required criteria as specified in the policy table.both

See full policy table for the detailed subcriteria for Crestor.

Ezallor Sprinkle (rosuvastatin capsule)

Ezallor Sprinkle is medically necessary when ONE of the following is met (Standard/Performance/Value/Advantage/Cigna Total Savings) or per Legacy plans additional requirements apply:

Ezallor options: 1) Inability to swallow capsules and tablets; OR 2) BOTH of the following: A. Failure or intolerance to rosuvastatin tablet; AND B. Failure, contraindication or intolerance to TWO of: atorvastatin; fluvastatin/fluvastatin ER; lovastatin; pitavastatin; pravastatin; simvastatin.two alternatives

Legacy plans require trial of generic rosuvastatin and formulation-allergy reasoning (trial of bioequivalent generic and inability to take due to formulation difference).

FloLipid (simvastatin suspension)

FloLipid is medically necessary when ONE of the following is met:

FloLipid options: 1) Inability to swallow capsules and tablets; OR 2) BOTH of the following: A. Failure or intolerance to simvastatin tablet; AND B. Failure, contraindication or intolerance to TWO of: atorvastatin.two alternatives

Applies to Standard/Performance/Value/Advantage/Cigna Total Savings Drug List Plans.

Lescol XL (fluvastatin ER)

Lescol XL is medically necessary when BOTH are met:

Lescol XL: 1) Trial of fluvastatin extended release (the bioequivalent generic product) AND cannot take due to a formulation difference in the inactive ingredient(s) which would result in a significant allergy or serious adverse reaction; AND 2) Additional required criterion as listed in the policy.both

See policy for full second-criterion details.

Lipitor (atorvastatin)

Lipitor is medically necessary when BOTH are met:

Lipitor: 1) Trial of atorvastatin (the bioequivalent generic product) AND cannot take due to a formulation difference in the inactive ingredient(s) which would result in a significant allergy or serious adverse reaction; AND 2) Failure, contraindication or intolerance to TWO of: fluvastatin/fluvastatin ER; lovastatin; pitavastatin; pravastatin.two alternatives

Step therapy may apply for some plans.

Livalo / pitavastatin (brand and generic)

Livalo (pitavastatin) is medically necessary when BOTH are met:

Livalo: 1) Trial of pitavastatin (the bioequivalent generic product) AND cannot take due to a formulation difference in the inactive ingredient(s) which would result in a significant allergy or serious adverse reaction; AND 2) Failure, contraindication or intolerance to TWO of: atorvastatin; fluvastatin/fluvastatin ER; lovastatin; pravastatin; rosuvastatin; simvastatin.two alternatives

Pravachol (pravastatin)

Pravachol is medically necessary when BOTH are met:

Pravachol: 1) Trial of pravastatin (the bioequivalent generic product) AND cannot take due to a formulation difference in the inactive ingredient(s) which would result in a significant allergy or serious adverse reaction; AND 2) Failure, contraindication or intolerance to TWO of: atorvastatin; fluvastatin/fluvastatin ER; lovastatin; pitavastatin.two alternatives

Roszet / rosuvastatin/ezetimibe (brand and generic)

Roszet is medically necessary when failure, contraindication, or intolerance to ezetimibe and/or atorvastatin/rosuvastatin is documented; plan-specific logic varies:

Roszet options: Per Standard/Performance/Legacy: medically necessary when documentation of failure, contraindication, or intolerance to EITHER: 1) ezetimibe; OR 2) atorvastatin or rosuvastatin. For some plan types the policy requires BOTH—see plan-specific table.either_or_both

Plan-specific variance noted across Employer Group plans.

Vytorin (simvastatin/ezetimibe)

Vytorin may be subject to step therapy; for Value/Advantage/Cigna Total Savings plans specific criteria apply:

Vytorin (Value/Advantage/Cigna Total Savings): 1) Trial of simvastatin/ezetimibe (the bioequivalent generic product) AND cannot take due to a formulation difference in the inactive ingredient(s) which would result in a significant allergy or serious adverse reaction; AND 2) Failure, contraindication or intolerance to TWO of: atorvastatin; fluvastatin/fluvastatin ER; lovastatin; pitavastatin; pravastatin.two alternatives

Step therapy may apply for Standard/Performance/Legacy plans.

Zocor (simvastatin)

Zocor is medically necessary when BOTH are met:

Zocor: 1) Trial of simvastatin (the bioequivalent generic product) AND cannot take due to a formulation difference in the inactive ingredient(s) which would result in a significant allergy or serious adverse reaction; AND 2) Failure, contraindication or intolerance to TWO of: atorvastatin; fluvastatin/fluvastatin ER; lovastatin; pitavastatin; pravastatin.two alternatives

Zypitamag (pitavastatin magnesium)

Zypitamag is medically necessary when documentation shows failure, contraindication, or intolerance to THREE of the listed statins:

Zypitamag: Documentation of failure, contraindication, or intolerance to THREE of: atorvastatin; fluvastatin/fluvastatin ER; lovastatin; pitavastatin; pravastatin; rosuvastatin; simvastatin.three alternatives

Applies to Standard/Performance/Value/Advantage/Cigna Total Savings Drug List Plans.

Individual & Family Plans — Pitavastatin products

Pitavastatin tablets are covered when documentation shows failure, contraindication, or intolerance to THREE of the following:

Pitavastatin (IFP): Failure, contraindication, or intolerance to THREE of: atorvastatin; fluvastatin/fluvastatin ER; lovastatin; pravastatin; rosuvastatin; simvastatin.three alternatives

Applies to Individual and Family Plans Non-Covered Products and Criteria.

This policy applies to a list of branded statin products and statin/ezetimibe combinations that are non-covered unless specific medical necessity criteria are met. For each product, coverage is conditional on meeting the product-specific requirements shown in the policy tables (for example: documented trials of bioequivalent generics, documented inability to swallow, formulation-difference exemptions for inactive-ingredient allergies/serious adverse reactions, or documented failure/contraindication/intolerance to specified alternative statins).

Providers should submit prior authorization requests that include the documentation specified for the relevant product (trial/failure history, contraindication or intolerance details, or formulation allergy evidence). Note that receipt of sample product does not satisfy any criteria requirements for coverage and will not be accepted in lieu of the required documentation.

Initial Authorization Requirements

Initial therapy criteria

Initial coverage for listed non-covered products is conditional on meeting product- and plan-specific trial/failure or formulation-exemption criteria.

Initial therapy: See product-specific criteria: trials of bioequivalent generics, documented inability to swallow, formulation allergy/serious adverse reaction exemptions, and required failures/intolerances to specified alternative statins per plan.varies by product

Initial approvals up to 12 months; step therapy may apply per product and plan.

Reauthorization / Continuation Criteria

Continuation of HMG-CoA Reductase Inhibitors (Statins) and combination products is considered medically necessary when the above medical necessity criteria are met AND there is documentation of beneficial response. Reauthorization approval duration: up to 12 months.

Documentation Required

Reauthorization documentation — required evidence

When submitting reauthorization requests, include documentation demonstrating continued medical benefit. Note that sample products cannot be used as evidence of ongoing therapy benefit.

Include clinical notes showing symptomatic or objective improvement attributable to the statin or combination product.
Attach recent lipid panel results demonstrating therapeutic response when applicable.
Provide dates of therapy initiation and any changes in dosing.
Do not submit sample medication as proof of current therapy or benefit.

What Providers Must Do

Prior Authorization

Prior authorization required; approval contingent on meeting criteria

Prior authorization is required for the listed non-covered statins and statin/ezetimibe combination products; approval is contingent on meeting the product- and plan-specific trial/failure, contraindication, intolerance, or formulation-exemption criteria detailed in the policy tables.

Step Therapy

Step therapy may apply depending on plan and product

Step therapy may apply for certain plan types and specific products; verify the member’s plan (Standard/Performance/Legacy versus Value/Advantage/Cigna Total Savings) and follow any required trials of lower-step or generic agents as noted for the product.

Examples: Altoprev and Vytorin may be subject to step therapy per plan language.

Denial Risk

Samples do not meet coverage criteria

Receipt of a manufacturer sample does not satisfy any of the policy's trial, failure, or formulation-exemption requirements and therefore does not meet criteria for coverage.

Do not rely on sample product use when documenting prior trials or intolerances.

Formulation & Clinical Definitions

Formulation difference exemption

DefinitionCoverage may be allowed when a member cannot take the bioequivalent generic product due to a formulation difference in the inactive ingredient(s) that would result in a significant allergy or serious adverse reaction.

Applies toEmployer group and Value/Advantage/Cigna Total Savings drug list plans for listed brand products (e.g., Lipitor, Vytorin, Zocor, Lescol XL, Ezallor Sprinkle).

Required evidenceDocumentation that the member tried the bioequivalent generic (trial) and cannot take it because of the inactive-ingredient formulation difference causing the allergy or serious adverse reaction.

Effect on criteria logicWhen met, the formulation-difference exemption allows coverage despite lack of tolerability to the bioequivalent generic; other product-specific failure or alternative requirements may still apply.

Where detailedSee product-specific tables for which brands permit this exemption (e.g., Lipitor, Lescol XL, Vytorin, Zocor, Ezallor Sprinkle) and the companion failure/alternative requirements.

Inability to swallow — liquid/suspension or sprinkle formulations

Coverage conditionsCertain liquid/suspension or sprinkle formulations are covered when there is an inability to swallow capsules or tablets; OR when other product-specific failure/intolerance criteria are met (see product tables).

Examples of formulationsAtorvaliq (atorvastatin oral suspension), FloLipid (simvastatin suspension), Ezallor Sprinkle (rosuvastatin sprinkle capsule).

Documentation neededEvidence of inability to swallow tablets/capsules OR documentation of required trials/failures/intolerances to specified alternative statins per the product's criteria (e.g., failure or intolerance to rosuvastatin tablet plus two alternative statin failures for Ezallor Sprinkle).

Plan varianceStandard/Performance/Value/Advantage/Cigna Total Savings plans explicitly allow inability-to-swallow as one qualifying option; Legacy or other plans may require additional generic trials or formulation-allergy reasoning (see product row).

Next steps for providerProvide clinical documentation of swallowing impairment or attach records showing prior trials and documented intolerances/failures to meet the product-specific two/three alternative requirements.

Step Therapy Rules

Product	Affected Plans	Step therapy / Step requirements
Altoprev (lovastatin ER)	Value/Advantage/Cigna Total Savings; Standard/Performance/Legacy (step therapy may apply)	Value/Advantage/Cigna Total Savings: Coverage requires documentation of failure, contraindication, or intolerance to lovastatin and to TWO of the following: atorvastatin; fluvastatin/fluvastatin ER; pitavastatin; pravastatin; rosuvastatin. Standard/Performance/Legacy: step therapy may apply.
Atorvaliq (atorvastatin oral suspension)	Standard/Performance/Value/Advantage/Cigna Total Savings; Legacy	Considered medically necessary when ONE of the following is met: 1) inability to swallow capsules/tablets; OR 2) BOTH: failure or intolerance to atorvastatin tablet AND failure/contraindication/intolerance to TWO of: fluvastatin/fluvastatin ER; lovastatin; pitavastatin; pravastatin; rosuvastatin; simvastatin.
Atorvastatin/ezetimibe (Liptruzet generic)	Legacy Drug List	Medically necessary when there is documentation of failure, contraindication, or intolerance to BOTH: 1) ezetimibe; AND 2) atorvastatin or rosuvastatin.
Vytorin (simvastatin/ezetimibe)	Value/Advantage/Cigna Total Savings	May be subject to step therapy: requires trial of the bioequivalent generic simvastatin/ezetimibe and inability to take it due to a formulation difference in inactive ingredients causing significant allergy/serious adverse reaction; AND failure, contraindication, or intolerance to TWO of: atorvastatin; fluvastatin/fluvastatin ER; lovastatin; pitavastatin; pravastatin.
Zocor (simvastatin)	Value/Advantage/Cigna Total Savings	Medically necessary when BOTH are met: 1) trial of simvastatin (bioequivalent generic) and inability to take it due to a formulation difference in inactive ingredients causing significant allergy/serious adverse reaction; AND 2) failure, contraindication, or intolerance to TWO of: atorvastatin; fluvastatin/fluvastatin ER; lovastatin; pitavastatin; pravastatin.
Zypitamag (pitavastatin magnesium)	Standard/Performance/Value/Advantage/Cigna Total Savings	Medically necessary when there is documentation of failure, contraindication, or intolerance to THREE of the following: atorvastatin; fluvastatin/fluvastatin ER; lovastatin; pitavastatin; pravastatin; rosuvastatin; simvastatin.

Clinical Background

HMG-CoA reductase inhibitors (statins) are lipid-lowering agents used to manage hyperlipidemia and reduce cardiovascular risk. This policy addresses medical necessity review for a set of specific branded statin formulations and combination products when those products are listed as non-covered on plan formularies.

The scope includes formulation variants (for example, extended-release tablets, oral suspensions, and sprinkle/capsule forms) and combination products with ezetimibe. The policy focuses on circumstances in which a member cannot take a bioequivalent generic due to a formulation difference or has documented failure, contraindication, or intolerance to alternative statins, as well as situations of inability to swallow where liquid or sprinkle formulations may be appropriate.

Policy Summary

PayerCigna

PolicyHMG-CoA Reductase Inhibitors (Statins) and Combination Products

Policy CodePolicy IP0064

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and document trial/failure, contraindication, intolerance, or formulation-exemption criteria as specified for the requested statin or combination product.

SourceLink

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