CurrentCignaPolicy IP0064

HMG-CoA Reductase Inhibitors (Statins) and combination products — Coverage Criteria

Governs medical necessity review and formulary exception criteria for specified non-covered statin products for Cigna-administered health benefit plans; affects providers requesting coverage for listed branded and combination statin products.

Policy Summary

PayerCigna

PolicyHMG-CoA Reductase Inhibitors (Statins) and combination products — Coverage Criteria

Policy CodePolicy IP0064

Change TypeNo material change

Effective DateFeb 1, 2024

Next Review DateFeb 1, 2025

Key ActionObtain prior authorization and document trials, failures, contraindications, or intolerances to required alternative statins per product-specific criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

up to 12 monthsinitial authorization duration

up to 12 monthsreauthorization duration

multidrugstep/failure complexity

not acceptedsample products

Product Coverage and Criteria

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Product-specific initial coverage criteria

Products covered only when the specific product-level criteria (trials, intolerances, contraindications, or inability to take alternative formulation) are met for the patient's plan type.

Altoprev (lovastatin) ER - Value/Advantage/Cigna Total Savings Plans: Documentation of failure, contraindication, or intolerance to ALL of the following: 1) lovastatin; AND 2) TWO of: atorvastatin; fluvastatin/fluvastatin ER; pitavastatin; pravastatin; rosuvastatin.

Atorvaliq (atorvastatin) oral suspension: Either: 1) inability to swallow capsules/tablets; OR 2) BOTH: A) failure or intolerance to atorvastatin tablet; AND B) failure, contraindication, or intolerance to TWO of: fluvastatin/fluvastatin ER; lovastatin; pitavastatin; pravastatin; rosuvastatin; simvastatin.

Atorvastatin/ezetimibe (Liptruzet generic) - Legacy Plans: Documentation of failure, contraindication, or intolerance to BOTH of the following: 1) ezetimibe; AND 2) atorvastatin or rosuvastatin.

Crestor (rosuvastatin) tablet: Crestor (rosuvastatin) is medically necessary when there is documentation of BOTH specified conditions (documented in policy).

Source lists Crestor criteria but text truncated in document.

Ezallor Sprinkle (rosuvastatin) capsule: 1) Trial of rosuvastatin (the bioequivalent generic product) AND cannot take due to a formulation difference in inactive ingredient(s) causing a significant allergy or serious adverse reaction; AND 2) failure, contraindication, or intolerance to TWO of: atorvastatin; fluvastatin/fluvastatin ER; lovastatin; pitavastatin; pravastatin; simvastatin.

FloLipid (simvastatin) suspension: Either: 1) inability to swallow capsules and tablets; OR 2) meet plan-specific step therapy where applicable.

Lescol XL (fluvastatin ER): Trial of fluvastatin extended release (the bioequivalent generic product) AND cannot take due to a formulation difference in inactive ingredient(s) causing a significant allergy or serious adverse reaction; plus failure/intolerance criteria per plan.

Lipitor (atorvastatin) tablet: Trial of atorvastatin (the bioequivalent generic product) AND cannot take due to a formulation difference in inactive ingredient(s) causing a significant allergy or serious adverse reaction; AND failure, contraindication, or intolerance to TWO of: fluvastatin/fluvastatin ER; lovastatin; pitavastatin; pravastatin; rosuvastatin.

Livalo / pitavastatin products: Trial of pitavastatin (the bioequivalent generic product) AND cannot take due to a formulation difference in inactive ingredient(s) causing a significant allergy or serious adverse reaction; AND failure, contraindication, or intolerance to TWO of: atorvastatin; fluvastatin/fluvastatin ER; lovastatin; pravastatin; rosuvastatin.

Pravachol (pravastatin): Trial of pravastatin (the bioequivalent generic product) AND cannot take due to a formulation difference in inactive ingredient(s) causing a significant allergy or serious adverse reaction; AND failure, contraindication, or intolerance to TWO of: atorvastatin; fluvastatin/fluvastatin ER; lovastatin; pitavastatin; rosuvastatin.

Roszet (rosuvastatin/ezetimibe) and generic: Documentation of failure, contraindication, or intolerance to EITHER: 1) ezetimibe; OR 2) atorvastatin or rosuvastatin. (Some plan text indicates requirement for BOTH for certain plan types.)

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

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

Zypitamag (pitavastatin magnesium): Documentation of failure, contraindication, or intolerance to THREE of the following: atorvastatin; fluvastatin/fluvastatin ER; lovastatin; pitavastatin; pravastatin; rosuvastatin; simvastatin.

Individual and Family Plans - Pitavastatin tablets: Documented failure, contraindication, or intolerance to THREE of: atorvastatin; fluvastatin/fluvastatin ER; lovastatin; pravastatin; rosuvastatin; simvastatin.

This policy applies to the list of non-covered HMG-CoA Reductase Inhibitors (statins) and combination products shown in the Overview. Providers should note that receipt of a sample product does not satisfy any criteria requirements for coverage and therefore cannot be used in lieu of meeting the documented trials, intolerances, contraindications, or step-therapy requirements specified for each product.

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for the listed non-covered statin products. Requests must include documentation that meets the medical necessity criteria specific to the product and the member's plan.

Applies to non-covered HMG-CoA Reductase Inhibitors and combination products listed in policy (e.g., Altoprev, Atorvaliq, Lipitor, Crestor, Vytorin, Zocor, etc.).
Prior authorization must document trials, failures, contraindications, or intolerances to required alternative agents per the product-specific criteria.
Coverage determinations vary by Employer Group, Value/Advantage/Cigna Total Savings, Standard/Performance, Legacy, and Individual & Family plans—follow the criteria for the member's plan.

Step Therapy

Step Therapy May Apply

Step therapy rules may apply depending on the member's plan and the specific product. Prescribers should confirm plan-specific step requirements and provide documentation of required prior trials or reasons they are not appropriate.

Step therapy may be required for products such as Altoprev, FloLipid, Lescol XL, Vytorin, and others as specified by plan type.
If step therapy is in effect, documentation must show trial and failure (or intolerance/contraindication) of the specified alternative statin(s).

Documentation Required

Submit supporting documentation that demonstrates trials, failures, contraindications, or intolerances to the required alternative agents. For continuation (reauthorization), include documentation of clinical benefit.

Documentation should specify which agents were tried, dates of therapy, reasons for discontinuation (e.g., adverse events, lack of efficacy), and any relevant clinical data.
Reauthorization requires that initial medical necessity criteria remain met and there is documentation of beneficial response.
Receipt of sample product does not satisfy documentation requirements for coverage.

Note

Sample Products Do Not Satisfy Criteria

Receipt of a sample product does not satisfy any criteria requirements for coverage; full documentation of trials and failures or contraindications/intolerances is still required.

Product / Plan type	Step therapy rule
Zypitamag (pitavastatin) — Standard/Performance/Value/Advantage/Cigna Total Savings Drug List Plans
Medically necessary when there is documentation of failure, contraindication or intolerance to THREE of: atorvastatin; fluvastatin/fluvastatin ER; lovastatin; pitavastatin; pravastatin; rosuvastatin; simvastatin.

Definitions and Terms

Bioequivalent generic trial (definition)

DefinitionA documented trial of the bioequivalent generic product when required (e.g., trial of atorvastatin generic before Lipitor).

Documentation requirementRecord that the patient cannot take the bioequivalent generic because of a formulation difference in inactive ingredient(s) that would result in a significant allergy or serious adverse reaction.

ScopeApplies when a product’s criteria explicitly require a trial of the bioequivalent generic (examples in policy: Ezallor Sprinkle requires trial of rosuvastatin generic; Lescol XL requires trial of fluvastatin ER generic; Lipitor requires trial of atorvastatin generic).

Alternative allowancesIf unable to tolerate or contraindicated for the generic, meeting additional product-specific failure/intolerance criteria to specified alternative statins may still be required (see product criteria).

Sample productsReceipt of sample product does not satisfy the bioequivalent generic trial requirement or any criteria requirements for coverage.

OpenPayer

HMG-CoA Reductase Inhibitors (Statins) and combination products — Coverage Criteria

Product Coverage and Criteria

Initial Therapy Requirements

Provider Requirements and Actions

Step Therapy Details

Reauthorization / Continuation Criteria

Site of Care and Administration

Definitions and Terms

Background