CurrentCignaPolicy N/A

HMG‑CoA Reductase Inhibitors (statins) step therapy

Defines step therapy requirements for coverage of single‑entity and combination HMG‑CoA reductase inhibitors (statins) for Cigna-administered health benefit plans; affects prescribers and payers when requesting coverage of listed statin products.

Policy Summary

PayerCigna

PolicyHMG‑CoA Reductase Inhibitors (statins) step therapy

Policy CodePolicy N/A

Change TypeStep therapy updates with ACA/HRSA/PHS exceptionStep 1 roster revised

Effective DateN/A

Next Review DateN/A

Key ActionDocument trial of one Step 1 product prior to approval of a Step 2 product; when Step Therapy rules are not met, submit prior authorization for Step 2 (approvals are for 1 year).

SourceLink

POLICY UPDATE CHANGES

A note was added to the Policy Statement granting approval for requested single‑entity drugs used for primary prevention of CVD in adults 40–75 with ≥10% 10‑year risk when ACA/HRSA/PHS section 2713 compliance is required and Step 1 products are not as medically appropriate.

Pitavastatin (generic) was added as a Step 1 Product.

Ezetimibe/atorvastatin (generic) and Lescol (brand) were removed from Step 2 because they are no longer available.

Step 1 & Step 2Distinct step therapy product groups defined

1 yearApproval duration

40–75, ≥10%ACA/HRSA/PHS exception threshold

Policy Summary

PayerCigna

PolicyHMG‑CoA Reductase Inhibitors (statins) step therapy

Policy CodePolicy N/A

Change TypeStep therapy updates with ACA/HRSA/PHS exceptionStep 1 roster revised

Effective DateN/A

Next Review DateN/A

Key ActionDocument trial of one Step 1 product prior to approval of a Step 2 product; when Step Therapy rules are not met, submit prior authorization for Step 2 (approvals are for 1 year).

SourceLink

On This Page

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Coverage and Medical Necessity Criteria

Step Therapy Criteria

Covered when ALL of the following are met

Primary step therapy conditions: (1) Patient has tried one Step 1 Product; AND (2) If patient cannot swallow or has difficulty swallowing tablets or capsules, approve specified non‑tablet/capsule formulations (Atorvaliq, Flolipid, or Ezallor Sprinkle).n/a

Approvals granted for 1 year; exceptions allowed per ACA/HRSA/PHS note in Policy Statement.

Primary prevention exception

Exception allowing Step 2 single‑entity drug without Step 1 trial when required by applicable mandates

ACA/HRSA/PHS exception: Requested single‑entity drug is used for primary prevention of cardiovascular disease (CVD) in an adult aged 40 to 75 years who has one or more CVD risk factors (e.g., dyslipidemia, diabetes, hypertension, or smoking) and an estimated 10‑year CVD event risk of 10% or greater AND who does NOT have a history of (or signs or symptoms of) CVD AND the prescriber attests that alternative Step 1 Products would not be as medically appropriate for the patient.age 40–75; 10‑year risk >= 10%

Applies only when compliance with ACA/HRSA/PHS section 2713 is required.

Any use that does not meet the Step Therapy criteria or the Policy Statement exception is considered not medically necessary.

Requests for Step 2 products that do not meet the requirement to have tried one Step 1 Product, and that do not meet the swallowing/formulation exception, are considered not medically necessary. Specifically, approval of a Step 2 product requires either documentation that the patient has tried one Step 1 agent or that the patient cannot swallow tablets/capsules and the request is for an approved non‑tablet/capsule formulation (Atorvaliq, Flolipid, or Ezallor Sprinkle).

Clinical Thresholds and Coding Details

inv-05: 10-year CVD event risk threshold

10-year CVD event risk threshold>= 10%

Applicable age range for exception40–75 years

Required clinical contextRequested single‑entity drug used for primary prevention with one or more CVD risk factors (dyslipidemia, diabetes, hypertension, or smoking)

Exclusion—clinical historyNo history (or signs/symptoms) of CVD

Policy applicability noteApplies only when compliance with ACA/HRSA/PHS section 2713 is required

Provider Responsibilities and Authorization Rules

Documentation Required

Required documentation

Providers must submit prior authorization requests with the most appropriate diagnosis and procedure codes and include supporting clinical documentation that demonstrates why the requested Step 2 product is medically necessary and why the Step 1 product trial requirement does not apply or was unsuccessful. Documentation should include relevant medical records, prior medication trials (drug name, dose, dates, and reason for discontinuation), clinical rationale for exceptions (e.g., intolerance, contraindication, inability to swallow), and any pertinent laboratory or diagnostic results.

Include accurate ICD-10 and procedure codes reflecting the condition being treated
Provide documentation of Step 1 product trial: drug name, dose, start/stop dates, and reason for failure when applicable
If claiming inability to swallow, include clinical notes describing the swallowing impairment
For ACA/HRSA/PHS Act primary prevention exceptions, include prescriber rationale and CVD risk assessment

Step Therapy

General step therapy requirement

Step 1 (Initial Therapy) Requirements

Initial therapy (Step 1)

Step 1 requirement

Step 1 products (trial before Step 2): Step 1 products include atorvastatin, atorvastatin/amlodipine, ezetimibe/simvastatin, fluvastatin, fluvastatin extended‑release, lovastatin, pravastatin, pitavastatin, rosuvastatin, simvastatin.trial of one Step 1 product required before Step 2

If patient has tried one Step 1 product, a Step 2 product may be approved.

Step Therapy Product Lists and Rules

Requirement	Details	Coverage status
{"text":"Documented trial of one Step 1 Product","status":""},{"text":"If the patient has tried one Step 1 Product, a Step 2 Product may be approved. Step 1 products include atorvastatin; atorvastatin/amlodipine; ezetimibe/simvastatin; fluvastatin (including extended‑release); lovastatin; pravastatin; pitavastatin; rosuvastatin; and simvastatin.","status":"covered"},{"text":"Approvals are provided for 1 year when criteria are met.","status":""}
{"text":"Inability to swallow or difficulty swallowing tablets/capsules","status":""},{"text":"If the patient cannot swallow or has difficulty swallowing tablets or capsules, approve Atorvaliq, Flolipid, or Ezallor Sprinkle without requiring a trial of a Step 1 Product.","status":"covered"},{"text":"Approval duration: 1 year (when criteria met).","status":""}
{"text":"ACA/HRSA/PHS exception for primary prevention","status":""},{"text":"When compliance with the Affordable Care Act, HRSA guidelines, and Public Health Service Act section 2713 is required, approval is granted for a requested single‑entity drug without a Step 1 trial if: the drug is for primary prevention of CVD in an adult aged 40–75 years with ≥1 CVD risk factor and an estimated 10‑year CVD event risk ≥10%, the patient has no history/signs/symptoms of CVD, and the prescriber attests that alternative Step 1 products would not be as medically appropriate.","status":"covered"},{"text":"Applies only when ACA/HRSA/PHS section 2713 compliance is required; approvals provided for 1 year.","status":""}

Continuation and Duration of Approval

Continuation/Duration

Duration of approval

Approval duration: Approvals for covered products are provided for 1 year.1 year

Renewal requires meeting criteria again.

Background and Clinical Context

HMG‑CoA reductase inhibitors (statins) are managed under a step therapy program that encourages use of a Step 1 Product prior to a Step 2 Product. The Policy Statement notes that approvals are provided for 1 year. An operational exception is included for situations where compliance with ACA/HRSA/PHS section 2713 is required: a requested single‑entity statin may be approved without a prior Step 1 trial for primary prevention in adults aged 40–75 years with one or more CVD risk factors and an estimated 10‑year CVD event risk ≥ 10%, provided the patient has no history or signs/symptoms of CVD and the prescriber attests that Step 1 products would not be as medically appropriate.

Definitions and Intensity Categories

inv-11: Statin intensity — High-, moderate-, and low-intensity statin therapy

High-intensity statin examplesAtorvastatin (40–80 mg), Rosuvastatin (20–40 mg)

Moderate-intensity statin examplesAtorvastatin 10–20 mg; Rosuvastatin 5–10 mg; Simvastatin 20–40 mg; Pravastatin 40–80 mg; Fluvastatin formulations

Low-intensity statin examplesSimvastatin 10 mg; Pravastatin 10–20 mg; Lovastatin 20 mg; Fluvastatin 20–40 mg; Pitavastatin 2–4 mg (listed under low intensity)

Clinical guidance sourceIntensity categories per ACC/AHA guidelines (high, moderate, low) — use maximum‑tolerated intensity for groups shown to benefit

Policy product listing relevanceStep 1 and Step 2 product lists include specific statin agents (e.g., atorvastatin, rosuvastatin, pitavastatin, simvastatin, lovastatin, pravastatin, fluvastatin)