CurrentCignaPolicy N/A

HMG-CoA Reductase Inhibitors (statins) — Drug Quantity Management Policy - Per Rx

Defines per-prescription drug quantity limits and coverage criteria for HMG-CoA reductase inhibitors (statins) for Cigna-administered health benefit plans; affects prescribers, pharmacists, and utilization reviewers processing statin prescriptions.

Policy Summary

PayerCigna

PolicyDrug Quantity Management Policy - Per Rx (statins)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateDec 9, 2024

Key ActionApprovals for exceptions to drug quantity limits are provided for 1 year when override criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearException approval duration

30 / 90Common tablet max per Rx (retail / home)

600 / 1800 mLAtorvaliq suspension max (retail / home)

240 / 720Atorvastatin override max (retail / home)

120 / 360Simvastatin 20 mg override (retail / home)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria and Overrides

Drug Quantity Limits and Overrides

Products are covered as medically necessary when drug quantity limits per prescription are met; any other exception is considered not medically necessary. All approvals for exceptions are provided for 1 year.

Drug Quantity Limits general: Each product has specified retail and home delivery maximum quantities per Rx (see product-specific table entries).per product as listed

See product table entries for exact per-product limits

Atorvastatin strength-based override: If the patient requires a dose that does not correspond to a commercially available dosage form (requires multiple same-strength tablets AND would otherwise require two or more strengths), approve the requested quantity up to the product-specific override limits (example: atorvastatin up to 240 capsules retail / 720 home delivery to allow up to 80 mg/day).<=240 retail, <=720 home delivery (when applicable)

Allows quantity sufficient for up to 80 mg/day

Product‑specific per‑prescription quantity override criteria

Approve the requested quantity up to the product/strength specific retail and home delivery maximums when the following override conditions apply:

Overrides for non‑commercial strengths: If the patient is taking a dose that does not correspond to a commercially available dosage form (requires multiple same‑strength tablets AND would otherwise require two or more strengths), approve the requested quantity up to the product/strength specific retail and home delivery limits as listed for that product.See product entries for exact limits

Applied to many products/strengths; individual limits vary by product and strength.

Fluvastatin special override: For fluvastatin 20 mg capsules: if the patient is taking cyclosporine or fluconazole and requires 20 mg twice daily, approve 60 capsules retail or 180 capsules home delivery.20 mg twice daily dosing

Specific drug–drug interaction scenario.

Simvastatin long-term high-dose override:

Simvastatin 20 mg tablet quantity override

Approve when ANY of the following override conditions are met:

sim20_override_1: Patient is taking a dose that does not correspond to a commercially available dosage form (requires multiple same‑strength tablets AND would otherwise require two or more strengths). Approve requested quantity not to exceed 120 tablets per dispensing at retail or 360 tablets per dispensing at home delivery.max per-dispense limits: 120 retail / 360 home delivery

Allows for dosing up to 80 mg/day.

Simvastatin 20 mg long-term high-dose override

Approve when ALL of the following are met:

sim20_override_2: Patient has been taking 80 mg per day in three divided doses (e.g., 20 mg morning, 20 mg mid‑day, 40 mg evening) for 12 months or more without evidence of muscle toxicity.>=12 months; dose = 80 mg/day

If met, approve 120 tablets retail / 360 tablets home delivery.

Simvastatin 40 mg tablet quantity override

Approve when the following condition is met:

sim40_override: Patient is taking a dose that does not correspond to a commercially available dosage form (requires multiple same‑strength tablets AND would otherwise require two or more strengths). Approve requested quantity not to exceed 60 tablets per dispensing at retail or 180 tablets per dispensing at home delivery.max per-dispense limits: 60 retail / 180 home delivery

Allows for dosing up to 80 mg/day.

Simvastatin 80 mg tablets

Coverage stance

sim80_no_override: No overrides recommended for simvastatin 80 mg tablets.none

Requests are subject to standard quantity limits.

Ezetimibe and Simvastatin (Vytorin) tablets

Coverage stance

vytorin_no_override: No overrides recommended for ezetimibe and simvastatin combination tablets (Vytorin, e.g., 10/10, 10/20, 10/40 mg).none

Standard quantity limits apply.

Flolipid 20 mg/5 mL suspension

Coverage stance

flolipid20_no_override: No overrides recommended for Flolipid 20 mg/5 mL oral suspension.none

Standard quantity limits apply.

Flolipid 40 mg/5 mL suspension long-term high-dose override

Approve when the following condition is met:

flolipid40_override: Patient has been taking 80 mg per day for 12 months or more without evidence of muscle toxicity. Approve requested quantity not to exceed 300 mL (2 bottles) per dispensing at retail or 900 mL (6 bottles) per dispensing at home delivery.>=12 months; dose = 80 mg/day; max 300 mL retail / 900 mL home delivery

Products included in this Drug Quantity Management program are covered as medically necessary when the specified per‑prescription drug quantity limits for the product and strength are met. If a requested quantity does not meet the Drug Quantity Management limits and does not meet an approved override condition described in this policy, the request is considered not medically necessary.

Many strengths and combination products are listed with product‑specific quantity rules; for several products there are explicitly no overrides recommended. Examples include higher‑strength atorvastatin and atorvastatin/ezetimibe combinations (e.g., atorvastatin 80 mg; atorvastatin/ezetimibe tablets), fluvastatin 40 mg, certain lovastatin (Altoprev) strengths, pitavastatin products, Zypitamag, pravastatin 80 mg, and some rosuvastatin and rosuvastatin/ezetimibe formulations. The product table entries identify which strengths permit an override for non‑commercially available dosage forms and which do not.

No overrides are recommended for simvastatin 80 mg tablets. Similarly, no overrides are recommended for ezetimibe‑simvastatin combination (Vytorin) tablets; requests for those products are subject to the standard per‑prescription quantity limits.

Any exception request that does not meet the Drug Quantity Management rule and does not satisfy an override condition specified in this policy will be considered not medically necessary.

Coding and Duration Key Values

No specific codes providedmixed

N/A	No billing or procedure codes listed in this section of the document.

Duration for long-term use — definition

Duration for long-term use>= 12 months

Daily dose threshold cited for overrides

Daily dose threshold for overridesup to 80 mg/day

ContextMost per-dispensing override notes cite quantities sufficient to allow dosing up to this daily amount

Provider Actions, Overrides, and Documentation

Note

Policy statement and approval duration

This Drug Quantity Management program has been developed to promote the safe, effective, and economic use of HMG-CoA Reductase Inhibitors. If the Drug Quantity Management rule is not met for the requested medication at the point of service, coverage will be determined by the Criteria below. All approvals are provided for 1 year in duration.

Note

Coverage determinations require consideration of applicable benefit terms, laws/regulations, and collateral materials

Coverage determinations in each specific instance require consideration of: 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws and regulations; 3) any relevant collateral source materials including coverage policies; and 4) the specific facts of the particular situation. Medical Directors exercise clinical judgment and have discretion in individual coverage determinations.

Denial Risk

Exceeding per-dispensing quantity limits

Per‑Prescription Quantity Limits (Retail / Home Delivery)

Atorvaliq — per‑Rx limits

ProductAtorvaliq (atorvastatin 20 mg/5 mL suspension)

Retail maximum per Rx600 mL (4 bottles)

Home delivery maximum per Rx1,800 mL (12 bottles)

Atorvastatin tablets — standard per‑Rx limits

ProductAtorvastatin tablets (Lipitor/generic)

Retail maximum per Rx30 tablets

Home delivery maximum per Rx90 tablets

Continuation / Long‑term Use Overrides

Long-term high-dose continuation

Continuation / long-term use overrides for high-dose therapy:

long_term_80mg_simvastatin: Member has been taking 80 mg/day for >=12 months without evidence of muscle toxicity (applies to simvastatin 20 mg divided regimen and certain simvastatin suspensions).>=12 months

Permits the specified quantity approvals (simvastatin 20 mg: 120 tablets retail / 360 home delivery; Flolipid 40 mg/5 mL: 300 mL retail / 900 mL home delivery).

Background

HMG‑CoA reductase inhibitors (statins) act by inhibiting the enzyme HMG‑CoA reductase, reducing cholesterol synthesis and lowering LDL‑C. They are indicated as adjuncts to diet for the treatment of primary hypercholesterolemia and mixed dyslipidemia; specific indications and dosing vary by agent.

Definitions

HMG-CoA reductase inhibitors (statins) — definition

DefinitionHMG-CoA reductase inhibitors (statins): medications that inhibit the conversion of HMG-CoA to mevalonate, decreasing cholesterol synthesis to reduce total cholesterol and LDL-C.

Non‑commercially available dosage form — definition

DefinitionNon‑commercially available dosage form: a prescribed dose that requires multiple same‑strength tablets and would otherwise require two or more different strengths to be used; qualifies for quantity override as specified per product.

Long‑term divided 80 mg/day simvastatin regimen — definition

DefinitionLong‑term divided 80 mg/day simvastatin regimen: use of 80 mg/day provided as three divided doses (e.g., 20 mg morning, 20 mg mid‑day, 40 mg evening) for at least 12 months without evidence of muscle toxicity; may qualify for specified override quantities.

Policy Summary

PayerCigna

PolicyDrug Quantity Management Policy - Per Rx (statins)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateDec 9, 2024

Key ActionApprovals for exceptions to drug quantity limits are provided for 1 year when override criteria are met.

SourceLink

On This Page

For simvastatin 20 mg tablets: if the patient has been taking 80 mg/day in three divided doses for >=12 months without evidence of muscle toxicity, approve 120 tablets retail or 360 tablets home delivery.

>=12 months without muscle toxicity; dose = 80 mg/day

Applies only to specified simvastatin strength and regimen.

If a request exceeds the product-specific retail or home delivery per-dispensing quantity limits, it will not be approved unless one of the product-specific override conditions is met (for example, dose cannot be achieved with commercially available strengths, interaction-based dosing, or documented long-term prior use without muscle toxicity).

Requests exceeding product retail or home delivery limits are subject to denial unless override criteria are satisfied.
Examples of override conditions include non-commercial dosage needs, drug–drug interaction requiring alternative dosing, or documented long-term prior use without adverse effects.

Documentation Required

Supporting documentation required for overrides

When an override is requested for a quantity above the standard per-dispensing limit, supporting documentation must be provided. Acceptable documentation includes clinical justification that the prescribed dose cannot be achieved with commercially available strengths, evidence of relevant drug interactions necessitating the higher quantity, and medical records demonstrating long-term prior use (e.g., 12 months) without muscle toxicity when applicable.

Documentation of the exact dosing regimen showing why standard strengths are inadequate.
Clinical notes or medication history showing interaction-based dosing (e.g., cyclosporine or fluconazole with certain statins).
Evidence of long-term prior use (when required by product-specific rules) and absence of muscle toxicity.

Note

Atorvastatin Products — Atorvaliq 20 mg/5 mL oral suspension

Atorvaliq 20 mg/5 mL oral suspension: no overrides are recommended; quantities are limited to the product-specific retail and home delivery maximums (600 mL retail / 1,800 mL home delivery).

Denial Risk

Quantity limit exceedance — examples and limits

Quantity limit exceedance — examples: For simvastatin 20 mg, per-dispensing overrides permit up to 120 tablets retail (360 home delivery) when dose cannot be achieved with standard strengths; simvastatin 40 mg permits up to 60 tablets retail (180 home delivery) under the same condition. Requests beyond these thresholds will be denied unless supporting override documentation is provided.

Simvastatin 20 mg: up to 120 tablets per dispensing (retail) or 360 tablets (home delivery) when override criteria met.
Simvastatin 40 mg: up to 60 tablets per dispensing (retail) or 180 tablets (home delivery) when override criteria met.
Requests exceeding these product-specific thresholds require documentation as described above.

Denial Risk

Flolipid quantity limit exceedance and required documentation

Flolipid 40 mg/5 mL oral suspension — quantity limit exceedance: If the patient has been taking 80 mg per day for 12 months or more without evidence of muscle toxicity, approve the requested quantity not to exceed 300 mL (2 bottles) per dispensing at retail or 900 mL (6 bottles) per dispensing at home delivery. Requests exceeding those limits will be denied unless the stated condition is met and documented.

Approve up to 300 mL retail or 900 mL home delivery when 12 months of 80 mg/day use without muscle toxicity is documented.
Requests exceeding 300 mL retail or 900 mL home delivery require additional justification and are subject to denial.

Fluvastatin 20 mg — per‑Rx limits

ProductFluvastatin 20 mg capsules

Retail maximum per Rx30 capsules

Home delivery maximum per Rx90 capsules

Fluvastatin 40 mg — per‑Rx limits

ProductFluvastatin 40 mg capsules

Retail maximum per Rx60 capsules

Home delivery maximum per Rx180 capsules

Typical tablet statins — per‑Rx limits

ProductsMany tablet statins (rosuvastatin, simvastatin, pravastatin, pitavastatin, lovastatin)

Retail maximum per Rx (typical)30 tablets

Home delivery maximum per Rx (typical)90 tablets

Atorvastatin — override for non‑commercial dosage form

ConditionAtorvastatin when dose requires multiple same-strength tablets (non-commercial dosage form)

Allowed per-dispensing quantity (retail)up to 240 capsules

Allowed per-dispensing quantity (home delivery)up to 720 capsules

Flolipid (oral suspension) — standard per‑Rx limits

ProductFlolipid (simvastatin oral suspension)

Retail maximum per Rx150 mL (per Rx)

Home delivery maximum per Rx450 mL (per Rx)

Atorvastatin 10 mg — retail limit

Product and strengthAtorvastatin 10 mg tablets

Retail maximum per dispensing240 tablets

Atorvastatin 10 mg — home delivery limit

Product and strengthAtorvastatin 10 mg tablets

Home delivery maximum per dispensing720 tablets

Atorvastatin 20 mg — retail limit

Product and strengthAtorvastatin 20 mg tablets

Retail maximum per dispensing120 tablets

Atorvastatin 20 mg — home delivery limit

Product and strengthAtorvastatin 20 mg tablets

Home delivery maximum per dispensing360 tablets

Atorvastatin 40 mg — retail limit

Product and strengthAtorvastatin 40 mg tablets

Retail maximum per dispensing60 tablets

Atorvastatin 40 mg — home delivery limit

Product and strengthAtorvastatin 40 mg tablets

Home delivery maximum per dispensing180 tablets

Fluvastatin 20 mg — retail override limit

Product and strengthFluvastatin 20 mg capsules

Retail maximum per dispensing120 capsules

Fluvastatin 20 mg — home delivery override limit

Product and strengthFluvastatin 20 mg capsules

Home delivery maximum per dispensing360 capsules

Fluvastatin 20 mg — DDI (cyclosporine/fluconazole) override

ScenarioFluvastatin 20 mg with cyclosporine or fluconazole requiring 20 mg twice daily

Retail maximum per dispensing60 capsules

Home delivery maximum per dispensing180 capsules

Fluvastatin 20 mg — DDI home delivery limit

ScenarioFluvastatin 20 mg with cyclosporine or fluconazole requiring 20 mg twice daily

Home delivery maximum per dispensing180 capsules

Lovastatin 10 mg — retail limit

Product and strengthLovastatin 10 mg tablets

Retail maximum per dispensing240 tablets

Lovastatin 10 mg — home delivery limit

Product and strengthLovastatin 10 mg tablets

Home delivery maximum per dispensing720 tablets

Lovastatin 20 mg — retail limit

Product and strengthLovastatin 20 mg tablets

Retail maximum per dispensing120 tablets

Lovastatin 20 mg — home delivery limit

Product and strengthLovastatin 20 mg tablets

Home delivery maximum per dispensing360 tablets

Pravastatin 10 mg — retail limit

Product and strengthPravastatin 10 mg tablets

Retail maximum per dispensing240 tablets

Pravastatin 10 mg — home delivery limit

Product and strengthPravastatin 10 mg tablets

Home delivery maximum per dispensing720 tablets

Pravastatin 20 mg — retail limit

Product and strengthPravastatin 20 mg tablets

Retail maximum per dispensing120 tablets

Pravastatin 20 mg — home delivery limit

Product and strengthPravastatin 20 mg tablets

Home delivery maximum per dispensing360 tablets

Pravastatin 40 mg — retail limit

Product and strengthPravastatin 40 mg tablets

Retail maximum per dispensing60 tablets

Pravastatin 40 mg — home delivery limit

Product and strengthPravastatin 40 mg tablets

Home delivery maximum per dispensing180 tablets

Rosuvastatin 5 mg — retail limit

Product and strengthRosuvastatin 5 mg tablets / Ezallor Sprinkle 5 mg

Retail maximum per dispensing240 tablets/capsules

Rosuvastatin 5 mg — home delivery limit

Product and strengthRosuvastatin 5 mg tablets / Ezallor Sprinkle 5 mg

Home delivery maximum per dispensing720 tablets/capsules

Rosuvastatin 10 mg — retail limit

Product and strengthRosuvastatin 10 mg tablets / Ezallor Sprinkle 10 mg

Retail maximum per dispensing120 tablets/capsules

Rosuvastatin 10 mg — home delivery limit

Product and strengthRosuvastatin 10 mg tablets / Ezallor Sprinkle 10 mg

Home delivery maximum per dispensing360 tablets/capsules

Rosuvastatin 20 mg — retail limit

Product and strengthRosuvastatin 20 mg tablets / Ezallor Sprinkle 20 mg

Retail maximum per dispensing60 tablets/capsules

Rosuvastatin 20 mg — home delivery limit

Product and strengthRosuvastatin 20 mg tablets / Ezallor Sprinkle 20 mg

Home delivery maximum per dispensing180 tablets/capsules

Simvastatin 5 mg — retail limit

Product and strengthSimvastatin 5 mg tablets

Retail maximum per dispensing480 tablets

Simvastatin 5 mg — home delivery limit

Product and strengthSimvastatin 5 mg tablets

Home delivery maximum per dispensing1,440 tablets

Simvastatin 10 mg — retail limit

Product and strengthSimvastatin 10 mg tablets

Retail maximum per dispensing240 tablets

Simvastatin 10 mg — home delivery limit

Product and strengthSimvastatin 10 mg tablets

Home delivery maximum per dispensing720 tablets

Simvastatin 20 mg — retail limit

Product and strengthSimvastatin 20 mg tablets

Retail maximum per dispensing120 tablets

Simvastatin 20 mg — home delivery limit

Product and strengthSimvastatin 20 mg tablets

Home delivery maximum per dispensing360 tablets

Simvastatin 40 mg — retail limit

Product and strengthSimvastatin 40 mg tablets

Retail maximum per dispensing60 tablets

Simvastatin 40 mg — home delivery limit

Product and strengthSimvastatin 40 mg tablets

Home delivery maximum per dispensing180 tablets

Simvastatin 20 mg — retail (duplicate entry)

Product and strength (duplicate)Simvastatin 20 mg tablets — 120 retail

Product and strength (duplicate)Simvastatin 20 mg tablets — 360 home delivery

Simvastatin 20 mg — home delivery (duplicate entry)

Product and strength (duplicate)Simvastatin 20 mg tablets — 120 retail

Product and strength (duplicate)Simvastatin 20 mg tablets — 360 home delivery

Simvastatin 40 mg — retail (duplicate entry)

Product and strength (duplicate)Simvastatin 40 mg tablets — 60 retail

Product and strength (duplicate)Simvastatin 40 mg tablets — 180 home delivery

Simvastatin 40 mg — home delivery (duplicate entry)

Product and strength (duplicate)Simvastatin 40 mg tablets — 60 retail

Product and strength (duplicate)Simvastatin 40 mg tablets — 180 home delivery

Flolipid 40 mg/5 mL — long‑term high‑dose override limits

ProductFlolipid 40 mg/5 mL oral suspension

Retail maximum per dispensing300 mL (2 bottles)

Home delivery maximum per dispensing900 mL (6 bottles)

Flolipid 40 mg/5 mL — standard and override retail limits

ProductFlolipid 40 mg/5 mL oral suspension

Retail standard per Rx150 mL (1 bottle)

Retail override per dispensing300 mL (2 bottles) when long-term 80 mg/day criteria met

Override for non-commercial dosage form — definition

DefinitionOverride for non-commercial dosage form: approval granted when a patient's prescribed dose requires multiple same-strength tablets and would otherwise require two or more strengths to be used, allowing a larger per-dispensing quantity to accommodate the dosing.

Long‑term use without muscle toxicity — definition

DefinitionLong-term use without muscle toxicity: member history of taking a specified high daily dose (e.g., 80 mg/day) for 12 months or more without evidence of muscle toxicity, permitting certain quantity overrides (e.g., simvastatin 20 mg and Flolipid 40 mg/5 mL).