CurrentUnitedHealthcarePolicy N/A

Livalo (pitavastatin) prior authorization

Defines Oxford prior authorization and medical necessity requirements for Livalo (pitavastatin) for members, including initial and reauthorization criteria and required documentation of trials of therapeutically equivalent statins.

Policy Summary

PayerUnitedHealthcare

PolicyLivalo (pitavastatin) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2025

Next Review DateJan 1, 2025

Key ActionSubmit medical records documenting trial and failure, inadequate response, or intolerance to three therapeutically equivalent covered statins for initial authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

3required statin trials

120 daysclaims window for reauth

≥8minimum age (HeFH)

Coverage Criteria

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ALL of the following

Submission of medical records documenting history of trial and failure, inadequate response, or intolerance to three of the Therapeutically Equivalent covered medications listed below.
Therapeutically Equivalent statins (examples)
- atorvastatin (generic Lipitor)
- lovastatin (generic Mevacor)
- fluvastatin (generic Lescol)
- pravastatin (generic Pravachol)
- simvastatin (generic Zocor)
- rosuvastatin (generic Crestor)
Authorization will be issued for 12 months.

Coverage caveats: State mandates and Oxford plan requirements may impose additional prior authorization conditions. Federal requirements and the member’s specific benefit plan limits (including step therapy, quantity limits, and formulary tiering) apply and may affect coverage. Providers should submit complete medical records with documentation of trials, intolerances, or contraindications to support authorization requests. Therapeutic equivalence determinations are made by UnitedHealthcare P&T and do not imply FDA Orange Book equivalence.

Initial Authorization Criteria

Initial Authorization

Initial approval criteria

Initial Authorization: Medical records documenting trial and failure, inadequate response, or intolerance to three therapeutically equivalent covered statins (atorvastatin, lovastatin, fluvastatin, pravastatin, simvastatin, rosuvastatin).

Authorization will be issued for 12 months

Reauthorization / Continuation Criteria

Reauthorization

Livalo will be approved for reauthorization when ALL of the following are met:

Reauthorization: a) Documentation of positive clinical response; AND b) Member is currently on the requested medication as documented in claims history (evidence of claims in the past 120 days).claims evidence within 120 days

Authorization will be issued for 12 months

Reauthorization

Reauthorization requirements

Continuation: Documentation of positive clinical response AND evidence of recent claims (within 120 days) showing member is currently on the requested medication.

Authorization will be issued for 12 months

Step	Required prior therapy
1	Trial and failure, inadequate response, or intolerance to three therapeutically equivalent covered statins: atorvastatin; lovastatin; fluvastatin; pravastatin; simvastatin; rosuvastatin.

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Livalo (pitavastatin). Providers must submit a prior authorization request and supporting documentation showing the member meets the step therapy and documentation requirements. Authorizations, when approved, are issued for 12 months.

Authorization length: 12 months
Program: UnitedHealthcare Pharmacy Clinical Pharmacy Programs

Step Therapy

Step Therapy Requirement

Initial authorization requires documented trials and failures of three therapeutically equivalent, covered statins prior to approval for Livalo.

Required trials/failures of three of the following therapeutically equivalent covered medications: atorvastatin, lovastatin, fluvastatin, pravastatin, simvastatin, rosuvastatin
Evidence must show trial and failure, inadequate response, or intolerance to each agent

Documentation Required

Required Documentation

Providers must submit medical records that document the required trials/failures, inadequate response, or intolerance for the three required statins. Medical record documentation should clearly indicate dates, medications tried (including dose and duration), and the clinical reason for failure or intolerance.

Include medication history with dates, doses, and duration of therapy
Document clinical rationale for failure or intolerance (e.g., adverse effects, lab results, lack of LDL reduction)

Denial Risk

Provider Action — Risk of Denial if Records Not Provided

Failure to provide the requested medical records documenting trials/failures, inadequate response, or intolerance may result in denial of the prior authorization request. Providers should supply all requested records timely to avoid risk of denial.

Denial risk if records not provided documenting trials/failures/intolerance
Providers may be contacted for additional information; lack of response can lead to adverse determination

Denial Risk

Reauthorization Documentation — Denial Risk

For reauthorization, submit documentation of a positive clinical response and evidence the member is currently on the requested medication. Lack of documented positive response or absence of claims evidence for the medication in the past 120 days may result in denial of reauthorization.

Reauthorization criteria: documentation of positive clinical response AND claims evidence of medication use within the past 120 days
No claims or no documented positive response = potential denial of reauthorization

Definitions

Therapeutically Equivalent — definition

DefinitionMedications/products that have essentially the same efficacy and adverse effect profile as determined by the UnitedHealthcare Pharmacy and Therapeutics (P&T) Committee (this is UnitedHealthcare's definition and is not the FDA Orange Book definition).

Decision authorityDetermination of therapeutic equivalence is made by the UnitedHealthcare Pharmacy and Therapeutics Committee.

ScopeApplies to medications/products considered for step therapy and prior authorization under UnitedHealthcare/Oxford plans.

Not FDA Orange BookThis definition is not intended to imply therapeutic equivalence as defined by the FDA Orange Book.

Use in prior authorizationUsed to establish required trials of 'therapeutically equivalent' statins for initial authorization of Livalo (pitavastatin).

Background

Livalo (pitavastatin) is indicated as an adjunct to diet to reduce low‑density lipoprotein cholesterol (LDL‑C) in adults with primary hyperlipidemia and in pediatric patients aged ≥ 8 years with heterozygous familial hypercholesterolemia (HeFH). UnitedHealthcare defines therapeutically equivalent products as those with essentially the same efficacy and adverse effect profile as determined by the UnitedHealthcare Pharmacy and Therapeutics Committee (this definition is distinct from the FDA Orange Book definition).

Policy Summary

PayerUnitedHealthcare

PolicyLivalo (pitavastatin) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2025

Next Review DateJan 1, 2025

Key ActionSubmit medical records documenting trial and failure, inadequate response, or intolerance to three therapeutically equivalent covered statins for initial authorization.

SourceLink

On This Page

OpenPayer

Livalo (pitavastatin) prior authorization

Coverage Criteria

Initial Authorization Criteria

Reauthorization / Continuation Criteria

Step Therapy Requirements

Provider Actions and Documentation

Definitions

Background