CurrentAnthemPolicy N/A

PCSK9 and ATP Citrate Lyase prior authorization requirements

Defines prior authorization requirements and documentation for PCSK9 inhibitors (Praluent®, Repatha®) and ATP citrate lyase agents (Nexletol®, Nexlizet™) for Anthem HealthKeepers Plus Medicaid members; intended for prescribers requesting new or continued therapy.

Policy Summary

PayerAnthem

PolicyPCSK9 and ATP Citrate Lyase prior authorization requirements

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form with member, prescriber, drug, diagnosis, labs, and supporting clinical notes demonstrating LDL-C response or genetic confirmation as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥30%PCSK9 LDL-C reduction threshold

15–20%ATP citrate lyase LDL-C reduction

3 monthsMin statin+ezetimibe trial

13 yrsMin age for HoFH

Coverage Criteria

Initial and continuation therapy criteria

Coverage is considered when ALL of the following groups of criteria are met as applicable to the indication:

Indication: Requested drug must be for one of the listed indications: secondary prevention of ASCVD events (to reduce risk of myocardial infarction, stroke, coronary revascularization), primary hyperlipidemia including HeFH as adjunct to diet and other lipid-lowering therapies, or HoFH requiring additional LDL-C lowering.

See checklist of indications on form.

Prior therapy: Member has trialed highest available dose or maximally tolerated dose of a high-intensity statin (atorvastatin or rosuvastatin) plus ezetimibe for at least three continuous months with failure to reach target LDL-C OR member has documented statin intolerance meeting the specified criteria (muscle symptoms that resolved on discontinuation, recurred on rechallenge or with alternative statin, and other criteria per form).>= 3 months or documented intolerance

Statin + ezetimibe duration and statin intolerance criteria are captured on the form.

Policy Summary

PayerAnthem

PolicyPCSK9 and ATP Citrate Lyase prior authorization requirements

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form with member, prescriber, drug, diagnosis, labs, and supporting clinical notes demonstrating LDL-C response or genetic confirmation as applicable.

SourceLink

On This Page

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.

Coding and Key Thresholds

Coding (none specified on form)mixed

N/A	No specific CPT/HCPCS/ICD-10 codes provided on form

inv-04: PCSK9 LDL-C reduction — >= 30%.

ThresholdPCSK9 agents (Praluent®, Repatha®): ≥ 30% reduction in LDL-C since initiation

Action requiredAttach clinical notes and laboratory results that support the ≥30% LDL-C reduction

ApplicabilityApplies to continuation/renewal requests to document benefit of PCSK9 therapy

inv-05: ATP citrate lyase LDL-C reduction — 15-20%.

ThresholdATP citrate lyase agents (Nexletol®, Nexlizet™): 15–20% reduction in LDL-C since initiation

Action requiredAttach clinical notes and laboratory results that support the 15–20% LDL-C reduction

ApplicabilityApplies to continuation/renewal requests to document benefit of ATP citrate lyase therapy

inv-06: Statin+ezetimibe trial duration — >= 3 continuous months.

Minimum durationMember must have trialed maximally tolerated high-intensity statin (atorvastatin or rosuvastatin) plus ezetimibe for at least 3 continuous months

PurposeDemonstrates failure to reach target LDL-C prior to PCSK9 or M4V therapy consideration

AlternativeDocumented statin intolerance per specified criteria may substitute for the 3-month trial

inv-07: Age for HoFH — >= 13 years.

Age thresholdMember must be at least 13 years of age for HoFH consideration

ContextApplies when evaluating requests for HoFH-specific indications for additional LDL-C lowering therapies

DocumentationProvide diagnosis and supporting lab/clinical documentation when HoFH and age criteria met

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for PCSK9 inhibitors (Praluent®, Repatha®) and ATP citrate lyase agents (Nexletol®, Nexlizet™) for Anthem HealthKeepers Plus Medicaid. Submit one PA form per request. Incomplete, incorrect, or illegible forms or missing documentation can delay processing.

Applies to Anthem HealthKeepers Plus Medicaid
Use one PA form per member
Fax completed form to 844-512-7020

Step Therapy

Step Therapy / Prior Lipid-Lowering Therapy

Member must have prior treatment with a maximally tolerated high-intensity statin (atorvastatin or rosuvastatin) AND ezetimibe for at least three continuous months without reaching target LDL-C, unless statin intolerance is documented. Document highest available dose or maximally tolerated dose and treatment duration. This step-therapy requirement applies before initiating PCSK9 or ATP citrate lyase therapy.

Maximally tolerated high-intensity statin: atorvastatin or rosuvastatin
Ezetimibe in combination with statin
Minimum 3 continuous months of therapy unless documented intolerance

Documentation Required

Required Supporting Documentation

Attach clinical notes and laboratory results supporting LDL-C reduction after initiation of therapy: for PCSK9 agents (Praluent® or Repatha®) show ≥30% LDL-C reduction; for ATP citrate lyase agents (Nexletol® or Nexlizet™) show a 15–20% LDL-C reduction. For HoFH or HeFH provide genetic testing or diagnostic documentation as specified.

PCSK9 (Praluent®, Repatha®): ≥30% reduction in LDL-C with supporting labs
ATP citrate lyase (Nexletol®, Nexlizet™): 15–20% reduction in LDL-C with supporting labs
HoFH: genetic testing copy or diagnostic criteria documentation
HeFH: lab report with LDL-C at diagnosis and supporting clinical/family history

Denial Risk

Documentation Missing / Delayed

Incomplete forms or missing supporting documentation (e.g., lab reports demonstrating LDL-C reduction, genetic testing for HoFH, documentation of statin intolerance) will delay or result in denial of the PA. Ensure prescriber signature and all requested information are included.

Missing lab reports showing LDL-C change after therapy initiation
Missing genetic test results or diagnostic documentation for HoFH/HeFH
No documentation of statin intolerance when claiming inability to use max dose
Form lacking prescriber signature

Definitions

inv-13: HoFH — Homozygous familial hypercholesterolemia: genetic confirmation of two mutant alleles in LDLR, APOB, PCSK9, or LDLRAP1 loci or clinical criteria.

DefinitionHomozygous familial hypercholesterolemia (HoFH): Genetic confirmation of two mutant alleles at LDLR, APOB, PCSK9, or LDLRAP1 loci

Alternate clinical criteriaOr clinical confirmation per form: untreated LDL-C > 500 mg/dL with xanthoma before age 10, or treated LDL-C ≥ 300 mg/dL with xanthoma before age 10, or untreated LDL-C consistent with HeFH in both parents

Action requiredIf genetic testing confirms two mutant alleles, attach a copy of the genetic testing result

inv-14: HeFH — Heterozygous familial hypercholesterolemia: diagnosis per Dutch Lipid Clinic Network criteria (score >8) or Simon Broome criteria as required.

DefinitionHeterozygous familial hypercholesterolemia (HeFH): Definite diagnosis per Dutch Lipid Clinic Network criteria (total score > 8) or Simon Broome criteria

Action requiredIf Yes, provide lab report with LDL-C at time of diagnosis and supporting clinical/family history or physical findings

Form optionsForm asks separately whether member meets Dutch criteria (score >8) and Simon Broome criteria

Background

PCSK9 inhibitors (e.g., Praluent®, Repatha®) and ATP citrate lyase agents are intended as adjunctive lipid-lowering therapies to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia, familial hypercholesterolemia (HeFH or HoFH), or to reduce atherosclerotic cardiovascular disease (ASCVD) risk. The form captures the indication, prior lipid-lowering therapy, and objective measures of response for both initiation and continuation decisions.

Before consideration, the member must have trialed a maximally tolerated high-intensity statin (atorvastatin or rosuvastatin) plus ezetimibe for at least 3 continuous months with failure to reach target LDL-C, or documentation of statin intolerance per the form. For continuation of therapy, the form requires documented benefit: a reduction in LDL-C of ≥30% for PCSK9 agents and approximately 15–20% for ATP citrate lyase agents. For HoFH, the form requests genetic confirmation of two mutant alleles in relevant loci or specified clinical criteria and notes that age thresholds (e.g., ≥13 years where applicable) are considered in approval decisions.