CurrentAnthemPolicy N/A

In_Caid_Pcsk9Selectlipotropics

Prior authorization (PA) request form and clinical criteria for coverage of Evkeeza (evinacumab-dgnb), Juxtapid (lomitapide), Leqvio (inclisiran), Niacin ER, Praluent (alirocumab), Repatha (evolocumab), and Tryngolza (olezarsen) for Anthem Indiana Medicaid lines of business. The document lists diagnosis, age, prescriber specialty, prior therapy/trial requirements, dosing limits, and documentation requirements for PA submission.

Policy Summary

PayerAnthem

PolicyIn_Caid_Pcsk9Selectlipotropics

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescribing provider must complete the form in its entirety and fax it with required documentation (diagnosis confirmation, labs, prior therapy dates/doses, REMS enrollment where applicable) to the PA center; incomplete requests will be returned.

SourceLink

POLICY UPDATE CHANGES

No material changes

8Drugs / agents covered with PA criteria

MultipleDistinct clinical pathways

Coverage Summary

This PA request form and accompanying clinical criteria cover Evkeeza, Juxtapid, Leqvio, Niacin ER, Praluent, Repatha, and Tryngolza for Anthem Indiana Medicaid. Coverage stance: covered_with_criteria. The form operationalizes prior authorization by specifying required diagnoses, age limits, prescriber specialty, trial-and-failure or intolerance documentation, dosing limits, REMS enrollment when applicable, and lab or genetic documentation as needed. Stats: 8 drugs/agents covered with PA criteria; Multiple distinct clinical pathways (age/diagnosis/prior therapy).

Key dosing thresholds

Evkeeza dosing limit15 mg/kg every 4 weeks or less

Juxtapid dosing limit60 mg per day or less

Leqvio dosing limit (initiation)≤284 mg every 3 months

Leqvio dosing limit (maintenance)≤284 mg every 6 months

Tryngolza dosing limit80 mg per month or less

PA Criteria by Agent

Evkeeza (evinacumab-dgnb) PA criteria

Covered when ALL of the following are met:

ALL of the following

Member has a diagnosis of homozygous familial hypercholesterolemia (HoFH)
Medication prescribed by, or in consultation with, a cardiologist or endocrinologist
Age-specific requirements
- Member age 1 to <7 years: Member is one year of age or older and less than seven years of age
- Member age 7 to <10 years
  - One of
    Member has a trial and failure history of at least 90 days of therapy with rosuvastatin 20 mg
    Provider has submitted documentation of intolerance/contraindication to rosuvastatin
- Member age 10 to <18 years
  - One of
    Member has trial and failure history with Repatha (evolocumab)
    Trial and failure history of at least 90 days of high dose rosuvastatin (20 mg/40 mg) or atorvastatin (40 mg/80 mg, if rosuvastatin intolerant) therapy concurrently with ezetimibe, or documented intolerance/contraindication to statins/ezetimibe, AND provider has submitted medical justification for use of Evkeeza (evinacumab-dgnb) over Repatha (evolocumab)
- Member age >=18 years
  - One of
    Member has trial and failure history with Praluent (alirocumab) OR Repatha (evolocumab)
    Trial and failure history of at least 90 days of high dose rosuvastatin (20 mg/40 mg) or atorvastatin (40 mg/80 mg, if rosuvastatin intolerant) therapy concurrently with ezetimibe, or documented intolerance/contraindication to statins/ezetimibe, AND provider has submitted medical justification for use of Evkeeza over Praluent and Repatha
Concomitant statin requirement or intolerance
- Member will use maximally tolerated statin therapy with or without ezetimibe concurrently with Evkeeza (for those ≥7 years of age)
- Provider has submitted documented intolerance to statin and ezetimibe therapy or medical rationale against the use of statin or ezetimibe therapy
Dose and weight: Requested dose is 15 mg/kg every four weeks or less
Member weight must be provided

Juxtapid (lomitapide) PA criteria

Covered when ALL of the following are met:

ALL of the following

REMS: Member is enrolled in the Juxtapid/lomitapide REMS program and prescriber is monitoring in accordance with REMS requirements
Age: Member is 18 years of age or older
Prescriber: Medication prescribed by, or in consultation with, a cardiologist or endocrinologist
Prior therapy requirement
- Member has trial and failure history of Praluent (alirocumab) or Repatha (evolocumab)

Leqvio (inclisiran) PA criteria

Covered when ALL of the following are met:

ALL of the following

Indication and LDL thresholds
- Member has a diagnosis of primary hyperlipidemia with clinical ASCVD or is at increased risk for ASCVD with a baseline LDL-C level of ≥55 mg/dL (documentation required)
- Member has a diagnosis of heterozygous familial hypercholesterolemia (HeFH) with a baseline LDL-C level of ≥70 mg/dL (documentation required)
Age: Member is 18 years of age or older
Prescriber: Prescribed by, or in consultation with, a cardiologist or endocrinologist

Niacin ER PA criteria

Covered when ALL of the following are met:

ALL of the following

Diagnosis of severe hypertriglyceridemia (baseline triglycerides ≥500 mg/dL)
Concurrent therapy or intolerance
- Member is on concurrent therapy with all the following for at least 90 days: omega-3 fatty acid (omega-3-acid ethyl esters or icosapent ethyl), fibric acid derivative, statin therapy
- Member has a documented intolerance of omega-3 fatty acid, fibric acid derivative, and statin therapy OR medical justification for use of Niacin ER over these therapies (explain)
Age: Member is 17 years of age or older

Praluent (alirocumab) PA criteria

Covered when ALL of the following are met (select applicable diagnosis/pathway):

ALL of the following

Permitted diagnoses with LDL thresholds and prior therapy requirements
- Clinical ASCVD, Very High Risk requiring secondary prevention, and persistently elevated LDL-C (≥55 mg/dL) despite 90 days of high intensity rosuvastatin (20 mg/40 mg) or atorvastatin (40 mg/80 mg if rosuvastatin intolerant) OR documented intolerance of both rosuvastatin and atorvastatin OR medical rationale against statin therapy
- Clinical ASCVD, NOT Very High Risk, persistently elevated LDL-C (≥70 mg/dL) despite 90 days of high intensity rosuvastatin or atorvastatin WITH ezetimibe OR documented intolerance of rosuvastatin and atorvastatin and/or ezetimibe OR medical rationale against statin/ezetimibe
- Clinical ASCVD with baseline LDL-C ≥190 mg/dL not due to secondary causes, without familial hypercholesterolemia, requiring secondary prevention, and persistently elevated LDL-C (≥70 mg/dL) despite 90 days of high intensity statin OR documented intolerance/medical rationale

Tryngolza (olezarsen) PA criteria

Covered when ALL of the following are met:

ALL of the following

Genetic confirmation: Member has a diagnosis of familial chylomicronemia syndrome (confirmed by genetic testing - documentation must be submitted)
Triglyceride threshold: Member has a baseline fasting triglyceride level ≥880 mg/dL (lab documentation within past 90 days required)
Age: Member is 18 years of age or older
Prescriber: Prescribed by, or in consultation with, a cardiologist, endocrinologist, or lipid specialist (lipidologist)

Required Provider Actions and Documentation

Prior Authorization

Submit completed PA form and documentation

The prescribing provider must complete the PA form in its entirety and fax it to the Prior Authorization of Benefits Center with required documentation. Required attachments include diagnosis confirmation, pertinent labs, prior therapy details (drug, dose, dates), and REMS enrollment documentation when applicable. Incomplete or partially completed requests will be returned.

Fax completed form and attachments to the PA center (numbers listed on form).
Include diagnosis confirmation and relevant lab results.
Include prior therapy details: drug name, dose, and dates.
Attach REMS enrollment/monitoring documentation when required (e.g., Juxtapid).
Incomplete requests will be returned.

Documentation Required

Provide prior therapy and intolerance documentation

Provide documentation of prior therapy trials and any intolerance or contraindication. For each required prior agent list the drug, dose, and dates to demonstrate trial-and-failure history or document intolerance/contraindication. For Tryngolza, submit genetic testing confirming familial chylomicronemia. Ensure referenced lab values are provided within the timeframes specified by each drug pathway.

Document trial-and-failure history for required agents (include drug, dose, and dates).
Or provide documentation of intolerance/contraindication to required statin/ezetimibe/PCSK9 therapies as specified.
For Tryngolza, submit genetic testing confirming familial chylomicronemia syndrome.
Provide lab values per drug-specific timing requirements (see lab timing block).

Prior Authorization

REMS enrollment for Juxtapid

For Juxtapid (lomitapide) requests, confirm member enrollment in the Juxtapid/lomitapide REMS program and that prescriber monitoring is in accordance with REMS requirements. For members of childbearing potential include documentation of a negative pregnancy test obtained within the past 30 days and confirmation that the prescriber counseled the member on conception risks and appropriate contraception.

Confirm member is enrolled in the Juxtapid REMS program and prescriber monitoring per REMS is in place.
Attach negative pregnancy test obtained within the past 30 days for those of childbearing potential.
Document prescriber counseling on risks of conceiving while on Juxtapid and contraception methods.

Billing Rule

Dose limits

Requested doses must not exceed the agent-specific dosing limits listed on the form. Provide member weight when required for weight-based dosing.

Evkeeza (evinacumab-dgnb): requested dose ≤ 15 mg/kg every 4 weeks (member weight required).
Juxtapid (lomitapide): requested dose ≤ 60 mg/day.
Leqvio (inclisiran): initiation dosing ≤ 284 mg every 3 months; maintenance dosing ≤ 284 mg every 6 months.
Tryngolza (olezarsen): requested dose ≤ 80 mg per month.

Documentation Required

Lab timing requirements

Attach baseline LDL-C or fasting triglyceride labs within the agent-specific windows. Tryngolza requires a baseline fasting triglyceride level ≥880 mg/dL with lab documentation obtained within the past 90 days. Leqvio and other agents require baseline LDL-C documentation as specified in their pathways.

Tryngolza (olezarsen): baseline fasting triglycerides ≥880 mg/dL with lab obtained within past 90 days.
Leqvio (inclisiran) and other LDL-focused agents: submit baseline LDL-C documentation as required per indication (thresholds specified on form).
Provide fasting vs non-fasting status as applicable for triglyceride measurements when requested.

Billing / Coding Notes

No specific billing codes listed on formmixed

No codes listed

Background and Definitions

Background: This multi-agent prior authorization (PA) form is used by Anthem Indiana Medicaid to collect information to review requests for PCSK9 inhibitors and selected lipid-modifying agents. It operationalizes coverage pathways by requiring documentation of specific diagnoses (e.g., HoFH, HeFH, clinical ASCVD, familial chylomicronemia, severe hypertriglyceridemia), LDL-C or triglyceride thresholds (e.g., Leqvio ≥55 mg/dL for ASCVD, HeFH ≥70 mg/dL; Niacin ER triglycerides ≥500 mg/dL; Tryngolza triglycerides ≥880 mg/dL), age limits (agent-specific pediatric/adult cutoffs), and prescriber specialty requirements (cardiologist, endocrinologist, or lipid specialist for select agents). The form requires prior therapy or documented intolerance (trial-and-failure histories including drug, dose, dates, or intolerance/contraindication documentation), enrollment in REMS where required (Juxtapid REMS and monitoring plus pregnancy testing/contraception counseling for those of childbearing potential), and adherence to stated dosing limits (e.g., Evkeeza ≤15 mg/kg q4w; Juxtapid ≤60 mg/day; Leqvio ≤284 mg per dosing interval; Tryngolza ≤80 mg/mo). It also operationalizes submission processes: the prescribing provider must complete the form and fax required documentation (diagnosis confirmation, labs, prior therapy dates/doses, REMS enrollment where applicable) to the PA center; incomplete requests will be returned.

Definitions: Maximally tolerated statin therapy — not explicitly defined on the form but implied as the highest statin dose the patient can tolerate, with or without ezetimibe, as documented by the prescriber.

Definitions: Trial and failure history — documentation of prior therapy including drug, dose, and dates demonstrating inadequate response or intolerance; the form frequently requires ≥90 days of specified high-intensity statin or documented intolerance, or prior failure on alternative agents (e.g., Praluent/Repatha) depending on the drug pathway.

Policy Summary

PayerAnthem

PolicyIn_Caid_Pcsk9Selectlipotropics

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Trial and failure history of at least 90 days of high dose rosuvastatin (20 mg/40 mg) or atorvastatin (40 mg/80 mg, if rosuvastatin intolerant) therapy concurrently with ezetimibe, or documented intolerance/contraindication to statins/ezetimibe, AND provider has submitted medical justification for use of Juxtapid over Praluent and Repatha

Reproductive safety: For those of childbearing potential, documentation of a negative pregnancy test obtained in the past 30 days is attached; prescriber has counseled the member on risks associated with conceiving while utilizing Juxtapid and appropriate methods of contraception

Concomitant statin requirement or intolerance

Member will utilize maximally tolerated statin therapy with or without ezetimibe concurrently with Juxtapid
Provider has submitted documented intolerance to statin and/or ezetimibe therapy or medical rationale against use of statin or ezetimibe therapy

Dose limit: Requested dose is 60 mg/day or less

Prior therapy requirement

Member has trial and failure history of Praluent (alirocumab) or Repatha (evolocumab)
Trial and failure history of at least 90 days of high dose rosuvastatin (20 mg/40 mg) or atorvastatin (40 mg/80 mg, if rosuvastatin intolerant) therapy concurrently with ezetimibe, or documented intolerance/contraindication to statins/ezetimibe, AND provider has submitted medical justification for use of Leqvio over Praluent and Repatha

Concomitant statin requirement or intolerance

Member will utilize maximally tolerated statin therapy with or without ezetimibe concurrently with Leqvio
Provider has submitted documented intolerance to statin and/or ezetimibe therapy or medical rationale against use of statin or ezetimibe therapy

Dose limits by status

Initiating therapy: Member is initiating therapy and requested dose does not exceed 284 mg every three months
Established on therapy: Member is established on therapy and the requested dose does not exceed 284 mg every six months

Clinical ASCVD, Very High Risk with baseline LDL-C ≥190 mg/dL not due to secondary causes, diagnosed familial hypercholesterolemia, requiring secondary prevention, and persistently elevated LDL-C (≥55 mg/dL) despite 90 days of high intensity statin OR documented intolerance/medical rationale

Primary hyperlipidemia, without clinical ASCVD, with baseline LDL-C ≥190 mg/dL not due to secondary causes, requiring primary prevention and persistently elevated LDL-C (≥100 mg/dL) despite 90 days of high intensity statin OR documented intolerance/medical rationale

HoFH or HeFH with persistently elevated LDL-C (≥70 mg/dL) despite 90 days of high intensity statin therapy WITH ezetimibe OR documented intolerance/medical rationale

Role of % lowering: For members requiring >25% additional LDL-C lowering ONLY; ≤25% lowering should use high intensity statin WITH ezetimibe as first line

Age

Member is 18 years of age or older
Member is eight years of age or older and has a diagnosis of HeFH

Concomitant statin requirement or intolerance

Member will utilize maximally tolerated statin therapy with or without ezetimibe concurrently with Praluent
Provider has submitted documented intolerance to statin and/or ezetimibe therapy or medical rationale against use of statin or ezetimibe therapy

Requested dose options and conditions

Requested dose is 75 mg every two weeks
Requested dose is 300 mg every four weeks
150 mg every two weeks
- Diagnosis of homozygous familial hypercholesterolemia; OR Diagnosis of heterozygous familial hypercholesterolemia and member undergoing LDL apheresis; OR Member has not achieved a clinically meaningful response after at least four weeks of dosing at 75 mg every two weeks or 300 mg every four weeks
150 mg every four weeks for pediatric <50 kg
- Diagnosis of heterozygous familial hypercholesterolemia

Diet attestation: Prescriber attests member will use Tryngolza as an adjunct to a low-fat diet of ≤ 20 g fat per day to reduce triglycerides

Dose limit: Requested dose is 80 mg (0.8 mL) per month or less

OpenPayer

In_Caid_Pcsk9Selectlipotropics

Coverage Summary

PA Criteria by Agent

Required Provider Actions and Documentation

Billing / Coding Notes

Background and Definitions

Revision History