CurrentCareSourcePolicy N/A

Juxtapid (lomitapide) — Pharmacy Coverage Criteria

Defines pharmacy benefit coverage, prior authorization, quantity limits, and clinical criteria for Juxtapid (lomitapide) for members in the payer's Arkansas PASSE program; applies to pharmacy benefit claims with allowed home site of service.

Policy Summary

PayerCareSource

PolicyJuxtapid (lomitapide) — Pharmacy Coverage Criteria

Policy CodePolicy N/A

Change TypeOperational update (non-material)

Effective DateJan 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and submit baseline cholesterol labs within 90 days to support initial approval.

SourceLink

POLICY UPDATE CHANGES

Removed prescriber specialty requirement

New policy for Juxtapid created

30quantity limit

Homesite of service

PAcoverage requirement

6 moinitial approval

12 moreauthorization

Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met for initial authorization:

Initial authorization criteria: 1. Member is 18 years old or older; AND 2. Diagnosis of homozygous familial hypercholesterolemia (HoFH) confirmed by genetic testing OR by LDL-C >500 mg/dL untreated or LDL-C >300 mg/dL if treated (not including PCSK9 inhibitors) PLUS supporting clinical features (e.g., xanthoma before age 10 or evidence of HeFH in both parents); AND 3. Chart notes include baseline cholesterol labs within 90 days before starting Juxtapid; AND 4. Member is unable to achieve LDL-C goal after trials with BOTH: a) a 90-day trial of a high-intensity statin (rosuvastatin ≥20 mg or atorvastatin ≥40 mg) together with ezetimibe (if statin intolerance, retry with a moderate or low-intensity statin + ezetimibe); AND b) an 8-week trial with Repatha (prior authorization required); AND 5. Juxtapid will be used as an adjunct to other lipid-lowering therapies (e.g., statin, ezetimibe, LDL apheresis); AND 6. Prescriber attests the member will follow a low-fat diet during treatment; AND 7. Dosage does not exceed 60 mg daily (1 capsule daily).

If met, approve for 6 months

Reauthorization

Covered for reauthorization when:

Policy Summary

PayerCareSource

PolicyJuxtapid (lomitapide) — Pharmacy Coverage Criteria

Policy CodePolicy N/A

Change TypeOperational update (non-material)

Effective DateJan 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and submit baseline cholesterol labs within 90 days to support initial approval.

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.

Reauthorization criteria:

Chart notes and recent labs demonstrate a meaningful reduction from baseline in cholesterol levels (e.g., LDL-C, total cholesterol, apolipoprotein B) OR all cholesterol levels are at goal.

If met, approve for 12 months

CareSource considers Juxtapid (lomitapide) not medically necessary for the treatment of diseases that are not listed in this document.

Use of Juxtapid (lomitapide) for diagnoses other than the specified Homozygous familial hypercholesterolemia (HoFH) indication is considered not medically necessary and will not be covered under the pharmacy benefit.

Initial Authorization Requirements

Initial Therapy

Initial authorization criteria and required prior therapies

Initial: Age ≥ 18 years; confirmed HoFH by genetic testing OR LDL-C diagnostic thresholds with supporting clinical/family features; baseline cholesterol labs within 90 days; failure to achieve LDL-C goal after both: 90-day high-intensity statin + ezetimibe (or retry with moderate/low-intensity statin + ezetimibe if intolerant) AND 8-week trial of Repatha (prior authorization required); Juxtapid used as adjunct therapy; prescriber attests to low-fat diet; dosage up to 60 mg daily; approve for 6 months if criteria met.

Step	Required trial	Duration / details
1	High-intensity statin plus ezetimibe (e.g., rosuvastatin ≥20 mg or atorvastatin ≥40 mg together with ezetimibe). If intolerance occurs, a second attempt with a moderate- or low-intensity statin plus ezetimibe is required.	90 days. Member must be unable to achieve LDL‑C goal after this trial.
2	Repatha (evolocumab) trial	8 weeks (prior authorization required). Member must have trialed and failed or been intolerant to therapy.

Reauthorization and Continuation Requirements

Reauthorization

Reauthorization requirements and duration

Reauthorization: Chart notes and recent labs demonstrating meaningful reduction from baseline OR cholesterol levels at goal.

If met, approve for 12 months

Billing and Coding

Billing codesNDC

NDC	Must use valid NDC code

inv-06: LDL-C thresholds for HoFH diagnosis

Untreated LDL-C thresholdLDL-C > 500 mg/dL (before any treatment)

Treated LDL-C thresholdLDL-C > 300 mg/dL if treated with a lipid-lowering drug (excludes PCSK9 inhibitors)

ContextThresholds are used as part of diagnostic criteria when genetic testing is not available

Provider Responsibilities and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Juxtapid (non-preferred product). Billing must use a valid NDC code. Initial approvals are for 6 months when criteria are met.

Affected product: Juxtapid (lomitapide) — Non-Preferred
Billing requirement: Must submit a valid NDC code on pharmacy claim
Approval length: Initial approval = 6 months

Step Therapy

Prior Therapy Requirement

Members must have documentation of prior therapy trials before Juxtapid is approved. Specifically, chart notes must show a trial and failure or intolerance to a high-intensity statin plus ezetimibe and an 8-week trial of Repatha (prior authorization required for Repatha).

Statin requirement: 90-day trial of high-intensity statin (rosuvastatin ≥20 mg or atorvastatin ≥40 mg) + ezetimibe; if intolerance, attempt moderate/low-intensity statin + ezetimibe
PCSK9 requirement: 8-week trial of Repatha (prior authorization required) before Juxtapid

Documentation Required

Documentation Requirements

Chart notes must include baseline cholesterol lab levels obtained within 90 days prior to starting Juxtapid. For reauthorization, chart notes and recent labs must demonstrate a meaningful reduction in cholesterol levels from baseline or that cholesterol levels are at goal.

Baseline labs: LDL-C, total cholesterol, apolipoprotein B, or other relevant lipid panels within 90 days before treatment start
Reauthorization evidence: Documentation of meaningful LDL-C (or other lipid) reduction from baseline OR attainment of LDL-C goals

Denial Risk

Billing / Denial Risk

Failure to obtain prior authorization for this non-preferred product or failure to bill with a valid NDC may result in claim denial.

Denial triggers: No prior authorization on file for Juxtapid (non-preferred)
Denial triggers: Pharmacy claim submitted without a valid NDC code

Quantity Limit and Dispensing

inv-16: Juxtapid (lomitapide) — quantity limit

ProductJuxtapid (lomitapide)

Quantity limit30 capsules per 30 days

Billing noteProduct is covered under the pharmacy benefit; prior authorization required for non-preferred product

Allowed Site of Service

Note

Home permitted as site of service

Home is an allowed site of service for Juxtapid under the pharmacy benefit; products may be provided for use in the member’s home.

Site of service allowed: Home

Definitions and Clinical Terms

inv-12: HoFH — definition for Homozygous familial hypercholesterolemia (clinical and genetic criteria)

Clinical definitionHomozygous familial hypercholesterolemia (HoFH): clinical diagnosis confirmed by genetic testing OR very high LDL-C with supporting clinical/family features (see criteria)

Genetic confirmationDiagnosis confirmed by genetic testing

LDL-C with clinical featuresLDL-C > 500 mg/dL untreated or LDL-C > 300 mg/dL if treated (excluding PCSK9 inhibitors) plus either: xanthoma before age 10 OR evidence of HeFH in both parents

Additional requirementsBaseline cholesterol labs within 90 days required for documentation

Clinical Background

Homozygous familial hypercholesterolemia (HoFH) is a rare genetic disorder characterized by markedly elevated LDL-C levels and early onset, premature atherosclerotic cardiovascular disease; lomitapide (Juxtapid) is indicated as an adjunct lipid‑lowering therapy for adults with HoFH when other treatments are insufficient.

Policy Revision History

2021-12-21policy revision

Removed prescriber specialty requirement from the policy.

2020-07-22policy creationLatest

New policy for Juxtapid (lomitapide) was created.