CurrentUnitedHealthcarePolicy 2026 P 1053-14

Juxtapid (lomitapide) prior authorization

Prior authorization and notification requirements for Juxtapid (lomitapide) for members; governs initial and reauthorization coverage criteria and administrative rules for UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyJuxtapid (lomitapide) prior authorization

Policy CodePolicy 2026 P 1053-14

Change TypeClarified/Added/Revised

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain prior authorization; approvals (initial and reauthorization) are issued for 12 months when coverage criteria are met.

SourceLink

POLICY UPDATE CHANGES

Initial authorization period changed to 12 months.

Requirement for patient to be on a low-fat diet added to initial authorization in earlier change control and reflected in reauthorization.

P&T approval dates and annual review history updated through 2/2026.

12 monthsauthorization period

HoFHindication required

2/2013-2/2026P&T review range

Coverage Criteria for Juxtapid (lomitapide)

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inv-01: Initial Authorization

Covered when ALL of the following are met

Initial authorization criteria: Diagnosis of homozygous familial hypercholesterolemia (HoFH)

Authorization issued for 12 months

Initial authorization criteria: Patient is receiving other lipid-lowering therapy (e.g., statin, LDL apheresis)

Initial authorization criteria: Patient is on a low-fat diet

(requirement reflected in policy change control)

inv-02: Reauthorization

Covered when ALL of the following are met

Reauthorization criteria: Patient is on a low-fat diet

Reauthorization criteria: Patient is receiving other lipid-lowering therapy (e.g., statin, LDL apheresis)

Reauthorization criteria: Documentation of positive clinical response to Juxtapid therapy

Authorization issued for 12 months

Coverage for Juxtapid (lomitapide) is limited to patients with a diagnosis of homozygous familial hypercholesterolemia (HoFH). Prior authorization is required, and approvals are issued for 12 months when all coverage criteria are met. Initial therapy requires documentation that the member is receiving other lipid-lowering therapy (for example, a statin or LDL apheresis) and is on a low-fat diet; continuation requires ongoing low-fat diet adherence, continued other lipid-lowering therapy, and documentation of a positive clinical response.

Initial Therapy Requirements

inv-11: Initial Authorization

Covered when ALL of the following are met

Initial therapy: Diagnosis of homozygous familial hypercholesterolemia (HoFH)

Authorization issued for 12 months

Initial therapy: Patient is receiving other lipid-lowering therapy (e.g., statin, LDL apheresis)

Initial therapy: Patient is on a low-fat diet

(requirement added in policy change control)

Reauthorization / Continuation Requirements

inv-12: Reauthorization

Covered when ALL of the following are met

Continuation therapy: Patient must remain on a low-fat diet

Continuation therapy: Patient must continue other lipid-lowering therapy (e.g., statin, LDL apheresis)

Continuation therapy: Documentation of positive clinical response to Juxtapid therapy

Authorization period: 12 months

Provider Actions, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for Juxtapid (lomitapide). Approvals are issued for 12 months when criteria are met.

Initial and reauthorization approvals: 12 months

Note

Automated Approvals / Supply Limits

Not specified in policy: specific program-level automated approval triggers and exact supply limits. UnitedHealthcare may apply automated processes or program limits which are not detailed in this policy.

Automated approval processes and supply limits may vary by program/therapeutic class
State mandates, federal requirements, and member-specific benefit plans may further impact coverage

Documentation Required

Required Documentation for Reauthorization

Documentation of positive clinical response to Juxtapid is required for reauthorization. UnitedHealthcare may rely on prior claims/medication history, diagnosis codes (ICD-10), and previous documentation when making reauthorization decisions.

Reauthorization requires documentation of positive clinical response
UHC may approve initial or reauthorization based on prior claim/medication history and diagnosis codes

Denial Risk

Triggers for Denial

Denial may be triggered if the member does not meet all criteria (e.g., no documented HoFH diagnosis, not receiving other lipid‑lowering therapy, not on a low‑fat diet, or absence of documented positive clinical response).

No documentation of homozygous familial hypercholesterolemia (HoFH)
Not receiving other lipid‑lowering therapy (e.g., statin, LDL apheresis)
Not on a low‑fat diet as required
No documentation of positive clinical response to therapy

Background

Juxtapid (lomitapide) is a microsomal triglyceride transfer protein (MTP) inhibitor indicated as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis when available, to reduce LDL-C, total cholesterol, apolipoprotein B, and non-HDL-C in patients with HoFH. The effect on cardiovascular morbidity and mortality has not been determined.

Definitions

HoFH — definition / key concept

TermHomozygous familial hypercholesterolemia (HoFH)

DescriptionA genetic condition characterized by markedly elevated LDL-C and other lipids; Juxtapid (lomitapide) is indicated as an adjunct to a low-fat diet and other lipid-lowering treatments to reduce LDL-C, total cholesterol, apo B, and non‑HDL‑C in patients with HoFH.

Not indicated forPatients with hypercholesterolemia who do not have HoFH, including heterozygous familial hypercholesterolemia (HeFH); safety and efficacy in these groups have not been established.

Clinical impactUse of Juxtapid in HoFH aims to lower LDL-C and related lipid parameters; effect on cardiovascular morbidity and mortality is unknown.

Revision History and Policy Changes

2026-05-01effective_dateLatest

Policy effective date reflecting operational alignment with prior decisions and authorization period set to 12 months.

2024-02policy_change

Initial authorization period changed to 12 months (documented in change control).

2014-02policy_change

Added requirement for patient to be on a low-fat diet to initial authorization; reauthorization criteria updated to require low-fat diet and other lipid-lowering therapy.

2013-02policy_creation

Policy/program created (new prior authorization/notification program for Juxtapid).

Policy Summary

PayerUnitedHealthcare

PolicyJuxtapid (lomitapide) prior authorization

Policy CodePolicy 2026 P 1053-14

Change TypeClarified/Added/Revised

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain prior authorization; approvals (initial and reauthorization) are issued for 12 months when coverage criteria are met.

SourceLink

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