CurrentUnitedHealthcarePolicy 1 = 2025 P 3064-13

Step therapy for Juxtapid (lomitapide)

Defines UnitedHealthcare's step therapy requirements for coverage of Juxtapid (lomitapide) for patients with homozygous familial hypercholesterolemia (HoFH) and notes continuity rules for current users; affects providers submitting prior authorization requests for Juxtapid.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy for Juxtapid (lomitapide)

Policy CodePolicy 1 = 2025 P 3064-13

Change TypeNo material change

Effective Date10/1/2025

Next Review Date

Key ActionObtain prior authorization with documented failure, contraindication, or intolerance to both Repatha (evolocumab) and Evkeeza (evinacumab).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period for Juxtapid

Repatha, Evkeezarequired step agents before Juxtapid

HoFHindication targeted by program

Step Therapyprogram classification

Coverage Criteria for Juxtapid (lomitapide)

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.

Juxtapid coverage criteria

Covered when ANY one of the following sets of conditions is met:

Pathway A — Initial therapy: Both of the following: (1) History of failure, contraindication, or intolerance to Repatha (evolocumab); AND (2) History of failure, contraindication, or intolerance to Evkeeza (evinacumab).

Pathway B1 — Continuation (current user without manufacturer sample): Patient is currently on Juxtapid therapy AND patient has not received a manufacturer supplied sample or a 30-day free trial to establish current use.

Pathway B2 — Continuation (current user with manufacturer sample): Patient is currently on Juxtapid therapy AND all of the following: (i) Patient has received a manufacturer supplied sample or 30-day free trial to establish current use; AND (ii) History of failure, contraindication, or intolerance to Repatha (evolocumab); AND (iii) History of failure, contraindication, or intolerance to Evkeeza (evinacumab).

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Juxtapid (lomitapide) for treatment of Homozygous Familial Hypercholesterolemia (HoFH). Requests must include documentation that the member has a history of failure, contraindication, or intolerance to both Repatha (evolocumab) and Evkeeza (evinacumab) unless the request meets the criteria for an established/current Juxtapid user (see documentation requirements). Authorizations will be issued for up to 12 months.

Applies to Juxtapid (lomitapide) for HoFH
Authorization duration: up to 12 months

Step Therapy

Step Agents Required

Step therapy is required. Members must have documented failure, contraindication, or intolerance to both Repatha (evolocumab) and Evkeeza (evinacumab) prior to approval of Juxtapid for HoFH. Requests lacking this documented trial of both agents may be denied.

Required step agents: Repatha (evolocumab) and Evkeeza (evinacumab)
Documented trial = failure, contraindication, or intolerance

Documentation Required

Continuation and Established User Documentation

For continuation requests or for members already receiving Juxtapid, documentation must show the patient is currently on therapy. If the member’s status was established using a manufacturer‑supplied sample given in the prescriber’s office or a 30‑day free trial from a pharmacy, the request must also include additional documentation per below. If the current-user claim was NOT established solely by a free sample or 30‑day trial, standard continuity documentation that the patient is on therapy is sufficient.

Established user path: patient currently on Juxtapid therapy
If current use was established solely via manufacturer sample or 30‑day free trial, the prescriber must document receipt of the sample/trial and provide supporting clinical records
If sample/trial was used to establish current use, the patient still must have documented failure/contraindication/intolerance to Repatha and Evkeeza unless criterion A.b.(1) and A.b.(2)(a) are satisfied

Initial Therapy — Criteria for New Starts

Initial therapy

Initial coverage requirement for Juxtapid in HoFH

Initial therapy requirement: Documented history of failure, contraindication, or intolerance to Repatha (evolocumab) AND documented history of failure, contraindication, or intolerance to Evkeeza (evinacumab).

Prior authorization required

Continuation of Therapy

Continuation of therapy

Continuation rules for members already on Juxtapid

Continuation - without manufacturer sample: Patient currently on Juxtapid therapy AND patient has not received a manufacturer supplied sample or 30-day free trial as a means to establish current use.

Authorize for 12 months

Continuation - with manufacturer sample: Patient currently on Juxtapid therapy AND patient has received a manufacturer supplied sample or 30-day free trial to establish current use AND documented history of failure, contraindication, or intolerance to Repatha (evolocumab) AND documented history of failure, contraindication, or intolerance to Evkeeza (evinacumab).

Authorize for 12 months

Step Therapy Requirements

Step	Required prior agents	Coverage requirement
1	Repatha (evolocumab); Evkeeza (evinacumab)	Member must have documented history of failure, contraindication, or intolerance to both Repatha and Evkeeza before Juxtapid (lomitapide) will be approved for HoFH.
Continuation - current user without manufacturer sample	N/A (current Juxtapid user)	If patient is currently on Juxtapid and has not received a manufacturer‑supplied sample or a 30‑day free trial to establish current use, continuation may be authorized (authorization period: 12 months).
Continuation - current user with manufacturer sample	Repatha (evolocumab); Evkeeza (evinacumab)	If current Juxtapid use was established via a manufacturer‑supplied sample or 30‑day free trial, documentation must show history of failure, contraindication, or intolerance to both Repatha and Evkeeza for continuation (authorization period: 12 months).

Key Definitions

HoFH definition

TermHoFH (homozygous familial hypercholesterolemia)

DescriptionA severe genetic disorder causing markedly elevated LDL-C for which adjunct LDL‑C lowering therapies are indicated.

Therapies indicated as adjunct LDL‑C lowering agentsJuxtapid (lomitapide); Repatha (evolocumab); Evkeeza (evinacumab)

Age indications (referenced agents)Repatha: adults and pediatric patients ≥10 years; Evkeeza: adults and pediatric patients ≥5 years

Juxtapid mechanismMicrosomal triglyceride transfer protein (MTP) inhibitor used as adjunct to low‑fat diet and other lipid‑lowering treatments

Background

Homozygous familial hypercholesterolemia (HoFH) is a severe inherited disorder characterized by markedly elevated LDL-C. Juxtapid (lomitapide) is an adjunct lipid‑lowering therapy that inhibits microsomal triglyceride transfer protein (MTP) and is indicated for lowering LDL‑C in patients with HoFH. Prior authorization for Juxtapid requires documentation that step therapy requirements have been met; specifically, members must have documented failure, contraindication, or intolerance to the step agents Repatha (evolocumab) and Evkeeza (evinacumab) unless continuation criteria for current users apply. Authorizations, when approved, are issued for 12 months.