CurrentBlue Cross Blue Shield - IowaPolicy 05.04.36

Wellmark Blue Cross and Blue Shield Evkeeza Policy

Defines prior authorization, medical necessity criteria, dosing limits, documentation requirements, continuation criteria, billing code, and quantity limits for Evkeeza as adjunct LDL-C lowering therapy for patients with HoFH age ≥1 year.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyWellmark Blue Cross and Blue Shield Evkeeza Policy

Policy CodePolicy 05.04.36

Change TypeRevised (Oct 2025)

Effective DateDec 19, 2025

Next Review Date

Key ActionSubmit prior authorization with untreated baseline LDL, LDL levels while on statin therapy, current LDL (within 90 days), records confirming maximally tolerated lipid therapy, HoFH documentation, and statin intolerance/contraindication if applicable.

SourceLink

POLICY UPDATE CHANGES

Policy reviewed and revised October 2025 with current effective date December 19, 2025.

1FDA Indication (HoFH age ≥1 year)

15 mg/kg q4wMaximum Dosing Frequency

12 monthsApproval Duration

J1305Billing Code

Evkeeza (evinacumab-dgnb) is an ANGPTL3 inhibitor indicated as adjunct LDL-C lowering therapy for adult and pediatric patients aged 1 year and older with homozygous familial hypercholesterolemia (HoFH). The policy aligns coverage with FDA labeling and trial evidence, recognizing benefit demonstrated in the ELIPSE phase 3 trial versus placebo. The coverage stance is: Covered with criteria (prior authorization and medical necessity criteria apply).

Safety highlights: Evkeeza is associated with risk of serious hypersensitivity reactions (including anaphylaxis in clinical trials) and has potential to cause fetal harm; it is contraindicated in patients with a history of serious hypersensitivity to evinacumab-dgnb. (Policy reviewed October 2025; current effective date December 19, 2025.)

Key thresholds and stats

Dose limit≤ 15 mg/kg every 4 weeks

Approval duration12 months

Treatment goalsLDL-C ≤ 100 mg/dL (or ≤ 70 mg/dL if clinical ASCVD)

LDL-C documentation timingCurrent LDL-C must be documented within 90 days of prior authorization request

Billing codeJ1305 (Injection, evinacumab-dgnb (Evkeeza), 5 mg)

OpenPayer

Wellmark Blue Cross and Blue Shield Evkeeza Policy

Coverage Summary