CurrentCentenePolicy HIM.PA.166

Evinacumab-dgnb (Evkeeza) (PDF)

Defines medical necessity criteria, prior authorization requirements, dosing limits, approval durations, and exclusions for Evkeeza (evinacumab-dgnb) for treatment of HoFH for Centene-affiliated health plans (except CA Commercial Exchange).

Policy Summary

PayerCentene

PolicyEvinacumab-dgnb (Evkeeza) (PDF)

Policy CodePolicy HIM.PA.166

Change TypeRevised (annual reviews and RT4 updates)

Effective Date03.01.23

Next Review Date

Key ActionProvider must submit documentation (office chart notes, labs, other clinical information) supporting that member meets all approval criteria, including weight in kg and recent LDL-C values.

SourceLink

POLICY UPDATE CHANGES

1Q 2026 annual review revised step therapy to require use in conjunction with at least one LDL lowering therapy for IL HIM per IL HB 5395; reduced statin adherence duration from 4 months to 8 weeks; simplified statin trial and failure criteria; extended initial approval duration from 6 months to 12 months.

RT4 updated FDA pediatric extension from ≥5 years to ≥1 year for HoFH.

1Q 2025 annual review lowered untreated LDL requirement to 400 mg/dL and revised parental FH evidence to at least one parent; modified Repatha redirection to apply only to age ≥10 years.

Policy created/adapted from CP.PHAR.511; prior updates lowered LDL requirement to 55 mg/dL for very high risk ASCVD and updated drug-specific HCPCS code.

1FDA-approved indication (HoFH)

15 mg/kg q4wMaximum dosing

12 monthsApproval duration

Coverage Summary

Coverage stance: covered_with_criteria for evinacumab-dgnb (Evkeeza) for the FDA‑approved indication of Homozygous Familial Hypercholesterolemia (HoFH). Evkeeza is indicated as an adjunct to diet, exercise, and other LDL‑C lowering therapies for adults and pediatric patients aged ≥ 1 year with HoFH per FDA labeling. The policy defines LDL‑C thresholds and treatment‑response thresholds to qualify for coverage, including treated LDL‑C ≥ 300 mg/dL (or non‑HDL‑C ≥ 330 mg/dL), untreated LDL‑C ≥ 400 mg/dL with supporting clinical features, pediatric LDL‑C ≥ 130 mg/dL (age 1 to <18) despite statin and ezetimibe, and adult LDL‑C ≥ 70 mg/dL (or ≥ 55 mg/dL if ASCVD at very high risk). Coverage excludes California Commercial Exchange plans.

Quick facts & thresholds

Treated LDL-C (adult HoFH)≥ 300 mg/dL

Treated non-HDL-C (adult HoFH)≥ 330 mg/dL

Untreated LDL-C≥ 400 mg/dL

Pediatric LDL-C (age 1–<18)≥ 130 mg/dL within last 60 days despite statin and ezetimibe

Adult LDL-C (age ≥18)≥ 70 mg/dL (or ≥ 55 mg/dL if ASCVD very high risk)

Maximum dose15 mg/kg every 4 weeks

Approval duration12 months

HCPCS codeJ1305 (Injection, evinacumab-dgnb, 5 mg)

Initial Therapy Criteria — Homozygous Familial Hypercholesterolemia

Initial Therapy Criteria — Other Indications

Initial Approval Criteria - Other Diagnoses/Indications

If initial request is for other indications:

ANY of the following

ALL of the following
- For drugs on the formulary or PDL, see HIM.PA.33 for health insurance marketplace (formulary/no coverage)
- For drugs NOT on the formulary or PDL, see HIM.PA.103 for health insurance marketplace (non-formulary)
If the requested use is NOT listed under section III and criterion 1 does not apply, refer to the off-label use policy HIM.PA.154

Continuation (Renewal) Criteria — Homozygous Familial Hypercholesterolemia

Continuation (Renewal) Criteria - Homozygous Familial Hypercholesterolemia

Covered when ALL of the following are met:

ALL of the following

ANY of the following
- Member is currently receiving medication via Centene benefit or previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations
  Refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B
If statin tolerant, documentation of adherence to a statin at the maximally tolerated dose
For Illinois HIM requests, the step therapy requirements do not apply per IL HB 5395

Not Authorized / Exclusions

Not Authorized Indications

Coverage NOT authorized for:

ALL of the following

Non-FDA approved indications not addressed in this policy unless sufficient documentation per off-label use policy HIM.PA.154 or evidence of coverage documents

Applicable Codes

HCPCS - drug-specificHCPCSCovered

J1305

Injection, evinacumab-dgnb, 5 mg

Provider Actions & Prior Authorization Requirements

Prior Authorization

Documentation required for prior authorization

Providers must submit office chart notes, laboratory results, and other clinical information demonstrating that the member meets all approval criteria. Required documentation should include the member's current weight in kilograms and recent LDL-C values.

J1305

Prior Authorization

Specialist prescription requirement

Evkeeza must be prescribed by or in consultation with a cardiologist, endocrinologist, or lipid specialist.

Clinical Evidence & Background

Background: Evkeeza (evinacumab‑dgnb) is a human monoclonal antibody targeting ANGPTL3 indicated to reduce LDL‑C as an adjunct to diet, exercise, and other LDL‑C lowering therapies in adults and pediatric patients aged ≥ 1 year with HoFH per FDA labeling. Key clinical evidence includes the ELIPSE HoFH pivotal study demonstrating efficacy in HoFH, and guideline influence from the 2022 ACC expert consensus decision pathway, which informed LDL‑C threshold adjustments incorporated into the policy. The product is dosed at 15 mg/kg IV every 4 weeks and uses HCPCS code J1305.

Key definitions

HoFH (term)Homozygous familial hypercholesterolemia

LDL-C (term)Low‑density lipoprotein cholesterol

SAMS (term)Statin‑associated muscle symptoms (clinical muscle pain/weakness related to statin; resolves with discontinuation and may recur on rechallenge)

ASCVD very high risk (term)History of multiple major ASCVD events OR 1 major event plus multiple high‑risk conditions (see Appendix H for specific events/conditions)

Revision History

1Q2026 (P&T 02.26)annual_reviewLatest

1Q 2026 annual review revised step therapy to require Evkeeza be used in conjunction with at least one LDL‑lowering therapy for Illinois HIM per IL HB 5395; reduced statin adherence duration from 4 months to 8 weeks and simplified statin trial/failure criteria for moderate/low‑intensity regimens (insufficient response to one high‑intensity statin for 8 weeks or reversible muscle‑related symptoms with both rosuvastatin and atorvastatin); extended initial approval duration from 6 months to 12 months; references reviewed and updated.

09.30.25 (RT4) / reflected earlier 03.28.23pediatric_age_alignment

Pediatric age eligibility aligned to FDA approvals: RT4 updated FDA pediatric extension from ≥5 years to ≥1 year for HoFH (09.30.25; earlier RT4 update reflected 03.28.23).

Policy Summary

PayerCentene

PolicyEvinacumab-dgnb (Evkeeza) (PDF)

Policy CodePolicy HIM.PA.166

Change TypeRevised (annual reviews and RT4 updates)

Effective Date03.01.23

Next Review Date

Key ActionProvider must submit documentation (office chart notes, labs, other clinical information) supporting that member meets all approval criteria, including weight in kg and recent LDL-C values.

SourceLink

On This Page

Member is responding positively to therapy as evidenced by lab results within the last 3 months showing an LDL-C reduction since initiation of Evkeeza therapy

Documentation of member's current weight in kg

If request is for a dose increase, new dose does not exceed 15 mg/kg every 4 weeks

Documentation Required

Evidence of response for renewal

For renewal (continuation) requests, provide laboratory results from within the last 3 months that demonstrate an LDL-C reduction since initiation of Evkeeza therapy.

Billing Rule

Dose limit

Dose must not exceed 15 mg/kg every 4 weeks. Use the drug-specific HCPCS code for billing as applicable.

J1305

Step Therapy

Prior therapy requirements

Prior therapy requirements include trials of statin and ezetimibe (with specified adherence/trial durations) and, for patients age ≥10 years, an 8-week trial of Repatha unless contraindicated. Requirements vary for Illinois HIM requests per IL HB 5395 — some step therapy requirements do not apply; Evkeeza may also need to be prescribed in conjunction with at least one LDL-C–lowering therapy for Illinois HIM.

1Q2025 (P&T 02.25)annual_review

1Q 2025 annual review lowered untreated LDL requirement to 400 mg/dL and revised evidence of familial hypercholesterolemia to require evidence in at least one parent; modified Repatha redirection to apply only to age ≥10 years; references reviewed and updated.

11.09.22 (creation) and subsequent historical editspolicy_creation_and_history

Policy created/adapted from CP.PHAR.511 (11.09.22); per 2022 ACC expert consensus pathway, lowered minimum LDL requirement to 55 mg/dL for very high risk ASCVD, added Appendix H, and updated drug‑specific HCPCS code (J1305); references reviewed and updated.