CurrentAnthemPolicy CC-0235

Revcovi (elapegademase-lvlr) — enzyme replacement therapy for ADA‑SCID

Clinical criteria governing prior authorization and medical necessity for Revcovi (elapegademase-lvlr) as enzyme replacement therapy for adenosine deaminase severe combined immunodeficiency (ADA‑SCID); affects providers requesting coverage under the member's medical benefit.

Policy Summary

PayerAnthem

PolicyRevcovi (elapegademase-lvlr) — enzyme replacement therapy for ADA‑SCID

Policy CodePolicy CC-0235

Change TypeCoding revisions

Effective Date

Next Review Date

Key ActionObtain prior authorization and provide diagnostic documentation demonstrating ADA‑SCID (genetic testing, positive newborn screen, or characteristic lab findings).

SourceLink

POLICY UPDATE CHANGES

Removed all diagnosis pend and added ICD-10-CM D81.31 to coding.

Added HCPCS codes J3590 and C9399 for Revcovi (hospital outpatient use only).

1Covered ERT agent

D81.31ICD‑10 specified

J3590,C9399HCPCS listed

03/20/2025Last review

Coverage Criteria for Revcovi (elapegademase-lvlr)

Initial Therapy

Initial requests for Revcovi may be approved when ALL of the following are met:

Initial approval: I. Individual has a diagnosis of adenosine deaminase deficient severe combined immunodeficiency (ADA‑SCID); AND II. Documentation is provided that diagnosis is demonstrated by any of the following: A. Genetic testing revealing biallelic mutations in the ADA1 gene; OR B. Positive newborn screening via T cell receptor excision circles (TRECs); OR C. Characteristic laboratory findings including but not limited to decreased or absent ADA activity and increase in erythrocyte deoxyadenosine nucleotide (dATP/dAXP) levels; AND III. Revcovi will be used only until definitive therapy with hematopoietic stem cell transplantation (HSCT); OR IV. Individual is not a suitable candidate for HSCT (including but not limited to matched sibling or family donor not available); OR V. Individual has failed HSCT (Grunebaum 2023).

Prescriber must document diagnostic proof and intended use relative to HSCT.

Continuation Therapy

Continuation requests may be approved when the following is met:

Continuation approval:

Policy Summary

PayerAnthem

PolicyRevcovi (elapegademase-lvlr) — enzyme replacement therapy for ADA‑SCID

Policy CodePolicy CC-0235

Change TypeCoding revisions

Effective Date

Next Review Date

Key ActionObtain prior authorization and provide diagnostic documentation demonstrating ADA‑SCID (genetic testing, positive newborn screen, or characteristic lab findings).

SourceLink

On This Page

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Provider Requirements and Operational Guidance

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial requests will be approved only when diagnostic criteria for ADA‑SCID are met and planned use aligns with role relative to definitive therapy (see documentation and treatment-role callouts).

Affected product: Revcovi (elapegademase‑lvlr).

Note

Role Relative to Definitive Therapy

Revcovi is intended as enzyme replacement therapy to provide a bridge to definitive therapy. Use is appropriate only until hematopoietic stem cell transplantation (HSCT) is performed, when the individual is not a suitable HSCT candidate, or when HSCT has failed.

Documentation Required

Diagnostic Documentation Required

Documentation must demonstrate the diagnosis of ADA‑SCID by one of the following: (A) genetic testing showing biallelic ADA1 mutations; OR (B) positive newborn screening via T‑cell receptor excision circles (TRECs); OR (C) characteristic laboratory findings such as decreased or absent ADA activity and elevated erythrocyte deoxyadenosine nucleotide (dATP/dAXP) levels. Include supporting clinical data (e.g., plasma ADA activity, dAXP levels, total lymphocyte counts, immune function tests) and rationale for continued ERT when submitting continuation requests.

Genetic testing report showing biallelic ADA1 mutations.
Newborn screening results with abnormal TRECs.
Laboratory reports showing low/absent ADA activity and increased dATP/dAXP.
Clinical monitoring data for continuation requests (plasma ADA activity, dAXP, lymphocyte counts, immune function).

Denial Risk

Denial Triggers

Requests may be denied if the individual has severe thrombocytopenia (IM administration contraindication) or when required diagnostic or clinical criteria are not met.

Definitions

ADA deficiency — Adenosine deaminase deficiency (ADA deficiency)

TermAdenosine deaminase deficiency (ADA deficiency)

PathophysiologyInherited absence or very low ADA activity leading to accumulation of adenosine substrates and toxic deoxyadenosine nucleotides (e.g., elevated erythrocyte dATP/dAXP)

Typical clinical presentationSevere combined immunodeficiency (SCID) with dysfunction of T, B, and NK cells that typically presents in the first few months of life

Diagnostic methodsNewborn screening (TRECs), genetic testing demonstrating biallelic ADA1 mutations, or laboratory findings including absent/very low ADA activity and increased dATP/dAXP

Key laboratory findingsAbsent or very low ADA activity in lysed erythrocytes or dried blood spots; marked increase in erythrocyte dATP (dAXP); decreased erythrocyte ATP

Revcovi (elapegademase-lvlr) — Enzyme replacement therapy

AgentRevcovi (elapegademase-lvlr)

MechanismRecombinant adenosine deaminase enzyme replacement therapy administered intramuscularly to replace deficient ADA activity

Indications within policyUsed as ERT for ADA‑SCID as a bridge to hematopoietic stem cell transplantation (HSCT), for patients not candidates for HSCT, or after failed HSCT

Key safety considerationShould not be used in patients with severe thrombocytopenia (intramuscular administration)

Clinical monitoringClose clinical monitoring required; declining immunity may occur due to disease progression, poor compliance, or neutralizing antibodies

OpenPayer

Revcovi (elapegademase-lvlr) — enzyme replacement therapy for ADA‑SCID

Coverage Criteria for Revcovi (elapegademase-lvlr)

Billing and Diagnosis Codes

Provider Requirements and Operational Guidance

Clinical Background

Definitions

J3590	Unclassified biologics (When specified as [Revcovi] (elapegademase-lvlr))
C9399	Unclassified drugs or biologicals (When specified as [Revcovi] (elapegademase-lvlr)) (Hospital Outpatient Use ONLY)