CurrentViva HealthPolicy IC-0268

Empliciti (elotuzumab) (Intravenous) — Prior Authorization Coverage Criteria

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Prior authorization policy for Empliciti (elotuzumab) IV for treatment of multiple myeloma and related plasma cell disorders for Viva Health members; defines dosing limits, initial and renewal criteria, administration, and applicable diagnosis codes.

Policy Summary

PayerViva Health

PolicyEmpliciti (elotuzumab) (Intravenous) — Prior Authorization Coverage Criteria

Policy CodePolicy IC-0268

Change TypeNo material change

Effective Date

Last ReviewMay 5, 2026

Next Review DateMay 5, 2026

Key ActionObtain prior authorization for Empliciti; initial approvals are for 6 months and may be renewed every 6 months if criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial prior authorization length

J9176

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CurrentViva HealthPolicy IC-0268

Empliciti (elotuzumab) (Intravenous) — Prior Authorization Coverage Criteria

Customize your policy alerts

Sign up for Viva Health Policy IC-0268 alerts

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Policy Summary

PayerViva Health

PolicyEmpliciti (elotuzumab) (Intravenous) — Prior Authorization Coverage Criteria

Policy CodePolicy IC-0268

Change TypeNo material change

Effective Date

Last ReviewMay 5, 2026

Next Review DateMay 5, 2026

Key ActionObtain prior authorization for Empliciti; initial approvals are for 6 months and may be renewed every 6 months if criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial prior authorization length

J9176

Coverage Criteria for Empliciti (elotuzumab)

Initial Therapy Criteria

Covered when ALL of the following are met

Age: Member is at least 18 years of age>=18 years

Diagnosis and treatment setting: Member has previously treated relapsed or progressive disease

Applies to multiple myeloma and may also apply to POEMS, MIDD, and MGRS

Regimen-specific combination therapy

Lenalidomide regimen: Elotuzumab used in combination with lenalidomide and dexamethasone
Pomalidomide regimen (reserved): Elotuzumab used in combination with pomalidomide and dexamethasone after at least two prior therapies including lenalidomide and a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib)
Regimen reserved for patients with prior exposure to ≥2 therapies including lenalidomide and a proteasome inhibitor
Bortezomib regimen: Elotuzumab used in combination with bortezomib and dexamethasone

Renewal Therapy Criteria

Renewal coverage requires ALL of the following

Continuation of indication-specific criteria: Member continues to meet the indication-specific relevant criteria such as concomitant therapy requirements and performance status (does not include prerequisite therapy)

See initial criteria for regimen- and indication-specific requirements

Disease response: Documented disease response defined as stabilization of disease or decrease in size of tumor or tumor spread

Toxicity: Absence of unacceptable toxicity from elotuzumab (examples: severe infusion reactions, infections, second primary malignancies, hepatotoxicity)

Renewal may be denied for unacceptable toxicity

This policy is limited to use of elotuzumab (Empliciti) for previously treated, relapsed or progressive disease and does not provide coverage for primary prophylactic use or frontline-only indications. Coverage is specific to the combination regimens listed under the multiple myeloma and related plasma-cell disorder indications and requires that the member meet the regimen-specific criteria (see covered regimens and authorization requirements).

Approved Dosing Regimens and Administration

Regimen	Indication	Coverage
10 mg/kg IV weekly for first two 28-day cycles (Days 1, 8, 15, & 22) — 8 doses; then every 2 weeks (Days 1 & 15) beginning with cycle 3; continue until disease progression or unacceptable toxicity.
Relapsed or progressive multiple myeloma in combination with lenalidomide and dexamethasone.
Covered with criteria

Regimen	Indication / Prerequisite	Coverage
10 mg/kg IV weekly for first two 28-day cycles (Days 1, 8, 15, & 22) — 8 doses; then 20 mg/kg every 4 weeks (Day 1) beginning with cycle 3; continue until disease progression or unacceptable toxicity.
Relapsed or progressive multiple myeloma in combination with pomalidomide and dexamethasone. Reserved for use after at least two prior therapies including lenalidomide and a proteasome inhibitor.
Covered with criteria

Regimen	Indication	Coverage
10 mg/kg IV weekly for first two 21-day cycles (Days 1, 8 & 15) — 6 doses; then Days 1 & 11 for the next six 21-day cycles (cycles 3–8; 12 doses); then every 2 weeks (Days 1 & 15) per 28-day cycle beginning with cycle 9; continue until disease progression or unacceptable toxicity.
Relapsed or progressive multiple myeloma in combination with bortezomib and dexamethasone.
Covered with criteria

Billing and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J9176

Injection, elotuzumab, 1 mg

NDCsNDC

00003-2291-xx	Empliciti 300 mg single-dose vial
00003-4522-xx	Empliciti 400 mg single-dose vial

Covered ICD-10 Diagnosis CodesICD-10Covered

C90.00	Multiple myeloma not having achieved remission
C90.02	Multiple myeloma, in relapse
C90.10	Plasma cell leukemia not having achieved remission
C90.12	Plasma cell leukemia in relapse
C90.20	Extramedullary plasmacytoma not having achieved remission
C90.22	Extramedullary plasmacytoma in relapse
C90.30	Solitary plasmacytoma not having achieved remission
C90.32	Solitary plasmacytoma in relapse
Z85.79	Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues

Provider Requirements and Documentation

Prior Authorization

Obtain prior authorization; approvals issued for 6-month intervals

Prior authorization is required for Empliciti (elotuzumab) IV. Initial approvals are provided for 6 months (180 days) and may be renewed every 6 months. Member must be at least 18 years of age and meet regimen-specific criteria for previously treated relapsed or progressive disease.

Initial authorization length: 6 months (180 days).
Renewals may be granted in 6-month (180 day) increments.
Member age requirement: ≥ 18 years.

Step Therapy

Confirm prerequisite therapies for pomalidomide-containing regimen

Some covered regimens require prior exposure to specific therapies before approval; notably, the pomalidomide + dexamethasone combination requires at least two prior therapies including lenalidomide and a proteasome inhibitor.

Pomalidomide combination: reserved for use after at least two prior therapies including lenalidomide and a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib).

Line of Therapy Definitions

Second-line

Regimen-specific line: Used for previously treated relapsed or progressive disease in combination regimens; pomalidomide combination specified after at least two prior therapies

Indicates use in relapse (second-line) setting

Key Definitions

Previously treated relapsed or progressive multiple myeloma — Relapsed or progressive disease

DefinitionPreviously treated relapsed or progressive disease (multiple myeloma): patient has disease that has recurred or progressed after prior therapy.

Permitted combination regimensUse in combination with lenalidomide and dexamethasone.

Permitted combination regimens (reserved)Use in combination with pomalidomide and dexamethasone after at least two prior therapies including lenalidomide and a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib).

Permitted combination regimensUse in combination with bortezomib and dexamethasone.

Related indicationsRegimens may also apply to POEMS, MIDD, and MGRS (plasma cell–related disorders).

Background

Elotuzumab (Empliciti) is an anti-SLAMF7 monoclonal antibody used in combination with other agents for the treatment of relapsed or progressive multiple myeloma. The policy references FDA-approved and compendia-recommended combination regimens and expects treatment to continue until disease progression or unacceptable toxicity. Applicable regimens in this policy may also be used for related plasma cell disorders such as POEMS, MIDD, and MGRS.