CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Drug Policy: Empliciti (elotuzumab) — Coverage Criteria

Defines accepted indications, continuation and exclusion criteria, and utilization management processes for Empliciti (elotuzumab) for members; applies to UM processing of medication requests for covered populations.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDrug Policy: Empliciti (elotuzumab) — Coverage Criteria

Policy CodePolicy N/A

Change TypeAdministrative — no material clinical or coverage changes

Effective DateNovember 29, 2024

Next Review DateN/A

Key ActionSubmit prior authorization requests showing Empliciti will be used in specified combination regimens and include supporting evidence from FDA labeling, CMS compendia, or recognized oncology guidelines.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 (MM)primary covered indication

20 mg/kgmax dose

Multiplecommittee history

Coverage Criteria

inv-01: Initial therapy — Relapsed/Refractory Multiple Myeloma

Empliciti with lenalidomide regimen: Member has relapsed/refractory multiple myeloma AND request is for Empliciti in combination with Revlimid (lenalidomide), with or without dexamethasonemember has received 1-3 prior therapies

lenalidomide is specified as the immunomodulatory agent unless intolerance/contraindication

Empliciti with pomalidomide regimen: Member has relapsed/refractory multiple myeloma AND request is for Empliciti in combination with Pomalyst (pomalidomide), with or without dexamethasonemember has received at least 2 prior regimens including an immunomodulatory agent (eg, lenalidomide) and a proteasome inhibitor (eg, Velcade)

allows exceptions for intolerance/contraindication to specified agents

inv-02: Continuation therapy

Continuation therapy exemption when ALL of the following are met

Continuation exemption conditions: Requested medication used within the last year AND no disease progression AND no intolerance AND no additional medications are being added to the continuation request

Continuation requests for a not-approvable medication shall be exempt if these conditions are met

Coverage is contingent on clinical appropriateness and adherence to the policy requirements. Requests will be denied when there is disease progression while receiving an Empliciti-containing regimen, or when dosing exceeds the stated maximum. Empliciti used for indications that are investigational or off-label without sufficient supportive evidence — i.e., not supported by CMS-recognized compendia or acceptable peer-reviewed literature — will also be excluded. The policy defines sufficient evidence by factors such as representativeness of the patient and regimen in published studies, clinically meaningful outcome measures (for example ASCO-recommended thresholds), and the overall quality and design of the supporting clinical data.

Initial Therapy — Multiple Myeloma

inv-11: Initial therapy — Multiple Myeloma

Initial authorization criteria for multiple myeloma

Empliciti + lenalidomide: Use in combination with lenalidomide ± dexamethasone for relapsed/refractory multiple myeloma in members who have received 1-3 prior therapies1-3 prior therapies

lenalidomide specified unless intolerance/contraindication

Empliciti + pomalidomide: Use in combination with pomalidomide ± dexamethasone for relapsed/refractory multiple myeloma in members who have received at least 2 prior regimens including an immunomodulatory agent (eg, lenalidomide) and a proteasome inhibitor (eg, Velcade)>=2 prior regimens

allows exceptions for intolerance/contraindication

Continuation Criteria

inv-12: Continuation exemption

Continuation requests may be exempt from standard policy review if all listed conditions are met.

Continuation exemption: Medication used within last year AND no disease progression/intolerance AND no additional meds added

Exempts continuation requests for a not-approvable medication

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Empliciti (elotuzumab) may be authorized for relapsed/refractory multiple myeloma only when used in an approved combination and supported by appropriate evidence sources (FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature).

Authorized combinations: lenalidomide (Revlimid) ± dexamethasone for members who have received 1–3 prior therapies; pomalidomide (Pomalyst) ± dexamethasone for members who have received ≥2 prior regimens including an immunomodulatory agent (e.g., lenalidomide unless intolerance/contraindication) and a proteasome inhibitor (e.g., bortezomib/Velcade unless intolerance/contraindication).
Use must be supported by FDA labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature meeting CMS Medicare B evidentiary standards.

Denial Risk

Triggers for Denial / Exclusion

Requests that meet any of the following will be denied or excluded.

Disease progression while receiving an Empliciti‑containing regimen.
Use exceeding the maximum dose of 20 mg/kg.
Investigational or off‑label uses lacking sufficient evidence or not generally accepted by the medical community (e.g., not supported by CMS compendia or acceptable peer‑reviewed literature). Insufficiency includes inadequate representation of patient/cancer characteristics, regimen, or clinically meaningful outcomes; reliance on uncontrolled case reports or abstracts without full peer‑reviewed publication.

Documentation Required

Supporting Evidence and Documentation Requirements

Support for any request must align with the policy purpose: treatment indication and evidence requirements. Evolent (on behalf of the payer) will process medication requests and may deem medications not authorized as not approvable and not reimbursable.

Documentation should reference relevant FDA labeling, CMS‑recognized compendia, NCCN/ASCO guideline citations, or full peer‑reviewed articles that meet CMS evidence standards.
When an off‑label request is submitted, include full supporting literature demonstrating applicability to the member (patient characteristics, regimen, and clinically meaningful outcomes).

Coding and Dosing Limits

inv-04: Maximum dose — 20 mg/kg

Maximum recommended doseDo not exceed 20 mg/kg.

ContextListed as an exclusion criterion — requests exceeding this dose may be denied.

Related policy language"The maximum dose should not exceed 20 mg/kg." (Exclusion criteria)

Step Therapy Requirements

Step	Requirement
1	Empliciti (elotuzumab) must be used in combination with Revlimid (lenalidomide), with or without dexamethasone, for members with relapsed/refractory multiple myeloma who have received 1–3 prior therapies.
2	Empliciti (elotuzumab) must be used in combination with Pomalyst (pomalidomide), with or without dexamethasone, for members with relapsed/refractory multiple myeloma who have received at least 2 prior regimens including an immunomodulatory agent (specifically lenalidomide unless intolerance/contraindication) and a proteasome inhibitor (specifically Velcade unless intolerance/contraindication).

Definitions

inv-10: Continuation request exemption — Continuation requests may be exempt from this policy if the medication was used within the last year, there is no disease progression or ...

DefinitionContinuation requests for a not-approvable medication shall be exempt if the requested medication was used within the last year.

No disease progression/intoleranceMember has not experienced disease progression and/or no intolerance to the requested medication.

No changes to regimenAdditional medication(s) are not being added to the continuation request.

ScopeApplies to continuation requests for medications that would otherwise be not approvable under this policy.

Background

Empliciti (elotuzumab) is an immunotherapy used in relapsed/refractory multiple myeloma. This policy authorizes Empliciti only in specified combination regimens for multiple myeloma and includes criteria for initial and continuation use, exclusions, and utilization management requirements. Exclusions explicitly include disease progression on an Empliciti-containing regimen and a maximum dose of 20 mg/kg, and investigational or off-label uses lacking sufficient evidence are not accepted unless supported by recognized compendia or acceptable peer-reviewed literature.