CurrentEmblemHealthPolicy N/A

Empliciti (elotuzumab) Policy

Policy defines accepted indications, continuation and exclusion criteria, and utilization management authority for Empliciti (elotuzumab) use in members, specifically for relapsed/refractory multiple myeloma in defined combinations and prior-therapy contexts. It also lists sources that support coverage decisions and general medication management reference to FDA labeling.

Policy Summary

PayerEmblemHealth

PolicyEmpliciti (elotuzumab) Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 29, 2024

Next Review Date

Key ActionEvolent (UM) must process all medication requests and requests must be supported by FDA labeling, CMS-approved compendia, NCCN/ASCO guidelines, or qualifying peer-reviewed literature.

POLICY UPDATE CHANGES

No material clinical/coverage changes

2Covered combination indications listed

1Exclusion: disease progression

20 mg/kgMaximum dose threshold

Coverage Summary

This policy stance is covered with criteria for Empliciti (elotuzumab). It defines accepted indications, continuation and exclusion criteria, and utilization management authority for Empliciti use in members. Covered, high‑level uses include treatment of relapsed/refractory multiple myeloma in the following combinations: (1) with Revlimid (lenalidomide), with or without dexamethasone, for members who have received 1–3 prior therapies; and (2) with Pomalyst (pomalidomide), with or without dexamethasone, for members who have received at least 2 prior regimens including an immunomodulatory agent (specifically lenalidomide unless intolerance/contraindication) and a proteasome inhibitor (specifically bortezomib/Velcade unless intolerance/contraindication). The policy purpose is to define accepted indications for Empliciti and require that medication requests be processed by the UM vendor (Evolent).

Initial Therapy Criteria

Covered Indications — Multiple Myeloma

Empliciti (elotuzumab) may be used in members with relapsed/refractory multiple myeloma in any one of the following combinations:

ANY of the following

In combination with Revlimid (lenalidomide), with or without dexamethasone, in members who have received 1-3 prior therapies
In combination with Pomalyst (pomalidomide), with or without dexamethasone, in members who have received at least 2 prior regimens including an immunomodulatory agent (specifically Revlimid unless intolerance/contraindication) and a proteasome inhibitor (specifically Velcade unless intolerance/contraindication)

Continuation Therapy Criteria

Continuation exemption

Continuation requests for a not-approvable medication shall be exempt provided ALL of the following are met:

ALL of the following

The requested medication was used within the last year
The member has not experienced disease progression and/or intolerance to the requested medication
Additional medication(s) are not being added to the continuation request

Prior Authorization

Continuation requests require UM review by Evolent

Continuation requests remain subject to utilization management review. Even when a continuation exemption may apply, Evolent (the UM vendor) is responsible for processing medication requests and must review continuation requests to confirm the criteria for exemption are met and to issue any required authorization.

Exclusion / Not Medically Necessary

Exclusion Criteria (Not Medically Necessary/Not Covered)

ANY of the following

Insufficient evidence defined by any of the following
- Whether the clinical characteristics of the patient and the cancer are adequately represented in the published evidence
- Whether the administered chemotherapy/biologic therapy/immune therapy/targeted therapy/other oncologic therapy regimen is adequately represented in the published evidence
- Whether the reported study outcomes represent clinically meaningful outcomes experienced by patients (generally ASCO definitions e.g., hazard ratio < 0.80 and recommended survival benefit for OS and PFS of at least 3 months)
- Whether the experimental design is appropriate to address the investigative question (acknowledging some studies may be non-randomized)
- Non-randomized clinical trials may be supportive if significant subject numbers are included
- Case reports are generally uncontrolled and anecdotal and do not provide adequate evidence
- Abstracts without full peer-reviewed articles lack adequate supporting clinical evidence
Investigational use of Empliciti with an off-label indication that is not sufficient in evidence or is not generally accepted by the medical community
Dose exceeds the maximum dose of 20 mg/kg20 mg/kg
Maximum dose should not exceed 20 mg/kg
Disease progression while receiving an Empliciti (elotuzumab) containing regimen

Requests for off‑label indications that lack sufficient supporting evidence as defined in this policy may be denied as investigational or not medically necessary. The policy defines sufficient evidence to include representation of the patient/cancer characteristics in published evidence, adequate representation of the specific regimen in published studies, clinically meaningful outcomes (generally ASCO definitions such as hazard ratio < 0.80 and recommended survival benefit for OS and PFS of at least 3 months), appropriate experimental design, and preference for substantive clinical trials over case reports or abstracts. Coverage decisions must be supported by FDA labeling, CMS‑recognized compendia, NCCN or ASCO guidelines, or peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Provider Actions / Utilization Management

Prior Authorization

Medication requests processed by Evolent

Medication requests must be processed by Evolent. Evolent is responsible for processing all medication requests from network ordering providers; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Documentation Required

Supportive evidence requirement

Supportive evidence must accompany Empliciti use. Acceptable sources include FDA-approved product labeling, CMS‑approved compendia, National Comprehensive Cancer Network (NCCN) guidelines, American Society of Clinical Oncology (ASCO) clinical guidelines, or peer‑reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Denial Risk

Denial for investigational/off-label with insufficient evidence

Requests for off‑label or investigational uses may be denied if supporting evidence is insufficient or not generally accepted. The policy ties investigational denials to Exclusion Criteria, including lack of adequate representation of patient/condition in published evidence, inadequate representation of the administered regimen, outcomes not clinically meaningful (ASCO standards), inappropriate experimental design, reliance on only case reports or abstracts, or otherwise inadequate peer‑reviewed support.

Operational note: the policy specifies a maximum dose threshold for Empliciti of 20 mg/kg. Dose exceedance beyond 20 mg/kg is listed as an exclusion criterion and may render the request not approvable.

Clinical Evidence

Key evidence sources referenced in the policy include the ELOQUENT‑3 trial (Dimopoulos et al., NEJM 2018), the ELOQUENT‑2 extended follow‑up analysis (Dimopoulos MA et al., Cancer 2018), and the Empliciti (elotuzumab) prescribing information (Bristol‑Myers Squibb 2022). Coverage decisions require support from these sources or equivalent evidence meeting the policy’s accepted standards (FDA labeling, CMS compendia, NCCN/ASCO guidelines, or CMS‑acceptable peer‑reviewed literature).

Policy Background & Definitions

Background / policy purpose: to define and describe the accepted indications for Empliciti (elotuzumab) and to require that all medication requests be processed by the UM vendor (Evolent). Medications not authorized by Evolent may be deemed not approvable and not reimbursable. The policy requires coverage support from FDA approved product labeling, CMS‑approved compendia, NCCN, ASCO clinical guidelines, or peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Definitions

Continuation request exemption (definition)A continuation for a not-approvable medication may be exempt if: the medication was used within the last year; the member has not experienced disease progression or intolerance to the medication; and no additional medications are being added to the continuation request.