Subject:
Elotuzumab (Empliciti)
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Empliciti (elotuzumab) is a SLAMF7-directed immunostimulatory antibody indicated in combination with Revlimid (lenalidomide) and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies. The FDA granted breakthrough therapy designation for this indication.
The safety and efficacy of Empliciti were tested in a randomized, open-label clinical study of 646 participants whose multiple myeloma came back after, or did not respond to previous treatment. Those taking Empliciti plus Revlimid and dexamethasone experienced a delay in the amount of time before their disease worsened (19.4 months) compared to participants taking only Revlimid and dexamethasone (14.9 months). Additionally, 78.5 percent of those taking Empliciti with Revlimid and dexamethasone saw a complete or partial shrinkage of their tumors compared to 65.5 percent in those only taking Revlimid and dexamethasone.
The most common side effects of Empliciti include fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite and pneumonia.
Empliciti’s labeling contains warnings and precautions for the occurrence of second primary malignancies (SPM) which occurred in higher incidences in controlled clinical trials for patients with multiple myeloma. Additionally, patients should have their liver function monitored while on Empliciti and if hepatotoxicity occurs, discontinue treatment.
Policy:
(NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance)
The requirements of the Horizon BCBSNJ Elotuzumab (Empliciti) Program may require a precertification/prior authorization via MagellanRx Management. These requirements are member-specific: please verify member eligibility and requirements through the Horizon Provider Portal (www.horizonblue.com/provider). Ordering clinicians should request pre-certification from MagellanRx Management at ih.magellanrx.com or call 1-800-424-4508 (when applicable).
1. Empliciti (elotuzumab) is medically necessary for the treatment of multiple myeloma in members that meet ALL of the following criteria:
A. Member is 18 years of age or older, AND
B. Empliciti will be used in combination with lenalidomide and dexamethasone in patients who have received one to three prior therapies; OR
C. Empliciti will be used in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor; AND
D. The prescriber is a specialist in the area of the patient’s diagnosis (e.g. oncologist) or has consulted with a specialist in the area of the patient’s diagnosis
2. When Empliciti (elotuzumab) is medically necessary, therapy will be approved for 6 months based on FDA recommendations which are as follows:
A. When used in combination with lenalidomide and dexamethasone: Administer 10 mg/kg intravenously every week for the first two cycles and every 2 weeks thereafter until disease progression or unacceptable toxicity
B. When used in combination with pomalidomide and dexamethasone: Administer 10 mg/kg administered intravenously every week for the first two cycles and 20 mg/kg every 4 weeks thereafter until disease progression or unacceptable toxicity
C. Pre-medicate with dexamethasone, diphenhydramine, ranitidine, and acetaminophen prior to each infusion of Empliciti
D. Interrupt Empliciti for Grade 2 or higher infusion treactions and permanently discontinue for severe infusion reactions
E. Monitor liver function and if hepatotoxicity is suspected, permanently discontinue treatment.
3. Continued therapy with Empliciti (elotuzumab) will be approved every 12 months based on treatment response and absence of intolerable toxicity (i.e. hepatotoxicity, infusion reactions, clinically important infections, etc.)
4. Empliciti (elotuzumab) is considered medically necessary for off-label indications that have in effect a rating of ‘Category 1’ or ‘Category 2A’ in the current recommendations in the National Comprehensive Cancer Network (NCCN) compendium. Refer to National Comprehensive Cancer Network: Drugs and Biologics Compendium - [elotuzumab]. Available at: [https://www.nccn.org/professionals/drug_compendium/content/].
5. Empliciti (elotuzumab) for the treatment of other conditions/diseases is considered investigational.
Medicare Coverage
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage will follow the Horizon Policy. See generally: Local Coverage Article: Approved Drugs and Biologicals; Includes Cancer Chemotherapeutic Agents (A53049). Available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00024370
Medicaid Coverage
For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Elotuzumab (Empliciti)
Empliciti (Elotuzumab)
References:
1. Empliciti® [package insert]. Bristol-Myers Squibb. Princeton, NJ. November 2018.
2. FDA News Release: FDA approves Empliciti, a new immune-stimulating therapy to treat multiple myeloma. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm474684.htm
3. Lonial S, Dimopoulos M, Palumbo A, et al. Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma. N Engl J Med 2015; 373:621-631. August 13, 2015. DOI: 10.1056/NEJMoa1505654
4. ClinicalTrials.gov accessed 1 December 2015 at https://clinicaltrials.gov/ct2/results?term= elotuzumab=Search
5. Empliciti: Elotuzumab. National Comprehensive Cancer Network: Drugs and Biologics Compendium. 2020. Available at https://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=443428 [Accessed July 30, 2020]
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
J9176
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association..
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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