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Horizon BCBSNJ
Uniform Medical Policy ManualSection:Radiology
Policy Number:185
Effective Date: 08/01/2020
Original Policy Date:08/01/2020
Last Review Date:
Date Published to Web: 08/01/2020
Subject:
Radiation Therapy - Xofigo®

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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Radium-223 (Xofigo®) is an alpha emitter that targets areas of increased bone turnover in osteoblastic or sclerotic metastases. Xofigo® is administered intravenously once a month for 6 months.

Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
    1. Radium-223 (Xofigo®) is medically necessary for the treatment of castration-resistant prostate cancer for a member with all of the following:
        1. Symptomatic skeletal (bone) metastases
        2. No evidence of visceral metastases or bulky regional lymph nodes greater than 3 cm on imaging performed within the past 30 days
        3. Who has received and exhausted all medical - or surgical-ablative hormonal treatments. The individual may be kept on his ablative hormonal treatment to maintain a castrate level in accordance with NCCN Guidelines®.
        4. Medically- or surgically-castration resistant prostate cancer, as defined by:
            1. a serum testosterone level of less than 50 ng/dl and either:
                1. Sequential rise of prostate specific antigen (PSA) levels OR
                2. Worsening of existing bone metastases or development of new bone metastases on a bone scan performed within the past 60 days despite androgen-deprivation treatment
    2. The combination of Xofigo® and gonadotropin-releasing hormone analogues, denosumab or zoledronic acid is considered medically necessary.
    3. The combination of Xofigo® and all other agents, including concurrent chemotherapy is considered investigational.


(Information to guide medical necessity determination based on the criteria contained within the policy statements above.)

Please be aware that a warning and precaution was identified by the company. Specifically, "Xofigo® is not recommended for use in combination with abiraterone acetate plus prednisone/prednisolone outside of clinical trials...At the primary analysis(of the phase 3 ERA=223 study that evaluated concurrent initiation of Xofigo® in combination with abiraterone acetate plus prednisone/prednisolone in 806 asymptomatic or mildly symptomatic mCRPC patients,) an increased incidence of fractures (28.6% vs 11.4%) and deaths (38.5% vs 35.5%) have been observed in patients who received Xofigo® in combination with abiraterone acetate plus prednisone/prednisolone compared to patients who received placebo in combination with abiraterone acetate plus prednisone/prednisolone. Safety and efficacy with the combination of Xofigo® and agents other than gonadotropin-releasing hormone analogues have not been established." (Bayer, 2018)..

[RATIONALE:
A phase III study examined patients with castration resistant prostate cancer with two or more bone metastases and no visceral metastases and randomized them to Radium-223 or matching placebo. It found improved overall survival (OS) for patients who received Radium-223 with a survival of 14.9 months vs. 11.3 months (p < 0.001) in those who received best standard of care. The targeted nature of Radium-2223 with alpha particles of short range minimizes myelosuppression and has limited effects on the normal tissue. Based on these results, Radium-223 is medically necessary for the treatment of castration resistant prostate cancer with bone metastases but no visceral metastases and is administered intravenously once a month for 6 months.]

Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.

FIDE SNP:

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

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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:
Radiation Therapy - Xofigo®
Xofigo®
Prostate Cancer - castration resistant
Castration resistant prostate Cancer
Radium-223
Xofigo

References:

    1. Hoskin P, Sartor O, O'Sullivan JM, et al. Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomized, double-blind, phase 3 ALSYMPCA trial. Lancet Oncol. 2014 Nov; 15(12):1397-1406.
    2. Parker C, Nilsson S, Heinrich D, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013 Jul 18; 369(3):213-223.
    3. Vapiwala N, Glatstein E. Fighting prostate cancer with Radium-223--not your madame's isotope. N Engl J Med. 2013 Jul 18; 369(3):276-278.
    4. Xofigo® Full Prescribing Information. Whippany, NJ. Bayer HealthCare Pharmaceuticals Inc. 8/2018.
    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

* 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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