Subject:
Strontium-89 Chloride (Metastron)
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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Strontium-89 Chloride for intravenous injection is marketed as Metastron by Medi-Physics, Inc. Metastron is indicated as an adjunct to and as an alternative to external beam radiotherapy for the palliation of pain from bone metastases secondary to prostatic carcinoma at the stage of hormone therapy failure. After injection, Strontium-89 Chloride is rapidly deposited in bone and selectively irradiates sites of primary and metastatic bone involvement with minimal irradiation of soft tissues distant from the bone lesions. It has been shown to provide relief of pain in cancer patients for bone metastasis. Following intravenous injection, soluble strontium compounds behave like their calcium analogs, clearing rapidly from the blood and selectively localizing in bone mineral. Uptake of strontium by bone occurs preferentially in sites of active osteogenesis; thus primary bone tumors and areas of metastatic involvement (blastic lesions) can accumulate significantly greater concentrations of strontium than surrounding normal bone. Strontium-89 Chloride is retained in metastatic bone lesions much longer than in normal bone, where turnover is about 14 days. In patients with extensive skeletal metastases, well over half of the injected dose is retained in the bones.
Policy:
(Note: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)
I. Strontium-89 Chloride (Metastron) is considered medically necessary for the relief of bone pain in members with painful skeletal metastases. The presence of bone metastases is confirmed prior to therapy. (e.g., bone metastases from breast cancer, liver cancer, prostate cancer, or any other cancer that metastasizes to the bone) in adult patients 18 years or older.
[INFORMATIONAL NOTE: Administration of Metastron may be an adjunct to any combination or single use of radiation therapy, chemotherapy and/or hormone therapy.]
II. When considered medically necessary, strontium-89 chloride (Metastron) will be approved at the FDA recommended dose of 148 MBq, 4 mCi, OR 1.5 -2.2 MBq/kg, 40-60 ìCi/kg body weight, administered by slow intravenous injection (1-2 minutes) every 90 days until disease progression when the following criteria are met:
a. Prior to administration, patients should have baseline platelet counts > 60,000/mm3 and white blood cell counts > 2,400/mm3.
b. Complete blood counts monitored at least every other week for 8 weeks following strontium-89 chloride (Metastron) administration.
[INFORMATIONAL NOTE: As per the FDA approved labeling: Use of Metastron in patients with evidence of seriously compromised bone marrow from previous therapy or disease infiltration is not recommended unless the potential benefit of the treatment outweighs its risks. Bone marrow toxicity is to be expected following the administration of Metastron, particularly white blood cells and platelets. The extent of toxicity is variable. It is recommended that the patient’s peripheral blood cell counts be monitored at least once every other week. Typically, platelets will be depressed by about 30% compared to preadministration levels. The nadir of platelet depression in most patients is found between 12 and 16 weeks following administration of Metastron. White blood cells are usually depressed to a varying extent compared to pre-administration levels. Thereafter, recovery occurs slowly, typically reaching pre-administration levels six months after treatment unless the patient's disease or additional therapy intervenes]
[INFORMATIONAL NOTE: Evidence of pain relief is generally seen within 7 to 21 days and sustained for 3 to 6 months. The literature indicates that a repeat dose can be administered at 3-month intervals if necessary.]
III. Continuation of Stronitium-89 will be approved every 90 days based on the following criteria:
a. Disease response indicated by a reduction in pain score
b. Complete blood counts monitored at least every other week for 8 weeks following strontium-89 chloride (Metastron) administration.
c. Prior to re-administration, patients should have baseline platelet counts > 60,000/mm3 and white blood cell counts > 2,400/mm3.
IV. Strontium-89 is considered investigational for all other indications including use in members with cancer not involving the bone.
Medicare Coverage
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ medical policy.
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:
Strontium-89 Chloride
Metastron
References:
1. 1998 Physicians' Desk Reference Generics. 4th Edition. Medical Economics Publishing Company.
2. Metastron package insert from the manufacturer, Medi-Physics, Inc. Arlington Heights, IL; November 2013.
3. Porter AT, McEwan AJ, et al. Results of a Randomized Phase-III Trial to Evaluate the Efficacy of Strontium-89 Adjuvant to Local Field External Beam Irradiation in the Management of Endocrine Resistant Metastatic Prostate Cancer. Int J Radiation Oncology Biol Phys. November 5, 1993;25:805-813.
4. Lawrentschuk N, Davis ID, Bolton DM, et al. Diagnostic and therapeutic use of radioisotopes for bony disease in prostate cancer: current practice. Int J Urol 2007 Feb;14(2):89-95.
5. MICROMEDEX® 1.0 (Healthcare Series). DRUGDEX® Evaluations.Metastron. Available at: http://www.thomsonhc.com. Accessed December 17, 2019.
6. American Cancer Society. Treating Bone Metastases. 2016. Found at: https://www.cancer.org/treatment/understanding-your-diagnosis/advanced-cancer/treating-bone-metastases.html
7. Serafini, Aldo N. “Therapy of Metastatic Bone Pain*.” Journal of Nuclear Medicine, 1 June 2001, jnm.snmjournals.org/content/42/6/895.long.
8. Oncolink.org. (2019). Bone Metastasis Treatment with Medications | OncoLink. [online] Available at: https://www.oncolink.org/cancers/bone/bone-metastases/bone-metastasis-treatment-with-medications [Accessed 17 Dec 2019].
9. Schneider, Guido et al. “Cancer Pain Management and Bone Metastases: An Update for the Clinician” Breast care (Basel, Switzerland) vol. 7,2 (2012): 113-120.
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
A9600
* 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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