Subject:
Antineoplaston Therapy
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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Antineoplastons are naturally occurring peptides found in the human blood and urine which are thought to provide a natural form of anti-cancer protection and to possess anti-tumor activity.
Antineoplaston therapy was developed by Dr. Stanislaw R. Burzynski using synthetic compounds that were originally isolated from human blood and urine. These compounds have been used to treat patients with cancer, HIV infection, and autoimmune diseases. They can be administered through intravenous infusion or oral route in capsule form. At this time, there is no antineoplaston approved by the U.S. Food and Drug Administration (FDA) for any indication.
Antineoplastons A10 (3-phenylacetylamino-2, 6-piperidinedione) and AS2-1 (phenylacetic acid/phenylacetylglutamine) have been most commonly researched as a treatment for a wide variety of malignancies. Sodium phenylbutyrate (Buphenyl®) taken orally is metabolized in the liver into a combination of phenylacetylglutamine and phenylacetate, which then enter the blood stream. These 2 by-products are the prime ingredients of antineoplaston AS2-1.
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
1. Antineoplaston therapy for any indication is considered investigational. Antineoplastons are not approved by the FDA for any indication. Furthermore, there is lack of scientific evidence in the published medical literature to support their effectiveness in the treatment of cancer or any other disease.
2. Any procedures, services and supplies associated with antineoplaston therapy (e.g., placement of catheter, infusion pump and supplies, imaging studies, laboratory procedures, etc.) are also considered investigational.
3. The off-label use of sodium phenylbutyrate (Buphenyl®) as a form of antineoplaston therapy 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 Products will follow the Horizon BCBSNJ Medical Policy.
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:
Antineoplaston Therapy
Burzynski Treatment
Therapy, Antineoplaston
Sodium Phenylbutyrate
Phenylbutyrate
Buphenyl
References:
1. Green S. ‘Antineoplastons’. An unproved cancer therapy. JAMA 1992 Jun; 267(21):2924-8.
2. National Cancer Institute. Antineoplastons. Cancer Facts. Revised: 05/20/2002. http://cis.nci.nih.gov/fact/7_43.htm (accessed 2/10/03)
3. American Cancer Society. Antineoplaston Therapy. Last reviewed 11/01/08. Available at: http://www.cancer.org/docroot/ETO/content/ETO_5_3X_Antineoplaston_Therapy.asp?sitearea=ETO (last accessed 09/24/2012)
4. Tsuda H, Sata M, Kumabe T, et al. Quick response of advanced cancer to chemoradiation therapy with antineoplastons. Oncol Rep 1998 May-Jun;5(3):597-600.
5. Kumabe T, Tsuda H, Uchida M, et al. Antineoplaston treatment for advanced hepatocellular carcinoma. Oncol Rep 1998 Nov-Dec;5(6):1363-7.
6. Buckner JC, Malkin MG, Reed E, et al. Phase II study of antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in patients with recurrent glioma. Mayo Clin Proc 1999 Feb;74(2):137-45.
7. Badria F, Mabed M, Khafagy W, et al. Potential utility of antineoplaston A-10 levels in breast cancer. Cancer Lett 2000 Jul;155(1):67-70.
8. Badria F, Mabed M, El-Awadi M, et al. Immune modulatory potentials of antineoplaston A-10 in breast cancer patients. Cancer Lett 2000 Aug;157(1):57-63.
9. Matono K, Ogata Y, Tsuda H, et al. Effects of antineoplaston AS2-1 against post-operative lung metastasis in orthotopically implanted colon cancer in nude rat. Oncol Rep 2005 Mar; 13(3):389-95.
10. Burzynski SR, Weaver RA, Lewy RI, et al. Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma: a preliminary report. Drugs R D 2004;5(6):315-26.
11. Burzynski SR, Lewy RI, Weaver R, et al. Long-term survival and complete response of a patient with recurrent diffuse intrinsic brain stem glioblastoma multiforme. Integr Cancer Ther 2004 Sep;3(3):257-61.
12. Burzynski SR, Weaver RA, Janicki T, et al. Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with antineoplastons A10 and AS2-1. Integr Cancer Ther 2005 Jun;4(2):1689-77.
13. Fujii T, Nakamura AM, Yokoyama G, et al. Antineoplaston induces G(1) arrest by PKCalpha and MAPK pathway in SKBR-3 breast cancer cells. Oncol Rep 2005 Aug;14(2):489-94.
14. Burzynski SR, Janicki TJ, Weaver RA, et al. Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma. Integr Cancer Ther 2006 Mar;5(1):40-7.
15. National Cancer Institute (NCI). Antineoplastons (PDQ) Health Professional Version. Last modified: 08/16/12. Available at: http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page1/AllPages (accessed 11/12/2013)
16. Buphenyl® - FDA-approved Label. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020572s016,020573s015lbl.pdf (accessed 11/12/2013)
17. Burzynski SR. Novel cancer research and the fight to prove its worth. Altern Ther Health Med 2012 May-Jun;18(3):54-61.
18. Blaskiewicz R. Comment to the paper: The response and survival of children with recurrent diffuse intrinsic pontine glioma based on phase II study of antineoplastons A10 and AS2-1 in patients with brainstem glioma : Stanislaw R. Burzynski, Tomasz J. Janicki, Gregory S. Burzynski, Ania Marszalek. Childs Nerv Syst. 2014 Aug 22. [Epub ahead of print]
19. Wong TT. Comment to the paper "The response and survival of children with recurrent diffuse intrinsic pontine glioma based on phase II study of antineoplastons A10 and AS2-1 in patients with brain stem glioma" by Burzynski et al. Childs Nerv Syst. 2014 Aug 21. [Epub ahead of print]
20. Di Rocco C. Main editor's comment to the paper: the response and survival of children with recurrent diffuse intrinsic pontine glioma based on phase II study of antineoplastons A10 and AS2-1 in patients with brainstem glioma. Stanislaw R. Burzynski, Tomasz J. Janicki, Gregory S. Burzynski, Ania Marszalek. Childs Nerv Syst. 2014 Aug 6. [Epub ahead of print]
21. Massimino M, Clerici CA. Commentary: The response and survival of children with recurrent diffuse intrisic pontine glioma based on phase II study of antineoplastons A10 and AS2-1 in patients with brainstem glioma, by Burzynski G, et al. Childs Nerv Syst. 2014 Jul 31. [Epub ahead of print]
22. Burzynski SR, Janicki TJ, Burzynski GS, Marszalek A. The response and survival of children with recurrent diffuse intrinsic pontine glioma based on phase II study of antineoplastons A10 and AS2-1 in patients with
brainstem glioma. Childs Nerv Syst. 2014 Apr 10. [Epub ahead of print]
23. Burzynski SR, Janicki TJ, Burzynski GS, Marszalek A. Long-term Survival (>13 Years) in a Child With Recurrent Diffuse Pontine Gliosarcoma: A Case Report. J Pediatr Hematol Oncol. 2013 Oct 23. [Epub ahead of print]
24. Ogata Y, Matono K, Tsuda H, et al. Randomized phase II study of 5-fluorouracil hepatic arterial infusion with or without antineoplastons as an adjuvant therapy after hepatectomy for liver metastases from colorectal cancer. PLoS One. 2015 Mar 19;10(3):e0120064.
25. Figg WD. Antineoplastons: when is enough enough?. Lancet Oncol. 2018 Jun:19(6):733-734.
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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