Subject:
Insulin Potentiation 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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Insulin potentiation therapy (IPT), which was developed in the 1930s in Mexico by Donato Perez Garcia, Sr, MD, uses insulin as an adjunctive agent to potentiate the effects of pharmacologic therapy in the treatment of cancer, infectious diseases, chronic degenerative disorders, and many other conditions.
The physiologic effects of insulin in IPT are thought to increase the permeability of cell membranes and facilitate increased intracellular absorption of pharmacologic agents. Theoretically, the increased absorption of a pharmacologic agent could result in higher intracellular drug concentrations, lower dosage requirements, and reductions in toxicity and adverse side effects. IPT is primarily used in the treatment of cancer, for which increasing the intracellular concentration and cytotoxic effects of chemotherapy agents while decreasing the adverse effects is thought to increase antitumoral activity and patient tolerance to treatment.
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
Insulin potentiation therapy (IPT) is considered investigational.
Medicare Coverage:
There is no National Coverage Determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination 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.
[RATIONALE: Insulin potentiation therapy (IPT) has been explored in a minority of physician practices since the 1930s. (Ayre SG et al, 1986 and 2000) However, there is only 1 randomized controlled trial on the effects of IPT in metastatic breast cancer. No studies have demonstrated that IPT is safe or effective in improving long-term health outcomes over standard or conventional pharmacologic treatment for any disease state. Also, it appears that this is not an area of active research.
The only randomized controlled clinical trial on IPT was published by Lasalvia-Prisco and colleagues who reported on 30 patients (three groups of 10) randomized to receive two 21-day courses of insulin with methotrexate (IPT), methotrexate alone, or insulin alone. (Lasalvia-Prisco E et al, 2004) Patients had metastatic breast cancer that was resistant to fluorouracil, adriamycin, and cyclophosphamide as well as hormone therapy (if they had a positive estrogen receptor status). The primary outcome assessed at 8 weeks after initiation of treatment was tumor response using the response evaluation criteria in solid tumors (RECIST) system. The authors reported finding the RECIST status in the IPT group was 9 stable diseases and 1 progressive disease versus 7 progressive and 3 stable diseases in the methotrexate-only group and 8 progressive and 2 stable diseases in the insulin-only group (distribution of results = p<.01, Chi-squared test). In addition, the IPT group had significantly lower increases in tumor size than the methotrexate-only and the insulin-only treatment groups (p<.001). Toxicities were low in both the IPT group (only 1 World Health Organization [WHO] grade 1 mucositis) and the methotrexate-only group (WHO grade 1-2), as the individual methotrexate dosage of 2.5 mg/m² used in the study was lower than optimal. The authors suggest that these findings support the theory that the antitumoral effects of methotrexate were potentiated by the insulin. While this study may suggest insulin enhances some biochemical event with the administration of chemotherapy in the short term, it does not report on any long-term effects or health outcomes. Therefore, further studies are needed to demonstrate any improvements in health outcomes with the use of insulin potentiation therapy.
A 2006 publication described preclinical safety and antitumor efficacy of insulin combined with irradiation. (Jordan BF et al, 2006) Using the intestinal crypt regeneration assay, a delay in regrowth was noted when insulin therapy was combined with radiation. The need for larger preclinical assays was noted by the authors as a next step, before studies of possible clinical utility are conducted.
According to the American Cancer Society, " Despite, individual reports, there are no published scientific studies available showing IPT is safe and effective in treating cancer in humans. IPT may have serious side effects."]
One clinical trial found on ClinicalTrials.gov - NCT02598479 - which was planning on measuring Quality of Life - was withdrawn due to IRB withdrawal.
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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:
Insulin Potentiation Therapy
Potentiation Therapy, Insulin
References:
1. Ayre SG, Perez Garcia y Bellon D, Perez Garcia D Jr. Insulin potentiation therapy: a new concept in the management of chronic degenerative disease. Med Hypotheses 1986; 20(2):199-210.
2. Ayre SG, Garcia y Bellon DP, Garcia DP Jr. Insulin, chemotherapy, and the mechanisms of malignancy: the design and the demise of cancer. Med Hypotheses 2000; 55(4):330-4.
3. Lasalvia-Prisco E, Cucchi S, Vazquez J et al. Insulin-induced enhancement of antitumoral response to methotrexate in breast cancer patients. Cancer Chemother Pharmacol 2004; 53(3):220-4.
4. Jordan BF, Beghein N, Crokart N et al. Preclinical safety and antitumor efficacy of insulin combined with irradiation. Radiother Oncol 2006; 81(1):112-7.
5. ECRI Institute. Hotline Response: Insulin Potentiation Therapy to Increase the Effectiveness of Chemotherapy and other Pharmacological Therapies. 06/07/2007 (last accessed 03/30/10)
6. American Cancer Institute. Insulin Potentiation Therapy. Revised: 11/01/2008. Available at: http://www.cancer.org/docroot/ETO/content/ETO_5_3X_Insulin_Potentiation_Therapy.asp?sitearea=ETO (last accessed 03/30/10).
7. Browne BC, Crown J, Venkatesan N, et al. Inhibition of IGF1R activity enhances response to trastuzumab in HER-2-positive breast cancer cells. Ann Oncol 2010;22(1):68-73.
8. Damyanov C, Gerasimova D, Maslev I, et al. Low-dose chemotherapy with insulin (insulin potentiation therapy) in combination with hormone therapy for treatment of castration-resistant prostate cancer. ISRN Urol 2012;2012:140182 Epub 2012 May 8.
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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