Medical Policy

 

Subject: Insulin Potentiation Therapy
Document #: DRUG.00034 Publish Date:    12/12/2018
Status: Reviewed Last Review Date:    11/08/2018

Description/Scope

This document addresses insulin potentiation therapy (IPT) as an adjunctive agent to potentiate the effects of pharmacologic therapy in the treatment of cancer as well as infectious diseases, chronic degenerative disorders, fibromyalgia, chronic fatigue syndrome, arthritis, and many other conditions. IPT uses insulin as an adjunctive agent to potentiate the effect of chemotherapy and other medications. The adjunctive use of insulin is believed to enhance the effect of chemotherapy by “opening up” the receptors on cancer cells to increase absorption of the pharmacological agent or chemotherapy, thereby lowering the effective chemotherapy dose.  

Position Statement

Investigational and Not Medically Necessary:

Insulin potentiation therapy (IPT) is considered investigational and not medically necessary for the treatment of cancer, infectious diseases, chronic degenerative disorders, and all other conditions.

Rationale

There is currently only one published randomized controlled trial (RCT) evaluating the effects of IPT in metastatic breast cancer (Lasalvia-Prisco, 2004). The trial studied 30 women with metastatic breast cancer and measurable lesions resistant to fluorouracil, adriamycin, cyclophosphamide, and also hormone therapy. Participants were divided into 3 separate groups, each consisting of 10 women. Group 1 received two 21-day courses of insulin and methotrexate; group 2 received two 21-day courses of methotrexate; and group 3 received two 21-day courses of insulin. In each subject, the size of the target tumor was measured before and after treatment. The changes in the size of the target tumor in the three groups were compared statistically. The median increase in tumor size was significantly lower with insulin and methotrexate than with each drug used separately. The authors concluded that insulin enhanced the chemotherapy effect. While this small study may suggest insulin enhances a biochemical event with the administration of chemotherapy in the short term, it does not report any long-term effects or health outcomes. Therefore, further studies are warranted to provide more conclusive evidence of any improvement in health outcomes with the use of insulin potentiation therapy.

In a small non-randomized study, Damyanov and colleagues (2012) evaluated the results and quality of life (QOL) of 16 men with castration-resistant prostate tumors previously treated with IPT combined with hormone therapy. The individuals were divided into 2 groups of 8 men. Group A had been treated with low-dose chemotherapy (epirubicin, vinblastine, and cyclophosphamide combined with goserelin depot) and group B had been treated with low-dose chemotherapy (docetaxel combined with goserelin depot). Prostate specific antigen (PSA) results after 6 treatments of IPT showed partial effect in 50% of the men, stabilization in 25%, and progression in 25%. The authors concluded that the advantage of this method was its effectiveness along with improved QOL; however, well-designed RCTs are needed for routine implementation of IPT.

The majority of the evidence regarding IPT is derived from individual (anecdotal) case reports. Even among these, however, there has been no evidence that those who reported being helped by IPT were followed long enough to verify treatment efficacy. IPT has also reportedly been used as treatment for fibromyalgia, chronic fatigue syndrome, arthritis, and some infections. However, the safety and efficacy of this therapy have not been confirmed with well-designed clinical trials for these additional indications. 

Background/Overview

IPT was developed in the 1930s in Mexico by Donato Perez Garcia, Sr, MD and has been explored by a few physician practices (Ayre, 2000). IPT involves fasting for 6 to 8 hours, followed by initiation of intravenous (IV) fluids, and administration of an insulin dose based on body weight. For those with cancer, low doses of chemotherapy drugs are administered a few minutes later after the initiation of insulin to lower blood sugar. This is called the “therapeutic moment” by some IPT providers.

At this point, a treated individual usually has some symptoms of hypoglycemia, which can be quite severe, especially during first-time treatment, as responses may vary to a standard dose of insulin. As a result, the IV infusion can be modified to a high-sugar solution to raise the blood sugar. After the symptoms of low blood sugar begin to improve, food may be given to raise the blood sugar further. At the next treatment, the insulin dose may be raised or lowered, depending on the individual’s response to the first dose. 

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the following procedure and diagnosis codes, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

CPT

 

96549

Unlisted chemotherapy procedure [when specified as insulin potentiation therapy]

 

 

HCPCS

 

J1815

Injection, insulin, per 5 units

J1817

Insulin for administration through DME (i.e., insulin pump) per 50 units

 

 

ICD-10 Diagnosis

 

A00.0-B99.9

Certain infectious and parasitic diseases

C00.0-C96.9

Malignant neoplasms

D00.00-D09.9

In situ neoplasms

M00.00-M19.93

Infectious arthropathies, inflammatory polyarthropathies, osteoarthritis

M79.7

Fibromyalgia

R53.81-R53.83

Other malaise and fatigue

Z51.11-Z51.12

Encounter for antineoplastic chemotherapy and immunotherapy

Z85.00-Z85.9

Personal history of malignant neoplasm

References

Peer Reviewed Publications:

  1. 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):330-334.
  2. 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.
  3. Damyanov C, Gerasimova D, Maslev I, Gavrilov V. 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.
  4. 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):220-224.
Websites for Additional Information
  1. Complementary and Alternative Medicine for Cancer (CAM-Cancer). Insulin Potentiation Therapy. Updated June 27, 2017. Available at: http://www.cam-cancer.org/CAM-Summaries/Dietary-approaches/Insulin-potentiation-therapy. Accessed on September 20, 2018.
Index

Insulin-Potentiated Targeted Low-Dose Therapy (IPTLD)
Insulin Potentiation Therapy
IPT 

Document History

Status

Date

Action

Reviewed

11/08/2018

Medical Policy & Technology Assessment Committee (MPTAC) review.

Reviewed

10/31/2018

Hematology/Oncology Subcommittee review. Websites for Additional Information section updated.

Reviewed

11/02/2017

MPTAC review.

Reviewed

11/01/2017

Hematology/Oncology Subcommittee review. The document header wording updated from “Current Effective Date” to “Publish Date.” Websites for Additional Information section updated.

Reviewed

11/03/2016

MPTAC review.

Reviewed

11/02/2016

Hematology/Oncology Subcommittee review. Websites for Additional Information section updated.

Reviewed

11/05/2015

MPTAC review.

Reviewed

11/04/2015

Hematology/Oncology Subcommittee review. Rationale, Background/ Overview, References and Websites for Additional Information sections updated. Removed ICD-9 codes from Coding section.

Reviewed

11/13/2014

MPTAC review.

Reviewed

11/12/2014

Hematology/Oncology Subcommittee review. Rationale and Reference sections updated.

Reviewed

11/14/2013

MPTAC review.

Reviewed

11/13/2013

Hematology/Oncology Subcommittee review. References updated.

Reviewed

11/08/2012

MPTAC review.

Reviewed

11/07/2012

Hematology/Oncology Subcommittee review. Rationale, Reference, and Index sections updated.

Reviewed

11/17/2011

MPTAC review.

Reviewed

11/16/2011

Hematology/Oncology Subcommittee review. Rationale and reference link updated.

Reviewed

11/18/2010

MPTAC review.

Reviewed

11/17/2010

Hematology/Oncology Subcommittee review. Description, rationale, background, and references updated.

Reviewed

11/19/2009

MPTAC review.

Reviewed

11/18/2009

Hematology/Oncology Subcommittee review. Rationale, background, coding, and references updated. Web sites for additional information section added.

Reviewed

11/20/2008

MPTAC review.

Reviewed

11/19/2008

Hematology/Oncology Subcommittee review. Rationale and reference link updated.

 

10/01/2008

Updated Coding section with 10/01/2008 ICD-9 changes.

Reviewed

11/29/2007

MPTAC review.  

Reviewed

11/28/2007

Hematology/Oncology Subcommittee review. Rationale and references updated. The phrase “investigational/not medically necessary” was clarified to read “investigational and not medically necessary.”

New

12/07/2006

MPTAC review.

New

12/06/2006

Hematology/Oncology Subcommittee review. Initial document development.