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Medical Policy

Policy Num:     02.001.002
Policy Name:   Immunotherapy for Allergies
Policy ID:         [02.001.002]  [Ar / L / M+ / P]  [0.00.00]

Last Review:      July 08, 2022
Next Review:      Policy Archived
Issue:                  7:2022

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Related Policies: None

 Immunotherapy for Allergies

Summary

Immunotherapy in allergies requires regular injections of an allergen for months in order to reduce symptoms. It begins with small doses to avoid reactions and gradually increase by injecting once or twice a week until the patient develops immunity to the antigen. Once the maintenance dose is reached, the interval between injections can vary between two and six weeks. This regime can be maintained continuously for a few years if necessary.

Objective

The objective of this reviews to determine the clinical utility of prepared allergen extracts in managing human disease.

Policy Statements

Immunotherapy for allergies is considered for payment in patients with hypersensitivity that cannot be managed with the use of medications or avoiding exposure. Injections with the specific allergen are prepared for a patient. The following conditions are considered for payment:

·         Allergic rhinitis

·         Allergic asthma

·         Atopic dermatitis

·         Food allergy

The following methods are not considered for payment:

•  Provocation and neutralization therapy

•  Urine injections

• Emulsion Therapy

Policy Guidelines

Allergens will be defined as molecules capable of eliciting immunoglobulin E (IgE)-mediated hypersensitivity reactions. Allergen extracts are used in a variety of diagnostic and therapeutic applications, including diagnostic skin testing, provocation testing, and in vitro tests, as well as allergen-specific immunotherapy (both oral and subcutaneous). In all applications, the active ingredient is theoretically the relevant allergens from that source, although the formulation may differ between applications.

Benefit Application

BlueCard/National Account Issues

N/A

Background

Allergen extracts are complex mixtures of allergenic and nonallergenic substances, including proteins, glycoproteins, polysaccharides, lipids, nucleic acids, low molecular weight metabolites, salts, and pigments. Most allergens are proteins or glycoproteins, but in certain rare circumstances, pure carbohydrates or low molecular weight chemicals can act as allergens. All foreign proteins are potential allergens in theory, although only a limited number of proteins are confirmed to be allergenic in humans. No structural properties have been identified that distinguish allergenic from nonallergenic proteins.

  Allergen extracts are usually prepared by aqueous extraction of allergenic source materials obtained from natural sources. The composition and biologic             properties may be influenced by the quality and purity of the source material, as well as their processing, extraction, and storage conditions. For batch- to-         batch consistency, it is sufficient to consider the proteins as active ingredients

Regulatory Status

N/A

Rationale

Allergen immunotherapy (AIT) has been used to treat allergic disease since the early 1900s. Despite numerous clinical trials and meta-analyses proving AIT efficacious, it remains underused and is estimated to be used in less than 10% of patients with allergic rhinitis or asthma worldwide. In addition, there are large differences between regions, which are not only due to socioeconomic status. There is practically no controversy about the use of AIT in the treatment of allergic rhinitis and allergic asthma, but for atopic dermatitis or food allergy, the indications for AIT are not well defined. The elaboration of a wider consensus is of utmost importance because AIT is the only treatment that can change the course of allergic disease by preventing the development of asthma and new allergen sensitizations and by inducing allergen-specific immune tolerance.

Population Reference No. 1 

Individuals: Allergen – induced reactions. Interventions of interest are: Allergen specific inmunotherapy. Comparator of interest are: Standard care without allergen specifIc inmunotherapy.   Relevant outcomes include: Symptoms, Qualirty of life, Hospitalizations, Treatment related morbidity.

Supplemental Information

N/A

Practice Guidelines and Position Statements

N/A

Medicare National Coverage

N/A

References

1.  J. David et al. History of Immunotherapy: The First 100 Years. Immunol Allergy Clin N Am 31 (2011) 149–157.

2.  Noon L, Cantab BC. Prophylactic inoculation against hay fever. Lancet. 1911:1572- 3

3.  Akdis M, Akdis CA. Mechanisms of allergen-specific immunotherapy. J Allergy Clin Immunol. 2007 Feb 23;

4.  Pajno GB. Sublingual immunotherapy: The optimism and the issues. J Allergy Clin Immunol. 2007 Feb 13; 5.

5.  Bussmann C, Bockenhoff A, Henke H, Werfel T, Novak N. Does allergen-specific immunotherapy represent a therapeutic option for patients with            atopic dermatitis? J Allergy Clin Immunol. 2006 Dec;118(6):1292-8.

  6. Enrique E, Cistero-Bahima A. Specific immunotherapy for food allergy: basic principles and clinical aspects. Curr Opin Allergy Clin Immunol. 2006                       Dec;6(6):466- 9.

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