MEDICAL POLICY POLICY TITLE POLICY NUMBER ALLERGY IMMUNOTHERAPY MP-2.002

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1 Original Issue Date (Created): July 1, 2002 Most Recent Review Date (Revised): Effective Date: November 20, 2007 July 1, RETIRED I. DESCRIPTION/BACKGROUND Immunotherapy involves routine injections of an offending allergen over a period of months, with the goal of reducing symptoms. It begins with low doses of the antigen. The dosage is gradually increased until the patient develops immunity to the antigen. Once immunity is achieved the patient begins maintenance therapy. During maintenance, the interval between injections may range from two to six weeks. Immunotherapy may be administered continuously for several years. II. III. DEFINITIONS ALLERGEN Any substance that causes a hypersensitivity reaction. Among common allergens are inhalants (dusts, pollens, fungi, smoke, perfumes, and odors of plastics), foods (wheat, eggs, milk, chocolate and strawberries) drugs (aspirin, antibiotics, and serums), infectious agents (bacteria, viruses and fungi), contactants (chemicals, animals, plants and metals), and physical agents (heat, cold, light and pressure). ALLERGY An immune response to a foreign antigen that results in inflammation and organ dysfunction. Allergies range from the life threatening to the annoying, and include systemic anaphylaxis, laryngeal edema, transfusion reaction, urticaria, hay fever and rhinitis. ANTIGEN A protein that induces the formation of antibodies, which interact specifically with it. This antigen antibody reaction forms the basis of immunity. ANTIBODY A protein substance produced in response to a unique antigen. The substance developed combines with a specific antigen to destroy or control it. INTRADERMAL- refers to intracutaneous, or more specifically, within the dermis. POLICY Allergy immunotherapy may be considered medically necessary and appropriate for patients with demonstrated hypersensitivity that cannot be managed by medication, avoidance or environmental control measures. Injections of airborne or insect venom allergens should be prepared for the patient individually. 1

2 Cross-Reference MP Allergy Testing IV. EXCLUSIONS The following immunotherapy methods are considered investigational, as there is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure. Sublingual immunotherapy (including antigen preparation); Provocative and neutralization therapy for food allergies; Autogenous urine immunization (urine autoinjections); Repository emulsion therapy; and Serial dilution endpoint titration therapy (also know as Rinkel). The following are not medical items and therefore are considered personal convenience items: Allergen-proof supplies (e.g. mattresses, mattress casings, pillows, pillow casings, etc.) Environmental control equipment (e.g. air conditioners or air filters), even if the equipment is prescribed by a physician. V. BENEFIT VARIATIONS The existence of this medical policy does not mean that this service is a covered benefit under the member's contract. Benefit determinations should be based in all cases on the applicable contract language. Medical policies do not constitute a description of benefits. A member s individual or group customer benefits govern which services are covered, which are excluded, and which are subject to benefit limits and which require preauthorization. Members and providers should consult the member s benefit information or contact Capital for benefit information. VI. DISCLAIMER Capital s medical policies are developed to assist in administering a member s benefits, do not constitute medical advice and are subject to change. Treating providers are solely responsible for medical advice and treatment of members. Members should discuss any medical policy related to their coverage or condition with their provider and consult their benefit information to determine if the service is covered. If there is a discrepancy between this medical policy and a member s benefit information, the benefit information will govern. Capital considers the information contained in this medical policy to be proprietary and it may only be disseminated as permitted by law. 2

3 VII. REFERENCES Allergen immunotherapy: a practice parameter. American Academy of Allergy, Asthma and Immunology. Ann Allergy Asthma Immunol 2003 Jan;90(1 Suppl 1):1-40. [Website]: Accessed August 1, Baena-Cagnani CE, Passalacqua G, Baena-Cagnani RC, et al. Sublingual immunotherapy in pediatric patients: Beyond clinical efficacy. Curr Opin Allergy Clin Immunol. 2005; 5(2): BCBSA 2003 TEC Assessment: Sublingual Immunotherapy for Allergies. BCBSA 2002 TEC Assessment: Serial Endpoint Testing for the Diagnosis and Testing of Allergic Disorders. Bowen T, Greenbaum J, Charbonneau Y et al. Canadian trial of sublingual swallow immunotherapy for ragweed rhinoconjunctivitis. Ann Allergy Asthma Immunol 2004; 93(5): Bufe A, Ziegler-Kirbach E, Stoeckmann E et al. Efficacy of sublingual swallow immunotherapy in children with severe grass pollen allergic symptoms: a double-blind placebo-controlled study. Allergy 2004; 59(5): Calamita, Z, Saconato, H, Pela, AB, and Atallah, AN. Efficacy of sublingual immunotherapy in asthma: systematic review of randomized-clinical trials using the Cochrane Collaboration method. Allergy. 2006;61(10): Calderon, MA, Alves, B, Jacobson, M, Hurwitz, B, Sheikh, A, and Durham, S. Allergen injection immunotherapy for seasonal allergic rhinitis. Cochrane Database Syst Rev. 2007;(1):CD Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) Durable Medical Equipment. Effective 05/05. CMS [Website]: %3A280%2E1%3A2%3ADurable+Medical+Equipment+Reference+List. Accessed August 1, Cox, L, Cohn, JR. Duration of allergen immunotherapy in respiratory allergy: when is enough, enough? Ann Allergy Asthma Immunol. 2007;98(5): Cox LS, Linnemann DL, Nolte H et al. Sublingual immunotherapy: a comprehensive review. J Allergy Clin Immunol 2006; 117(5): Durham SR, Yang WH, Pedersen MR et al. Sublingual immunotherapy with once-daily grass allergen tablets: a randomized controlled trial in seasonal allergic rhinoconjunctivitis. J Allergy Clin Immunol 2006; 117(4): ECRI. Hotline. Sublingual Drops for Treating Allergies. January ECRI. Hotline. Specific Allergen Immunotherapy (SIT). July

4 Highmark Medicare Services Local Coverage Determination (LCD) I-3I: Allergy Immunotherapy. Effective 09/15/2005. [Website]: Accessed August 1, Khinchi MS, Poulsen LK, Carat F et al. Clinical efficacy of sublingual and subcutaneous birch pollen allergen-specific immunotherapy: a randomized, placebo-controlled, double-blind, double-dummy study. Allergy 2004; 59(1): Malling, HJ. Sublingual immunotherapy: efficacy--methodology and outcome of clinical trials. Allergy. 2006;61(Suppl 8) Passalacqua, G, Durham, SR. Allergic rhinitis and its impact on asthma update: allergen immunotherapy. J Allergy Clin Immunol. 2007;119(4): Reider N. Sublingual immunotherapy for allergic rhinoconjunctivitis--the seeming and the real. Int Arch Allergy Immunol. 2005; 137(3): Smith H, White P, Annila I et al. Randomized controlled trial of high-dose sublingual immunotherapy to treat seasonal allergic rhinitis. J Allergy Clin Immunol 2004; 114(4): Taber s Cyclopedic Medical Dictionary, 19 th edition VIII. PRODUCT VARIATIONS [N] = No product variation, policy applies as stated [Y] = Standard product coverage varies from application of this policy, see below [N] CHIP POS [N] PPO [N] HMO [N] CHIP HMO [N] SeniorBlue [N] SeniorBlue PPO [N] Indemnity [N] SpecialCare [N] POS [N] FEP HMO [N] FEP PPO Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage Insurance Company and Keystone Health Plan Central. Independent licensees of the Blue Cross and Blue Shield Association. Communications issued by Capital BlueCross in its capacity as administrator of programs and provider relations for all companies. 4

5 IX. POLICY HISTORY MP CAC 10/28/03 CAC 10/26/04 CAC 11/29/05 CAC 10/31/06 CAC 9/25/07 Policy approved for retirement 7/1/