Oscar Allergen Sublingual Immunotherapy (SLIT) (PG093) Form

Allergies and Immunotherapy

Allergies are often the result of a hypersensitive immune response to specific substances causing an exaggerated reaction. These allergies can develop in response to various antigens including insect bites/stings, molds, dust mites, cockroaches, or seasonal pollen. Symptoms include runny nose or congestion, watery or itchy eyes, asthma symptoms, skin rashes, and in severe cases, anaphylaxis. Most allergy cases are successfully treated with over-the-counter medications, although some may require prescriptions in the form of nasal sprays, inhalers, or oral medications to prevent and/or address symptoms.

When symptoms are severe or unresponsive to prescription medication, a specialized type of treatment called allergy immunotherapy may be indicated. Allergen immunotherapy works by slowly introducing very small amounts of the allergic substance over a prolonged period of time in a controlled environment to allow a person's immune system to become desensitized.

Per practice parameters of the American Academy of Allergy, Asthma & Immunology for sublingual immunotherapy, the first dose must be medically supervised in a healthcare setting while subsequent doses can be self-administered at home. Because of the associated risks, allergy immunotherapy should always be carried out under the close supervision of a licensed practitioner trained and experienced in prescribing and administering immunotherapy. Sublingual immunotherapy treatment options include Grastek, Odactra, Oralair, and Ragwitek.

Definitions

• Allergen immunotherapy is a treatment where very small amounts of an allergic substance are introduced via injection or sublingual administration to a patient with that specific allergy in order to desensitize the immune system.
• Allergy refers to having both allergen-specific IgE and developing symptoms upon exposure to substances containing that allergen.
• Anaphylaxis is a severe, systemic immune response (e.g., affecting more than 1 organ system) which may be characterized by flushing, trouble breathing, vomiting/diarrhea, swelling in the mouth/throat, rash, etc. It can be rapidly fatal without immediate treatment.
• Antigen (or Allergen) refers to an offending substance that causes the allergic reaction through immune system hypersensitivity. Examples of an antigen include molds, dust mites, cockroaches, certain types of pollen, or the venom of a bee sting.
• Compendia are summaries of drug information and medical evidence to support decision-making about the appropriate use of drugs and medical procedures. Examples include, but are not limited to:
  1. American Hospital Formulary Service Drug Information
  2. Clinical pharmacology
  3. National Comprehensive Cancer Network Drugs and Biologics Compendium
  4. Thomson Micromedex DrugDex
  5. United States Pharmacopeia-National Formulary (USP-NF)
• Rapid Desensitization is an allergen immunotherapy technique where the protocol is performed on a shorter time scale, whereas standard allergy immunotherapy is performed over 3-5 years.
• Sensitization is when individuals produce IgE or immune responses to allergens verified through blood or positive skin tests but do not develop symptoms upon exposure to that substance.
• Sublingual refers to the delivery of medication under a patient's tongue.

Medical Necessity Criteria for Initial Authorization

The Plan considers sublingual allergy immunotherapy medically necessary when ALL the following criteria are met for the applicable indication listed below:

1. The requested medication is prescribed by an allergy or immunology specialist; AND
2. The member is within the appropriate age group for the requested medication formulation:
   • For Grastek: age 5 to 65 years; or
   • For Odactra: age 18 to 65 years; or
   • For Oralair: age 5 to 65 years; or
   • For Ragwitek: age 5 to 65 years; AND
3. The member has IgE mediated allergic rhinitis or conjunctivitis AND ALL the following criteria are met:
   • The member has experienced ONE or more of the following:
     • Asthma exacerbation specifically associated with allergic rhinitis; or
     • History of 2 or more consecutive seasons of related allergy symptoms; or
     • Perennial allergies; and
   • The member has a documented inadequate response after an appropriate trial of ALL of the following, unless specifically contraindicated or poorly tolerated:
     • Avoidance of environmental or situational antigen exposure; and
     • ONE of the following nasal spray treatments:
       1. Nasal antihistamine (e.g., azelastine, olopatadine); or
       2. Nasal cromolyn (sodium cromoglycate); or
       3. Nasal ipratropium; and
     • ONE formulary nasal steroid (e.g., flunisolide, fluticasone, triamcinolone); and
     • ONE of the following oral medication therapies:
       1. Oral antihistamine (e.g., cetirizine, desloratadine, diphenhydramine); or
       2. Oral antihistamine-decongestant (e.g., cetirizine-pseudoephedrine); or
       3. Oral leukotriene receptor antagonist (e.g., montelukast); and

1. There is documented positive skin prick test or allergen-specific IgE test to the specific antigen being used for immunotherapy; and
2. The condition and antigen are such that there is expected to be a therapeutic benefit for the member to the requested treatment for the specified allergen; AND
3. The member does NOT have any of the following contraindications:
   • Current pregnancy or breastfeeding; or
   • Concurrent use of non-cardioselective beta blockers (e.g. carvedilol, labetalol, propranolol, sotalol, timolol); or
   • Moderate to severe asthma or any uncontrolled asthma; or
   • History of severe reaction to any form of immunotherapy; or
   • History of eosinophilic esophagitis; or
   • Comorbidities that may reduce ability to survive a severe reaction to the immunotherapy or reduce the effectiveness of epinephrine, including but not limited to:
     1. Acute or chronic compromised lung function; or
     2. Significant cardiovascular diseases (e.g., unstable angina, recent myocardial infarction, significant arrhythmia, and uncontrolled hypertension); or
   • Active oral inflammatory condition such as ulcers or dental extractions; AND [NOTE: sublingual immunotherapy can be started once this condition resolves]
4. The requesting provider has submitted the required clinical documentation (chart notes, laboratory reports, disease progression, previous medications tried and failed, etc) for review;AND
5. The medication is being prescribed within the manufacturer’s published dosing guidelines (see Table 1 below) or falls within dosing guidelines found in a compendia of current literature.

Table 1: Immunotherapy for Allergic Rhinitis Dosing Information

NOTE: First dose should be administered in a healthcare setting under supervision of a physician experienced with severe allergic reactions. Patients should be monitored closely for 30 minutes.

If the above prior authorization criteria are met, sublingual immunotherapy will be approved for 12 months.

Medical Necessity Criteria for Reauthorization

Reauthorization for 12 months will be granted if BOTH of the following are met:

1. the member still meets the applicable initial criteria; AND
2. there is documented clinical response in chart notes meeting ONE of the following criteria:
   • decrease in the amount of medication required to control symptoms; or
   • improvement in clinical symptoms and benefit from treatment is sustained.

Experimental or Investigational / Not Medically Necessary

Sublingual allergen immunotherapy for any other indication is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven.

Applicable Codes

References

1. Akdis M. Allergen immunotherapy for allergic disease: Therapeutic mechanisms. UptoDate. UpToDate.com. Waltham, MA. Last updated Sept 2018.
2. Bousquet et al. 2019 ARIA Care pathways for allergen immunotherapy. Allergy. 2019 Nov; 74(11):2087-2102
3. Burks AW, Calderon MA, Casale T, et al. Update on allergy immunotherapy: American Academy of Allergy, Asthma & Immunology/European Academy of Allergy and Clinical Immunology/PRACTALL consensus report. The Journal of Allergy and Clinical Immunology. 2013;131(5):1288-1296. https://doi.org/10.1016/j.jaci.2013.01.049
4. Calabria CW, Stolfi A, Tankersley MS.

1. The REPEAT study: recognizing and evaluating periodic local reactions in allergen immunotherapy and associated systemic reactions. Ann Allergy Asthma Immunol 2011; 106:49.
2. Calderon MA, Cox L, Casale TB, et al. Multiple-allergen and single-allergen immunotherapy strategies in polysensitized patients: Looking at the published evidence. J Allergy Clin Immunol. 2012;129 (4): 929-934.
3. Class Comparison: Beta Blockers. Micromedex. www.micromedexsolutions.com. Greenwood Village, CO: Truven Health Analytics. Last updated May 2016. Accessed April 23, 2021.
4. Creticos PS. Sublingual immunotherapy for allergic rhinoconjunctivitis and asthma. UptoDate. UpToDate.com. Waltham, MA. Last updated May 2019.
5. deShazo RD, Kemp SF. Pharmacotherapy of allergic rhinitis. UptoDate. UpToDate.com. Waltham, MA. Last updated April 2020.
6. Creticos PS, Esch RE, Couroux P, et al. Randomized, double-blind, placebo-controlled trial of standardized ragweed sublingual-liquid immunotherapy for allergic rhinoconjunctivitis. J Allergy Clin Immunol 2014; 133:751.
7. GRASTEK® (Timothy Grass Pollen Allergen Extract) [package insert]. Hørsholm,Denmark: ALK- Abelló A/S; 2014. Revised December 2019. https://www.fda.gov/media/88510/download
8. Greenhawt M, Oppenheimer J, Nelson M, et al. Sublingual immunotherapy: A focused allergen immunotherapy practice parameter update. Ann Allergy Asthma Immunol. 2017;118(3):276-282.e2.
9. Jutel M, Agache I, Bonini S, et al. International consensus on allergy immunotherapy. J Allergy Clin Immunol. 2015;136(3):556-68.
10. Lin SY, Erekosima N, Suarez-Cuervo C, et al. Allergen-specific immunotherapy for the treatment of allergic rhinoconjunctivitis and/or asthma: Comparative Effectiveness Review No. 111. AHRQ; Agency for Healthcare Research and Quality, Rockville, MD 2013.
11. Normansell R, Kew KM, Bridgman AL. Sublingual immunotherapy for asthma. Cochrane Database Syst Rev 2015;CD011293.
12. ODACTRA™ House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract [package insert]. Hørsholm, Denmark: ALK-Abelló A/S; published 2018. Revised August 2019. https://www.fda.gov/media/103380/download
13. ORALAIR® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) [package insert]. Antony, France: Stallergenes SAS; published 2014. Revised November 2018. https://www.fda.gov/media/87935/download
14. Pitsios C, Demoly, P, Bilò MB, et al. Clinical contraindications to allergen immunotherapy: an EAACI position paper. European Journal of Allergy and Clinical Immunology. 2015; 70(8): 897-909. https://doi.org/10.1111/all.12638
15. RAGWITEK® (Short Ragweed Pollen Allergen Extract) [package insert]. Whitehouse Station, NJ; Merck & Co, Inc., 2014. Revised April 2017. https://www.fda.gov/media/88712/download
16. The Joint Task Force on Practice Parameters of Allergy, Asthma & Immunology. Allergen immunotherapy: A practice parameter third update. The Journal of Allergy and Clinical Immunology. 2011;127(1). https://doi.org/10.1016/j.jaci.2010.09.034 https://www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Documents/Practice%20and%20Parameters/Allergen-immunotherapy-Jan-2011.pdf
17. The Joint Task Force on Practice Parameters of Allergy, Asthma & Immunology. Sublingual immunotherapy: A focused allergen immunotherapy practice parameter update. Ann Allergy Asthma Immunol. 2017;118( ):276-282. https://doi.org/10.1016/j.anai.2016.12.009 https://www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Documents/Practice%20and%20Parameters/Sublingual-Immunotherapy-2017.pdf
18. Wahn U, Klimek L, Ploszczuk A, et al. High-dose sublingual immunotherapy with single-dose aqueous grass pollen extract in children is effective and safe: a double-blind, placebo-controlled study. J Allergy Clin Immunol 2012; 130:886.
19. Worm M, Rak S, de Blay F, et al. Sustained efficacy and safety of a 300IR daily dose of a sublingual solution of birch pollen allergen extract in adults with allergic rhinoconjunctivitis: results of a double-blind, placebo-controlled study. Clin Transl Allergy 2014; 4:7.

Clinical Guideline Revision / History Information

Original Date: 06/24/2021

Reviewed/Revised: 12/01/2021, 06/23/2022, 06/29/2023