The Plan members who have severe allergies may be eligible for treatment with allergen immunotherapy to alleviate their symptoms. 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 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 allergen 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 train a person's immune system to adapt to the allergic substance. It can be performed with skin injections or sublingual medications. All subcutaneous immunotherapy must be administered in medically supervised settings that can manage adverse reactions; however, for sublingual immunotherapy, the first dose must be medically supervised and subsequent doses can be administered at home as per practice parameters of American Academy of Allergy, Asthma & Immunology. Because of the risks associated, allergen immunotherapy should always be carried out under the close supervision of a licensed practitioner trained and experienced in prescribing and administering immunotherapy.

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 the immune system hypersensitivity. An antigen can be anything from a certain type of pollen to the venom of a bee sting.

"Rapid Desensitization"

is an allergen immunotherapy technique where the protocol is performed on a shorter time scale, where standard allergen immunotherapy is performed over longer periods of time (e.g., 3-5 years).

"Sensitization"

is when individuals may produce IgE to allergens verified through blood or positive skin tests but do not develop symptoms upon exposure to that substance.

"Subcutaneous"

refers to the delivery of medication via injection just under the skin.

"Sublingual"

refers to the delivery of medication under a patient’s tongue.

The Plan

Members who have severe allergies may be eligible for treatment with allergen immunotherapy to alleviate their symptoms. 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 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 allergen 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 train a person's immune system to adapt to the allergic substance. It can be performed with skin injections or sublingual medications.

All subcutaneous immunotherapy must be administered in medically supervised settings that can manage adverse reactions; however, for sublingual immunotherapy, the first dose must be medically supervised and subsequent doses can be administered at home as per practice parameters of American Academy of Allergy, Asthma & Immunology. Because of the risks associated, allergen immunotherapy should always be carried out under the close supervision of a licensed practitioner trained and experienced in prescribing and administering immunotherapy.

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 the immune system hypersensitivity. An antigen can be anything from a certain type of pollen to the venom of a bee sting.
• Rapid Desensitization is an allergen immunotherapy technique where the protocol is performed on a shorter time scale, where standard allergen immunotherapy is performed over longer periods of time (e.g., 3-5 years).
• Sensitization is when individuals may produce IgE to allergens verified through blood or positive skin tests but do not develop symptoms upon exposure to that substance.
• Subcutaneous refers to the delivery of medication via injection just under the skin.
• Sublingual refers to the delivery of medication under a patient’s tongue.

Clinical Indications

Medical Necessity Criteria for Initial Authorization

Subcutaneous immunotherapy (SCIT)

SCIT should be administered under medical supervision (e.g., MD/PA/NP) with a minimum of 30 minutes of monitoring to promptly recognize and manage adverse reactions (e.g., anaphylaxis).

The Plan considers subcutaneous immunotherapy (SCIT) medically necessary for members diagnosed with allergies when ALL the following criteria are met:

1. The member has ONE of the following conditions and meets the condition-specific criteria as below:
   1. Allergic rhinitis or conjunctivitis, when ALL the following criteria are met:
      • ONE or more of the following:
        1. Asthma exacerbation directly linked to allergic rhinitis; or
        2. A minimum of 2 consecutive seasons of related allergy symptoms; or
        3. Chronic (perennial) allergies; and
      • 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 sprays:
          1. Nasal antihistamine (e.g., azelastine); or
          2. Nasal cromolyn (sodium cromoglycate); or
          3. Nasal ipratropium; and
        • Nasal steroids (e.g., fluticasone); and
        • One of the following oral medications:
          1. Oral antihistamine (e.g., cetirizine); or
          2. Oral antihistamine-decongestant (e.g., cetirizine-pseudoephedrine); or
          3. Oral leukotriene receptor antagonist (e.g., montelukast); and
        • There is documented positive skin prick test or serologic IgE test to the allergen being used for immunotherapy; and
        • The condition and allergen are such that there is expected to be a therapeutic benefit to the treatment for that specific allergen.
      • Allergic (extrinsic) asthma, when ALL the following criteria are met:
        • Forced Expiratory Volume in 1 second (FEV1) is >70% of the predicted age-specific value; and
        • At least ONE of the following situations is present:
          1. Severity of symptoms, when present, prevents normal daily functioning; or
          2. Symptoms have persisted for 2 or more consecutive seasons or are perennial; and
        • Documented inadequate response after an appropriate trial of ONE of the following, unless specifically contraindicated or poorly tolerated:
          1. Increasing use of short-acting beta2-agonist (e.g., albuterol) or use >2 days/week for symptom relief (not related to incidents of exercise-induced bronchospasm); or
          2. Diagnosed with persistent asthma needing daily medication within levels step 2, step 3, or step 4 as defined by National Asthma Education and Prevention Program or National Heart, Lung, and Blood Institute (e.g., low-medium dose inhaled corticosteroids, long-acting beta2-agonist, cromolyn, leukotriene receptor antagonist, or theophylline).
        • There is documented positive skin prick test or serologic IgE test to the specific allergen being used for immunotherapy; and
        • Avoidance of environmental or situational allergen exposure (e.g, tobacco smoke); and
        • The condition and allergen are such that there is expected to be a therapeutic benefit to the treatment for that specific allergen.
      • Hymenoptera (e.g., bees, ants, hornets, etc.) sting/bite allergy, when ALL the following criteria are met:
        • Documented history of anaphylactic or systemic reaction to the suspected offending venom; and
        • There is documented serologic or skin allergen-specific IgE test evidence to the venom being used for immunotherapy; and
        • Baseline serum tryptase level assessed; and
        • The venom immunotherapy (VIT) used is appropriate for the allergen(s) positive on the skin test and is a single preparation (e.g., not mixed); and
        • The protocol should be as appropriate per manufacturer guidelines (e.g., 1-3 injections per week during the initial treatment phase and then once per 4-12 weeks for maintenance); and
        • The total duration of injections should be 3 years, unless member has any of the following circumstances necessitating longer durations:
          1. History of severe, life threatening reaction; or
          2. Honey bee venom allergy; or
          3. Systemic reactions to VIT; or
          4. Elevated tryptase from baseline (>11.4 ng/ml)
        • The condition and allergen are such that there is expected to be a therapeutic benefit to the treatment for that specific allergen.
2. The member has no contraindications to treatment, including but not limited to any of the following:
   • Current pregnancy or breastfeeding (note; if treatment is started prior to pregnancy or breastfeeding, treatment may be continued in the absence of adverse effects); or
   • Concurrent use of beta blockers; or
   • Moderate to severe asthma or any uncontrolled asthma; or
   • History of severe reaction to any form of immunotherapy; 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)

Accelerated Schedules for SCIT (Rapid Desensitization, Rush/Cluster Schedules)

The Plan considers SCIT with a rapid desensitization protocol medically necessary when ONE or more of the following situations are present:

1. The member has a specific medication allergy and ALL the following criteria are met:
   • The medication is essential for a condition that cannot be effectively treated with alternatives; and
   • The allergic side effects are severe enough to warrant discontinuation; and
   • Member would be at risk of serious complications or health outcomes without the medication; or
2. Member meets above general allergen immunotherapy criteria for hymenoptera allergy above AND is at a reasonable risk of another bite/sting in the near future; or
3. Member has allergic conjunctivitis/rhinitis meeting ALL the following criteria:
   • The above general allergen immunotherapy criteria are met; and
   • Symptoms are moderate to severe in intensity; and
   • Treatment is needed during or immediately before the allergy season; or
4. Member is contemplating pregnancy and meets ONE or more of the following criteria:
   • The general allergen immunotherapy criteria above are met; and
   • ONE of the following situations is present:
     1. The current allergy medications would increase risk to the fetus if the member becomes pregnant; or
     2. Allergen immunotherapy is already being initiated but member plans to get pregnant within the next 3 years

Preparation for SCIT

1. The preparation of allergen extracts should follow these guidelines:
   • Fungal (mold) or cockroach allergen extracts must be prepared and administered individually, not mixed with any other extracts
   • House dust mite, animal dander, and pollen allergens can be mixed together for members sensitized with those specific allergens

Medical Necessity Criteria for Reauthorization

The initial therapy duration is expected to last at least three years. After three years, therapy may be extended only if there is a documented clinical response meeting ONE of the following criteria:

1. Decreased medication usage
2. Improvement in clinical symptoms and sustained benefit from treatment.

Experimental or Investigational / Not Medically Necessary

Allergen immunotherapy for any other indication or using any other method is considered experimental, investigational, or unproven. Non-covered indications include, but are not limited to, the following:

• Home administration of SCIT or non-monitored sublingual immunotherapy (SLIT) taken by mouth for the initial doses
• Allergen immunotherapy in the presence of the following contraindications, or any other contraindication listed above:
  • Severe or very labile asthma, as patients with unstable asthma are at risk for severe bronchospasm during systemic reactions;
  • Significant cardiovascular disease (e.g., unstable angina, recent myocardial infarction, significant arrhythmia, and uncontrolled hypertension);Pregnancy
• Allergen immunotherapy for any of the following indications:
  • Bradykinin-induced, idiopathic, or isolated (standalone) angioedemaAtopic dermatitis not related to dust mites
  • Chronic urticaria
  • Latex allergy
  • Medication allergy except as specifically documented above in criteria
  • Food allergy
  • Intrinsic (non-allergic) asthma
  • Migraine headaches
  • Non-allergic vasomotor rhinitis
• Oral immunotherapy with Palforzia (peanut allergen powder)
• Sublingual immunotherapy for any condition other than allergic rhinitis or conjunctivitis
• The following treatments:
  • Urine auto injections
  • Repository emulsion treatment
  • Low-dose Rinkel technique
  • Acupuncture
  • Rhinophototherapy
  • Oral mucosal/Allerdent
• Venom immunotherapy for severe cutaneous reactions, defined as a generalized rash, swelling, or other skin manifestation of the venom reaction not meeting criteria for anaphylaxis (e.g., no involvement of other organ systems, no swelling of the mouth or throat, etc.)
• Venom immunotherapy for severe local reactions, defined as a reaction localized to the sting/bite site but that does not spread elsewhere in the body and does not meet criteria foranaphylaxis
• Repeat skin or serum IgE testing for response to treatment