Colorado Rocky Mountain Health Plans SLIT Prior Auth

Coverage Criteria for SLIT Products

Initial Therapy - Grastek

Grastek — Covered when ALL of the following are met

Grastek initial criteria: (1) Diagnosis of moderate to severe grass pollen-induced allergic rhinitis defined by symptoms severe enough to interfere with quality of life (e.g., sleep disturbances; impairment of daily, sport, or leisure activities; impairment of school or work performance); AND (2) Diagnosis confirmed by one of the following: a. Positive skin test to Timothy grass or cross-reactive grass pollens (e.g., Sweet Vernal, Orchard/Cocksfoot, Perennial Rye, Kentucky blue/June grass, Meadow Fescue, or Redtop); b. in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens; AND (3) Treatment is started or will be started at least 12 weeks before the beginning of the grass pollen season; AND (4) History of failure, contraindication, or intolerance to two of the following: a. oral antihistamine; b. intranasal antihistamine; c. intranasal corticosteroid; d. leukotriene inhibitor; AND (5) Not received in combination with similar cross-reactive grass pollen immunotherapy (e.g., Oralair); AND (6) Patient does not have unstable and/or uncontrolled asthma; AND (7) Prescribed by or in consultation with a specialist in allergy and immunology.

Reauthorization - Grastek

Grastek — Reauthorization

Grastek reauthorization: Documentation of positive clinical response to Grastek therapy.

Initial Therapy - Oralair

Oralair — Covered when ALL of the following are met

Oralair initial criteria: (1) Diagnosis of moderate to severe grass pollen-induced allergic rhinitis defined by symptoms severe enough to interfere with quality of life (e.g., sleep disturbances; impairment of daily, sport, or leisure activities; impairment of school or work performance); AND (2) Diagnosis confirmed by one of the following: a. Positive skin test to any of the five grass species contained in Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue grass) or cross-reactive grass pollens; b. in vitro testing for pollen-specific IgE antibodies to any of the five grass species contained in Oralair or cross-reactive grass pollens; AND (3) Treatment is started or will be started at least 4 months before the beginning of the grass pollen season; AND (4) History of failure, contraindication, or intolerance to two of the following: a. oral antihistamine; b. intranasal antihistamine; c. intranasal corticosteroid; d. leukotriene inhibitor; AND (5) Not received in combination with similar cross-reactive grass pollen immunotherapy (e.g., Grastek); AND (6) Patient does not have unstable and/or uncontrolled asthma; AND (7) Prescribed by or in consultation with a specialist in allergy and immunology.

Reauthorization - Oralair

Oralair — Reauthorization

Oralair reauthorization: Documentation of positive clinical response to Oralair therapy.

Initial Therapy - Ragwitek

Ragwitek — Covered when ALL of the following are met

Ragwitek initial criteria: (1) Diagnosis of moderate to severe short ragweed pollen-induced allergic rhinitis defined by symptoms severe enough to interfere with quality of life (e.g., sleep disturbances; impairment of daily, sport, or leisure activities; impairment of school or work performance); AND (2) Diagnosis confirmed by one of the following: a. Positive skin test to short ragweed pollen; b. in vitro testing for pollen-specific IgE antibodies for short ragweed pollen; AND (3) Treatment is started or will be started at least 12 weeks before the beginning of the short ragweed pollen season; AND (4) History of failure, contraindication, or intolerance to two of the following: a. oral antihistamine; b. intranasal antihistamine; c. intranasal corticosteroid; d. leukotriene inhibitor; AND (5) Patient does not have unstable and/or uncontrolled asthma; AND (6) Prescribed by or in consultation with a specialist in allergy and immunology.

Reauthorization - Ragwitek

Ragwitek — Reauthorization

Ragwitek reauthorization: Documentation of positive clinical response to Ragwitek therapy.

Initial Therapy - Odactra

Odactra — Covered when ALL of the following are met

Odactra initial criteria: (1) Diagnosis of house dust mite (HDM)-induced allergic rhinitis; AND (2) Diagnosis confirmed by one of the following: a. Positive skin test to licensed house dust mite allergen extracts; b. in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites; AND (3) History of failure, contraindication, or intolerance to two of the following: a. oral antihistamine; b. intranasal antihistamine; c. intranasal corticosteroid; d. leukotriene inhibitor; AND (4) Patient does not have unstable and/or uncontrolled asthma; AND (5) Prescribed by or in consultation with a specialist in allergy and immunology.

Reauthorization - Odactra

Odactra — Reauthorization

Odactra reauthorization: Documentation of positive clinical response to Odactra therapy.

This coverage policy prohibits simultaneous use of cross-reactive grass pollen sublingual immunotherapy (SLIT) products. Specifically, Grastek must not be used in combination with Oralair, and vice versa. This constraint reflects the products’ overlapping indications for grass pollen allergens and is enforced as part of the product-specific authorization requirements.

Use of any SLIT product in patients with unstable and/or uncontrolled asthma is excluded from coverage. Requests for Grastek, Oralair, Ragwitek, or Odactra will not be approved when the patient has evidence of unstable or uncontrolled asthma, and prescribers must document asthma control status as part of the authorization submission.

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for sublingual immunotherapy products (Grastek, Oralair, Ragwitek, Odactra). When product-specific criteria are met, authorization will be issued for 12 months.

Applies to Grastek, Oralair, Ragwitek, Odactra
Authorization duration: 12 months when criteria met

Step Therapy

Step Therapy Requirement

A history of failure, contraindication, or intolerance to two listed therapies is required before initiating SLIT therapy. Ensure documentation clearly states prior use and reason for discontinuation/intolerance for each therapy.

Required failures/contraindications/intolerances must include two of: oral antihistamine (e.g., cetirizine), intranasal antihistamine (e.g., azelastine), intranasal corticosteroid (e.g., fluticasone), leukotriene inhibitor (e.g., montelukast)
Separate requirements for specific products: Grastek, Ragwitek, and Odactra require treatment start ≥12 weeks before pollen season (where applicable); Oralair requires start ≥4 months before season

Key Definitions

Definition — SLIT medications indicated for allergic rhinitis with specific IgE to relevant allergens (e.g., grass pollens, ragweed, house dust mite).

Indication overviewSLIT medications are indicated for patients with allergic rhinitis due to natural exposure to relevant allergens who demonstrate specific IgE antibodies to the relevant allergen.

Examples of product–allergen pairsGrastek — Timothy grass; Oralair — mix of Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue grass pollens; Ragwitek — short ragweed pollen; Odactra — Dermatophagoides farinae and D. pteronyssinus (house dust mite).

Candidate patient characteristicsPatients with symptoms not adequately controlled by medications and avoidance measures, those with unacceptable medication adverse effects, or patients wishing to reduce long-term medication use.

Diagnostic requirementDemonstration of specific IgE antibodies to the relevant allergen (positive in vitro test) or equivalent confirmation (e.g., skin test).

Clinical settingUsed for allergic rhinitis caused by natural exposure to the named allergens (grass pollens, ragweed, house dust mite).

Background

Sublingual immunotherapy (SLIT) products are indicated for patients with allergic rhinitis due to specific allergens who demonstrate sensitization by positive skin testing or in vitro pollen-specific IgE. These prescription SLIT medications (including Grastek, Oralair, Ragwitek, and Odactra) deliver allergen extracts sublingually to induce immunologic tolerance and reduce symptoms over time. Candidates typically have symptoms that interfere with quality of life despite conventional therapies or have contraindications/intolerance to those therapies; confirmation of allergen-specific IgE and specialist involvement are required for authorization.

OpenPayer

Prior Authorization and Medical Necessity Criteria — Sublingual Immunotherapy (SLIT)

Coverage Criteria for SLIT Products

Provider Actions, Authorization, and Documentation

Key Definitions

Background