CurrentMass General Brigham Health PlanPolicy N/A

Allergy-Specific Immunology: Grastek Odactra Oralair Ragwitek

Prior authorization and quantity limit policy for pharmacy benefit coverage of Grastek, Odactra, Oralair, and Ragwitek for treatment of specific allergen-induced allergic rhinitis/conjunctivitis in eligible members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyAllergy-Specific Immunology: Grastek Odactra Oralair Ragwitek

Policy CodePolicy N/A

Change TypeMaterial revisions to age eligibility and therapy timing

Effective Date08/01/2025

Next Review DateN/A

Key ActionObtain prior authorization and document specialist prescriber or specialist consult within the prior year with required diagnostic testing and prior therapy trials.

SourceLink

POLICY UPDATE CHANGES

Added language for members who are new to the plan regarding authorization review within the first 90 days when currently receiving treatment.

Specified diagnosis criteria for each agent and updated minimum ages for Odactra and Ragwitek from 18 to 5 years to align with FDA labeling.

Clarified that therapy start timing is required relative to pollen/season (Grastek and Ragwitek: 12 weeks prior; Oralair: 4 months prior) and duration limits (Grastek max 3 consecutive years).

5-65Approved age range

30/30dQuantity limit

12 monthsApproval duration

PA required

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Coverage Criteria for Allergen SLIT Tablets

General and Drug-Specific Coverage Criteria

Authorization may be granted when OR: member is new to the plan and currently receiving treatment within the past 90 days OR all of the following general AND drug-specific criteria are met.

Authorization pathways

General Approval Criteria: 1. Prescriber is an allergist or immunologist, or the therapy has been recommended by a specialist via consult within the previous year; 2. Documentation member does not have a diagnosis of severe or uncontrolled asthma; 3. Documented side effect, allergy, inadequate response, or treatment failure with at least one non-sedating antihistamine (e.g., loratadine, cetirizine, fexofenadine); 4. Documented side effect, allergy, inadequate response, or treatment failure with an intranasal corticosteroid; 5. Documented side effect, allergy, inadequate response, or treatment failure with an intranasal antihistamine; 6. Documented side effect, allergy, inadequate response, or treatment failure with a leukotriene modifier (e.g., montelukast); 7. Documentation that the member will be prescribed and trained to self-administer epinephrine rescue therapy; 8. Drug-specific criteria are met.
All General Approval Criteria (items 1-7) must be satisfied before reviewing drug-specific criteria.
Grastek-specific: 1. Diagnosis of grass pollen-induced allergic rhinitis with or without conjunctivitis; 2. Member is 5 to 65 years of age; 3. Positive skin test or in vitro testing confirming pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens; 4. Therapy will begin 12 weeks prior to the allergy season and will not exceed 3 consecutive years (including intervals between seasons).
Grastek (Timothy grass pollen allergen extract).
Odactra-specific: 1. Diagnosis of house dust mite (HDM) induced allergic rhinitis with or without conjunctivitis; 2. Member is 5 to 65 years of age; 3. Positive skin test or in vitro testing confirming IgE to Dermatophagoides farinae or D. pteronyssinus, or skin testing to licensed HDM extracts in adults 65 years and younger.
Odactra (Dermatophagoides farinae and D. pteronyssinus).
Oralair-specific: 1. Diagnosis of grass pollen-induced allergic rhinitis with or without conjunctivitis; 2. Member is 5 to 65 years of age; 3. Positive skin test or in vitro testing confirming pollen-specific IgE antibodies to any of the five grass species contained in the product (Sweet Vernal, Orchard, Perennial Rye, Timothy, Kentucky Blue Grass); 4. Therapy will begin 4 months prior to the expected onset of each specific grass pollen season.
Oralair (mixed grass pollens).
Ragwitek-specific: 1. Diagnosis of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis; 2. Member is 5 to 65 years of age; 3. Positive skin test or in vitro testing for short ragweed pollen-specific IgE antibodies; 4. Therapy will begin 12 weeks prior to the expected onset of each ragweed pollen season.
Ragwitek (short ragweed pollen).

Per the policy's general approval criteria, members with a diagnosis of severe or uncontrolled asthma are excluded from authorization. This requirement is part of the General Approval Criteria that must be met for any of the drug-specific immunotherapy products to be approved; documentation must explicitly confirm the member does not have severe or uncontrolled asthma.

If the member does not meet the policy's General Approval Criteria — including a specialist prescriber or specialist consult within the prior year, absence of severe or uncontrolled asthma, documented trials or intolerance/failure of a non-sedating antihistamine, an intranasal corticosteroid, an intranasal antihistamine, and a leukotriene modifier, and documentation of epinephrine rescue therapy training — and the applicable drug-specific criteria, the request is considered not medically necessary and should be denied.

Provider Requirements and Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required for these pharmacy products. Authorization may be reviewed for members new to the plan within the past 90 days who are currently receiving treatment with the requested medication.

Step Therapy

No step therapy requirement

Step therapy is not required for these products; the policy does not indicate a step therapy requirement.

Documentation Required

Required documentation and tests

Documentation must demonstrate specialist involvement, confirmation of diagnosis by testing, age eligibility, prior medication trials or documented intolerance, and a plan for epinephrine rescue therapy and training.

Key Definitions

Allergen-specific immunotherapy — definition

DefinitionTherapy that exposes patients to controlled amounts of specific allergens to induce immune tolerance and reduce allergy symptoms.

MechanismRepeated administration of allergen extracts (sublingual/tablet) to decrease immune sensitivity to targeted allergens and thereby reduce allergic rhinitis/conjunctivitis symptoms.

Indications (examples)Product-specific indications include treatment of grass pollen–induced allergic rhinitis (Grastek, Oralair), house dust mite–induced allergic rhinitis (Odactra), and short ragweed pollen–induced allergic rhinitis (Ragwitek), each confirmed by positive skin or in vitro testing for allergen-specific IgE.

Age range (typical)Approved for patients 5 through 65 years of age for Grastek, Odactra, Oralair, and Ragwitek.

Intended outcomeInduce immune tolerance to specific allergens and decrease frequency/severity of allergic rhinitis or conjunctivitis symptoms.

Background and Clinical Context

Grastek, Odactra, Oralair, and Ragwitek are allergen-specific immunotherapies intended to reduce sensitivity and symptoms of allergen-induced allergic rhinitis, with or without conjunctivitis. Approval for these products requires meeting the policy’s General Approval Criteria plus product-specific diagnostic confirmation (positive skin or in vitro testing) and other drug-specific requirements.