CurrentCignaPolicy N/A

Allergen Immunotherapy - Grass Pollen Sublingual Products Prior Authorization Policy

Defines prior authorization requirements and medical necessity criteria for coverage of Grastek and Oralair for grass pollen–induced allergic rhinitis for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyAllergen Immunotherapy - Grass Pollen Sublingual Products Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateOct 8, 2025

Key ActionObtain prior authorization and document patient age and positive testing confirming grass pollen–induced allergic rhinitis.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2sublingual grass pollen products covered

5-65FDA-indicated age range

12w / 4moinitiation timing

1 yrapproval period

Coverage and Medical Necessity Criteria

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FDA-Approved Indication: Approval for 1 year requires meeting A, B, and C

A: Patient is >= 5 years of age>=5 years

FDA age indication 5-65 years

B.i: Grastek initiated 12 weeks prior to expected grass pollen season OR dosed daily continuously for consecutive grass pollen seasons12 weeks or continuous
Grastek labeling
B.ii: Oralair initiated 4 months prior to expected onset of grass pollen season4 months
Oralair labeling

C.i: Positive skin test response to a grass pollen from the Pooideae subfamilypositive skin prick test
Examples include sweet vernal, Kentucky blue, Timothy, orchard, perennial rye
C.ii: Positive in vitro test for allergen-specific IgE to a Pooideae grasspositive specific IgE

Concurrent use of Grastek or Oralair with any other allergen immunotherapy is excluded from coverage. This includes concomitant subcutaneous allergen immunotherapy ("allergy shots") and other sublingual or oral products such as Odactra®, Ragwitek®, and Palforzia®. Product labeling states the efficacy of Grastek and Oralair has not been evaluated when given with other allergen immunotherapy, and concomitant dosing may increase the risk of local or systemic adverse events; such concurrent use is considered not medically necessary and will not be covered.

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Grastek and Oralair. Approvals are provided for 1 year when criteria are met.

Applies to Grastek and Oralair
Approval duration: 1 year when criteria met

Note

Provider Instructions / Action

Submit each coverage request with the specific clinical facts of the patient’s situation. Medical directors may exercise clinical judgment. Ensure claims use the most appropriate diagnosis and procedure codes as of the submission date; services billed without covered codes under the applicable coverage policy will be denied.

Use most appropriate codes as of the effective date of submission
Coverage determinations rely on submitted diagnosis/procedure codes

Documentation Required

Required Clinical Documentation

Required clinical documentation: patient age within the FDA-indicated range and evidence confirming grass pollen–induced allergic rhinitis.

Age: ≥ 5 and ≤ 65 years (per product labeling)
Documentation of allergy confirmation via one of the following:
• Positive skin test to a grass pollen from the Pooideae subfamily (examples: sweet vernal, Kentucky blue grass, Timothy, orchard, perennial rye); OR
• Positive in vitro (blood) test for allergen-specific IgE to a grass in the Pooideae subfamily

Denial Risk

Denial Triggers / Billing Risks

Denial triggers include missing or incorrect diagnosis/procedure codes and services that do not meet coverage criteria.

Missing or incorrect diagnosis or procedure codes
Services not meeting the coverage criteria (e.g., age outside FDA range, lack of confirmatory skin or in vitro testing, initiation timing not consistent with product labeling)
Concurrent use with other allergen immunotherapy (subcutaneous or certain sublingual products) — considered not medically necessary

Background

Grastek and Oralair are sublingual grass pollen allergen extracts indicated for treatment of grass pollen–induced allergic rhinitis, with or without conjunctivitis, when the diagnosis is confirmed by positive skin testing or in vitro specific IgE to relevant grasses. Per labeling, Grastek (Timothy grass pollen extract) is typically initiated 12 weeks prior to the expected grass pollen season or may be dosed continuously across seasons, while Oralair (a mix of sweet vernal, orchard, perennial rye, Timothy, and Kentucky blue grass pollens) is initiated 4 months before season onset; both are continued throughout the season. The FDA-indicated age range for these products is 5 through 65 years. Prior authorization is recommended for prescription benefit coverage when criteria are met; approvals are provided for 1 year.

Definitions

Pooideae subfamily grasses — diagnostic examples and testing criteria

DefinitionPooideae subfamily grasses: group of grasses used for diagnostic testing and as examples of relevant allergens including sweet vernal, Kentucky blue grass, Timothy grass, orchard, and perennial rye grass.

Diagnostic requirementA positive skin test response to a grass pollen from the Pooideae subfamily fulfills the documented testing requirement for grass pollen–induced allergic rhinitis.

Alternate diagnosticA positive in vitro test (blood test) for allergen-specific IgE to a Pooideae grass also confirms diagnosis.

Examples (non‑exhaustive)Sweet vernal; Kentucky blue grass; Timothy grass; Orchard grass; Perennial rye grass.

Relevance to productsThese Pooideae grasses are the referenced allergens for confirming eligibility for Grastek (Timothy or cross-reactive pollens) and Oralair (contains five grass pollens) per FDA‑approved indications.