CurrentHealth NetPolicy CP PMN.85

Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract (Oralair)

Covers medical necessity and prior authorization criteria for Oralair (sweet vernal, orchard, perennial rye, timothy, and Kentucky bluegrass mixed pollens) used as sublingual immunotherapy for grass pollen-induced allergic rhinitis for commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicySweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract (Oralair)

Policy CodePolicy CP PMN.85

Change TypeNo material change

Effective Date11.16.16

Next Review DateAug 25, 2025

Key ActionSubmit prior authorization with documentation confirming diagnosis, prescriber specialty, age, positive testing for at least one of the five grasses, and step therapy failures as specified.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5-65FDA approved age range

300 IR/dayMaximum maintenance dose

12 monthsApproval duration

5 speciesAllergens contained

100, 300 IRTablet strengths

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Coverage Criteria for Oralair

Initial Therapy

Covered when ALL of the following are met

Initial Approval: 1. Diagnosis of grass pollen-induced allergic rhinitis; 2. Prescribed by or in consultation with an allergist or immunologist; 3. Age 5 through <65 years; 4. Confirmation of a positive skin test or in vitro testing for pollen-specific IgE for at least one of the five grass species (sweet vernal, orchard, perennial rye, timothy, Kentucky blue grass); 5. Failure of one intranasal corticosteroid unless clinically significant adverse effects or contraindication; 6. Failure of one oral antihistamine at up to maximally indicated doses unless clinically significant adverse effects or contraindication; 7. Dose requested does not exceed age-appropriate maximums (see dosing limits).age 5-64

For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395

Continuation Therapy

Covered when ALL of the following are met

Continuation Therapy: 1. Member is currently receiving the medication via the benefit or previously met initial approval criteria or is enrolled in continuity of care per state/product requirements; 2. Member is responding positively to therapy; 3. If a dose increase is requested, the new dose does not exceed 300 IR per day and does not exceed 1 tablet per day for adults.300 IR/day

Approval durations specified per line of business (e.g., Medicaid/HIM 12 months)

Non‑FDA approved indications for Oralair are not authorized under this policy unless the provider submits sufficient documentation of efficacy and safety in accordance with applicable off‑label use policies (e.g., CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP PMN.53 for Medicaid) or the member’s evidence of coverage. Requests for indications outside the FDA‑approved indication must include the clinical evidence required by those off‑label policies to be considered for coverage.

Oralair is contraindicated in members with a history of severe allergic reactions (boxed warning) and in those with severe, unstable, or uncontrolled asthma. Coverage is also precluded for members with a history of eosinophilic esophagitis, a prior severe systemic allergic reaction or any severe local reaction to sublingual allergen immunotherapy, or known hypersensitivity to any inactive ingredient in the product.

For Medicaid members, state Medicaid coverage provisions take precedence when they conflict with the provisions in this clinical policy. Providers should consult the applicable state Medicaid manual for any differing coverage requirements or limitations that apply to the member.

Requests for off‑label use that are not FDA‑approved and that do not include required documentation per the referenced off‑label policies will not be authorized. Providers must submit the supporting clinical documentation outlined in the off‑label guidance for the request to be considered.

Dosage, Strengths, and Coding

Oralair tablet strengthsmixed

100 IR	Oralair tablet strength
300 IR	Oralair tablet strength

Maximum daily dose — 300 IR/day

Maximum daily dose300 IR per day

Pediatric dosing noteAge 5–17: escalate to 300 IR per day (100 IR day 1, 200 IR day 2, 300 IR day 3 and thereafter)

Adult dosing noteAge 18–65: 300 IR sublingually once daily

Treatment initiation timing — start 4 months before season

Initiation timingStart treatment approximately 4 months before the expected onset of each grass pollen season

Treatment durationContinue treatment throughout the grass pollen season once initiated

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers must submit supporting documentation (such as office chart notes, lab results, or other clinical information) demonstrating the member meets all approval criteria. Failure to provide the required documentation may result in denial of the request.

Required documentation: office chart notes, results of positive skin test or in vitro pollen-specific IgE testing, history of prior therapies and adverse effects, and documentation of prescriber specialty or consultation.
Denial risk: incomplete or missing documentation of diagnosis, testing, age, prescriber specialty, or prior therapy failures may lead to denial.
Approval duration: follow applicable line-of-business approval durations (e.g., Commercial historically revised to 12 months).

Documentation Required

Follow Coverage Documents and Regulatory Requirements

Providers must follow the coverage documents (e.g., evidence of coverage, certificate of coverage, policy/contract) and applicable state and federal rules. This clinical policy does not supersede the terms, conditions, exclusions, and limitations in the member's coverage documents or any applicable law or regulation.

Background on Oralair

Oralair is a sublingual immunotherapy tablet formulated from extracts of five grass pollens (sweet vernal, orchard, perennial rye, timothy, and Kentucky bluegrass) for the treatment of grass pollen‑induced allergic rhinitis with or without conjunctivitis. Treatment is seasonal and should be initiated approximately 4 months before the expected start of the grass pollen season and continued throughout the season. The product is supplied in tablet strengths of 100 IR and 300 IR.

Definitions and Abbreviations

IR definition (index of reactivity)

DefinitionIR = index of reactivity; a unit used to express the potency/strength of Oralair tablets (e.g., 100 IR, 300 IR)

Clinical contextIR values are used in the dosing regimen (e.g., 100 IR on day 1, 200 IR on day 2, 300 IR once daily thereafter for children)

Product labelingIR is referenced in product availability and dosing instructions for Oralair

Oralair — tablet strengths and initiation timing definition

Available tablet strengths100 IR and 300 IR tablets

Initiation/uptitration regimen (age 5–17)Day 1: 100 IR; Day 2: 200 IR; Day 3 and thereafter: 300 IR once daily