CurrentBlue Cross Blue Shield - IowaPolicy 05.01.111

Ragwitek (short ragweed pollen) sublingual immunotherapy — Coverage Criteria

Covers medical necessity and prior authorization criteria for Ragwitek (short ragweed pollen sublingual immunotherapy) for members when prescribed by or in consultation with an allergist/immunologist, per member benefit and contract terms.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyRagwitek (short ragweed pollen) sublingual immunotherapy — Coverage Criteria

Policy CodePolicy 05.01.111

Change TypeNo material change

Effective DateAug 26, 2020

Next Review DateApr 1, 2025

Key ActionSubmit prior authorization and document a positive skin or in vitro test for short ragweed pollen-specific IgE and that the prescriber is an allergist/immunologist or consulted one.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5–65FDA-approved age range

12 moTypical approval duration

Prior authAdmin requirement

Positive IgEDiagnostic confirmation

Coverage Criteria for Ragwitek

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Initial Criteria for Approval

Covered when ALL of the following are met

Indication: Ragwitek is prescribed as immunotherapy for short ragweed pollen-induced allergic rhinitis (with or without conjunctivitis)

Includes FDA-approved and compendial uses

Diagnostic confirmation: Diagnosis confirmed by positive skin test or in vitro testing for short ragweed pollen-specific IgE antibodies

Required before approval

Contraindications absent: Patient does not have severe, unstable, or uncontrolled asthma; no history of any severe systemic allergic reaction or any severe local reaction to sublingual allergen immunotherapy; no history of eosinophilic esophagitis

Presence of any listed condition excludes approval

Prescriber: Requested drug is prescribed by or in consultation with an allergist/immunologist

Approval contingent on specialist involvement

Ragwitek is covered when all approval criteria are met. Indication: prescribed as immunotherapy for short ragweed pollen‑induced allergic rhinitis (with or without conjunctivitis). Diagnostic confirmation: diagnosis must be confirmed by a positive skin test or in vitro testing for short ragweed pollen‑specific IgE. Contraindications absent: the patient must not have severe, unstable, or uncontrolled asthma; a history of any severe systemic allergic reaction or any severe local reaction to sublingual allergen immunotherapy; or a history of eosinophilic esophagitis. Prescriber: Ragwitek must be prescribed by or in consultation with an allergist/immunologist. Approval is typically for 12 months.

Ragwitek is not indicated for immediate relief of allergic symptoms and is intended as allergen immunotherapy. Use of Ragwitek in patients with any of the listed contraindications (severe, unstable, or uncontrolled asthma; prior severe systemic allergic reaction or severe local reaction to sublingual allergen immunotherapy; or history of eosinophilic esophagitis) does not meet medical necessity and would be a basis for denial.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Ragwitek requires prior authorization and will be covered when the policy's approval criteria are met. Prior authorization is required before coverage is approved.

Authorization duration: 12 months
Prescriber requirement: prescribed by or in consultation with an allergist/immunologist

Note

Dosing limits may apply

Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and evidence-based practice guidelines.

Documentation Required

Required documentation

Providers must document that Ragwitek is prescribed for short ragweed pollen–induced allergic rhinitis and that the diagnosis was confirmed by positive skin test or in vitro testing for short ragweed pollen–specific IgE. Documentation should also show the patient does not have any contraindicating conditions and that the drug is prescribed by or in consultation with an allergist/immunologist.

Diagnosis confirmation: positive skin test or in vitro testing for short ragweed pollen–specific IgE
Contraindications documented: no severe, unstable, or uncontrolled asthma; no history of severe systemic allergic reaction to sublingual allergen immunotherapy; no history of severe local reaction to sublingual allergen immunotherapy; no history of eosinophilic esophagitis
Prescriber documentation: prescribed by or in consultation with an allergist/immunologist
Approval period documented: intended duration up to 12 months

Denial Risk

Denial risk conditions

Requests may be denied if the diagnosis is not confirmed by positive skin test or in vitro testing for short ragweed pollen–specific IgE, if the patient has severe/uncontrolled asthma or a history of severe systemic or severe local reaction to sublingual allergen immunotherapy, or if there is a history of eosinophilic esophagitis. Requests may also be denied if prescriber specialty/consultation or required documentation is not provided.

Denial reasons include missing diagnostic confirmation (no positive skin or in vitro test)
Denial reasons include presence of severe/uncontrolled asthma, history of severe systemic or severe local reaction to sublingual immunotherapy, or history of eosinophilic esophagitis
Denial reasons include lack of allergist/immunologist prescriber or consultation and insufficient documentation

Definitions

Ragwitek — definition

Product identityRagwitek (short ragweed pollen) — an allergen extract formulated for sublingual immunotherapy

Indication (FDA-approved)Immunotherapy for short ragweed pollen–induced allergic rhinitis, with or without conjunctivitis

Age range (FDA-approved)5–65 years

Diagnostic requirementConfirmed by positive skin test or in vitro testing for short ragweed pollen–specific IgE antibodies

Not indicated forImmediate relief of allergic symptoms

Route of administrationSublingual allergen extract (sublingual immunotherapy)