Currentharvard pilgrim health carePolicy N/A

Allergy immunotherapy (sublingual and oral immunotherapy) coverage

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Defines medical necessity criteria and authorization requirements for coverage of FDA-approved sublingual immunotherapy tablets (Oralair, Odactra) and oral peanut immunotherapy (Palforzia) for applicable Harvard Pilgrim members; excludes Medicare members.

Policy Summary

Payerharvard pilgrim health care

PolicyAllergy immunotherapy (sublingual and oral immunotherapy) coverage

Policy CodePolicy N/A

Change TypeUpdated age requirementsclarified Medicare exclusion

Effective DateDec 1, 2025

Last ReviewNov 4, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document age, confirmatory IgE or skin testing, allergist/immunologist involvement, and required prior trials where applicable.

SourceLink

POLICY UPDATE CHANGES

Updated age requirements for Odactra and Palforzia to reflect updated package labeling.

Clarified that the guideline does not apply to Medicare members.

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Currentharvard pilgrim health carePolicy N/A

Allergy immunotherapy (sublingual and oral immunotherapy) coverage

Customize your policy alerts

Sign up for all harvard pilgrim health care policy alerts

Know when harvard pilgrim health care releases new policies or updates existing guidance.

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Policy Summary

Payerharvard pilgrim health care

PolicyAllergy immunotherapy (sublingual and oral immunotherapy) coverage

Policy CodePolicy N/A

Change TypeUpdated age requirementsclarified Medicare exclusion

Effective DateDec 1, 2025

Last ReviewNov 4, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document age, confirmatory IgE or skin testing, allergist/immunologist involvement, and required prior trials where applicable.

SourceLink

POLICY UPDATE CHANGES

Updated age requirements for Odactra and Palforzia to reflect updated package labeling.

Clarified that the guideline does not apply to Medicare members.

3products with specific coverage criteria (Odactra, Oralair, Palforzia)

2standard approval duration (years)

5-65 yrsOdactra/Oralair age range

1-17 yrsPalforzia initial escalation age

Product-specific Coverage Criteria

Odactra (house dust mite SLIT)

Odactra covered when ALL of the following are met

Odactra coverage criteria: 1) Member age 5-65 years; 2) Confirmation by either in vitro testing for IgE antibodies to Dermatophagoides farina or Dermatophagoides pteronyssinus OR skin testing to licensed house dust mite allergen extracts; 3) Medication prescribed by, or based on the recommendations and consult of, an allergist or immunologist; 4) Member has tried and failed or had an insufficient response or intolerance to at least two generic oral antihistamines, nasal antihistamines, or nasal corticosteroids.all conditions required

per product-specific coverage section

Oralair (grass-mix pollen SLIT)

Oralair covered when ALL of the following are met

Oralair coverage criteria: 1) Member age 5-65 years; 2) Confirmation of a positive skin test or in vitro testing for pollen-specific IgE antibodies for any of: sweet vernal, orchard, perennial rye, Timothy, or Kentucky Blue Grass within the past 2 years; 3) Medication prescribed by, or based on the recommendations and consult of, an allergist or immunologist; 4) Member has tried and failed or had an insufficient response or intolerance to at least two generic oral antihistamines, nasal antihistamines, or nasal corticosteroids.all conditions required

per product-specific coverage section

Palforzia (peanut oral immunotherapy)

Palforzia covered when ALL of the following initial or reauthorization criteria are met

Palforzia initial criteria: Initial: 1) Documentation the Member meets one of: a) age 1-17 years for initial dose escalation OR b) age ≥1 year for up-dosing and maintenance; 2) Confirmed diagnosis of peanut allergy by both: a) documented history of allergic reaction to peanuts AND b) positive in vitro test for peanut-specific IgE or skin test; 3) Medication prescribed by an allergist or immunologist.all conditions required

Initial authorization duration 2 years

Palforzia reauthorization criteria: Reauthorization: 1) Documentation the Member meets one of: a) age ≥1 year for up-dosing and maintenance OR b) age ≥18 years and has been stable on a maintenance dose of Palforzia; 2) Medication prescribed by, or based on the recommendations and consult of, an allergist or immunologist.all conditions required

Subsequent authorizations for 2 years; members stable on drug and new to plan must meet reauthorization criteria

Duration of approval

General SLIT authorization duration

Approval duration: The length of approval for sublingual immunotherapy medications will be for 2 years; subsequent approval will require a new authorization. For Palforzia, initial authorizations are approved for 2 years and subsequent authorizations that meet reauthorization criteria will be for 2 years; members stable on drug and new to plan must meet reauthorization criteria.N/A

See product-specific Palforzia language for reauthorization

This guideline does not apply to Medicare members (includes dual-eligible members).

Requests that do not meet ALL of the product-specific coverage criteria listed in this guideline are not eligible for coverage under these policies.

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for sublingual immunotherapy medications and Palforzia. Approvals are generally issued for a duration of 2 years; subsequent authorizations require a new request and must meet reauthorization criteria. Members who are stable on therapy and are new to the plan must meet reauthorization criteria.

Approval duration: 2 years for sublingual immunotherapy medications and Palforzia
Subsequent approvals: new authorization required and must meet reauthorization criteria

Step Therapy

Required Prior Trials (Step Therapy)

For Odactra and Oralair, the plan requires prior trials (failed therapy) with at least two generic oral antihistamines, nasal antihistamines, or nasal corticosteroids before authorization will be granted.

Odactra: documentation of failure, insufficient response, or intolerance to ≥2 generic oral antihistamines, nasal antihistamines, or nasal corticosteroids

Relevant Codes

CODESmixed

No codes listed

Clinical Background

Sublingual and oral immunotherapy expose patients to controlled, small amounts of allergen extract to induce immune tolerance and reduce allergic symptoms. Sublingual immunotherapy (SLIT) delivers allergen extract under the tongue to modify the immune response and is indicated for pollen-induced allergic rhinitis in specified age ranges. Oral immunotherapy, such as peanut allergen powder, is taken orally to increase tolerance to food allergens and mitigate reactions from accidental exposures; it is used in conjunction with allergen avoidance and is not a substitute for emergency treatment.

FDA approvals for these therapies specify product-specific age ranges, required confirmatory testing (skin testing or in vitro specific IgE), and prescriber qualifications (allergist/immunologist). Coverage determinations in this guideline are made according to those product-specific criteria and required documentation.

Definitions and Product Descriptions

Sublingual immunotherapy (SLIT) — definition / description

DefinitionAdministration of an allergen extract under the tongue to induce immune tolerance and reduce allergic symptoms (sublingual immunotherapy).

MechanismContains small amounts of allergen extract to decrease immune sensitivity and reduce the natural allergic response, resulting in symptom reduction.

FDA age range (examples)Products like Oralair and Odactra are indicated for patients 5 to 65 years of age (product-specific).

Confirmatory testingIndications require confirmation by positive skin testing or in vitro testing for allergen-specific IgE per product labeling.

Clinical useUsed to treat allergic rhinitis (with or without conjunctivitis) due to specific allergens represented by the product formulation.

Policy Revision History

2025-12-01material_updateLatest

Updated age requirements for Odactra and Palforzia to reflect updated package labeling; listed as effective December 1, 2025 in approval history.

2023-12-01policy_change

Updated age requirements for Odactra to reflect updated package labeling; listed as effective December 1, 2023 in approval history.

2022-09-13review

Policy Summary

Payerharvard pilgrim health care

PolicyAllergy immunotherapy (sublingual and oral immunotherapy) coverage

Policy CodePolicy N/A

Change TypeUpdated age requirementsclarified Medicare exclusion

Effective DateDec 1, 2025

Last ReviewNov 4, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document age, confirmatory IgE or skin testing, allergist/immunologist involvement, and required prior trials where applicable.

SourceLink

On This Page

Oralair: documentation of failure, insufficient response, or intolerance to ≥2 generic oral antihistamines, nasal antihistamines, or nasal corticosteroids

Documentation Required

Documentation Requirements

Required documentation must accompany all prior authorization requests. Include age verification, confirmatory testing results, prescriber specialty, and origin of the prescription.

Age: documentation the member is within the age ranges specified by product (Odactra and Oralair: 5–65 years; Palforzia: initial dosing/up‑dosing rules and age per product labeling)
Confirmatory testing: Odactra — in vitro IgE to D. farinae or D. pteronyssinus OR skin testing to licensed house dust mite extracts; Oralair — positive skin test or in vitro pollen-specific IgE for listed grasses within the past 2 years; Palforzia — documented history of allergic reaction to peanuts AND positive peanut-specific IgE (in vitro or skin test)
Prescriber: documentation the medication is prescribed by, or based on the recommendations/consult of, an allergist or immunologist
Prescription origin: note if prescribed for initial dose escalation, up‑dosing, or maintenance as applicable

Denial Risk

Failure to Meet Product-Specific Criteria — Denial Risk

Requests that do not meet product-specific criteria (age limits, required confirmatory testing, prescriber specialty, or required prior trials) are at risk for denial. Ensure all required items are clearly documented to avoid delays or adverse determinations.

Denial risk if age criteria not met (e.g., Odactra/Oralair: 5–65 years)
Denial risk if confirmatory testing is absent or outdated (e.g., Oralair: tests >2 years old)
Denial risk if prescriber is not an allergist or immunologist or if consult/recommendation documentation is missing
Denial risk if required prior trials (≥2 agents) are not documented or if intolerance/insufficiency is not shown

Palforzia — product definition / indication summary

ProductPalforzia (Peanut, Arachis hypogaea, allergen powder-dnfp).

IndicationOral immunotherapy indicated to mitigate allergic reactions, including anaphylaxis, that may occur with accidental peanut exposure in patients with confirmed peanut allergy.

Age and dosing notesInitial dose escalation may be administered to patients 1 through 17 years of age; up-dosing and maintenance may be continued in patients 1 year of age and older.

Adjunctive measuresTo be used in conjunction with a peanut-avoidant diet; not indicated for emergency treatment of allergic reactions, including anaphylaxis.

Requirement for confirmationApproved for use in patients with a confirmed diagnosis of peanut allergy.

Policy reviewed by the Pharmacy & Therapeutics Committee (approval history entry).