CurrentAvMedPolicy N/A

Sublingual Grass Pollen Immunotherapy (Grastek, Oralair) Prior Authorization Coverage Criteria

Provides AvMed prior authorization and clinical coverage criteria for Grastek and Oralair (sublingual grass pollen allergen immunotherapy) for members; governs providers requesting pharmacy PA for these products.

Policy Summary

PayerAvMed

PolicySublingual Grass Pollen Immunotherapy (Grastek, Oralair) Prior Authorization Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed AvMed pharmacy PA form with prescriber signature and required documentation (including allergy test results and prior therapy verification) via fax to 1-305-671-0200.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 yearsLength of authorization

5-65Grastek age range

10-65Oralair age range

12–16 wksStart before season

Coverage Criteria

Initial therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Prescriber: Medication is prescribed by or in consultation with an allergist or immunologist.

Age requirement: For Grastek: member age between 5 and 65 years; For Oralair: member age between 10 and 65 years.

Treatment initiation timing: For Grastek: treatment initiated at least 12 weeks before the expected onset of each grass pollen season and continued throughout the season; For Oralair: treatment initiated at least 16 weeks before the expected onset of each grass pollen season and continued throughout the season.

Diagnosis confirmation:

Policy Summary

PayerAvMed

PolicySublingual Grass Pollen Immunotherapy (Grastek, Oralair) Prior Authorization Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed AvMed pharmacy PA form with prescriber signature and required documentation (including allergy test results and prior therapy verification) via fax to 1-305-671-0200.

SourceLink

On This Page

Prior pharmacotherapy: Member has had trial and inadequate symptom control with at least TWO of the following within the past 12 months, verified by chart notes or pharmacy paid claims: intranasal corticosteroid (e.g., fluticasone, budesonide, triamcinolone); intranasal antihistamine (e.g., azelastine, olopatadine); oral antihistamine (e.g., levocetirizine); leukotriene inhibitor (e.g., montelukast, zafirlukast).2 therapies

Provide documentation of trials (chart notes or paid claims).

Coverage will be denied if the member is receiving concomitant therapy with other allergen immunotherapy products (for example, concurrent use of Oralair, Grastek, or subcutaneous allergy injections), or if the member has any of the following: history of severe, unstable or uncontrolled asthma, history of severe systemic allergic reaction, or history of eosinophilic esophagitis. The provider must attest to absence of these excluded conditions and documentation (claims/chart notes) may be reviewed to confirm concurrent therapies or the listed medical histories.

Coding and Age Limits

Covered products (brand names)mixedCovered

Grastek	Timothy Grass Pollen Extract (sublingual tablet)
Oralair	Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract (sublingual tablets)

Covered products (brand names) - notesmixed

Length of Authorization	3 years (authorization issued for 12-month period and remains active for 3 consecutive years)
Dosing	Dissolve one tablet under the tongue daily for 3 consecutive years

Diagnosis code (member-supplied)ICD-10

ICD code

Member diagnosis ICD code — to be supplied on form

Age

Grastek age rangeMember must be between 5 and 65 years

Oralair age rangeMember must be between 10 and 65 years

Age verification sourceAge requirement documented on PA form under clinical criteria

Provider Actions & Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit a completed AvMed pharmacy prior authorization form signed by the prescribing physician (preprinted stamps not acceptable) and fax to 1-305-671-0200. Authorization length: up to a 12-month period and may be active for up to 3 consecutive years when criteria met. Incomplete, incorrect, or illegible forms or missing required documentation may delay or result in denial of authorization.

Fax: 1-305-671-0200
Prescriber signature required (no preprinted stamps)
Authorization length: 12 months per period; total approval may be for 3 consecutive years when criteria met

Denial Risk

Concurrent Therapy or Sample Initiation

Requests will be denied if samples were used to initiate therapy or if the member is receiving concurrent therapy with another allergen immunotherapy product (e.g., concurrent Oralair, Grastek, or SQ allergy shots). Review pharmacy and medical claims to confirm no overlapping allergen immunotherapy.

Use of samples to initiate therapy does not meet step edit/preauthorization criteria
Only one grass allergen-specific immunotherapy product can be approved at a time

Documentation Required

Allergy Test Documentation Required

Submit objective allergy test documentation demonstrating grass pollen sensitization. Provide results of a positive skin prick test or positive in vitro pollen-specific IgE testing for at least one grass pollen contained in the requested product.

Acceptable tests: positive skin prick test OR positive in vitro pollen-specific IgE
Test must demonstrate sensitivity to at least one grass species contained in the requested product (Sweet Vernal, Orchard, Perennial Rye, Timothy, Kentucky Blue Grass, meadow fescue, or Redtop)

Step Therapy

Therapy Trial and Epinephrine Documentation

Provide evidence of therapeutic trials and epinephrine availability. Documentation must show inadequate symptom control with at least two standard pharmacotherapies within the past 12 months and verification that auto-injectable epinephrine has been prescribed.

Trials required (at least TWO within past 12 months): intranasal corticosteroid; intranasal antihistamine; oral antihistamine; leukotriene inhibitor — verified by chart notes or pharmacy paid claims
Provider must prescribe auto-injectable epinephrine (verified by chart notes or pharmacy paid claims)

Background

Sublingual immunotherapy with grass pollen tablets (Grastek and Oralair) is used to treat grass pollen–induced allergic rhinitis with or without conjunctivitis. Treatment is generally recommended to be started several weeks before the grass pollen season (the form requires initiation timing and continued therapy through the season) and continued for a typical course of three consecutive years. Authorization and monitoring include documentation of diagnosis, allergy test results, and prior pharmacotherapy trials.

OpenPayer

Sublingual Grass Pollen Immunotherapy (Grastek, Oralair) Prior Authorization Coverage Criteria

Coverage Criteria

Coding and Age Limits

Provider Actions & Submission Requirements

Background

Definitions