ModifiedmhnPolicy CP.PMN.84

Timothy Grass Pollen Allergen Extract (Grastek)

Defines medical necessity criteria, dosing, contraindications, and prior authorization requirements for Grastek (timothy grass pollen sublingual immunotherapy) for beneficiaries across Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyTimothy Grass Pollen Allergen Extract (Grastek)

Policy CodePolicy CP.PMN.84

Change TypeStep therapy bypass (IL)commercial approval duration revised

Effective Date11.16.16

Next Review Date

Key ActionSubmit prior authorization with documentation that the member meets initial or continued therapy criteria; approvals granted for up to 12 months.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less.

References and template updates applied in 2021-2024 annual reviews with no significant clinical changes.

5-65 yrsFDA-approved age range

1 tablet/dayMaximum daily dose

12 monthsStandard approval duration

2,800 BAUTablet potency

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Approval - Allergic Rhinitis: 1. Diagnosis of grass pollen-induced allergic rhinitis; 2. Prescribed by or in consultation with an allergist or immunologist; 3. Age ≥ 5 years and ≤ 65 years; 4. Confirmation of a positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass pollen or cross-reactive grass pollens (e.g., sweet vernal, orchard, perennial rye, Kentucky blue/June grass, meadow fescue, or redtop); 5. Failure of one intranasal corticosteroid unless clinically significant adverse effects are experienced or all are contraindicated; 6. Failure of one oral antihistamine at up to maximally indicated doses unless clinically significant adverse effects are experienced or all are contraindicated; 7. Dose does not exceed 1 tablet per day.age 5-65; dose ≤1 tablet/day

For Illinois HIM requests, step therapy requirements (items 5 and 6) do not apply as of 1/1/2026 per IL HB 5395

Continuation Therapy

Covered when ALL of the following are met:

Continued Therapy - Allergic Rhinitis: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed 1 tablet per day.dose ≤1 tablet/day

Approval duration: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less.

Non-FDA approved indications not explicitly addressed in this clinical policy are not authorized for coverage unless the provider supplies sufficient documentation of efficacy and safety consistent with applicable off-label use policies. Refer to the off-label use policies for each line of business (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 when submitting supporting clinical information.

When state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid provisions take precedence. Providers must follow applicable state Medicaid manuals and the member's evidence of coverage; coverage decisions are subject to the terms, conditions, exclusions, and limitations of the coverage documents and governing law or regulation.

Use of Grastek outside the FDA-approved indication or age range (ages 5 through 65 years) or in patients with listed contraindications is not authorized unless the request is supported by sufficient evidence and processed per the applicable off-label use policies. Contraindications include severe, unstable, or uncontrolled asthma; history of eosinophilic esophagitis; history of severe systemic or severe local reactions to sublingual allergen immunotherapy; and hypersensitivity to inactive ingredients (gelatin, mannitol, sodium hydroxide).

Coding

Policy identifiermixed

CP.PMN.84

Policy reference number

Maximum daily dosing

Maximum daily dose1 tablet per day

Dosing frequencyOnce daily (sublingual)

Initiation timingStart at least 12 weeks before expected pollen season

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for products covered under this policy. Approvals are granted for 12 months for Medicaid/HIM. For Commercial lines of business, approvals are granted for 12 months or for the duration of the request, whichever is less. Requests lacking required prior authorization will be denied or returned.

Medicaid/HIM: 12 months
Commercial: 12 months or duration of request, whichever is less

Note

Coverage Decision Constraints

Providers must follow this clinical policy, applicable state and federal requirements, and Health Plan-level administrative policies when submitting requests and delivering care. Coverage decisions are subject to the terms, conditions, exclusions and limitations of the member's coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract) and applicable law. This policy is a guide to medical necessity and does not guarantee payment or dictate clinical practice.

Background

Grastek is an FDA-approved sublingual allergen immunotherapy indicated for the treatment of timothy grass (grass) pollen–induced allergic rhinitis with or without conjunctivitis. Approval requires confirmation by positive skin testing or in vitro testing for timothy grass or cross-reactive grass pollens. Grastek is approved for use in persons aged 5 through 65 years and is not indicated for immediate symptom relief.

Definitions

Grastek (definition and dosing)

Product descriptionSublingual immunotherapy tablet containing 2,800 BAU of timothy grass pollen extract

Dosage per administrationOne tablet (2,800 BAU) taken once daily

Approved age range5 through 65 years

Treatment duration guidanceMay be taken daily for three consecutive years for sustained season-long effectiveness

Clinical policy (definition)

PurposeGuide to medical necessity used to assist coverage decisions and administering benefits

Not a contract