Subject: Grastek PA 1133-A P02-2026 v2

Drug

GRASTEK  (timothy grass pollen allergen extract)

Policy:

Indications

FDA-approved Indications

Grastek is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. Grastek is approved for use in persons 5 through 65 years of age.

Grastek is not indicated for the immediate relief of allergic symptoms.

Coverage Criteria

Grass Pollen-Induced Allergic Rhinitis

Authorization may be granted when the requested drug is being prescribed as immunotherapy for the treatment of grass pollen-induced allergic rhinitis when ALL of the following criteria are met:

·        The diagnosis has been confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens.

·        The patient does not have ANY of the following: severe, unstable or uncontrolled asthma; history of any severe systemic allergic reaction; history of any severe local reaction after taking any sublingual allergen immunotherapy; history of eosinophilic esophagitis.

·        The requested drug is being prescribed by, or in consultation with, a healthcare professional with adequate training and experience in the diagnosis and treatment of allergic diseases.

Continuation of Therapy

Grass Pollen-Induced Allergic Rhinitis

Authorization may be granted when the requested drug is being prescribed as immunotherapy for the treatment of grass pollen-induced allergic rhinitis when ONE of the following criteria is met:

·        The patient has achieved or maintained improvement in rhinoconjunctivitis symptoms (e.g., runny nose, stuffy nose, sneezing, itchy nose, gritty/itchy eyes, watery eyes).

·        The patient had a reduction in use of allergy symptom-relieving medications (e.g., antihistamines, corticosteroids).

Duration of Approval (DOA)

·        1133-A: DOA: 12 Months

Place of Service:

Outpatient

The above policy is based on the following references:

1.     Grastek [package insert]. Hørsholm, Denmark: ALK-Abelló A/S; September 2022.

2.     Lexicomp Online, Lexi Drugs.. Waltham, MA: UpToDate, Inc.; 2026. https://online.lexi.com. Accessed January 03, 2026.

3.     Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 01/02/2026).

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

June 15, 2026