Subject: Grastek PA Policy 1133-A UDR 02-2024

Drug

GRASTEK  (timothy grass pollen allergen extract)

Policy:

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
The requested drug will be covered with prior authorization when the following criteria are met:
     •   The requested drug is being prescribed as immunotherapy for the treatment of grass pollen-
          induced allergic rhinitis
          AND
               °   The request is NOT for continuation of therapy
                    AND
                    •   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
                    AND
                    •   The patient does not have ANY of the following: A) Severe, unstable or uncontrolled
                         asthma, B) History of any severe systemic allergic reaction, C) History of any severe
                         local reaction after taking any sublingual allergen immunotherapy, D) History of
                         eosinophilic esophagitis
                    AND
                    •   The requested drug is being prescribed by, or in consultation with, an allergist or
                         immunologist
          OR
          °   The request is for continuation of therapy
               AND
               •   The patient has achieved or maintained improvement in rhinoconjunctivitis symptoms
                    (e.g., runny nose, stuffy nose, sneezing, itchy nose, gritty/itchy eyes, watery eyes), OR
                    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.; 2023. https://online.lexi.com. Accessed January 02,

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.

August 11, 2024