Subject: Grastek PA Policy 1133-A 04-2022

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 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 or any severe local reaction to
             sublingual allergen immunotherapy, C) History of eosinophilic
             esophagitis
      AND
      •      The requested drug is being prescribed by, or in consultation
              with, an allergist or immunologist

Place of Service:

Outpatient

The above policy is based on the following references:

1. Grastek [package insert]. Hørsholm, Denmark: ALK-Abelló A/S; August 2020.
2. Lexicomp Online, Lexi-Drugs. Hudson, Ohio: UpToDate, Inc.; 2021; Accessed March 14, 2022.
3. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed March 14, 2022.

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 14, 2022