Subject: Ragwitek PA Policy 1134-A 02-2023

Drug

RAGWITEK  (short ragweed pollen allergen extract)

Policy:

FDA-APPROVED INDICATIONS
Ragwitek is an allergen extract indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen. Ragwitek is approved for use in persons 5 through 65 years of age.

Ragwitek 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 short ragweed pollen-induced allergic rhinitis
     AND
          º   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 short
                    ragweed pollen.
               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
          º   The request is for continuation of therapy
               AND
               •   The patient 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)

Place of Service:

Outpatient

The above policy is based on the following references:

1. Ragwitek [package insert]. Hørsholm, Denmark: ALK-Abelló A/S.; September 2022.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed January 1, 2023.
3. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed January 1, 2023.

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.

September 27, 2023