Subject: Ragwitek PA Policy 1134-A UDR 02-2024

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
               °   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
               °   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):
          •   1134-A: DOA: 12 months

 

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, Lexi-Drugs. Waltham, MA: UpToDate, Inc.; 2023. https://online.lexi.com. Accessed January 03,
3. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 01/03/2024).

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