PAGE: 1 of 7 IMPORTANT REMINDER This Clinical Policy has been developed by appropriately experienced and licensed health care professionals based on a thorough review and consideration of generally accepted standards of medical practice, peerreviewed medical literature, government agency/program approval status, and other indicia of medical necessity. The purpose of this Clinical Policy is to provide a guide to medical necessity. Benefit determinations should be based in all cases on the applicable contract provisions governing plan benefits ( Benefit Plan Contract ) and applicable state and federal requirements, as well as applicable plan-level administrative policies and procedures. To the extent there are any conflicts between this Clinical Policy and the Benefit Plan Contract provisions, the Benefit Plan Contract provisions will control. Clinical policies are intended to be reflective of current scientific research and clinical thinking. This Clinical Policy is not intended to dictate to providers how to practice medicine, nor does it constitute a contract or guarantee regarding results. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. Description: The intent of the criteria is to ensure that patients follow selection elements established by Centene medical policy for the use of Budesonide and Fluticasone Generic: Budesonide Solution (Pulmicort Respules ) Fluticasone MDI (Flovent ) Policy Indication: For the use in the treatment of eosinophilic esophagitis.
PAGE: 2 of 7 Criteria for Approval: Initiation of therapy for up to 3 months (must meet A-D) A. Prescribed by a gastroenterologist or allergy immunology specialist B. Diagnosis of C. Trial and Failure of a Proton Pump Inhibitor (PPI) for at least 8 weeks unless contraindicated D. Does not exceed dosing regimens from Appendix C and medication will be swallowed Continuation of therapy for up to 6 months A. Currently receiving medication via Centene benefit or member has previously met all initial approval criteria B. Prior authorization form or chart notes documenting a positive response to therapy since last approval or an increase in dose is going to be utilized to gain a response in therapy C. Prescription records or chart notes documenting continued adherence to therapy since last authorization
PAGE: 3 of 7 Abbreviation: EoE = Eosinophilic Esophagitis GERD = Gastroesophageal Reflux Disease PPI =Proton Pump Inhibitor Background Eosinophilic esophagitis is a chronic immunological condition that involves inflammation of the esophagus. The disease can happen at any age with patients typically presenting in childhood (mean age 8.6 years) or in the third or fourth decade of life. Males are three times more likely to have a diagnosis of eosinophilic esophagitis than females. Signs and symptoms of esophageal dysfunction include unexplained feeding difficulties, vomiting, solid-food dysphagia, esophageal strictures and GERD-like symptoms. Children with eosinophilic esophagitis are more likely to display GERD-like symptoms than adults. The exact cause of eosinophilic esophagitis is unknown; however, there is a strong association with other immunologic conditions such as asthma, allergic rhinitis, IgE mediated food allergy and atopic dermatitis. Topical steroids are 1 st line therapy for patients with eosinophilic esophagitis. Goals of treatment are improvement in symptoms and inflammation. The following glucocorticoids were studied in patients with eosinophilic esophagitis: fluticasone, budesonide and ciclesonide. In children, swallowed topical steroids like fluticasone and budesonide were shown to improve symptoms and stimulate histological remission. Clinical trials displayed a 50% complete and 95% partial response when using topical steroids over 1-3 months. In addition, swallowed fluticasone may improve nausea which is often observed in patients with eosinophilic esophagitis. Patients should not eat or drink for 30 minutes after taking fluticasone.
PAGE: 4 of 7 References: 1. Bonis PA, Furuta GT. UpToDate [Internet]. Waltham, MA: UpToDate. 2016. Drug allergy: Clinical manifestations, diagnosis and treatment of eosinophilic esophagitis; [updated 2016 May 16; cited 2016 Jun 29]. Available from: http://www.uptodate.com/ 2. Dellon ES, Gonsalves N, Hirano I et al. ACG Clinical Guideline: Evidence-Based Approach to the Diagnosis and Management of Esophageal Eosinophilia and Eosinophilic Esophagitis. Am J Gastroenterol. 2013 May;108(5):679-92; doi: 10.1038/ajg.2013.71. Epub 2013 Apr 9 3. Papadopoulou A, Koletzko S, Heuschkel R, et al. European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Eosinophilic Esophagitis Working Group and the Gastroenterology Committee. Management guidelines of eosinophilic esophagitis in childhood. J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):107-18 4. Schaefer ET, Fitgerald JF, Molleston JP et al. Comparison of Oral Prednisone and Topical Fluticasone in the Treatment of EOE: Trial in Children. Clin Gastroenterol Hepatol 2008 Feb; 6: 165 173. 5. Konikoff MR, Noel RJ, Blanchard C et al. A Randomized, Double Blind Placebo-Controlled Trial of Fluticasone Propionate for Pediatric Eosinophilic Esophagitis. Aliment Pharmacol Therapy. 2012. 35: 300-307. 6. Bonis PA, Furuta GT. UpToDate [Internet]. Waltham, MA: UpToDate. 2017. Drug allergy: Clinical manifestations, diagnosis and treatment of eosinophilic esophagitis; [updated 2017 November 29; Accessed 12/1/2017]. Available from: http://www.uptodate.com/
PAGE: 5 of 7 Appendix A Signs and Symptoms of Esophageal Dysfunction Children Feeding dysfunction Vomiting Abdominal pain Dysphagia Food impaction Adults Dysphagia Food impaction Chest pain GERD/Heartburn Abdominal pain Appendix B Examples of Secondary Causes of EOE GERD Recurrent Vomiting Parasitic/Fungal Infections Crohns Disease Drug hypersensitivity Appendix C Patient Age Medication Dosing 1-4 years old Fluticasone 44 mcg Swallow 2 sprays BID 5-10 years old Fluticasone 110 mcg Swallow 2 sprays BID 11 years old Fluticasone 220 mcg Swallow 2 sprays BID
PAGE: 6 of 7 Patient Age Medication < 10 years old Budesonide 1 mg/day (using 0.5mg/2ml Respules) 10 years old Budesonide 2 mg/day (using 0.5mg/2ml Respules) Oral Viscous Slurry Dosing Swallow 10-1gram packets of Splenda per 1 mg of budesonide. May be divided in 2 doses. Swallow 10-1 gram packets of Splenda per 1 mg of budesonide. May be divided in 2 doses. Nebulized Dosing Swallow accumulated liquid Swallow accumulated liquid Reviews, Revisions, and Approvals Date New policy created Updated References. 09/16 12/17 Approv al Date 09/16
PAGE: 7 of 7 POLICY AND PROCEDURE APPROVAL Pharmacy & Therapeutics Committee: Approval on file Director, Pharmacy Operations: Approval on file Medical Director: Approval on file