EOHILIA (budesonide)

EOHILIA (budesonide)

Self-Administration – oral suspension

Diagnosis considered for coverage:

• Eosinophilic Esophagitis (EoE): Indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE). Limitations of Use EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks.

Coverage Criteria:

For diagnosis of Eosinophilic Esophagitis (EoE):

• Diagnosis of eosinophilic esophagitis (EoE), AND
• Patient has symptoms of esophageal dysfunction (e.g., dysphagia, food impaction, heartburn, abdominal pain), AND
• Patient has at least 15 intraepithelial eosinophils per high power field (HPF), AND
• Other causes of esophageal eosinophilia have been excluded, AND
• Patient is 11 years of age or older, AND
• Trial and failure (of a minimum 8-week duration), contraindication, or intolerance to a proton pump inhibitor (e.g., pantoprazole, omeprazole), AND
• Trial and failure (of a minimum 8-week duration), or intolerance to a topical (esophageal) corticosteroid (e.g., budesonide, fluticasone), AND
• Prescribed by or in consultation with one of the following:
  • Allergist/Immunologist
  • Gastroenterologist

Coverage Duration:

• Initial: 12 weeks

Dosing:

For diagnosis of Eosinophilic Esophagitis (EoE):

• The recommended dosage is 2 mg orally twice daily for 12 weeks.

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks

Policy Updates:

• 09/01/2024 (policy effective date) – New policy approved by WHA P&T Committee. (P&T, 08/20/2024) (P&T meeting date) 

References:

1. Eohilia Prescribing Information. Takeda Pharmaceuticals America Inc. Lexington, MA 02421. February 2024.
2. Study Details | A Study in Adolescents and Adults with Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved | ClinicalTrials.gov https://clinicaltrials.gov/study/NCT02605837. Accessed 8 March, 2024.
3. Gonsalves NP, Aceves SS. Diagnosis and treatment of eosinophilic esophagitis. J Allergy Clin Immunol. 2020;145(1):1-7.
4. Hirano I, Chan ES, Rank MA, et al. AGA Institute and the Joint Task Force on allergy-immunology practice parameters clinical guidelines for the management of eosinophilic esophagitis. Gastroenterology. 2020;158:1776-86.
5. Dellon ES, Khoury P, Muir AB, et al. A clinical severity index for eosinophilic esophagitis: development, consensus, and future directions. Gastroenterology. 2022;1-18.