VEOPOZ (pozelimab)

Office-Administration –intravenous, subcutaneous injection 

 

Diagnosis considered for coverage:

 

  • CD55-deficient protein-losing enteropathy (PLE): Indicated for the treatment of adult and pediatric patients 1 year of age and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease

 

Coverage Criteria:

 

For diagnosis of CD55-deficient protein-losing enteropathy (PLE):

  • Patient has a confirmed genotype of biallelic CD55 loss-of-function mutation AND
  • Patient is 1 year of age or older AND
  • Patient has hypoalbuminemia (serum albumin concentration of ≤3.2 g/dL) AND
  • Prescribed by or in consultation with either an immunologist, geneticist, or hematologist AND
  • Patient has at least one of the following signs or symptoms within the last 6 months: 
    • Abdominal pain
    • Diarrhea
    • Peripheral edema
    • Facial edema

 

Reauthorization Criteria:

 

For diagnosis of CD55-deficient protein-losing enteropathy (PLE):

  • Documentation of positive clinical response to therapy (e.g. decrease in albumin transfusions and hospitalizations, normalization of serum IgG concentrations, etc.)

 

Coverage Duration: 

 

  • Initial: 12 months
  • Reauthorization: 12 months

 

Dosing: 

 

For diagnosis of CD55-deficient protein-losing enteropathy (PLE):

  • Day 1 (loading dose): administer a single 30 mg/kg IV infusion after dilution
  • Day 8 and thereafter (maintenance dosing): Inject a 10 mg/kg SC injection once weekly

 

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: 
  • The main population affected by CHAPLE disease predominantly include infants, children, and adolescents, as the condition is associated with long-term morbidity that has substantial impact on daily functioning and a high risk of mortality
  • Veopoz was approved on August 18, 2023, through fast track, orphan drug, and rare pediatric designations, and it is the first FDA-approved treatment indicated for CHAPLE disease
  • Prior to the approval of Veopoz, off-label Soliris (eculizumab) and supportive care have been used to treat CHAPLE disease
  • Patients should be vaccinated against meningococcal infection ≥ 2 weeks prior to initiation of Veopoz, according to the most current Advisory Committee on Immunization Practices (ACIP) recommendations for patients receiving a complement inhibitor. If urgent Veopoz therapy is indicated in an unvaccinated patient, meningococcal vaccine(s) should be administered as soon as possible.

 

Policy Updates:
  • 3/1/2024 (policy effective date)- New Veopoz Criteria (P&T 2/20/2024) (P&T meeting February)

 

References:


1.    Veopoz Prescribing Information. Regeneron Pharmaceuticals, Inc. Tarrytown, NY. August 2023. 
2.    FDA news release. FDA approves first treatment for CD55-deficient protein-losing enteropathy (CHAPLE disease). FDA Web site. Updated August 18, 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-cd55-deficient-protein-losing-enteropathy-chaple-disease. Accessed January 4, 2024.
3.    Veopoz. IBM Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Accessed January 4, 2024. http://www.micromedexsolutions.com.

 

Last review date: March 1, 2024

Rite Aid Pharmacy Patients: All Rite Aid pharmacies nationwide are closing! Please be on the lookout for information from Rite Aid pharmacies about their bankruptcy and store closures. Call your Rite Aid pharmacy for questions about your prescriptions and new pharmacy options. WHA is here to help as well. Contact Us via Phone