Veopoz ( pozelimab)

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.