Xembify — Medical Mutual

Initial criteria

• Baseline values for BUN and serum creatinine obtained within 30 days of request; AND
• Primary Immunodeficiency (PID): Patient is at least age ≥ 2 years; AND
• IgG level <200 mg/dL; OR
• History of multiple hard to treat infections as indicated by ≥ 1 of the following: four or more ear infections within 1 year, ≥ 2 serious sinus infections within 1 year, ≥ 2 months of antibiotics with little effect, ≥ 2 pneumonias within 1 year, recurrent deep skin or organ abscesses, persistent thrush/fungal infection, need for IV antibiotics, ≥ 2 deep-seated infections including septicemia, family history of PID; AND deficiency in producing antibodies in response to vaccination with titers drawn before and between 4–8 weeks post vaccination
• CIDP [Hizentra and HyQvia ONLY]: Patient is at least age ≥ 18 years; AND physician assessed baseline disease severity via objective tool (e.g., INCAT, MRC, 6-MWT, Rankin, Modified Rankin); AND used as maintenance therapy after stabilization with IVIG OR for re-initiation after relapse requiring IVIG induction
• Acquired Immune Deficiency due to CLL/SLL: IgG <200 mg/dL; OR IgG <500 mg/dL AND recurrent sinopulmonary infections requiring IV antibiotics or hospitalization; OR history of multiple hard to treat infections as indicated by ≥ 1 of: four or more ear infections within 1 year, ≥ 2 serious sinus infections within 1 year, ≥ 2 months antibiotics with little effect, ≥ 2 pneumonias within 1 year, recurrent deep skin or organ abscesses, persistent thrush/fungal infection, IV antibiotics required, ≥ 2 deep-seated infections including septicemia; AND deficiency in producing antibodies in response to vaccination with titers drawn before and 4–8 weeks after challenge

Reauthorization criteria

• Patient continues to meet the indication-specific criteria in section III; AND
• Absence of unacceptable toxicity (e.g., severe hypersensitivity/anaphylaxis, thrombosis, aseptic meningitis, hemolytic anemia, hyperproteinemia, acute lung injury, etc.); AND
• BUN and serum creatinine obtained within 6 months; AND dose/infusion adjustments as appropriate
• PID: Disease response evidenced by decreased frequency OR severity of infections
• CIDP [Hizentra and HyQvia ONLY]: Renewal authorized if beneficial clinical response without relapses based on objective tool; OR patient re-initiating after relapse with improvement/stabilization on IVIG AND was not receiving maximum dosing before relapse
• CLL/SLL: Disease response evidenced by decreased infection frequency or severity; AND continued treatment is necessary to reduce infection risk

Approval duration

6 months initial, 12 months renewal