INEBILIZUMAB-CDON INJ,SOLN

Clinical Criteria Summary

Untreated active hepatitis B infection
Untreated latent or active tuberculosis infection
Active, clinically significant infection
Concomitant therapy with another biologic therapy for neuromyelitis optica spectrum disorder (NMOSD)
Concomitant chronic therapy with intravenous immunoglobulin or plasma exchange (use during exacerbations is reasonable)
Pregnancy

Care provided by VA or VA Community Care neurology provider or locally designated expert
Diagnosis of aquaporin-4 antibody positive NMOSD
Completed hepatitis B screening (HBsAg, total anti-HBc and anti-HBs) with consult/referral for hepatitis B management if either HBsAg or total anti-HBc is positive
Quantitative serum immunoglobulins tested; if low, neurologist has documented risk/benefit assessment and/or an immunology expert was consulted prior to start
All guideline recommended eligible immunizations administered at least 4 weeks prior to the start of treatment for live or live-attenuated vaccines, and whenever possible, at least 2 weeks prior to the start of treatment for inactivated vaccines
Contraindication, intolerance, or lack of therapeutic response to rituximab

For patients who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 6 months after stopping treatment

Untreated active hepatitis B infection
Untreated latent or active tuberculosis infection
Active, clinically significant infection
Concomitant therapy with another biologic therapy for immunoglobulin G4-related disease (IgG4-RD)
Pregnancy

Care provided by VA or VA Community Care rheumatology provider or locally designated expert
Completed hepatitis B screening (HBsAg, total anti-HBc and anti-HBs) and consult referral for hepatitis B management if either HBsAg or total anti-HBc positive
Quantitative serum immunoglobulins tested. If low, the rheumatologist has documented risk/benefit assessment and/or an immunology expert was consulted prior to start
All guideline recommended eligible immunizations administered at least 4 weeks prior to the start of treatment for live or live-attenuated vaccines, and whenever possible, at least 2 weeks prior to the start of treatment for inactivated vaccines
Contraindication, intolerance, or lack of therapeutic response to rituximab

For patients who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 6 months after stopping treatment

Untreated active hepatitis B infection
Untreated latent or active tuberculosis infection
Active, clinically significant infection
Concomitant therapy with another biologic therapy for immunoglobulin G4-related disease (IgG4-RD)
Pregnancy

Care provided by a VA/VA Community Care neurologist or locally designated expert
Acetylcholine receptor (AChR) antibody positive or muscle-specific tyrosine kinase (MuSK) antibody positive generalized myasthenia gravis
Myasthenia Gravis Foundation of America (MGFA) clinical classification II to IV
Myasthenia Gravis-specific Activities of Daily Living scale (MG-ADL) total score ≥ 52
Completed hepatitis B screening (HBsAg, total anti-HBc and anti-HBs) with consult referral for hepatitis B management if either HBsAg or total anti-HBc positive
Quantitative serum immunoglobulins tested; if low, the neurologist has documented risk/benefit assessment and/or an immunology expert was consulted prior to start
All guideline-recommended eligible immunizations administered at least 4 weeks prior to the start of treatment for live or live-attenuated vaccines, and whenever possible, at least 2 weeks prior to the start of treatment for inactivated vaccines

For AChR+ chronic therapy: Inadequate symptom control to maximally tolerated pyridostigmine and at least two immunosuppressive agents separately trialed for at least 6 months each [e.g., azathioprine, cyclosporine, mycophenolate, etc.]
For MuSK+ chronic therapy: Inadequate symptom control to rituximab trialed for at least 6 months
For AChR+ or MuSK+ chronic therapy: History of intolerance or contraindication preventing trial of above immunosuppressive agents

For patients who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 6 months after stopping treatment