OCRELIZUMAB INJ,SOLN

Clinical Criteria Summary

Care is provided by a VA/VA Community Care neurologist or locally designated MS expert (e.g., Spinal Cord Injury)

Patient has been screened for hepatitis B virus (HBV) including HBsAg, HBsAb and HBcAb; if HBsAb negative and HBcAb positive or HBsAg positive, a liver disease expert must be consulted first
Quantitative serum immunoglobulins tested; if low, neurologist has documented risk/benefit assessment and/or an immunology expert was consulted prior to start

History of life-threatening infusion reaction to another anti-CD20 antibody (e.g., ublituximab, rituximab)
Untreated active hepatitis B infection
Untreated latent or active tuberculosis infection
Active infection or receiving chemotherapy
Concurrent use of another disease modifying therapy (DMT) to treat multiple sclerosis (MS) unless the previous agent will be discontinued when ocrelizumab is initiated

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 patients who can become pregnant: Pregnancy should be excluded prior to receiving ocrelizumab
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

Diagnosis of primary progressive multiple sclerosis (PPMS) or secondary progressive multiple sclerosis without activity (non-active SPMS)
History of life-threatening infusion reaction to another anti-CD20 antibody (e.g., ublituximab, rituximab)
Untreated active hepatitis B infection
Untreated latent or active tuberculosis infection
Concurrent use of another disease modifying therapy (DMT) to treat multiple sclerosis (MS) unless the previous agent will be discontinued when ocrelizumab is initiated
Active infection or receiving chemotherapy
Pregnancy

Care provided by a VA/VA Community Care neurologist or locally designated MS expert (e.g., Spinal Cord Injury)
Diagnosis of a relapsing form of multiple sclerosis (relapsing-remitting MS, active secondary progressive MS, and clinically isolated syndrome) has been established
Intolerance or inadequate therapeutic response to ublituximab
Patient screened for hepatitis B virus (HBV) including HBsAg, HBsAb and HBcAb; if HBsAb negative and HBcAb positive or HBsAg positive, liver disease expert must be consulted first
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

Current treatment with natalizumab and patient has elevated risk factors for PML (anti-JC virus antibody positive, duration of therapy > 24 months or received immunosuppressant therapy prior to natalizumab)
Ineffectiveness with at least one other MS DMT defined as continued clinical relapses, central nervous system (CNS) lesion progression on MRI, or continued worsening of disability
Highly active disease demonstrated by heavy burden of gadolinium enhancing and/or T2 lesions on MRI at onset of disease, high accumulation of CNS lesions on MRI, or rapid accrual of disability

For patients who can become pregnant: Pregnancy should be excluded prior to receiving ocrelizumab
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

IV infusion daily for 5 days then 1 year later, IV infusion daily for 3 days
Repeat 3-day courses can be considered if clinically indicated and if at least 12 months after last dose
Typical pre-medication: high dose corticosteroid as methylprednisolone 1000mg immediately prior to first alemtuzumab dose and for the first 3 days of each treatment course

Baseline: HIV, VZV, TB, HBV, HCV, CBC w/ diff, CMP, UA w/ cell counts and adult onset Still's disease, thyroid function tests, autoimmune encephalitis, and acquired hemophilia
Routine: CBC w/ diff, CMP, TSH, LFT, and UA
Has a REMS program which also provides lab and imaging frequency guidance

Delay treatment if active skin infection
Instruct patients to avoid potential sources of Listeria and monocytegenes VZV antibodies
Give antivirals for herpes prophylaxis starting the first day of treatment until 2 months or CD4+ lymphocyte count is > 200 cells/microliter

Serious: Secondary autoimmune diseases (including autoimmune hepatitis, thyroid disorders, thrombotic thrombocytopenic purpura, hemophagocytic lymphohistiocytosis, protein, thyroid infusion reactions, stroke or cervicocephallic arterial dissection, malignancy, PML)
Common: rash, headache, pyrexia, nasopharyngitis, nausea/vomiting, minor infections, fatigue, insomnia, urticaria, pruritus, thyroid disorders, arthralgia, pain in extremity, back pain, diarrhea, sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal pian, flushing

An appropriate washout time from previous DMT is unknown
The risks of a longer washout period should be weighed against the risks of another relapse
Additive immunosuppression should be considered
If switching from alemtuzumab to another DMT, lymphocyte counts can help assess magnitude of immunosuppression and additive risks