OFATUMUMAB INJ,SOLN
Clinical Criteria Summary
Exclusion Criteria
- 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 ofatumumab is initiated
- Active infection or receiving chemotherapy
- Pregnancy
Inclusion Criteria
- 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, or clinically isolated syndrome) has been established
- Intolerance or inadequate therapeutic response to ublituximab OR patient not a candidate for IV anti-CD20 antibody therapy due to inability to access an infusion center or poor venous access
- Patient 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.
- 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.
Additional Inclusion Criteria (One of the following must be met)
- 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
Pregnancy and Counseling Requirements
- For patients who can become pregnant: Pregnancy should be excluded prior to receiving ofatumumab
- 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
Other Justification
- Select for ARZERRA (oncologic indications, not multiple sclerosis)