BRIUMVI (ublituximab-xiiy)

BRIUMVI (ublituximab-xiiy)

Office-Administration – intravenous

Diagnosis considered for coverage:

• Relapsing forms of Multiple Sclerosis: Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Coverage Criteria:

• Diagnosis of a relapsing form of multiple sclerosis (MS) (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions), AND
  • One of the following:
    • Failure after a trial of at least 4 weeks, contraindication, or intolerance of at least two of the following disease-modifying therapies for MS:
    • Plegridy (peginterferon beta-1a) 
    • Avonex
    • Betaseron
    • Any one of the glatiramer acetate injections (e.g., Copaxone, Glatopa, generic glatiramer acetate) 
    • generic dimethyl fumarate
    • Gilenya, OR
  • For continuation of prior therapy, AND
• Not used in combination with another disease-modifying therapy for MS, AND
• Not used in combination with another B-cell targeted therapy (e.g., rituximab [Rituxan], belimumab [Benlysta], ofatumumab [Arzerra, Kesimpta]), AND
• Not used in combination with another lymphocyte trafficking blocker (e.g., alemtuzumab [Lemtrada], mitoxantrone), AND
• Prescribed by or in consultation with a neurologist

Reauthorization Criteria:

• Documentation of positive clinical response to therapy (e.g., stability in radiologic disease activity, clinical relapses, disease progression), AND 
• Not used in combination with another disease-modifying therapy for MS, AND 
• Not used in combination with another B-cell targeted therapy (e.g., rituximab [Rituxan], belimumab [Benlysta], ofatumumab [Arzerra, Kesimpta]), AND
• Not used in combination with another lymphocyte trafficking blocker (e.g., alemtuzumab [Lemtrada], mitoxantrone), AND
• Prescribed by or in consultation with a neurologist

Dosing:

• Initial dose is 150 mg IV infusion, followed 2 weeks later by 450 mg IV infusion. Maintenance is 450 mg IV infusion once every 24 weeks. 
• Observe the patient for at least one hour after the completion of the first two infusions. Post-infusion monitoring of subsequent infusions is at physician discretion unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion.

Coverage Duration:

• Initial: 12 months
• Reauthorization: 12 months

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: 

• According to the National MS Society, of the four disease courses that have been identified in MS, relapsing-remitting MS (RRMS) is characterized primarily by relapses, and secondary-progressive MS (SPMS) has both relapsing and progressive characteristics. These two constitute “relapsing forms of MS” if they describe a disease course that is characterized by the occurrence of relapses. The effectiveness of interferon beta in SPMS patients without relapses is uncertain. 
• The advantage of using combination disease-modifying therapy (DMT) compared to monotherapy DMT use has not been demonstrated, but there are safety concerns, such as reduced efficacy or disease aggravation, with combination use. 

Policy Updates:

• 08/15/2023 – New policy approved by P&T.

References:

1. Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline: Disease-modifying therapies for adults with multiple sclerosis. Neurology 2018;90:777-788. 
2. National Multiple Sclerosis Society. Types of MS. Available at: https://www.nationalmssociety.org/What-is-MS/Types-of-MS. Accessed March 29, 2019. 
3. Mavenclad Prescribing Information. EMD Serono, Inc. Rockland, MA. April 2019. 
4. Wingerchuk, D., & Carter, J. (2014). Multiple Sclerosis: Current and Emerging Disease-Modifying Therapies and Treatment Strategies. Mayo Clinic Proceedings, 89(2), 225-240. 
5. Sorensen, P., Lycke, J., Erälinna, J., Edland, A., Wu, X., & Frederiksen, J. et al. (2011). Simvastatin as add-on therapy to interferon beta-1a for relapsing-remitting multiple sclerosis (SIMCOMBIN study): a placebo-controlled randomised phase 4 trial. The Lancet Neurology, 10(8), 691-701. 
6. Briumvi Prescribing Information. TG Therapeutics, Inc. Morrisville, NC. December 2022.