The recently approved CD20 inhibitor Briumvi (ublituximab-xiiy) has achieved a significant milestone with the issuance of a permanent insurance reimbursement code by the U.S. Centers for Medicare and Medicaid Services. The J-code, effective from July 1, will streamline the billing and reimbursement process for adults in the U.S. with relapsing forms of multiple sclerosis (MS) who are prescribed Briumvi. This simplification is expected to facilitate additional patient access to the therapy developed by TG Therapeutics.

Briumvi Patient Support Program Provides Comprehensive Assistance

In order to support patients prescribed Briumvi, TG Therapeutics has launched the Briumvi Patient Support program. The program offers a range of services, including information on insurance coverage, financial assistance for medication access, and support for infusion procedures. By providing these resources, the program aims to enhance patient experience and ensure smooth access to the treatment.

Efficiency and Efficacy Demonstrated in Phase 3 Trials

The approval of Briumvi in the U.S. was based on robust evidence from two Phase 3 trials: ULTIMATE I and ULTIMATE II. These trials enrolled over 1,000 patients with active, relapsing forms of MS and demonstrated that Briumvi significantly outperformed Aubagio, an oral MS therapy. The results showed a reduction in relapse rates, fewer lesions, and improvements in disability-related measures and quality of life for patients treated with Briumvi.

Briumvi: A Cost-Effective Option for MS Treatment

With a commercial availability since January, Briumvi has been priced at approximately $59,000 per year, making it the most affordable disease-modifying therapy for MS in the U.S. This lower price point, compared to other available treatments such as Ocrevus, aims to increase accessibility for patients in need. The permanent J-code issued for Briumvi further simplifies the reimbursement process, contributing to a more streamlined and efficient system.

Expanding Treatment Options: Briumvi’s Journey in Europe

Briumvi’s potential for treating relapsing forms of MS is not limited to the U.S. It is currently undergoing review in Europe, and a positive recommendation by a committee from the European Medicines Agency has been given. The final decision on approval is expected in the coming months, which could expand access to Briumvi for MS patients in Europe as well.

The approval of Briumvi and the issuance of a permanent J-code represent significant advancements in the treatment landscape for MS patients. With its cost-effectiveness, demonstrated efficacy, and comprehensive patient support program, Briumvi offers hope for improved outcomes and increased accessibility for those living with relapsing forms of multiple sclerosis.

Frequently Asked Questions

• What is the mechanism of action of Briumvi (ublituximab-xiiy)?

  Briumvi is a CD20 inhibitor, specifically a monoclonal antibody. It is designed to reduce the levels of B-cells, which are a type of immune cell involved in the inflammatory attack that causes damage in multiple sclerosis (MS).

• What are the Phase 3 trials that supported the approval of Briumvi in the US?

  The approval of Briumvi in the US was supported by data from two Phase 3 trials: ULTIMATE I (NCT03277261) and ULTIMATE II (NCT03277248). These trials collectively enrolled 1,094 patients with active, relapsing types of multiple sclerosis (MS).

• What is the Briumvi Patient Support program and what does it offer?

  The Briumvi Patient Support program is launched by TG Therapeutics to provide support to patients prescribed Briumvi during their treatment. The program offers information about insurance coverage and financial assistance to help access the medication. It also provides assistance with infusions.

• What is the current pricing of Briumvi compared to other disease-modifying therapies for MS?

  Briumvi became commercially available in the US at approximately $59,000 per year, making it the lowest-priced disease-modifying therapy for multiple sclerosis (MS). The next least-expensive drug after Briumvi is Ocrevus, which costs about $75,000 per year.

• What is the current status of Briumvi’s review in Europe for treating relapsing forms of MS?

  Briumvi is currently being reviewed in Europe for treating relapsing forms of multiple sclerosis (MS). Last month, a committee from the European Medicines Agency recommended its approval for that indication. A final decision is expected in the coming months.