ACTRIMS 2023: TG aims to make Briumvi accessible to patients

Support program set up to help patients with cost, insurance, and access

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Briumvi (ublituximab-xiiy) recently became the third anti-CD20 monoclonal antibody to be approved by the U.S. Food and Drug Administration (FDA) as a treatment for relapsing forms of multiple sclerosis (MS).

TG Therapeutics, the therapy’s developer, is now aiming to make Briumvi the most accessible therapy in its class. As part of this goal, TG has set the list price for Briumvi at $59,000 per year — the lowest list price for any branded MS therapy that’s currently on the market, according to the company.

“From really the beginning of this company, we’ve talked about trying to be responsible in pricing drugs,” Michael Weiss, CEO of TG Therapeutics, said in an interview with Multiple Sclerosis News Today during last week’s Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum.

The price has two goals, Weiss added: “One is just benefiting society generally, and two, permitting as quick access as possible to patients.”

“Some patients will feel the absolute effect of that lower cost in their pocketbook, and some will just feel it because it’s easier to get access to the drug because of the way we priced it,” he said.

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Support program to facilitate patient access

TG Therapeutics is offering a patient support program to help people with MS in the U.S. to access the therapy, which became commercially available in late January.

A key component of this program is “just helping the patient understand what their insurance coverage is all about,” Weiss said. “These are very complicated policies, so we have a team that’s going to work with them on that.”

Michael Weiss, CEO of TG Therapeutics, at the ACTRIMS 2023 Forum.

The support program also includes a quick-start initiative where patients can access the therapy as soon as possible even while insurance details are being worked out.

“We can give them a quick start where they get one or two doses for free while we work out the kinks, or they work out the kinks, in getting the coverage,” Weiss said.

The company is also offering copay assistance for patients on all forms of commercial insurance. For patients with Medicare or Medicaid — programs funded by the U.S. government that provide health insurance for elderly and low-income people, respectively — or those who do not have any health insurance, the support program can offer access to Briumvi for free.

“We help support the patients if they can’t afford the copay that’s required of them under their insurance. We can’t do that for Medicare or Medicaid patients, but we can provide free drugs. … Completely free. So not just copay support, but just completely free drug for those who can’t afford it,” Weiss said.

Thus, even with Briumvi being priced lower than other branded MS medications, “there’s some percentage really that’s lower than that because we’re giving away some portion of the drug for free,” Weiss said. “We want to make sure that it’s the most accessible [anti-CD20 therapy], if possible. That would be our goal.”

Briumvi engineered for efficacy and faster infusions

Briumvi is the third anti-CD20 monoclonal antibody to be approved for relapsing MS types, following Ocrevus (ocrelizumab) and Kesimpta (ofatumumab). An older anti-CD20 therapy, rituximab, is also sometimes used off-label in MS treatment.

Like all anti-CD20 therapies, Briumvi works by destroying B-cells, a type of immune cell with a central role in driving the inflammatory attack on the nervous system that causes MS. Uniquely among the available therapies, however, Briumvi has been glycoengineered, meaning certain sugar molecules were attached to the monoclonal antibody to increase its potency.

“If you look at the molecule itself, it is different. It’s the only [anti-CD20 monoclonal antibody] that’s been engineered to amplify the efficiency of its ability to deplete B-cells,” Weiss said. “We think that can confer a number of different benefits, some of which are clinical, some of which are convenience.”

Briumvi is administered by infusion into the bloodstream every six months after a loading dose — the same method of administration as Ocrevus and rituximab. Kesimpta, on the other hand, is given monthly by under-the-skin injection.

The higher potency of Briumvi means that lower doses of the therapy are needed, so infusions take less time than for other anti-CD20 therapies — after the initial dose, each infusion takes about one hour.

“That one-hour infusion is partially made possible because of the efficiency of this molecule; we use lower doses and we can infuse those lower doses as a one-hour infusion,” Weiss said, noting that this faster infusion time could make Briumvi more convenient for patients and is a major feature that makes Briumvi unique among the available therapies.

Trial data suggest early treatment could allow optimal clinical outcomes

The FDA’s approval of Briumvi in late 2022 was supported by data from two identically designed Phase 3 clinical trials, ULTIMATE I (NCT03277261) and ULTIMATE II (NCT03277248).

These studies collectively enrolled more than 1,000 people with relapsing types of MS who were randomly assigned to receive Briumvi or Aubagio (teriflunomide), an older approved MS therapy, for about two years in total.

Results showed that relapse rates were significantly lower among patients given Briumvi than Aubagio, by about 59% in ULTIMATE I and 49% in ULTIMATE II. The average annual relapse rate among Briumvi-treated patients was less than 0.1 per year — a lower rate than has been seen in any other trial testing treatments for relapsing MS. Positive results were also seen on measures of lesions, disability, and life quality.

“Our annualized relapse rate was the lowest of any report in a Phase 3 trial,” Weiss said. He added that this low relapse rate could be related to the way Briumvi was specifically engineered to increase its ability to kill B-cells.

“Certainly there’s an argument to be made that this could be a more efficacious [anti-CD20 therapy for relapsing MS],” Weiss said, though he stressed that it’s impossible to make this claim with certainty in the absence of studies that directly compare the available medications.

“Since we didn’t do any comparison studies, you can’t really make that kind of a claim [about relative efficacy], but I think the way it’s been designed, it definitely has the possibility to confer some of those clinical benefits,” he said.

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After six months, over 80% of patients show no evidence of disease activity

Data from the ULTIMATE studies presented at ACTRIMS showed that, after the first six months of the studies, over 80% of patients had no evidence of disease activity, or NEDA — meaning they didn’t experience any relapse, confirmed disability progression, or new or enlarging lesions on MRI scans.

“If you’re not having any additional disease activity, you should feel pretty much the same as you were,” Weiss said.

Ideally, achieving NEDA “should translate into [patients] living as if they don’t have MS. I mean, that is the goal,” he added, though he noted that patients who are already experiencing sustained symptoms or disability may continue to experience existing symptoms even with no evidence of disease activity, as NEDA is a measure of progression and not disability overall.

As such, starting treatment as early as possible, before significant disability accumulates, is likely to lead to the best clinical outcomes.

“Part of the goal of these therapies is to try to get patients on [treatment] as early as possible, before they do have any sort of disability that has emerged,” Weiss said, adding “And I think most folks are looking at and saying, ‘Hey, if we can stop this early, prevent any of those relapses that could create some permanent disability, we’re going to get a better outcome for the patient.’”

Note: The Multiple Sclerosis News Today team is providing in-depth coverage of the ACTRIMS Forum 2023 Feb. 23–25. Go here to see the latest stories from the conference. Follow along on Facebook, Twitter, and Instagram for live updates using the hashtag #actrims2023.