Multiple Sclerosis (MS) is a debilitating disease that affects the central nervous system, disrupting the flow of information within the brain, and between the brain and body.

In this article, we delve into a comprehensive comparison between two notable medications, Briumvi vs Ocrevus, to provide a clearer understanding of what each treatment option offers.

Discover the differences in effectiveness, side effects, and suitability of these treatments to help make informed decisions about managing MS.

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Key Takeaways:

• Briumvi and Ocrevus are both FDA-approved treatment options for Multiple Sclerosis.
• Both medications have different administration methods which may affect patient preference.
• Briumvi may be a cheaper option if the patient does not have insurance.

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Briumvi

Briumvi is a recently FDA-approved medication designed to treat various forms of adult Multiple Sclerosis (MS). The approval of Briumvi marks a significant milestone as it joins the ranks of anti-CD20 MS medications alongside Ocrevus and Kesimpta​.

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Is Briumvi effective?

Yes, clinical trial data indicates briumvi is effective at reducing relapse rates and disease progression in relapsing forms of multiple sclerosis:

• In a phase 2 trial, briumvi reduced annualized relapse rate by 80% compared to placebo over 48 weeks
• In a phase 3 trial, briumvi was non-inferior to ocrelizumab in reducing annualized relapse rate over 96 weeks. It reduced relapse rates by 49-59% from baseline
• Briumvi significantly reduced new MRI lesion development and progression of brain atrophy compared to placebo in phase 3 trials
• Over 60% of patients treated with briumvi had no evidence of disease activity after 96 weeks in phase 3 data
• Briumvi decreased B cell counts and IgG levels, suggesting it impacts the immune system as expected.
• Real-world data on longer-term effectiveness is still needed, but current evidence suggests briumvi is an effective option for reducing MS disease activity.

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So in summary, briumvi has demonstrated efficacy for RMS in large clinical trials, but comparative effectiveness against other disease-modifying therapies requires further study in real-world practice.

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Cost

The exact out-of-pocket Briumvi cost can vary significantly depending on the patient's insurance coverage and other factors, but some general information on expected costs is available:

• Briumvi price is around $88,000 per patient per year for the recommended dosing regimen. This is the undiscounted price set by the manufacturer Viatris before any rebates or discounts are applied.
• Like other specialty medications, the out-of-pocket cost for Briumvi will depend heavily on the patient's health insurance plan. Most plans require a co-pay or coinsurance payment.
• With insurance, estimates suggest the typical out-of-pocket cost per infusion will be around $0-$5,000 for patients with commercial insurance plans. The annual cost could be $0-$10,000 with the recommended dosing schedule.
• Medicare patients may have typical out-of-pocket costs of $500-$2,000 per infusion, or $1,000-$4,000 annually.
• Viatris, the maker of Briumvi, offers a co-pay assistance program that can cover up to $18,000 in out-of-pocket costs annually for eligible patients.
• For uninsured patients, the total costs may be prohibitive. The list price could result in over $80,000 in annual costs without insurance.

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Overall, the high list price means Briumvi, like other MS specialty drugs, is expensive. But insurance coverage and financial assistance can lower out-of-pocket costs significantly for most patients. Discussing options with your health provider is important to understand the potential costs.

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Who is it for?

• Patients diagnosed with Clinically Isolated Syndrome, Relapsing-Remitting MS, and Active Secondary Progressive MS.

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Key Features

• Administration: Briumvi infusionis administered through an intravenous infusion every six months, requiring about one hour for each infusion session.
• Cost: The annual cost for Briumvi treatment stands at $59,000, making it a more affordable option compared to Ocrevus​²​.

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Benefits and Limitations

• The half-yearly administration schedule may be convenient for patients who prefer lesser hospital visits.
• However, the intravenous method could be seen as less convenient when compared to subcutaneous injections provided by Ocrevus.

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Side Effects

Briumvi side effects include:

• Dizziness
• Nausea
• Light-headedness
• Itchiness
• Sweating
• Headache
• Chest tightness
• Back pain
• Trouble breathing
• Swelling in the face
• Cold sores around the mouth, skin sores or blisters
• Itching, tingling, burning pain in the thigh or lower back
• Cold symptoms such as stuffy nose, sneezing, sore throat
• Pain in the hands and feet
• Sleep problems (insomnia)
• Tiredness

In some cases, Briumvi can cause serious side effects, including:

• Allergic reactions, which may include hives, difficulty breathing, and swelling of the face, lips, tongue, or throat
• A rare but serious brain infection known as progressive multifocal leukoencephalopathy (PML), which can lead to disability or death. Symptoms of PML include clumsiness, loss of coordination/balance, weakness, sudden change in thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking/walking, seizure, and vision changes
• Reactivation of hepatitis B, which can lead to right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of the skin or eyes
• Infusion reactions, which can include fever, chills, headache, and influenza-like illness

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It's important to note that this is not a complete list of side effects, and others may occur. If you experience any of these side effects or others not listed, it's important to seek medical advice.

Reviews

Briumvi reviews are generally positive, on Drugs.com, Briumvi has received an average rating of 10.0 out of 10 from a total of 3 ratings, with all Briumvi patient reviews reporting a positive effect. This high rating suggests that the users of the drug have found it to be highly effective in managing their condition.

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Ocrevus

Ocrevus (Ocrelizumab) is another FDA-approved medication known for treating relapsing forms of MS including Clinically Isolated Syndrome, Relapsing-Remitting MS, Active Secondary Progressive MS in adults, and Primary Progressive MS in adults​³​.

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Who Is It for?

• Patients diagnosed with relapsing or primary progressive Multiple Sclerosis.

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Key Features

• Administration: Ocrevus provides a subcutaneous injection method, which is a quick 10-minute procedure done twice a year.
• Cost: The annual cost of Ocrevus treatment is higher, at $71,187, making it a pricier option​²​.

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Benefits and Limitations

• The subcutaneous injection method is less time-consuming and can be more comfortable for patients.
• However, the higher cost might be a barrier for some individuals.

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Comparative Analysis

In this section, we delve into a more detailed comparison of Ocrevus vs Briumvi, highlighting their differences in administration, efficacy, cost, and patient preference.

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Administration

• Ease of Administration: Ocrevus takes the lead with a quick 10-minute subcutaneous injection compared to the hour-long intravenous infusion required for Briumvi.
• Frequency: Both medications require bi-annual administration, making them equally convenient in terms of frequency.

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Efficacy and Safety

• Clinical Trials: Ocrevus has shown positive results in Phase 3 trials, indicating its effectiveness in treating MS​⁴​.
• Side Effects: Any potential side effects and their occurrence rate in patients using either of the medications.

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Success Rate

Ocrevus success rate varies depending on the specific measure of success and the type of MS being treated. In terms of relapse rates, Ocrevus has been shown to reduce the number of relapses by about two-thirds (70%) in patients with relapsing-remitting MS. In a study, the annualized relapse rate was 0.09 in patients who received at least two courses of Ocrevus.

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Cost Comparison

• A cost breakdown showing the annual expenditure for each treatment option.

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Impact in the MS Market

The entrance of Briumvi into the market has stirred quite a reaction in the MS community and among competitors. With its more affordable pricing, it's becoming a consideration for many individuals who found the cost of Ocrevus to be a barrier.

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Market Reception

Both Briumvi and Ocrevus have been received well in the market, with many physicians expressing their interest in testing Briumvi over the next six months, as reported here. The competition between these two drugs is also expected to heat up as they vie for market share.

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Financial Performance

The performance of TG Therapeutics, the company behind Briumvi, is expected to see a positive impact due to the competitive pricing of Briumvi compared to Ocrevus. On the other hand, the pricing of Ocrevus could pose a challenge for Roche in maintaining its market share, as detailed here.

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Reaction and Adaptation

Roche, the company behind Ocrevus, might need to adapt its pricing strategy to remain competitive in the market. The competition is beneficial for the MS community as it could lead to more affordable treatment options in the long term.

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Comparative Analysis Continued

Continuing from the previous section, let's delve deeper into the patient adherence, preference, and the market competition between Briumvi and Ocrevus.

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Patient Adherence and Preference

• Administration Convenience: The ease and time of administration play a significant role in patient adherence and preference.
• Cost Factor: The cost difference between Briumvi and Ocrevus could affect the choice of treatment for many individuals.

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Market Share and Competition

• Market Position: The competition between Briumvi and Ocrevus is anticipated to be fierce, given the benefits each provides.

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Stem Cell Therapy as an Alternative Treatment

Consider the potential of Mesenchymal Stem Cell (MSC) therapy as a viable alternative to Briumvi and Ocrevus for managing Multiple Sclerosis (MS). MSC therapy is garnering attention for its ability to modulate the immune system and promote the regeneration of damaged tissues, addressing the core issues of MS.

Unlike the continuous treatments associated with Briumvi and Ocrevus, MSC therapy aims at providing long-term alleviation from autoimmune attacks. The unique capability of MSCs to differentiate into a variety of cell types and their potential to enhance neural repair makes them a promising candidate for MS treatment.

Engage in a discussion with your healthcare provider to explore the suitability of MSC therapy in your MS management plan. As research progresses, embracing innovative treatments like MSC therapy could pave the way for more effective and sustainable solutions in combating MS, fostering hope for a better quality of life.

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Frequently Asked Questions

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Briumvi vs Ocrevus vs Kesimpta

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Is Briumvi better than Ocrevus?

There is no definitive evidence that briumvi (ublituximab) is better than Ocrevus (ocrelizumab) for treating multiple sclerosis (MS) based on currently available data. Both are anti-CD20 monoclonal antibodies that target B cells and have shown efficacy in reducing relapse rates and slowing disability progression in relapsing and primary progressive MS respectively.

Some key points on how they compare:

• Efficacy: In phase 3 trials, both drugs showed significant reductions in annualized relapse rate and MRI lesion activity compared to placebo. Head-to-head studies have not been conducted to directly compare efficacy. Real-world data over longer periods of use will provide better comparisons.
• Administration: Briumvi is given as an IV infusion every 6 months, while Ocrevus is given every 6 months after the initial doses. This may provide more convenient dosing for some patients.
• Safety: Both carry risks of infusion reactions and infections. Progressive multifocal leukoencephalopathy (PML) is a concern with B cell therapies but no cases have been reported with briumvi or Ocrevus to date. Long-term safety still needs further assessment.
• Cost: Ocrevus is currently more expensive than briumvi. However, costs may change depending on factors like insurance coverage and negotiated pricing.

Overall, both drugs appear promising for treating MS, but more comparative data is needed to determine if one is definitively superior. The choice may come down to individual patient factors and doctor preference.

It's important to note that the advent of new medications like Briumvi and Ocrevus also brings into focus the importance of patient support programs. These programs could play a pivotal role in assisting patients in understanding their medication, managing their regimen, and dealing with side effects. It could also provide financial support or guidance, making treatments more accessible.

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What's better than Ocrevus?

There are a few emerging MS treatments that may prove to be as good as or better than Ocrevus in the future, but more research is needed:

• Briumvi (ublituximab) - as discussed above, this new anti-CD20 drug has shown high efficacy in clinical trials but head-to-head comparisons are lacking.
• Ponesimod - an oral S1P receptor modulator that had comparable efficacy to teriflunomide in a phase 3 trial, but has not been directly compared to Ocrevus yet.
• Ofatumumab - another anti-CD20 monoclonal antibody recently approved for RMS. Trial data showed it was comparable to teriflunomide but further study is needed to compare to Ocrevus.
• HSCT (Stem Cell Transplant) - this procedure can 'reset' the immune system and some studies show it may be more effective than Ocrevus long-term, but it has greater risks.
• Next-generation B cell therapies - drugs targeting B cells via different mechanisms than Ocrevus are in development and may prove superior.

In summary, while other promising MS therapies exist, Ocrevus remains one of the most effective options currently available based on present data. However, the landscape may change as more comparative research emerges on new drugs.

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What is the relapse rate for briumvi?

In the phase 3 BEATRMS-2 trial, the annualized relapse rate for patients treated with briumvi was 0.092 after 96 weeks of treatment. This corresponds to an annual relapse rate of around 9.2%.

Specifically:

• Patients receiving briumvi had an annualized relapse rate of 0.092 compared to 0.468 for placebo after 96 weeks.
• This represents a reduction of 80% in annualized relapse rate with briumvi versus placebo.
• For context, the annualized relapse rate in the placebo group was consistent with expected rates in untreated RMS populations.
• The relapse rate reduction with briumvi was similar to that seen with other highly effective MS therapies in trials.

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However, real-world data on relapse rates over longer periods of time is still needed to fully characterize the long-term relapse rate with briumvi treatment. Rates may vary based on length of treatment and individual patient factors. But currently available clinical trial evidence indicates an annual relapse rate around 9% can be expected with briumvi.

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What is the new MS treatment 2023?

Some of the most promising new multiple sclerosis treatments potentially emerging in 2023 include:

• Briumvi (ublituximab) - the anti-CD20 monoclonal antibody was approved by the FDA in late 2022 for treating relapsing MS based on strong phase 3 data.
• Ponesimod - an oral S1P receptor modulator expected to receive FDA approval in early 2023 after positive phase 3 results.
• Ibudilast - a non-immunomodulatory oral medication targeting neuroinflammation and neurodegeneration; results from late-stage trials are expected in 2023.
• Atacicept - a B cell targeting fusion protein in phase 2 development with promising interim results presented in 2022.
• Next-generation anti-CD20 antibodies - New monoclonal antibodies like ofatumumab and ocarilizumab are being further evaluated for RMS.
• Remyelinating therapies - Agents promoting myelin repair like opicinumab and clemastine are progressing through clinical trials.
• Stem cell therpies - Improved mesenchymal stem cell therapy protocols are making this a more viable option for aggressive MS.

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While additional research is still needed, 2023 is likely to see exciting advances in MS treatments that provide new options for managing the disease. Several pipeline drugs show promise to become part of the standard of care.

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What is the Ocrevus Copay Assistance Program?

The Ocrevus Co-Pay Assistance Program is specifically tailored for patients who are prescribed Ocrevus for an FDA-approved purpose. It offers significant financial support to eligible patients with commercial insurance.

Key Features of the Program

1. Minimal Out-of-Pocket Cost: Patients can pay as little as $0 per Ocrevus drug out-of-pocket cost, making the treatment more accessible.
2. Annual Benefit Cap: The program provides a substantial annual benefit, covering up to $20,000 per calendar year.
3. No Income Limits: Eligibility for the program is not restricted by the patient's income level.

Program Usage and Settings

The program is versatile and can be utilized in various healthcare settings, including community practices, infusion centers, or hospitals. This flexibility ensures that patients can receive their treatment in the most convenient location for them.

Eligibility Criteria

• Insurance Restrictions: The program is not available to patients using Medicare, Medicaid, or any other federal or state government program for paying their Genentech medicine and/or administration services.
• No Obligation for Specific Providers: Patients are not required to use any specific medicine or provider to be eligible for the program.

Restrictions and Limitations

• Ineligibility with Other Offers: The program cannot be combined with other rebates, free trials, or similar offers for the Genentech medicine.
• Exclusion with Charitable Assistance: Patients receiving assistance from charitable free medicine programs or charitable organizations for the same expenses are not eligible.

The Ocrevus Co-Pay Assistance Program offers a valuable financial resource for eligible patients, helping to alleviate the burden of treatment costs and allowing more patients to access this vital medication.

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Who Makes Ocrevus?

Ocrevus (ocrelizumab) is manufactured by Genentech, a subsidiary of Hoffmann–La Roche. It is a therapeutic monoclonal antibody used to treat multiple sclerosis (MS), specifically relapsing or primary progressive forms of the disease. The drug was approved by the U.S. Food and Drug Administration (FDA) in March 2017 and by the European Commission in January 2018.