Introduction
Lisocabtagene maraleucel, marketed as BREYANZI, is a groundbreaking CD19-directed genetically modified autologous T cell immunotherapy developed by Juno Therapeutics, now part of Bristol Myers Squibb. This article delves into the market dynamics and financial trajectory of BREYANZI, highlighting its clinical significance, market assessment, and financial implications.
Clinical Significance and Indications
BREYANZI is indicated for the treatment of adult patients with various types of large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. It is also approved for relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), as well as relapsed or refractory mantle cell lymphoma (MCL) and follicular lymphoma (FL)[4].
Market Assessment
The market for BREYANZI is expected to grow significantly due to several factors:
Extensive Research and Healthcare Spending
The global market for DLBCL is anticipated to expand due to extensive research and increased healthcare spending. This expansion will enable drug manufacturers to penetrate the market more effectively[1].
Clinical Trials and Efficacy
Recent clinical trials, such as the TRANSCEND FL and TRANSCEND NHL 001 studies, have shown promising results. For instance, 97% of patients with relapsed or refractory follicular lymphoma treated with BREYANZI achieved a response, with 94% achieving a complete response. These outcomes underscore the drug's efficacy and potential market dominance[5].
Competitive Landscape
BREYANZI operates in a competitive landscape with other CAR-T cell therapies. However, its broad US label for second-line large B-cell lymphoma (LBCL) and anticipated capacity expansion in 2023 position it as a strong contender. Other emerging products for DLBCL will provide market competition, but BREYANZI's established presence and clinical data support its market standing[1].
Regulatory Milestones
BREYANZI has received several regulatory approvals and milestones:
FDA Approval
The FDA approved BREYANZI for various indications, including LBCL and CLL/SLL, with some approvals under accelerated approval based on response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials[4].
NTAP Status
Although BREYANZI was denied New Technology Add-on Payment (NTAP) status by CMS in 2022 due to not meeting the newness and substantial clinical improvement criteria, this decision does not diminish its clinical value but rather affects reimbursement dynamics[2].
Financial Trajectory
Sales Forecast
The market assessment for BREYANZI includes forecasted sales data from 2023 to 2032 across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. These forecasts indicate a significant market potential, driven by the drug's efficacy and the growing demand for CAR-T cell therapies[1].
Cost-Effectiveness
Despite the high costs associated with CAR-T cell therapies, cost-effectiveness analyses suggest that BREYANZI could provide substantial health benefits. For example, studies have shown that CAR-T cell therapies can be cost-effective if they result in a significant increase in overall survival compared to standard care. The incremental cost-effectiveness ratio for such therapies can range from $58,000 to $289,000 per quality-adjusted life year (QALY)[3].
Reimbursement and Pricing
The maximum NTAP payment for other CAR-T therapies approved in 2022 ranged from $259,350 to $272,675. While BREYANZI did not receive NTAP status, its pricing and reimbursement will be critical in determining its financial performance. The wholesale acquisition cost (WAC) and hospital charges will influence its adoption and market penetration[2].
Market Size and Country-Wise Analysis
The market size of BREYANZI is expected to vary across different countries:
United States
BREYANZI has the broadest US label for second-line LBCL, which positions it well in the US market. The forecasted sales data indicate a substantial market share in the US[1].
EU4 and the United Kingdom
In the EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, BREYANZI's market size will be influenced by regulatory approvals, reimbursement policies, and competition from other CAR-T cell therapies[1].
Japan
The Japanese market also presents opportunities for BREYANZI, given the growing demand for innovative cancer treatments. The drug's performance in clinical trials and its regulatory status will be key factors in this market[1].
Challenges and Opportunities
Competition from Emerging Therapies
The launch of late-stage emerging therapies in the near future will significantly impact the market for BREYANZI. However, its established clinical data and broad US label provide a competitive edge[1].
Regulatory and Reimbursement Challenges
Regulatory milestones and reimbursement policies will continue to shape the financial trajectory of BREYANZI. Securing favorable reimbursement terms and maintaining regulatory approvals will be crucial for its market success[2][4].
Key Takeaways
- Clinical Efficacy: BREYANZI has demonstrated deep and durable responses in clinical trials, particularly in relapsed or refractory follicular lymphoma and mantle cell lymphoma.
- Market Potential: The drug has significant market potential across seven major markets, driven by growing demand for CAR-T cell therapies.
- Regulatory Approvals: BREYANZI has received FDA approvals for various indications, although it was denied NTAP status.
- Cost-Effectiveness: Despite high costs, BREYANZI can be cost-effective if it results in substantial increases in overall survival.
- Competition: The market is competitive, but BREYANZI's broad US label and clinical data support its market standing.
FAQs
What is BREYANZI used for?
BREYANZI is used for the treatment of adult patients with various types of large B-cell lymphoma (LBCL), including DLBCL, high-grade B-cell lymphoma, and other specific lymphomas, as well as relapsed or refractory CLL/SLL and MCL[4].
What are the key clinical trials for BREYANZI?
Key clinical trials include the TRANSCEND FL and TRANSCEND NHL 001 studies, which have shown promising response rates and complete response rates in patients with relapsed or refractory follicular lymphoma and mantle cell lymphoma[5].
Why was BREYANZI denied NTAP status?
BREYANZI was denied NTAP status by CMS in 2022 because it did not meet the newness and substantial clinical improvement criteria[2].
How cost-effective is BREYANZI?
BREYANZI can be cost-effective if it results in a significant increase in overall survival compared to standard care, with cost-effectiveness estimates ranging from $58,000 to $289,000 per QALY[3].
What are the market forecasts for BREYANZI?
The market forecasts indicate significant sales potential from 2023 to 2032 across seven major markets, driven by the drug's efficacy and growing demand for CAR-T cell therapies[1].
Sources
- GlobeNewswire: BREYANZI (Lisocabtagene Maraleucel) Drug Insight and Market Forecasts 2019-2032[1].
- Avalere: CMS Updates CAR-T Reimbursement for 2022 in IPPS Final Rule[2].
- AJMC: Improving Outcomes and Mitigating Costs Associated With CAR T Cell Therapy[3].
- FDA: BREYANZI (lisocabtagene maraleucel)[4].
- Bristol Myers Squibb: Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel) Delivers Deep and Durable Responses in Relapsed or Refractory Follicular Lymphoma and Mantle Cell Lymphoma in TRANSCEND Clinical Trials[5].
Last updated: 2024-12-22
