Ciltacabtagene autoleucel - Biologic Drug Details

Summary for ciltacabtagene autoleucel

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for ciltacabtagene autoleucel

Recent Clinical Trials for ciltacabtagene autoleucel

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Washington University School of Medicine	Phase 1
Paula C. & Rodger O. Riney Blood Cancer Research	Phase 1
Janssen Research & Development, LLC	Phase 2

See all ciltacabtagene autoleucel clinical trials

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1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for ciltacabtagene autoleucel Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ciltacabtagene autoleucel Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for ciltacabtagene autoleucel Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Ciltacabtagene Autoleucel

Introduction to Ciltacabtagene Autoleucel

Ciltacabtagene autoleucel, a chimeric antigen receptor (CAR) T-cell therapy, is a groundbreaking treatment developed by Janssen and Legend Biotech for patients with relapsed or refractory multiple myeloma. This therapy represents a significant advancement in the field of oncology, particularly in the treatment of hematological malignancies.

Market Size and Growth Projections

The global CAR T-cell therapy market, which includes ciltacabtagene autoleucel, is projected to experience substantial growth. From a market size of approximately USD 4.6 billion in 2024, it is expected to reach USD 25 billion by 2035, growing at a Compound Annual Growth Rate (CAGR) of around 11.4%[1][4].

Target Indications and Clinical Trials

Ciltacabtagene autoleucel targets the B-cell maturation antigen (BCMA), which is highly expressed on multiple myeloma cells. The therapy has shown promising results in clinical trials, particularly in phase III trials where it has been evaluated as an earlier line of treatment compared to its current status as a fifth-line therapy. This expansion in treatment lines is expected to significantly increase its market potential[1][4].

Economic Burden and Cost Analysis

The economic burden of ciltacabtagene autoleucel is substantial. A study evaluating the economic impact of this therapy estimated the annual costs for drug acquisition, administration, and adverse event management. The total annual cost per patient was approximately $565,534, which includes $465,000 for drug acquisition, $60,167 for administration, and $40,368 for adverse event management[2].

Cost-Effectiveness and Value Assessment

Despite the high costs, cost-effectiveness analyses suggest that ciltacabtagene autoleucel can provide significant health benefits. For instance, the Incremental Cost-Effectiveness Ratio (ICER) for this therapy compared to standard treatment options for heavily refractory multiple myeloma was estimated to be around $319,000 per quality-adjusted life-year (QALY). However, for it to meet a willingness-to-pay threshold of $100,000/QALY, the list price would need to be reduced to around $200,000[5].

Market Forces and Challenges

Several market forces and challenges influence the financial trajectory of ciltacabtagene autoleucel:

Rising Incidence of Cancer

The increasing incidence and prevalence of cancer, particularly leukemia and lymphoma, drive the demand for CAR T-cell therapies. In 2023, there were 59,610 new cases of leukemia and 89,380 new cases of lymphoma in the US, many of which are targeted by CAR T-cell therapies[1][4].

Manufacturing Advancements

Recent advancements in manufacturing processes, such as those achieved by Kite Pharma, have significantly reduced turnaround times, making these therapies more accessible and efficient[1][4].

Financial Implications

The high cost of CAR T-cell therapies is a significant challenge. The financial implications affect patients, payers, and providers, making cost-effectiveness analyses crucial for determining the value of these therapies[5].

Competition and Pricing

The biologics market, including CAR T-cell therapies, faces increasing competition from biosimilars. This competition can lead to more competitive pricing, which may impact the revenue growth of these therapies[3].

Regulatory Approvals and Expansion

Ciltacabtagene autoleucel has been seeking regulatory approvals for various indications. For example, it has a Prescription Drug User Fee Act (PDUFA) date for the treatment of relapsed or refractory multiple myeloma. Positive outcomes from these regulatory processes can expand its market reach and potential[5].

Clinical Trials and Pipeline

With over 600 clinical trials globally for CAR T-cell therapies, the pipeline for ciltacabtagene autoleucel and similar treatments is robust. This ongoing research and development are expected to further solidify the market position of these therapies[5].

Uptake and Adoption

The uptake of CAR T-cell therapies has been slow but is rapidly expanding. According to an analysis of the Medicare fee-for-service population, the number of CAR T-cell claims is doubling every six months. This trend indicates growing acceptance and adoption of these therapies in clinical practice[5].

Value to Patients and Healthcare System

Despite the high costs, CAR T-cell therapies like ciltacabtagene autoleucel offer significant health benefits, including improved survival rates and quality of life. These benefits are quantified through metrics such as QALYs, which help in assessing the value of these therapies relative to their costs.

"CAR T-cell therapies could have significant value at their current price, although it should be noted that the wholesale acquisition cost (WAC) of axicabtagene ciloleucel has increased since these studies were published. However, CAR T-cell therapies must result in a substantial increase in overall survival compared with standard of care to achieve acceptable value."[5]

Future Outlook

The future outlook for ciltacabtagene autoleucel is promising, driven by positive clinical trial results, expanding treatment lines, and increasing adoption. However, addressing the high costs and ensuring cost-effectiveness will be crucial for sustained market growth.

Key Takeaways

• Market Growth: The global CAR T-cell therapy market is projected to grow significantly, reaching USD 25 billion by 2035.
• Clinical Success: Ciltacabtagene autoleucel has shown positive results in phase III trials, expanding its potential market size.
• Economic Burden: The therapy is costly, with an annual cost per patient of approximately $565,534.
• Cost-Effectiveness: Despite high costs, the therapy offers significant health benefits, with ICER estimates suggesting value at reduced prices.
• Regulatory Approvals: Ongoing regulatory approvals and clinical trials will further expand its market reach.
• Uptake and Adoption: The therapy is seeing rapid adoption, with CAR T-cell claims doubling every six months.

FAQs

1. What is ciltacabtagene autoleucel used for? Ciltacabtagene autoleucel is a CAR T-cell therapy used for the treatment of relapsed or refractory multiple myeloma.

2. How much does ciltacabtagene autoleucel cost? The total annual cost per patient for ciltacabtagene autoleucel is approximately $565,534, including drug acquisition, administration, and adverse event management costs.

3. What are the key drivers of the CAR T-cell therapy market? The key drivers include the rising incidence of cancer, advancements in manufacturing processes, and positive outcomes from clinical trials.

4. How does the cost-effectiveness of ciltacabtagene autoleucel compare to standard treatments? The therapy is more costly than standard treatments but offers greater health benefits, with ICER estimates suggesting it could be cost-effective at reduced prices.

5. What is the future outlook for ciltacabtagene autoleucel? The future outlook is promising, driven by clinical success, expanding treatment lines, and increasing adoption, but addressing high costs will be crucial.

Sources

1. GlobeNewswire: CAR T Cell Therapy Market Industry Trends and Global Forecasts to 2035[1].
2. PubMed: The Economic Burden of CAR T Cell Therapies Ciltacabtagene Autoleucel and Idecabtagene Vicleucel[2].
3. CAS.org: The Rise of Biologics: Emerging Trends and Opportunities[3].
4. Roots Analysis: CAR T-cell Therapy Market Size, Growth & Trends Report [2035][4].
5. AJMC: Improving Outcomes and Mitigating Costs Associated With CAR T Cell Therapy[5].