BELUMOSUDIL MESYLATE - Generic Drug Details

What are the generic drug sources for belumosudil mesylate and what is the scope of freedom to operate?

Belumosudil mesylate is the generic ingredient in one branded drug marketed by Kadmon Pharms Llc and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Belumosudil mesylate has forty-nine patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for BELUMOSUDIL MESYLATE

International Patents:	49
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
DailyMed Link:	BELUMOSUDIL MESYLATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BELUMOSUDIL MESYLATE

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BELUMOSUDIL MESYLATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Sanofi US Services, Inc	Phase 1/Phase 2
M.D. Anderson Cancer Center	Phase 1/Phase 2

See all BELUMOSUDIL MESYLATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BELUMOSUDIL MESYLATE

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for BELUMOSUDIL MESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kadmon Pharms Llc	REZUROCK	belumosudil mesylate	TABLET;ORAL	214783-001	Jul 16, 2021		RX	Yes	Yes
Kadmon Pharms Llc	REZUROCK	belumosudil mesylate	TABLET;ORAL	214783-001	Jul 16, 2021		RX	Yes	Yes			Y	Y
Kadmon Pharms Llc	REZUROCK	belumosudil mesylate	TABLET;ORAL	214783-001	Jul 16, 2021		RX	Yes	Yes
Kadmon Pharms Llc	REZUROCK	belumosudil mesylate	TABLET;ORAL	214783-001	Jul 16, 2021		RX	Yes	Yes
Kadmon Pharms Llc	REZUROCK	belumosudil mesylate	TABLET;ORAL	214783-001	Jul 16, 2021		RX	Yes	Yes
Kadmon Pharms Llc	REZUROCK	belumosudil mesylate	TABLET;ORAL	214783-001	Jul 16, 2021		RX	Yes	Yes
Kadmon Pharms Llc	REZUROCK	belumosudil mesylate	TABLET;ORAL	214783-001	Jul 16, 2021		RX	Yes	Yes

International Patents for BELUMOSUDIL MESYLATE

Country	Patent Number	Title	Estimated Expiration
Ecuador	SP077836	COMPUESTOS MEJORADOS FARMACOCINÉTICAMENTE
Eurasian Patent Organization	022875	ПРОИЗВОДНЫЕ 4-(ИНДАЗОЛ-5-ИЛ-АМИНО)-2-ФЕНИЛХИНАЗОЛИНА (4-(INDAZOLE-5-YLAMINO)-2-PHENYLQUINAZOLIN DERIVATIVES)
European Patent Office	4116293	INHIBITEURS DE RHO KINASE (RHO KINASE INHIBITORS)
China	105120869	Rho kinase inhibitors
Japan	6419076
Serbia	63503	INHIBITORI RHO KINAZE (RHO KINASE INHIBITORS)
World Intellectual Property Organization (WIPO)	2015157556

Supplementary Protection Certificates for BELUMOSUDIL MESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2903618	SPC/GB22/068	United Kingdom		PRODUCT NAME: BELUMOSUDIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK PLGB 53904/0001-0001 20220707

BELUMOSUDIL MESYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Belumosudil Mesylate

Introduction

Belumosudil mesylate, marketed as Rezurock, is a selective inhibitor of Rho kinase 2 (ROCK2) indicated for the treatment of chronic graft-versus-host disease (cGVHD) in patients aged 12 years and older who have received at least two prior lines of systemic therapy. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Indication and Target Population

Belumosudil mesylate is specifically approved for treating cGVHD, a significant complication following allogeneic hematopoietic stem cell transplantation. The target population includes patients who have failed at least two prior lines of systemic therapy, highlighting a niche but critical market segment[2][4][5].

Pricing and Cost Considerations

The list price of belumosudil is substantial, with 30 tablets of 200 mg costing £6,708.00 (excluding VAT). This high pricing is a critical factor in its cost-effectiveness analysis. The company has a commercial arrangement that offers discounts to the NHS, though the exact discount is confidential[2][5].

Cost-Effectiveness Analysis

The cost-effectiveness of belumosudil has been a subject of extensive analysis. The Canadian Agency for Drugs and Technologies in Health (CADTH) conducted a thorough review, which indicated that the incremental cost-effectiveness ratio (ICER) for belumosudil versus best available therapy (BAT) was $313,874 per quality-adjusted life-year (QALY) gained. This is significantly above the typical willingness-to-pay threshold of $50,000 per QALY, suggesting that the drug would need a 76% price reduction to be considered cost-effective at this threshold[1].

Health Economic Models and Assumptions

The economic models used to evaluate belumosudil's cost-effectiveness are complex and involve several assumptions. The company's model used a partitioned survival approach with three health states: failure-free, failure progressed, and death. However, these models have been criticized for their limitations, including the use of naive indirect comparisons and uncertain extrapolations of overall survival and failure-free survival[1][2][5].

Budget Impact Analysis

A budget impact analysis conducted in the US context suggested that the introduction of belumosudil could lead to cost savings. With belumosudil utilization increasing to 55% by 2026, the analysis predicted cost savings of approximately 5.5% and 6.7% from national and payer perspectives, respectively. These savings were primarily due to reduced adverse events and healthcare resource utilization[3].

Sensitivity and Scenario Analyses

Sensitivity and scenario analyses have been performed to assess the robustness of the cost-effectiveness estimates. These analyses varied parameters such as time horizons, concomitant medication use, and treatment-stopping rules. The results showed that the ICER for belumosudil versus BAT could range from $59,645 to $86,459 per QALY gained across different scenarios, highlighting the sensitivity of the model to various assumptions[1].

Regulatory and Reimbursement Decisions

Regulatory bodies such as the UK's National Institute for Health and Care Excellence (NICE) have scrutinized belumosudil's cost-effectiveness. NICE has noted substantial uncertainty in the clinical evidence and economic models, leading to a conclusion that further analyses are needed to address these uncertainties. As a result, belumosudil has not been recommended for routine use in the NHS due to these concerns[5].

Market Uptake and Utilization

The market uptake of belumosudil is expected to be significant but is subject to various factors, including pricing, reimbursement decisions, and competition from other therapies. The sponsor's initial assumptions included a market uptake of 50% in the first year, increasing to 65% and 80% in subsequent years. However, actual uptake may vary based on real-world performance and healthcare system dynamics[1].

Financial Projections and Cost Savings

Financial projections suggest that while belumosudil is costly, its introduction could lead to overall cost savings in the healthcare system. The reduction in adverse events and healthcare resource utilization are key drivers of these savings. For instance, the budget impact analysis estimated cost savings of $128.8 million and $4.9 million for national and payer perspectives, respectively, by 2026[3].

Challenges and Limitations

Several challenges and limitations affect the financial trajectory of belumosudil. These include the high drug acquisition costs, uncertainties in clinical efficacy and survival benefits, and the need for robust and clinically plausible economic models. Addressing these limitations through further research and data collection is crucial for a more accurate assessment of belumosudil's financial impact[1][2][5].

Future Outlook

The future outlook for belumosudil depends on addressing the current uncertainties and limitations. Further analyses, including more robust comparisons and real-world data, are necessary to solidify its position in the market. Additionally, negotiations on pricing and reimbursement will play a critical role in determining its financial trajectory.

Key Takeaways

• High Pricing: Belumosudil is costly, with a list price of £6,708.00 for 30 tablets.
• Cost-Effectiveness: The ICER is high, requiring significant price reductions to meet typical cost-effectiveness thresholds.
• Budget Impact: Introduction of belumosudil could lead to cost savings through reduced adverse events and healthcare resource utilization.
• Regulatory Scrutiny: Regulatory bodies have raised concerns about the robustness of clinical evidence and economic models.
• Market Uptake: Expected market uptake is significant but subject to various factors including pricing and reimbursement decisions.

FAQs

Q: What is the primary indication for belumosudil mesylate? A: Belumosudil mesylate is indicated for the treatment of chronic graft-versus-host disease (cGVHD) in patients aged 12 years and older who have received at least two prior lines of systemic therapy.

Q: How much does belumosudil cost? A: The list price of 30 belumosudil 200-mg tablets is £6,708.00 (excluding VAT).

Q: What are the key findings from the cost-effectiveness analysis? A: The ICER for belumosudil versus BAT is high, requiring a significant price reduction to be considered cost-effective at typical thresholds.

Q: What are the potential cost savings associated with belumosudil? A: The introduction of belumosudil could lead to cost savings of approximately 5.5% and 6.7% from national and payer perspectives, respectively, primarily due to reduced adverse events and healthcare resource utilization.

Q: Why has belumosudil not been recommended by NICE? A: NICE has noted substantial uncertainty in the clinical evidence and economic models, leading to a conclusion that further analyses are needed to address these uncertainties.

Sources

1. Pharmacoeconomic Review - Belumosudil (Rezurock) - NCBI
2. Belumosudil for treating chronic graft-versus-host disease after 2 or more systemic treatments in people 12 years and over - NICE
3. Budget impact analysis of belumosudil for chronic graft-versus-host disease - PubMed
4. Likelihood of Approval and Phase Transition Success Rate Model – Belumosudil Mesylate in Refractory Multiple Myeloma - GlobalData
5. Belumosudil for treating chronic graft-versus-host disease after 2 or more systemic treatments in people 12 years and over - Draft Guidance - NICE