Effective Date

Date of Origin 

04-01-2024            

10-01-2023

Rezurock®

(belumosudil)

Tablet

Treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy

1

Graft-Versus-Host-Disease

Chronic graft-versus-host disease (cGVHD) is the leading cause of non-relapse mortality (NRM) after an allogeneic hematopoietic cell transplant (HCT), has a profound impact on quality of life. cGVHD usually develops within the first year after HCT in most patients, but it can also develop many years later. cGVHD affects multiple organ systems and is characterized by fibrosis and variable clinical features resembling autoimmune disorders.(2) Standard of care in the treatment of cGvHD depends on the particular organ(s) or site(s) that is/are affected and adopted treatments can be topical or systemic. About 50%–60% of patients with cGvHD will require a second-line treatment within 2 years.(4,5)

Approximately 40% to 50% of patients with acute or chronic GVHD develop steroid-refractory disease, which is associated with high mortality. Currently, ruxolitinib, ibrutinib, and belumosudil are the only FDA-approved agents for treatment of steroid-refractory cGVHD.(2,3)

Efficacy

Study KD025-213 (NCT03640481) was a randomized, open-label, multicenter study of Rezurock for treatment of patients with chronic GVHD who had received 2 to 5 prior lines of systemic therapy and required additional treatment. There were 66 patients treated with Rezurock 200 mg taken orally once daily. Concomitant treatment with supportive care therapies for chronic GVHD was permitted. Concomitant treatment with GVHD prophylaxis and standard care systemic chronic GVHD therapies was permitted as long as the subject has been on a stable dose for at least 2 weeks prior to study. Initiation of new systemic chronic GVHD therapy while on study was not permitted.(1,6)

The efficacy of Rezurock was based on overall response rate (ORR) through Cycle 7 Day 1 where overall response included complete response or partial response according to the 2014 NIH Response Criteria. The ORR was 75% (95% CI: 63, 85). The median duration of response, calculated from first response to progression, death, or new systemic therapies for chronic GVHD, was 1.9 months (95% CI: 1.2, 2.9). The median time to first response was 1.8 months (95% CI: 1.0, 1.9). In patients who achieved response, no death or new systemic therapy initiation occurred in 62% (95% CI: 46, 74) of patients for at least 12 months since response.(1,6)

ORR results were supported by exploratory analyses of patient-reported symptom bother which showed at least a 7-point decrease in the Lee Symptom Scale summary score through Cycle 7 Day 1 in 52% (95% CI: 40, 65) of patients. The median duration of response was 54 weeks; 44% of patients remained on therapy for greater than or equal to one year. Overall median follow-up was 14 months.(1,6)

Safety

Rezurock carries no boxed warnings or contraindications.(1)

1

Rezurock prescribing information. Kadmon Pharmaceuticals, LLC. April 2023. 

2

National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology - Hematopoietic Cell Transplantation (HCT). Version 1.2023.

3

Hamilton BK. Updates in Chronic Graft-Versus-Host Disease. Hematology Am Soc Hematol Educ Program. 2021;1:648–654.

4

Wolff D, Fatobene G, Rocha V, et al. Steroid-Refractory Chronic Graft-Versus-Host Disease: Treatment Options and Patient Managment. Bone Marrow Transplant. 2021 Jul;56:2079-2087.

5

Saidu NEB, Bonini C, Dickinson A, et al. New Approaches for the Treatment of Chronic Graft-Versus-Host Disease: Current and Future Directions. Front Immunol. 2020;11:578314.

6

Cutler C, Lee SJ, Arai S. Belumosudil for Chronic Graft-Versus-Host Disease after Two or More Prior Lines of Therapy: the ROCKstar Study. Blood. 2021 Dec;138(22):2278-2289.

Rezurock

belumosudil mesylate tab

200 MG

M ; N ; O ; Y

N

Rezurock

Belumosudil Mesylate Tab

200 MG

30

Tablets

30

DAYS

Rezurock

belumosudil mesylate tab

200 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Rezurock

Belumosudil Mesylate Tab

200 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

1. ONE of the following:
   1. The requested agent is eligible for continuation of therapy AND ONE of the following:

1. 1. 1. Information has been provided that indicates the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
      2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
   2. BOTH of the following:
      1. The patient has chronic graft-versus-host disease (chronic GVHD) AND
      2. The patient has failed at least two prior lines of systemic therapy AND
2. If the patient has an FDA approved indication, then ONE of the following:
   1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
   2. The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication AND
3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist, oncologist) or has consulted with a specialist in the area of the patient’s diagnosis AND
4. The patient does NOT have any FDA labeled contraindications to therapy with the requested agent

Length of Approval: 12 months

Note: If Quantity Limit applies, please refer to Quantity Limit criteria. 

Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization Review process AND
2. The patient has had clinical benefit with the requested agent AND
3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist, oncologist) or has consulted with a specialist in the area of the patient’s diagnosis AND
4. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval: 12 months

Note: If Quantity Limit applies, please refer to Quantity Limit criteria. 

Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:

1. The requested quantity (dose) does NOT exceed the program quantity limit OR
2. ALL of the following:
   1. The requested quantity (dose) exceeds the program quantity limit AND
   2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
   3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR
3. ALL of the following:
   1. The requested quantity (dose) exceeds the program quantity limit AND
   2. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
   3. The prescriber has provided information in support of therapy with a higher dose for the for the requested indication

Length of Approval:  12 months