Pharmacy Prior Authorization Criteria

Rezurock (belumosudil) - PA, NF, QL

Indications for Prior Authorization

Rezurock (belumosudil)

• For diagnosis of Chronic graft-versus-host disease
  Indicated for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients 12 years and older.

Criteria

Rezurock

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic graft-versus-host disease

• Diagnosis of chronic graft-versus-host disease
AND
• Trial and failure of two or more lines of systemic therapy (e.g., corticosteroids [e.g., prednisone, methylprednisolone], mycophenolate, chemotherapy) [A]
AND
• Patient is 12 years of age or older

Rezurock

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic graft-versus-host disease

• Patient does not show evidence of progressive disease while on therapy

Rezurock

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Chronic graft-versus-host disease

• Submission of medical records (e.g., chart notes) confirming diagnosis of chronic graft-versus-host disease
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure of three or more lines of systemic therapy (e.g., corticosteroids [e.g., prednisone, methylprednisolone], mycophenolate, chemotherapy) [A]
AND
• Patient is 12 years of age or older

Rezurock

Quantity Limit

Length of Approval: 12 Month(s)
For diagnosis of Chronic graft-versus-host disease - Twice daily (BID) Therapy

• Patient is using medication concomitantly with one of the following:
• Strong CYP3A inducer (e.g., carbamazepine, phenobarbital, phenytoin, rifampin)
• Proton pump inhibitor (e.g., omeprazole, pantoprazole, lansoprazole)

P & T Revisions

2025-08-27, 2025-06-25, 2024-09-04, 2023-09-01, 2023-06-26, 2022-09-08, 2022-04-29, 2022-01-03, 2021-10-06, 2021-08-24

References

1. Rezurock Prescribing Information. Kadmon Pharmaceuticals, LLC. Warrendale, PA. December 2024.
2. Cutler C, Lee SJ, Arai S, et al. Belumosudil for chronic graft-versus-host disease after 2 or more prior lines of therapy: the ROCKstar study [published correction appears in Blood. 2022 Mar 17;139(11):1772. doi: 10.1182/blood.2022015598]. Blood. 2021;138(22):2278-2289. doi:10.1182/blood.2021012021

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End Notes

1. Participants in the pivotal study ranged from having a minimum of 2 to more than 6 prior lines of therapy. Prior systemic therapies included corticosteroids (e.g., prednisone), tacrolimus, extracorporeal photopheresis, sirolimus, ibrutinib (Imbruvica), ruxolitinib (Jakafi), mycophenolate, rituximab (Rituxan), methotrexate, cyclosporine, imatinib (Gleevec), ixazomib (Ninlaro), and ofatumumab (Arzerra, Kesimpta). [2]

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Revision History

• 2025-08-27: 2025 Annual Review - Addition of systemic therapy examples with no change to clinical intent. Background updates.
• 2025-06-25: Updated guideline name, added QL to GL name.
• 2024-09-04: 2024 Annual Review. Updated non-formulary criteria to require submission of medical records confirming diagnosis, and trial and failure of three or more lines of systemic therapy
• 2023-09-01: Annual Review - no criteria changes
• 2023-06-26: Removed Specialist request
• 2022-09-08: Annual Review - Addition of age requirement
• 2022-04-29: GPI Reclassification
• 2022-01-03: Addition of Non-Formulary criteria
• 2021-10-06: QL criteria added
• 2021-08-24: New UM Program

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