Pharmacy Prior Authorization Criteria

Rezurock (belumosudil) - PA, NF

Indications for Prior Authorization

Rezurock (belumosudil)

• For diagnosis of Chronic graft-versus-host disease
  Indicated for the treatment of chronic graft-versus-host disease (chronic 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, mycophenolate, etc.)
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, mycophenolate, etc.)(2)
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

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. April 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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Revision History

• 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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