REZUROCK (belumosudil)

REZUROCK (belumosudil)

Self-Administration – oral

Diagnosis considered for coverage:

• Indicated for the 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

Coverage Criteria:

For diagnosis of chronic GVHD:

• Dose does not exceed one of the following:
  • 200 mg once daily; OR
  • 200 mg twice daily for patients using Rezurock concomitantly with one of the following: strong CYP3A inducer (e.g., carbamazepine, phenobarbital, phenytoin, rifampin) OR proton pump inhibitor (e.g., omeprazole, pantoprazole, lansoprazole); AND
• Patient is 12 years of age or older; AND
• Patient has a diagnosis of chronic graft-versus-host disease confirmed by chart note documentation; AND
• Prescribed by or in consultation with a hematologist, oncologist, or physician experienced in the management of transplant patients; AND
• Patient has a history of allogenic hematopoietic cell transplant (HCT); AND
• Trial and failure of two or more lines of systemic therapy (e.g., corticosteroids, immunosuppressants, etc.); AND
• Rezurock is not prescribed in combination with Imbruvica® or Jakafi®

Reauthorization Criteria:

For diagnosis of chronic GVHD:

• Dose does not exceed one of the following:
  • 200 mg once daily; OR
  • 200 mg twice daily for patients using Rezurock concomitantly with one of the following: strong CYP3A inducer (e.g., carbamazepine, phenobarbital, phenytoin, rifampin) OR proton pump inhibitor (e.g., omeprazole, pantoprazole, lansoprazole); AND
• Patient does not show evidence of progressive disease while on therapy; AND
• Rezurock is not prescribed in combination with Imbruvica® or Jakafi®

Coverage Duration: 

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following: 

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Recommended dose: 200 mg given orally once daily until progression of chronic GVHD that requires new systemic therapy
• Increase the dosage of Rezurock to 200 mg twice daily when coadministered with strong CYP3A inducers or PPIs
• Treatment with Rezurock has not been studied in patients with pre-existing severe renal or hepatic impairment. For patients with pre-existing severe renal or hepatic impairment, consider the risks and potential benefits before initiating treatment with Rezurock
• Swallow Rezurock tablets whole. Do not cut, crush, or chew tablets.
• Warning for embryo-fetal toxicity
• Other systemic therapies for chronic GVHD: ruxolitinib (Jakafi), abatacept (Orencia), alemtuzumab (Campath), calcineurin inhibitors (e.g., tacrolimus, cyclosporine), etanercept (Enbrel), ECP (extracorporeal photopheresis), hydroxychloroquine, ibrutinib (Imbruvica), imatinib (Gleevec), IL-2, methotrexate, mTOR inhibitors (e.g., sirolimus), mycophenolate, pentostatin (Nipent), rituximab

Policy Updates:

• 2/15/2022 – New policy approved by P&T.

References:

• Rezurock Prescribing Information. Kadmon Pharmaceuticals, LLC. Warrendale, PA. July 2021.