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.
Last review date: February 15, 2022