Limited coverage criteria – belumosudil

 

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Generic name		belumosudil
Strength & form		200 mg oral tablet

Special Authority criteria	Approval period
Initial For the treatment of chronic graft-versus-host-disease (cGvHD) in patients aged 12 years and older when ALL the following criteria are met: Patient has moderate to severe cGvHD according to National Institutes of Health (NIH) consensus criteria  AND Patient has experienced inadequate response to corticosteroids1 or corticosteroids with other systemic therapies2  AND Patient has experienced an inadequate response to ruxolitinib AND The treatment is prescribed, and a Special Authority request is submitted by a specialist physician with the Leukemia/Bone Marrow Transplant Program of BC (BCL/BMT program)	Initial: 24 weeks
Renewal2,3 Treatment with belumosudil should be renewed for patients who have achieved an overall response (i.e., complete response (CR) or partial response (PR), or stable disease with significant reduction in steroid doses), according to NIH criteria after 24 weeks of therapy (approximately 6 months) and maintains an on-going clinical benefit	Renewal: 24 weeks

Practitioner exemptions

• None

Special notes

• ¹Corticosteroid refractory in cGvHD is defined according to the NIH consensus criteria is, irrespective of the concomitant use of a calcineurin inhibitor (CNI): 
  • a lack of response or disease progression after administration of minimum prednisone 1 mg/kg/day for at least 1 week (or equivalent); or 
  • disease persistence without improvement despite continued treatment with prednisone at > 0.5 mg/kg/day or 1 mg/kg/every other day for at least 4 weeks (or equivalent); or 
  • increase to prednisone dose to > 0.25 mg/kg/day after two unsuccessful attempts to taper the dose (or equivalent) 
  • patients who have recurrent flare ups or who develop prednisone toxicity during the prednisone taper 
• ²Treatment with belumosudil may be added to patients’ concurrent treatment of steroids with or without calcineurin inhibitor (CNI) and/or stable systemic therapies for cGVHD, but once belumosudil is started no new therapies for cGVHD can be initiated  
• ³Discontinuation criteria: Belumosudil should be discontinued upon the occurrence of any of the following: 
  • progression of cGvHD, defined as worsening of cGvHD symptoms or occurrence of new cGvHD symptoms 
  • the dose of corticosteroids remains at or above baseline dose for more than 6 weeks  
  • a patient experiences more than 2 cGVHD flares that require increased corticosteroid therapy within a 6-month period of belumosudil treatment 

Special Authority requests

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• HLTH 5869 – Belumosudil (PDF, 710KB)