Rezurock – NC Standard

Restricted Product(s)

• RezurockTM (belumosudil)

FDA Approved Use

• For the treatment of adults and pediatric patients 12 years of age or older with chronic graft-versus-host disease after failure of at least 2 prior lines of systemic therapy.

Criteria for Approval of Restricted Product(s)

Initial coverage

1. The patient is ≥ 12 years of age; AND 
2. The patient has a diagnosis of chronic graft vs host disease (medical record documentation required); AND 
3. The patient has received at least two prior lines of systemic therapy (e.g., glucocorticoids, ibrutinib, ruxolitinib, immunosuppressants, calcineurin inhibitors) (medical record documentation required); AND 
4. The patient has had an inadequate response or a clinical contraindication/intolerance to Imbruvica OR Jakafi; AND 
5. The patient is not currently taking a proton pump inhibitor (PPI); OR
   1. The patient will be transitioned off the PPI prior to starting Rezurock; AND 
6. Rezurock will NOT be used in combination with Imbruvica OR Jakafi; AND 
7. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND 
8. The patient is being managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., oncologist, hematologist); AND 
9. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 180 days (6 months)

Continuation coverage

1. The patient has been previously approved for Rezurock with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND 
2. Documentation of positive clinical response to Rezurock therapy (medical record documentation required); AND 
3. Rezurock will NOT be used in combination with Imbruvica OR Jakafi; AND 
4. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND
5. The patient continues to be managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., oncologist, hematologist).
   
   Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).
   
   Duration of Approval: 365 days (1 year)
   

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

July 2022: Criteria change: Added patient will not be using the requested agent in combination with Jakafi. Added prescriber is a specialist or consulted a specialist.
April 2022: Criteria update: Updated documentation of clinical response in the continuation criteria.
August 2021: Original utilization management policy issued.