Jesduvroq – NC Standard

Restricted Product(s)

• Jesduvroq (daprodustat) 

FDA Approved Use

• Treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least four months

Limitations of Use:

• Jesduvroq has not been shown to improve quality of life, fatigue, or patient well-being. 
• Jesduvroq is not indicated for use: 
  • As a substitute for transfusion in patients requiring immediate correction of anemia. 
  • In patients not on dialysis

Criteria for Approval of Restricted Product(s)

Initial Coverage Criteria

1. The patient has a diagnosis of chronic kidney disease; AND 
2. The patient has been on dialysis for at least 4 months; AND 
3. The patient’s ferritin, transferrin and hemoglobin have been measured in the previous 4 weeks; AND 
4. The patient is currently using an erythropoietin receptor agonist (ESA) (e.g., Aranesp, Epogen, Mircera, Procrit, Retacrit) and has a measured hemoglobin <12 g/dL [medical record documentation required]; OR 
   1. The patient is not currently using an ESA and has a measured hemoglobin ≤ 11 g/dL [medical record documentation required]; AND
5. The patient's ferritin is > 100 mcg/L; AND 
6. The patient's transferrin saturation (TSAT) is > than 20%; AND 
7. Other causes of anemia (e.g., pernicious anemia, thalassemia major, sickle cell) have been addressed; AND 
8. The patient will NOT be using the requested agent in combination with an ESA (e.g., Aranesp, Epogen, Mircera, Procrit, Retacrit); AND 
9. The prescriber is a specialist in the area of the patient's diagnosis (e.g., nephrologist) or has consulted with a specialist in the area of the patient's diagnosis; AND 
10. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND 
11. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 180 days (6 months)

Continuation Coverage Criteria

1. The patient has been previously approved 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. The patient has a diagnosis of chronic kidney disease; AND 
   1. The patient has had clinical benefit with the requested agent (e.g., increase in hemoglobin); AND 
   2. The patient's hemoglobin was measured within the previous 4 weeks; AND 
   3. The patient's hemoglobin does NOT exceed 12 g/dL [medical records required]; AND 
3. The patient will NOT be using the requested agent in combination with an ESA (e.g., Aranesp, Epogen, Mircera, Procrit, Retacrit); AND 
4. The prescriber is a specialist in the area of the patient's diagnosis (e.g., nephrologist) or has consulted with a specialist in the area of the patient's diagnosis

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

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

September 2023: Original utilization management criteria issued.