Xphozah – NC Standard

Restricted Product(s)

• Xphozah® (tenapanor)

FDA Approved Use

• To reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.

Criteria for Approval of Restricted Product(s)

1. The patient is 18 years of age or older; AND 
2. The patient has a diagnosis of hyperphosphatemia; AND 
3. The patient has chronic kidney disease; AND 
4. The patient is on dialysis; AND 
5. ONE of the following: 
   1. The patient has had an inadequate response to at least a 4-week trial of TWO unrestricted phosphate binder products (e.g., calcium acetate, sevelamer carbonate, etc.); AND 
      1. The patient will continue phosphate binder therapy with the requested agent; OR 
   2. The patient has a contraindication or intolerance to ALL unrestricted phosphate binder products; AND 
6. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 1 year (365 days)

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: 1 year (365 days)

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 Q3 annually.

November 2023: Original utilization management policy issued.