Xphozah (tenapanor)

Xphozah (tenapanor)

Self-Administration – Oral Tablets

Diagnosis considered for coverage:

• Hyperphosphatemia in Chronic Kidney Disease on Dialysis: Indicated to reduce serum phosphorus (sPh) 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.

Coverage Criteria:

For diagnosis of Hyperphosphatemia in Chronic Kidney Disease on Dialysis:

• Diagnosis of hyperphosphatemia in chronic kidney disease AND
• Patient is on dialysis AND
• Trail (minimum 30- day supply) and inadequate response, contraindication or intolerance to two of the following: 
  • calcium carbonate 
  • calcium acetate 
  • lanthanum carbonate 
  • sevelamer carbonate 
  • sevelamer HCl 
  • Velphoro 

Dosing: 

For diagnosis of Hyperphosphatemia in Chronic Kidney Disease on Dialysis:

• Recommended initial dose: 30 mg by mouth twice daily prior to morning and evening meals
• Dose can be adjusted down in 10 mg increments depending on sPh and GI tolerability
• Patient should be instructed to hold the morning dose on dialysis days, taking their dose right before the next meal following dialysis
• Missed dose: Skip the missed dose and take the next dose at the regular time. Do not take 2 doses at the same time

Coverage Duration: 

• Initial: 12 months

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: 

• Administer immediately prior to breakfast or first meal of the day and immediately prior to dinner
• Do not administer dose right before a hemodialysis session, instead take right before the next meal following dialysis, as patients may experience diarrhea after taking dose
• Discontinue treatment in patient who develop severe diarrhea
• Xphozah (tenapanor) is the first Food and Drug Administration (FDA)-approved phosphate-lowering agent that targets the passive uptake of phosphate from the GI tract.
• Tenapanor may be considered as monotherapy in patients with a demonstrated intolerance or contraindication to PBs but should not be used preferentially over these agents due to a lower magnitude of phosphate-lowering effect. 
• Xphozah (tenapanor) is contraindicated in pediatric patients < 6 years of age and in patients with known or suspected mechanical GI obstruction. 

Policy Updates:

• 6/1/2024 (policy effective date)- New Xphozah Criteria (P&T 5/20/2024) (P&T Meeting May)

References:

1. Xphozah [prescribing information]. Waltham, MA. Ardelyx Inc. October 2023. 
2. UptoDate. Management of hyperphosphatemia in adults with chronic kidney disease. Available at: https://www.uptodate.com/contents/management-of-hyperphosphatemia-in-adults-with-chronic-kidney-disease?search=dialysis%20in%20chronic%20kidney%20disease&source=search_result&selectedTitle=4~150&usage_type=default&display_rank=4#H169682201. Accessed December 11, 2023. 
3. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease–Mineral and Bone Disorder (CKD-MBD). Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6340919/. Accessed December 11, 2023. 
4. Tenapanor. IBM Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Accessed March 11, 2024. http://www.micromedexsolutions.com.