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tenapanor hcl — Blue Cross Blue Shield of Illinois

hyperphosphatemia in chronic kidney disease on dialysis

Preferred products

  • Ferric citrate 1 gm (210 mg ferric iron)
  • calcium carbonate
  • calcium acetate
  • calcium with magnesium
  • lanthanum carbonate
  • sevelamer carbonate
  • sevelamer HCl

Initial criteria

  • Target Agent(s) will be approved when ALL of the following are met:
  • 1. ONE of the following:
  • A. The prescriber states the patient has been treated with the requested agent within the past 90 days AND is at risk if therapy is changed OR
  • B. BOTH of the following:
  • 1. ONE of the following:
  • A. The prescriber has stated that the patient has been diagnosed with stage four advanced, metastatic cancer and the requested agent is being used to treat the cancer OR
  • B. The prescriber has submitted documentation that the patient has been diagnosed with stage four advanced, metastatic cancer and the requested agent is being used to treat an associated condition related to stage four advanced metastatic cancer AND
  • 2. The use of the requested agent is consistent with best practices for the treatment of stage four advanced, metastatic cancer, or an associated condition; supported by peer-reviewed, evidence-based literature; and approved by the United States Food and Drug Administration OR
  • C. BOTH of the following:
  • 1. ONE of the following:
  • A. The patient has a diagnosis of chronic kidney disease (CKD) AND ALL of the following:
  • 1. The patient is on dialysis AND
  • 2. The patient has a phosphorus level of at least 5.5 mg/dL AND
  • 3. BOTH of the following:
  • A. ONE of the following:
  • 1. The request is for a BCBS IL Fully Insured, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR
  • 2. The patient is currently being treated with the requested agent and stable on the requested agent [chart notes required] OR
  • 3. The patient has tried and had an inadequate response to at least ONE prerequisite agent [chart notes required] OR
  • 4. ONE prerequisite agent was discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR
  • 5. ONE prerequisite agent is expected to be ineffective or cause significant issues based on known patient characteristics [chart notes required] OR
  • 6. ONE prerequisite agent is NOT in the best interest of the patient based on medical necessity [chart notes required] OR
  • 7. The patient has tried another prescription drug in the same pharmacologic class or mechanism of action as ONE prerequisite agent and it was discontinued due to lack of efficacy or adverse event [chart notes required] AND
  • B. ONE of the following with respect to preferred agents:
  • 1. The request is for a BCBS IL Fully Insured, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR
  • 2. The patient is currently being treated with the requested agent and stable on the requested agent [chart notes required] OR
  • 3. The patient has tried and had an inadequate response to at least ONE preferred agent [chart notes required] OR
  • 4. A preferred agent was discontinued due to lack of efficacy or adverse event [chart notes required] OR
  • 5. A preferred agent is expected to be ineffective or cause significant issues based on patient characteristics [chart notes required] OR
  • 6. A preferred agent is NOT in the best interest of the patient based on medical necessity [chart notes required] OR
  • 7. The patient has tried another prescription drug in the same pharmacologic class or mechanism of action as a preferred agent and discontinued due to lack of efficacy or adverse event [chart notes required] AND
  • 8. The patient will be using the requested agent in combination with a preferred agent [chart notes required] OR
  • 9. The patient is intolerant or has hypersensitivity to ONE preferred agent [chart notes required] OR
  • 10. The patient has an FDA labeled contraindication to ALL preferred agent(s) [chart notes required] AND
  • 2. ONE of the following:
  • A. The patient will be using phosphate binder therapy in combination with the requested agent OR
  • B. The patient has intolerance, hypersensitivity, or contraindication to phosphate binder therapy AND
  • 3. The patient has another FDA labeled indication for the requested agent and route of administration AND
  • C. If the patient has an FDA labeled indication, then ONE of the following:
  • 1. The patient's age is within FDA labeling for the requested indication OR
  • 2. There is support for using the requested agent for the patient’s age for the requested indication AND
  • D. The prescriber is a specialist in the area of the patient's diagnosis (e.g., nephrologist), or has consulted such a specialist AND
  • E. The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

  • Continuation of therapy may follow same criteria as initial approval if patient remains stable, continues dialysis with phosphorus ≥ 5.5 mg/dL, and no contraindications are newly present.

Approval duration

12 months (BCBSIL, BCBSMT); 3 months (other plans)