tenapanor hcl — Blue Cross Blue Shield of New Mexico

Preferred products

• Ferric citrate 1 gm (210 mg ferric iron)

Initial criteria

• 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 conditions apply: 1. The patient has stage four advanced, metastatic cancer and the requested agent is being used to treat the cancer or an associated condition, supported by peer-reviewed, evidence-based literature and FDA approval OR 2. The use is consistent with best practices for the treatment of stage four advanced, metastatic cancer or associated condition OR C. BOTH of the following: 1. ONE of the following: - The patient has a diagnosis of chronic kidney disease (CKD), is on dialysis, and has a phosphorus level ≥ 5.5 mg/dL - AND fulfills 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 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. A prerequisite agent was discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR 5. A prerequisite agent is expected to be ineffective, cause adherence barrier, worsen a comorbid condition, decrease functional ability, or cause harm [chart notes required] OR 6. A 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 drug in same pharmacologic class or mechanism and it was discontinued due to lack of efficacy or adverse event B. ONE of the following referring to preferred agent(s): 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 stable on the requested agent [chart notes required] OR 3. The patient has tried and had 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, cause adherence barrier, worsen a comorbid condition, decrease functional ability, or cause harm [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 drug in same class as preferred agent and discontinued due to lack of efficacy or adverse event [chart notes required] OR 8. The patient will be using the requested agent in combination with preferred agent [chart notes required] OR 9. The patient is intolerant or hypersensitive to one preferred agent [chart notes required] OR 10. The patient has an FDA-labeled contraindication to all preferred agent(s) [chart notes required] 2. ONE of the following: A. The patient will use phosphate binder therapy in combination with the requested agent OR B. The patient has intolerance, hypersensitivity, or contraindication to phosphate binder therapy 3. The patient has another FDA-labeled indication for the requested agent and route of administration 4. If FDA-labeled indication applies, then one of the following: A. Patient’s age is within FDA labeling for that indication OR B. There is support for off-label age use 5. The prescriber is a specialist (e.g., nephrologist) or has consulted a specialist 6. The patient has no FDA-labeled contraindications to the requested agent

Approval duration

12 months (BCBSIL and BCBSMT); 3 months (all other plans)