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Symproic (naldemedine) — Blue Cross Blue Shield of Montana

constipation

Initial criteria

  • Symproic (naldemedine) and Movantik (naloxegol) are expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug; OR cause a significant barrier to the patient’s adherence of care; OR worsen a comorbid condition; OR decrease the patient’s ability to achieve or maintain reasonable functional ability in performing daily activities; OR cause an adverse reaction or cause physical or mental harm [chart notes are required]; OR
  • Symproic (naldemedine) and Movantik (naloxegol) are not in the best interest of the patient based on medical necessity [chart notes are required]; OR
  • The patient has tried another prescription drug in the same pharmacologic class or with the same mechanism of action as Symproic (naldemedine) and Movantik (naloxegol) and that prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event [chart notes are required]; AND
  • The patient will NOT be using the requested agent in combination with another constipation agent (i.e., Amitiza/lubiprostone, Ibsrela, Linzess, Motegrity, Movantik, Relistor, Symproic, Trulance); AND
  • The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

  • The patient has been previously approved for the requested agent through the plan’s Prior Authorization process; AND
  • If the patient has an FDA labeled indication, ONE of the following: (A) The patient’s age is within FDA labeling for the requested indication for the requested agent; OR (B) There is support for using the requested agent for the patient’s age for the requested indication; AND
  • The patient has had clinical benefit with the requested agent; AND
  • The patient will NOT be using the requested agent in combination with another constipation agent in this program for the requested indication (i.e., Amitiza/lubiprostone, Ibsrela, Linzess, Motegrity, Movantik, Relistor, Symproic, Trulance); AND
  • The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months