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Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
Lubiprostone (Amitiza®) is a chloride channel activator indicated for treatment of chronic idiopathic constipation in adults, opioid-induced constipation in adults with chronic, non-cancer pain, and for treatment of irritable bowel syndrome with constipation in women 18 years of age and older. Amitiza® exerts is pharmacologic effect by increasing intestinal fluid secretion leading to increased motility in the intestine, which facilitates the passage of stool and alleviates symptoms associated with chronic constipation. Amitiza has not been studied for use in patients with opioid-induced constipation who are taking diphenylheptane opioids (e.g methadone).
POLICYAmitiza will be approved when all of the following are met:
2. ONE of the following:
3. The patient does NOT have any FDA labeled contraindication(s) to therapy.
POLICY EXCEPTIONSAmitiza prior authorization is not required for Federal Employee Program (FEP) and State Health Plan members.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
01/01/2014: New policy added.
07/02/2015: Code Reference section updated for ICD-10.
SOURCE(S)Amitiza® Prescribing Information
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.