Lubiprostone (Amitiza®)

SELF ADMINISTRATION - ORAL 

Indications for Prior Authorization:

  • Treatment of chronic idiopathic constipation (CIC) in adults

  • Treatment of irritable bowel syndrome with constipation (IBS-C) in adult women

  • Treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation

    • Limitation of use:

      • Effectiveness of Amitiza in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established.

Patients must meet the following criteria for the indication(s) above:

Chronic idiopathic constipation (CIC)

  • Diagnosis of CIC confirmed by chart note documentation, AND
  • 18 years of age or older, AND
  • Member has increased fiber intake and tried-failed a stimulant laxative or osmotic laxative as confirmed by chart note documentation, AND
  • Member is not concomitantly taking Linzess, Trulance or Motegrity

Irritable bowel syndrome with constipation (IBS-C) in women

  • Diagnosis of IBS-C confirmed by chart note documentation, AND
  • 18 years of age or older, AND
  • Member has increased fiber intake and tried-failed an osmotic laxative as confirmed by chart note documentation, AND
  • Member is not concomitantly taking Linzess, Trulance or Motegrity

Opioid-Induced Constipation (OIC)

  • Diagnosis of OIC in chronic non-cancer pain (including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation) confirmed by chart note documentation, AND
  • 18 years of age or older, AND
  • Inadequate response to conventional laxatives, AND
  • Member is not concomitantly taking Linzess, Trulance or Motegrity

The following conditions do not meet the criteria for use as established by WHA P&T committee:

  • All non-FDA approved uses not listed in the approved indications

Dosing:

  • Chronic idiopathic constipation (CIC): Oral: 24 mcg twice daily

  • Irritable bowel syndrome with constipation (IBS-C): Females at least 18 years or older: Oral: 8 mcg twice daily

  • Opioid-induced constipation: Oral: 24 mcg twice daily

Approval:

  • 1 year

Last review date: November 14, 2019

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