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CRITERIA for DRUG COVERAGE Lubiprostone (Amitiza)

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CRITERIA for DRUG COVERAGE Lubiprostone (Amitiza) Criteria Based Consultation Prescribing Program CRITERIA FOR DRUG COVERAGE lubiprostone (Amitiza) Notes: Quantity Limits: Yes Initiation (new start) criteria: Non-formulary lubiprostone (Amitiza) will be covered on the prescription drug benefit when the following criteria are met: 1. Patient has a diagnosis of irritable bowel syndrome with constipation (IBS-C) • Patient is at least 18 years old • Patient is intolerant to, has a contraindication to, or had an inadequate response to at least 4 weeks of scheduled doses of the following medications: o Fiber supplement: Psyllium fiber (Metamucil, Konsyl) or methylcellulose (Citrucel) o Polyethylene glycol (MiraLAX/ClearLax) - OR - 2. Patient has a diagnosis of chronic idiopathic constipation (CIC) • Patient is at least 18 years old • Patient is intolerant to, has a contraindication to, or had an inadequate response to at least 4 weeks of scheduled doses of the following medications: o Fiber supplement: Psyllium fiber (Metamucil, Konsyl) or methylcellulose (Citrucel) o An osmotic laxative: polyethylene glycol (MiraLAX/ClearLax) or lactulose o A stimulant laxative: senna or bisacodyl - OR - 3. Patient has a diagnosis of opioid induced constipation with an active opioid prescription • Patient is at least 18 years old • Prescriber is an Oncologist, Gastroenterologist, Hospice/Palliative Care clinician for a patient currently enrolled in Hospice or Palliative Care program, or after consultation with a Pain Management Specialist • Patient is intolerant to, has a contraindication to, or had an inadequate response to at least 2 weeks of scheduled doses of the following medications: o Polyethylene glycol (MiraLAX/ClearLax) o Lactulose or sorbitol o Senna o Bisacodyl kp.org CPS/AWC Revised 04/08/21 Effective 05/06/21 Criteria Based Consultation Prescribing Program CRITERIA FOR DRUG COVERAGE lubiprostone (Amitiza) These agents should be used regularly to be effective in management of opioid-induced constipation. Medications with different mechanisms of action and/or route of administration can be used in combination for improved efficacy (ex. osmotic with stimulant laxatives). Criteria for new members entering Kaiser Permanente already taking the medication who have not been reviewed previously: Non-formulary lubiprostone (Amitiza) will be covered on the prescription drug benefit when the following criteria are met: 1. Patient has a diagnosis of irritable bowel syndrome with constipation (IBS-C) • Patient is at least 18 years old • Patient is intolerant to, has a contraindication to, or had an inadequate response to scheduled doses of the following medications: o Fiber supplement: Psyllium fiber (Metamucil, Konsyl) or methylcellulose (Citrucel) o Polyethylene glycol (MiraLAX/ClearLax) - OR - 2. Patient has a diagnosis of chronic idiopathic constipation (CIC) • Patient is at least 18 years old • Patient is intolerant to, has a contraindication to, or had an inadequate response to scheduled doses of the following medications: o Fiber supplement: Psyllium fiber (Metamucil, Konsyl) or methylcellulose (Citrucel) o An osmotic laxative: polyethylene glycol (MiraLAX/ClearLax) or lactulose o A stimulant laxative: senna or bisacodyl - OR - 3. Patient has a diagnosis of opioid induced constipation with an active opioid prescription • Patient is at least 18 years old • Medication is being prescribed by an Oncologist, Gastroenterologist, Hospice/Palliative Care clinician for a patient currently enrolled in Hospice or Palliative Care program, or after consultation with a Pain Management Specialist kp.org CPS/AWC Revised 04/08/21 Effective 05/06/21 Criteria Based Consultation Prescribing Program CRITERIA FOR DRUG COVERAGE lubiprostone (Amitiza) • Patient is intolerant to, has a contraindication to, or had an inadequate response to at least 2 weeks of scheduled doses of the following medications: o Polyethylene glycol (MiraLAX/ClearLax) o Lactulose or sorbitol o Senna o Bisacodyl kp.org CPS/AWC Revised 04/08/21 Effective 05/06/21 .
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