Criteria Based Consultation Prescribing Program

CRITERIA FOR DRUG COVERAGE

(Amitiza)

Notes: Quantity Limits: Yes

Initiation (new start) criteria: Non-formulary lubiprostone (Amitiza) will be covered on the benefit when the following criteria are met:

1. Patient has a diagnosis of with (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 : o Fiber supplement: fiber (Metamucil, Konsyl) or methylcellulose (Citrucel) o (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 : polyethylene glycol (MiraLAX/ClearLax) or o A stimulant laxative: senna or

- OR - 3. Patient has a diagnosis of 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 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 ).

Criteria for new members entering Kaiser Permanente already taking the 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