Prucalopride (Motegrity) Form

Prucalopride (Motegrity®) is a serotonin-4 (5-HT4) receptor agonist.
FDA Approved Indication(s) Motegrity is indicated for treatment of chronic idiopathic constipation (CIC) in adults.
Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Motegrity is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Chronic Idiopathic Constipation

1. Diagnosis of CIC;
   2. Age ≥ 18 years;
   3. Failure of all of the following laxatives (a, b, and c), unless clinically significant adverse effects are experienced or all are contraindicated:
      a. At least one bulk forming laxative (e.g., psyllium [Metamucil®], methylcellulose [Citrucel®], calcium polycarbophil [FiberCon®]); b. At least one stimulant laxative (e.g., bisacodyl, senna); c. At least one osmotic laxative (e.g., polyethylene glycol [MiraLax®]);
   4. Failure of generic lubiprostone, unless contraindicated or clinically significant adverse effects are experienced;
2. Failure of Linzess®, unless contraindicated or clinically significant adverse effects are experienced;
3. Dose does not exceed both of the following (a and b): a. 2 mg per day; b. 1 tablet per day. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):

4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): Page 1 of 6

   CLINICAL POLICY Prucalopride a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or

5. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace.
   II. Continued Therapy A. Chronic Idiopathic Constipation (must meet all):
   
   1. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Member is responding positively to therapy;
   3. If request is for a dose increase, new dose does not exceed both of the following (a and b): a. 2 mg per day; b. 1 tablet per day. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):
6. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or

7. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – HIM.PA.154 for health insurance marketplace, or evidence of coverage documents.
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   CLINICAL POLICY Prucalopride IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key 5-HT4: serotonin-4 CIC: chronic idiopathic constipation
   FDA: Food and Drug Administration polyethylene glycol 3350 (MiraLax®) sennosides (Senokot®) bisacodyl (Dulcolax®) psyllium (Metamucil®) calcium polycarbophil (FiberCon®) methylcellulose (Citrucel®) Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Dosing Regimen Drug Name Dose Limit/ Maximum Dose 34 grams per day
   17 g (approximately 1 heaping tablespoon) of powder in 120 to 240 mL of fluid PO once daily 1 to 2 tablets (8.6 to 17.2 mg sennosides) PO twice daily 68.8 mg sennosides per day 5 to 15 mg/day (1 to 3 tablets) PO given as a single dose, or 1 suppository or retention enema (10 mg) PR once daily 15 mg per day PO or 10 mg per day PR Either a suppository or oral tablet(s) may be used up to 3 times per week 1 rounded teaspoonful, tablespoonful, or premeasured packet in 240 mL of fluid PO, 1 to 3 times per day (2.4 g of soluble dietary fiber per dose) 1,000 mg PO 1 to 4 times per day or as needed Caplet: 2 caplets (total 1 g methylcellulose) PO with at least 240 ml (8 oz) of liquid, up to 6 times per day as needed Powder: 1 heaping tablespoonful (2 g methylcellulose per 19 g powder) in at least 240 ml (8 oz) of water PO, given 1 to 3 times per day as needed 24 mcg PO BID 7.2 g (as soluble dietary fiber) per day 6,000 mg per day Caplet: 12 caplets per day Powder: 6 grams per day lubiprostone (Amitiza®) Linzess® (linaclotide) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. 72 mcg or 145 mcg PO QD 145 mcg/day 48 mcg/day Page 3 of 6

   CLINICAL POLICY Prucalopride Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity to Motegrity; intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract such as Crohn’s disease, ulcerative colitis, and toxic megacolon/megarectum • Boxed warning(s): none reported V. Dosage and Administration
   Indication CIC Dosing Regimen Adults: 2 mg PO once daily Maximum Dose 2 mg/day VI. Product Availability
   Tablets: 1 mg, 2 mg VII.