Plecanatide (Trulance) Form

Plecanatide (Trulance®) is a guanylate cyclase-C agonist. FDA Approved Indication(s) Trulance is indicated in adults for the treatment of: • Chronic idiopathic constipation (CIC)
• Irritable bowel syndrome with constipation (IBS-C) 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 Trulance is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Chronic Idiopathic Constipation (must meet all):

1. Diagnosis of CIC;
   2. Age ≥ 18 years;
   3. Failure of one bulk forming laxative (e.g., psyllium (Metamucil®), methylcellulose (Citrucel®), calcium polycarbophil (FiberCon®)), unless clinically significant adverse effects are experienced or all are contraindicated;
2. Failure of one stimulant laxative (e.g., bisacodyl, senna), unless clinically significant adverse effects are experienced or all are contraindicated;
3. Failure of polyethylene glycol (MiraLax®) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;
4. Failure of generic lubiprostone, unless contraindicated or clinically significant adverse effects are experienced;
5. Failure of Linzess®, unless contraindicated or clinically significant adverse effects are experienced;
6. Dose does not exceed 3 mg (1 tablet) per day. Approval duration: 12 months
   B. Irritable Bowel Syndrome with Constipation (must meet all):

7. Diagnosis of IBS-C;

   2. Age ≥ 18 years; Page 1 of 7

   CLINICAL POLICY Plecanatide

8. Failure of one bulk-forming laxative (e.g. psyllium (Metamucil), methylcellulose (Citrucel), calcium polycarbophil (FiberCon)), unless clinically significant adverse effects are experienced or all are contraindicated;
9. Failure of generic lubiprostone, unless contraindicated or clinically significant adverse effects are experienced;
10. Failure of Linzess, unless contraindicated or clinically significant adverse effects are experienced;
11. Dose does not exceed 3 mg (1 tablet) per day. Approval duration: 12 months
    C. Other diagnoses/indications (must meet 1 or 2):
12. 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: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; 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: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
13. 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: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    II. Continued Therapy A. All Indications in Section I (must meet all):
14. 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 3 mg (1 tablet) per day. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):

15. 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: Page 2 of 7

    CLINICAL POLICY Plecanatide CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace and CP.PMN.255 for Medicaid; 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: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

16. 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: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    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 – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key CIC: chronic idiopathic constipation FDA: Food and Drug Administration IBS-C: irritable bowel syndrome with constipation
    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 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 1 to 4 times per day or as needed 6,000 mg/day Dose Limit/ Maximum Dose 7.2 g (as soluble dietary fiber)/day psyllium (Metamucil®) calcium polycarbophil (FiberCon®) methylcellulose (Citrucel®) Caplet: 12 caplets/day Powder: 6 grams/day 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 Page 3 of 7

    CLINICAL POLICY Plecanatide Drug Name Dosing Regimen Dose Limit/ Maximum Dose 68.8 mg sennosides/day sennosides (Senokot®) bisacodyl (Dulcolax®) polyethylene glycol 3350 (MiraLax®) lubiprostone (Amitiza®) Linzess® (linaclotide) 1 to 2 tablets (8.6 to 17.2 mg sennosides) PO BID 5 to 15 mg/day (1 to 3 tablets) PO given as a single dose, or 1 suppository or retention enema (10 mg) PR QD 15 mg/day PO or 10 mg/day PR Either a suppository or oral tablet(s) may be used up to 3 times per week 17 g (approximately 1 heaping tablespoon) of powder in 120 to 240 mL of fluid PO QD IBS-C: 8 mcg PO BID CIC: 24 mcg PO BID IBS-C: 290 mcg PO QD CIC: 72 mcg or 145 mcg PO QD 34 grams/day
    IBS-C: 16 mcg/day CIC: 48 mcg/day IBS-C: 290 mcg/day CIC: 145 mcg/day 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. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): patients less than 6 years of age due to the risk of serious dehydration, patients with known or suspected mechanical gastrointestinal obstruction
    • Boxed warning(s): risk of serious dehydration in pediatric patients V. Dosage and Administration
    Indication CIC, IBS-C Dosing Regimen 3 mg PO QD Maximum Dose 3 mg/day VI. Product Availability
    Tablet: 3 mg VII.