Tegaserod (Zelnorm) Form

Tegaserod (Zelnorm™) is a serotonin-4 (5-HT4) receptor agonist. FDA Approved Indication(s) Zelnorm is indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C). Limitation(s) of use: The safety and effectiveness of Zelnorm in men with IBS-C have not been established.
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 Zelnorm is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Irritable Bowel Syndrome with Constipation (must meet all):

1. Diagnosis of IBS-C;
   2. Age ≥ 18 years and < 65 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 generic lubiprostone, unless contraindicated or clinically significant adverse effects are experienced;
3. Failure of Linzess®, unless contraindicated or clinically significant adverse effects are experienced;
4. At the time of request, member does not have any of the following contraindications: a history of myocardial infarction, stroke, transient ischemic attack, or angina;
5. Dose does not exceed 12 mg (2 tablets) 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): Page 1 of 6

   CLINICAL POLICY Tegaserod 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.
   II. Continued Therapy A. Irritable Bowel Syndrome with Constipation (must meet all):
8. 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. At the time of request, member does not have any of the following contraindications: a history of myocardial infarction, stroke, transient ischemic attack, or angina;
   4. If request is for a dose increase, new dose does not exceed 12 mg (2 tablets) per day. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):
9. 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

10. 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 document. Page 2 of 6

    CLINICAL POLICY Tegaserod IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration IBS-C: irritable bowel syndrome with constipation MACE: major adverse cardiovascular events 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.
    Drug Name Dosing Regimen 1 rounded teaspoonful, tablespoonful, or premeasured packet in 240 mL of fluid PO, QD to TID (2.4 g of soluble dietary fiber per dose) 2 tablets (1,250 mg calcium polycarbophil) PO 1 to 4 times daily
    Dose Limit/ Maximum Dose 7.2 g (as soluble dietary fiber) per day 8 tablets/day (5,000 mg/day) Caplet: 2 caplets PO up to 6 times daily Caplet: 12 caplets/day
    psyllium (Metamucil®) [OTC] calcium polycarbophil (FiberCon®) [OTC] methylcellulose (Citrucel®) [OTC] Powder: 1 heaping tablespoonful in at least 240 ml of water PO, given 1 to 3 times per day as needed 8 mcg PO BID Powder: 3 tablespoons/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. 290 mcg PO QD
    290 mcg/day 16 mcg/day Appendix C: Contraindications/Boxed Warnings • Contraindication(s):
    o Major adverse cardiovascular events (MACE): history of myocardial infarction, stroke, transient ischemic attack, or angina o History of ischemic colitis or other forms of intestinal ischemia o Severe renal impairment (eGFR < 15 mL/min/1.73 m2) or end-stage renal disease o History of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions
    o Moderate or severe hepatic impairment (Child-Pugh B or C) o Hypersensitivy to tegaserod • Boxed warning(s): none reported Page 3 of 6

    CLINICAL POLICY Tegaserod Appendix D • On June 30, 2022, Alfasigma USA, Inc. announces the withdrawal of the NDA for Zelnorm (tegserod) effective June 30th. Alfasigma USA, Inc will no longer make the product available in the US market place. The decision to remove Zelnorm from the market is strictly a business decision and was not based on product efficacy, safety, or an imposed recall.
    V. Dosage and Administration
    Indication IBS-C Dosing Regimen 6 mg PO BID at least 30 minutes before meals.
    Maximum Dose 12 mg/day Discontinue in patients who have not had adequate control of symptoms after 4 to 6 weeks of treatment.
    VI. Product Availability
    Tablet: 6 mg VII.