Metoclopramide (Gimoti) Form

Metoclopramide (Gimoti™) is a dopamine-2 (D2) antagonist. FDA Approved Indication(s) Gimoti is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Limitation(s) of use: Gimoti is not recommended for use in: • Pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates • Moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions 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 Gimoti is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Diabetic Gastroparesis (must meet all):

1. Diagnosis of diabetic gastroparesis;
2. Age ≥ 18 years;

3. Documentation supports member’s inability to use all formulary generic metoclopramide products (oral tablets, oral disintegrating tablets, injection);

   4. Dose does not exceed one amber vial (10 mL) per month. Approval duration: 12 weeks B. Other diagnoses/indications (must meet 1 or 2):
   5. 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 1 of 5

   CLINICAL POLICY Metoclopramide 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

   2. 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. Diabetic Gastroparesis
   3. Re-authorization is not permitted. Members must meet the initial approval criteria. Approval duration: Not applicable 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): 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
   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: 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 FDA: Food and Drug Administration TD: tardive dyskinesia Page 2 of 5

   CLINICAL POLICY Metoclopramide 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 metoclopramide (Reglan®) Continuous dosing: 10-15 mg orally 4 times a day given 30 minutes before meals and at bedtime for 4 to 12 weeks Dose Limit/ Maximum Dose 60 mg/day, avoid use for longer than 12 weeks Intermittent dosing: up to 20 mg orally as a single dose given prior to provoking situation 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): history of TD or dystonic reactions to metoclopramide; when stimulation of the gastrointestinal motility might be dangerous; pheochromocytoma, catecholamine-releasing paragangliomas; epilepsy; hypersensitivity to metoclopramide • Boxed warning(s): TD; the risk of developing TD increases with duration of treatment and total cumulative dosage V. Dosage and Administration
   Indication Diabetic gastroparesis Dosing Regimen 1 spray in one nostril, 30 minutes before each meal and at bedtime, for 2 to 8 weeks, depending on symptomatic response Maximum Dose 4 sprays daily Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks because of the increased risk of developing TD with longer-term use VI. Product Availability
   Nasal spray: 15 mg metoclopramide in each 70 microliter spray Gimoti is supplied in a 10 mL amber glass bottled fitted with a metered spray pump attachment, a protective cap, and a safety clip. Each bottle is sufficient for 4 weeks of 4 times a day use.
   VII.