CurrentCentenePolicy CP.PMN.252

Metoclopramide (Gimoti) nasal spray — coverage criteria for diabetic gastroparesis

Policy governing medical necessity and prior authorization criteria for Gimoti (metoclopramide nasal spray) for treatment of adults with diabetic gastroparesis for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyMetoclopramide (Gimoti) nasal spray — coverage criteria for diabetic gastroparesis

Policy CodePolicy CP.PMN.252

Change TypeAdded dose limitIL HIM step therapy exemption

Effective DateDec 1, 2020

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis of diabetic gastroparesis, age ≥18, inability to use formulary generic metoclopramide, and adherence to dose limits.

SourceLink

POLICY UPDATE CHANGES

Added maximum quantity limit of 4 sprays daily to criteria.

Added step therapy bypass for Illinois HIM per IL HB 5395.

12 wksinitial approval duration

4/daymax daily doses

1 vial/momonthly limit

≥18min age

Not permitted

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Coverage Criteria

Diabetic Gastroparesis (Initial)

Covered when ALL of the following are met:

Diabetic Gastroparesis initial approval: 1) Diagnosis of diabetic gastroparesis;

Age requirement: 2) Age ≥ 18 years;

Step therapy / formulary failure: 3) Documentation supports the member's inability to use all formulary generic metoclopramide products (e.g., oral tablets, oral disintegrating tablets, injection).

For Illinois HIM requests, the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395

Dose limits

a) Does not exceed 4 sprays per day;
b) Does not exceed one amber vial (10 mL) per month;

Other Indications / Off-label

For other uses (not FDA-indicated):

Other diagnoses/indications: 1) If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, follow one of the specified policies depending on formulary status (no-coverage or non-formulary policies) for the relevant line of business; OR

Off-label referral: 2) If the requested use (diagnosis, age, dosing regimen) is NOT specifically listed under section III and criterion 1 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, CP.PMN.53 for Medicaid).

Requests for uses that are not FDA-approved and not specifically listed in this policy will not be authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy. Refer to the off‑label policies for the member's line of business: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid) for the documentation and justification required to consider non‑FDA indications.

For treatment of diabetic gastroparesis, re‑authorization is not permitted. Members must meet all initial approval criteria for each request; continuation or renewal beyond the initial authorization is not allowed under this policy. Approval duration for initial therapy is handled as specified in the initial criteria but subsequent re‑authorization requests will be denied.

Coding and Quantity Limits

Covered CPT/HCPCS/ICD-10 codesmixed

No codes listed

inv-06: Maximum daily sprays

Maximum daily sprays4 sprays per day

Per-dose instruction1 spray in one nostril, 30 minutes before each meal and at bedtime (per dosing regimen)

Treatment duration guidanceLimit treatment to ≤12 weeks to reduce risk of tardive dyskinesia

inv-07: Monthly vial limit

Monthly vial limitOne amber vial (10 mL) per month

Vial capacity and supply10 mL amber glass bottle with metered spray pump (sufficient for 4 weeks at 4 sprays/day)

Per-vial dosing content

Provider Actions and Requirements

Prior Authorization

Prior authorization required — Gimoti covered when criteria met

Prior authorization is required for Gimoti; the policy states Gimoti is medically necessary for diabetic gastroparesis when all listed criteria are met, including diagnosis of diabetic gastroparesis, age ≥ 18 years, documentation supporting inability to use all formulary generic metoclopramide products, and dose limits (4 sprays/day and one 10 mL amber vial/month). Approval duration: 12 weeks.

Prior authorization required for coverage of Gimoti when used for diabetic gastroparesis.
Medical necessity is contingent on meeting all criteria listed in the policy (diagnosis, age, step requirement, and dose limits).
Approval duration for initial therapy: 12 weeks.

Step Therapy

Step therapy: trial of generic metoclopramide required (IL HIM bypass)

A trial (or documentation showing inability to use) of formulary generic metoclopramide products (e.g., oral tablets, orally disintegrating tablets, injection) is required before coverage of Gimoti; for Illinois HIM requests the step therapy requirement does not apply per IL HB 5395 effective 1/1/2026.

Background

Metoclopramide is a dopamine‑2 (D2) receptor antagonist formulated as a nasal spray (Gimoti) for symptomatic relief in adults with diabetic gastroparesis. The nasal spray delivers a fixed dose per actuation and is supplied in a 10 mL amber vial. Because metoclopramide carries a boxed warning for tardive dyskinesia (TD), risk increases with longer duration of treatment and greater cumulative dose; dosing limits and treatment duration are used in this policy to mitigate TD risk.

Clinical use under this policy is limited to adults with a diagnosis of diabetic gastroparesis who meet the specified criteria, including documented inability to use formulary generic metoclopramide formulations and adherence to the policy's dose limits. The policy also lists specific contraindications (for example, prior history of TD or dystonic reactions, epilepsy, pheochromocytoma, or hypersensitivity to metoclopramide) that preclude use.

Definitions

inv-13: TD (tardive dyskinesia) definition and boxed warning note

DefinitionTardive dyskinesia (TD): a potentially irreversible movement disorder characterized by involuntary, repetitive movements; associated with metoclopramide use

Boxed warningTD is a boxed warning for metoclopramide; risk increases with duration of treatment and total cumulative dosage

Contraindication related to TDHistory of TD or prior dystonic reactions to metoclopramide is a contraindication