CurrentCignaPolicy IP0085

Gimoti (metoclopramide nasal spray) — Coverage Criteria for Diabetic Gastroparesis

Defines Cigna's coverage stance for metoclopramide nasal spray (Gimoti) for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyGimoti (metoclopramide nasal spray) — Coverage Criteria for Diabetic Gastroparesis

Policy CodePolicy IP0085

Change TypeAnnual revision — no criteria change

Effective Date

Next Review Date

Key ActionDo not request approval for Gimoti for diabetic gastroparesis; coverage requests are not recommended and require benefit-plan specific review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

n=205Phase III discussed

n=285Phase IIb discussed

Not recommendedCigna stance

≤12 weeksMax recommended duration

Coverage Determination and Criteria

Coverage determination

Not recommended for coverage for diabetic gastroparesis due to insufficient evidence.

Coverage determination: Metoclopramide nasal spray (Gimoti) is considered experimental, investigational, or unproven for relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults due to insufficient data establishing safety, efficacy, and improved health outcomes.

Policy cites Phase IIb (n=285) and Phase III (n=205) trials with mixed or negative primary endpoints and limitations including short duration, non‑commercial dose evaluated, limited populations, and lack of pivotal Gimoti data.

Gimoti (metoclopramide nasal spray) has important contraindications and safety precautions that must be considered before use. It is contraindicated in patients with a history of tardive dyskinesia (TD) or a prior dystonic reaction to metoclopramide. The product also is contraindicated when stimulation of gastrointestinal motility could be dangerous, such as in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation.

Additional contraindications and cautions include use in patients with pheochromocytoma, epilepsy, and known hypersensitivity to metoclopramide. Gimoti is not recommended as initial therapy in patients aged ≥ 65 years, and use is discouraged in patients with moderate or severe hepatic impairment or moderate or severe renal impairment (creatinine clearance < 60 mL/min). Concomitant use with strong CYP2D6 inhibitors or in CYP2D6 poor metabolizers can increase exposure and adverse reactions.

Policy Summary

PayerCigna

PolicyGimoti (metoclopramide nasal spray) — Coverage Criteria for Diabetic Gastroparesis

Policy CodePolicy IP0085

Change TypeAnnual revision — no criteria change

Effective Date

Next Review Date

Key ActionDo not request approval for Gimoti for diabetic gastroparesis; coverage requests are not recommended and require benefit-plan specific review.

SourceLink

On This Page

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Provider Actions, Prior Authorization, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for coverage determinations. Metoclopramide nasal spray (Gimoti) is considered experimental, investigational, or unproven for diabetic gastroparesis and requests for Gimoti are not recommended for approval due to insufficient evidence of safety and efficacy.

Gimoti (metoclopramide nasal spray) — considered experimental/investigational; approval not recommended
All coverage determinations require review of the member's specific benefit plan document

Documentation Required

Required Documentation

Submit claims with the appropriate diagnosis and procedure codes that correspond to covered services under the member's benefit plan. Coverage determinations depend on the specific terms of the applicable benefit plan document and applicable laws/regulations; services billed for conditions or diagnoses not covered under the policy will be denied.

Include relevant diagnosis codes supporting the medical necessity of the service
Use the most appropriate and current procedure/CPT/HCPCS codes as of the date of service
Provide supporting clinical documentation (e.g., history, prior treatments, symptom severity, diagnostic testing) when submitting for coverage review

Step Therapy

Step Therapy Guidance

Step therapy guidance: The American College of Gastroenterology (ACG) suggests metoclopramide for management of refractory gastroparesis symptoms versus no treatment. The guidelines do not specify sequencing between dosage forms (injection, tablets, nasal spray). Given Gimoti is considered experimental for diabetic gastroparesis, the policy does not support approving Gimoti as a step-therapy alternative; clinicians may consider oral or injectable metoclopramide per guideline recommendations and benefit plan coverage.

Consider oral or injectable metoclopramide for refractory gastroparesis consistent with ACG guidance and member benefit coverage
Gimoti is NOT an endorsed step-therapy agent for diabetic gastroparesis due to experimental/unproven status

Denial Risk

Denial Triggers

Services without a covered diagnosis or procedure code, or requests for therapies that the policy designates as experimental/unproven (eg, Gimoti for diabetic gastroparesis), are triggers for denial.

Denial likely when documentation lacks covered diagnosis/procedure codes
Denial likely for requests to cover Gimoti for diabetic gastroparesis given current policy classification

Clinical Background

Gastroparesis is a disorder of the upper gastrointestinal tract defined by delayed gastric emptying in the absence of mechanical obstruction, and commonly presents with nausea, vomiting, early satiety, and abdominal pain. Diabetic gastroparesis is a subtype seen in patients with diabetes and is often related to autonomic neuropathy and poor glycemic control, leading to delayed gastric emptying and the characteristic symptoms.

Metoclopramide is a dopamine-2 receptor antagonist that stimulates upper gastrointestinal motility and has antiemetic effects; however, for the metoclopramide nasal spray formulation (Gimoti) the policy highlights limited and mixed clinical trial data (including recent Phase IIb and Phase III studies) and concludes there is insufficient evidence of safety and efficacy to support coverage for diabetic gastroparesis.

Key Definitions

Diabetic gastroparesis — definition and key points

DefinitionDiabetic gastroparesis: a subtype of gastroparesis caused by autonomic neuropathy in patients with diabetes, leading to delayed gastric emptying and symptoms such as nausea, vomiting, and early satiety.

PathophysiologyCaused by autonomic neuropathy and more likely with poor glycemic control; results in delayed gastric emptying without mechanical obstruction.

SymptomsCommon symptoms include nausea, vomiting, and early satiety that reduce quality of life; refractory cases may require hospitalization for symptom and glucose control.

Mechanism relevant to treatmentMetoclopramide increases gastric contractions, relaxes the pyloric sphincter, and accelerates gastric emptying and small-bowel transit; also has antiemetic actions via dopamine-2 receptor antagonism.

EpidemiologyAffects an estimated ~5% of patients with type 1 diabetes and ~1% of patients with type 2 diabetes; women are affected more (approx. 4:1 ratio).

Tardive dyskinesia (TD) — description and relevance

DefinitionTardive dyskinesia (TD): a potentially irreversible movement disorder characterized by involuntary, sometimes disfiguring, movements of the face, tongue, trunk, or extremities.

Association with metoclopramideTD is a known risk of metoclopramide exposure; likelihood increases with longer duration of treatment and higher cumulative dose.

Risk factorsRisk is increased in the elderly (especially elderly women) and in patients with diabetes mellitus.

Management implicationAvoid treatment with metoclopramide (all formulations) for longer than 12 weeks to reduce TD risk; Gimoti carries a boxed warning for TD.

ContraindicationGimoti is contraindicated in patients with a history of TD or a dystonic reaction to metoclopramide.