CurrentMass General Brigham Health PlanPolicy N/A

Gimoti (metoclopramide) nasal solution coverage

Defines prior authorization, quantity limits, and coverage criteria for Gimoti nasal metoclopramide for members under the plan; affects pharmacy benefit prescribers and pharmacists for adult members with diabetic gastroparesis.

Policy Summary

PayerMass General Brigham Health Plan

PolicyGimoti (metoclopramide) nasal solution coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMar 1, 2021

Next Review DateN/A

Key ActionObtain prior authorization and document age (>18), diagnosis of acute and recurrent diabetic gastroparesis, and prior inadequate response or contraindication to oral metoclopramide.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moapproval duration

1 bottle/30dquantity limit

>18age restriction

Coverage Criteria for Gimoti (metoclopramide) nasal solution

inv-01: Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

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Initial Authorization: Member is > 18 years of age

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Initial Authorization: Member has a diagnosis of acute and recurrent diabetic gastroparesis

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Prior therapy or contraindication: One of the following: (a) inadequate response or adverse reaction to metoclopramide oral tablet OR metoclopramide oral elixir; OR (b) contraindication to metoclopramide oral tablet OR metoclopramide oral elixir

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inv-02: Continuation Therapy — Reauthorization requirements

Reauthorization requirements

Reauthorization: Physician documentation of improvement of member's condition (e.g., relief of symptoms)

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Duration: Approvals and reauthorizations will be for 12 months

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Authorization review exclusions: authorization review may be waived for members who are new to the plan but are currently receiving treatment with Gimoti when the product was obtained as samples or through the manufacturer's patient assistance programs. For all other requests, prior authorization may be granted only when documentation shows that ALL of the following are met: the member is > 18 years of age; the member has a diagnosis of acute and recurrent diabetic gastroparesis; and one of the following is met — inadequate response or adverse reaction to metoclopramide oral tablet or oral elixir, or a documented contraindication to metoclopramide oral tablet or oral elixir.

Initial Therapy

inv-10: Initial Therapy — Initial approval criteria (detailed operational criteria)

Initial approval criteria

Age: Member is > 18 years of age

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Diagnosis of acute and recurrent diabetic gastroparesis

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Prior therapy or contraindication: Inadequate response or adverse reaction to metoclopramide oral tablet or metoclopramide oral elixir OR contraindication to metoclopramide oral tablet or oral elixir

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Continuation / Reauthorization Criteria

inv-11: Reauthorization — Documentation of benefit required; approved up to 12 months

Reauthorization requires documentation of benefit; approvals may be issued up to 12 months

Documentation of benefit: Physician documentation of symptomatic improvement (e.g., relief of symptoms)

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Approval duration: Approvals and reauthorizations will be for 12 months

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Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Gimoti (metoclopramide) nasal solution when billed under the pharmacy benefit.

Applies to commercial/exchange plans and MassHealth UPPL where applicable
Contact: All Plans Phone: 877-519-1908; Fax: 855-540-3693; Non-Specialty Phone: 800-711-4555; Fax: 844-403-1029

Step Therapy

Step Requirement

Step therapy requirement: member must have had an inadequate response or an adverse reaction to, or a contraindication to, metoclopramide oral tablet or metoclopramide oral elixir before approval of Gimoti.

Documentation must show trial and failure or adverse reaction to oral metoclopramide formulations, OR documentation of a contraindication to oral metoclopramide.

Documentation Required

Required Documentation

Documentation must be submitted to support the request. Authorization will only be considered when documentation includes diagnosis, member age, and evidence of prior response/adverse reaction or documented contraindication to oral metoclopramide.

Required: member is > 18 years of age
Required: diagnosis of acute and recurrent diabetic gastroparesis
Required: documentation of inadequate response or adverse reaction to metoclopramide oral tablet or elixir, OR documentation of a contraindication to metoclopramide oral formulations
For reauthorization: physician documentation of clinical improvement (e.g., relief of symptoms)

Denial Risk

Denial Triggers

Denial triggers include missing or incomplete documentation of age, diagnosis, or the required step/contraindication information; requests without evidence of prior trial/failure or a documented contraindication to oral metoclopramide will be denied.

Missing member age (>18)
Missing or unclear diagnosis of acute and recurrent diabetic gastroparesis
No documentation of trial and inadequate response or adverse reaction to oral metoclopramide, and no documented contraindication

Step	Requirement
1	Must have prior inadequate response or adverse reaction to metoclopramide oral tablet or metoclopramide oral elixir, OR documented contraindication to metoclopramide oral tablet or oral elixir.

Background

Metoclopramide is a prokinetic agent that increases gastrointestinal motility and gastric emptying and is used to relieve symptoms associated with diabetic gastroparesis. Gimoti is the nasal formulation of metoclopramide intended for treatment of adults with acute and recurrent diabetic gastroparesis; coverage is contingent on meeting the policy's age, diagnosis, and prior-therapy/contraindication criteria.

Policy Summary

PayerMass General Brigham Health Plan

PolicyGimoti (metoclopramide) nasal solution coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMar 1, 2021

Next Review DateN/A

Key ActionObtain prior authorization and document age (>18), diagnosis of acute and recurrent diabetic gastroparesis, and prior inadequate response or contraindication to oral metoclopramide.

SourceLink

On This Page

OpenPayer

Gimoti (metoclopramide) nasal solution coverage

Coverage Criteria for Gimoti (metoclopramide) nasal solution

Initial Therapy

Continuation / Reauthorization Criteria

Provider Actions and Requirements

Step Therapy Requirements

Quantity Limits

Definitions

Background

Site of Care / Benefit Category