ModifiedmhnPolicy CP.PMN.194

Prucalopride (Motegrity) for chronic idiopathic constipation

Defines medical necessity criteria, prior authorization requirements, and dosing limits for prucalopride (Motegrity) for adults with chronic idiopathic constipation for Centene-affiliated health plans (Commercial and Medicaid); excludes California Exchange plans.

Policy Summary

Payermhn

PolicyPrucalopride (Motegrity) for chronic idiopathic constipation

Policy CodePolicy CP.PMN.194

Change TypeMaterial updates: generic product requirements and step therapy addition

Effective DateJan 29, 2021

Next Review Date

Key ActionObtain prior authorization and submit clinical documentation showing failure of required laxatives and generic lubiprostone (and use generic prucalopride if brand requested) to support approval.

SourceLink

POLICY UPDATE CHANGES

Clarification that these criteria do NOT apply to California Exchange Plans and requests for those plans should be reviewed using HIM.PA.159.

Added requirement to use generic prucalopride (redirect away from brand Motegrity) for initial approval and continued therapy, unless contraindicated or adverse effects occur.

Added requirement for failure of generic lubiprostone prior to approval.

≥18Minimum age for coverage

12 moApproval length

2 mg/dayDose limit

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Coverage Criteria for Prucalopride (Motegrity)

inv-01: Initial Therapy

Covered when ALL of the following are met

Initial CIC criteria: 1. Diagnosis of chronic idiopathic constipation (CIC); 2. Age >= 18 years; 3. Failure of all of the following laxatives unless contraindicated or clinically significant adverse effects are experienced: a) at least one bulk-forming laxative (e.g., psyllium, methylcellulose, calcium polycarbophil); b) at least one stimulant laxative (e.g., bisacodyl, senna); c) at least one osmotic laxative (e.g., polyethylene glycol); 4. If request is for brand Motegrity, member must use generic prucalopride unless contraindicated or clinically significant adverse effects are experienced; 5. Failure of generic lubiprostone unless contraindicated or clinically significant adverse effects are experienced; 6. Dose does not exceed both: a) 2 mg per day; b) 1 tablet per day.

Approval duration: 12 months

inv-02: Continuation Therapy

Covered when ALL of the following are met

Continued therapy CIC: 1. Member meets one of the following: a) currently receiving medication via Centene benefit or previously met initial approval criteria; or b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. Failure of all of the following laxatives unless contraindicated or clinically significant adverse effects are experienced: a) at least one bulk-forming laxative (e.g., psyllium, methylcellulose, calcium polycarbophil); b) at least one stimulant laxative (e.g., bisacodyl, senna); c) at least one osmotic laxative (e.g., polyethylene glycol); 4. If request is for brand Motegrity, member must use generic prucalopride unless contraindicated or clinically significant adverse effects are experienced; 5. Failure of generic lubiprostone unless contraindicated or clinically significant adverse effects are experienced; 6. If request is for a dose increase, new dose does not exceed both: a) 2 mg per day; b) 1 tablet per day.

Approval duration: 12 months

inv-03: Other Indications

If requested use is not listed

Other indications: 1. If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, refer to one of the following depending on formulary status and line of business: a) for drugs on the formulary/PDL use the no coverage criteria policy (CP.CPA.190 for commercial; CP.PMN.255 for Medicaid); b) for drugs NOT on the formulary/PDL use the non-formulary policy (CP.CPA.190 for commercial; CP.PMN.16 for Medicaid); OR 2. If the requested use is not listed in 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; CP.PMN.53 for Medicaid).

See referenced policies for routing

Non‑FDA approved indications that are not specifically addressed by this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 for Commercial lines and CP.PMN.53 for Medicaid, or unless coverage is supported by the member's evidence of coverage documents.

Use of prucalopride for indications that are not FDA‑approved and that lack adequate supporting evidence per the off‑label policies is not authorized. Providers seeking coverage for off‑label uses must follow the requirements in the referenced off‑label use policies and provide documentation demonstrating efficacy and safety.

Coverage for prucalopride is subject to the terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract). This clinical policy is a guidance document and does not guarantee payment; plan‑level medical necessity rules, state and federal requirements, and Health Plan administrative policies also govern coverage decisions.

Coding and Dose Limits

No explicit CPT/HCPCS/NDC/ICD-10 codes listed in this part of the documentmixed

No codes listed

inv-08: Maximum daily dose

Maximum daily dose2 mg per day

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval will be granted when the member meets the initial or continuation therapy criteria in this policy and all plan-specific prior authorization requirements are satisfied.

Prior authorization required for Motegrity and prucalopride per policy CP.PMN.194

Documentation Required

Required Supporting Documentation

Providers must submit supporting documentation (such as office chart notes, diagnostic testing, medication history, and laboratory results) demonstrating that the member meets all approval criteria. Documentation should include evidence of diagnosis, prior laxative therapy tried (agents, doses, durations), response to therapy, and any contraindications or adverse effects that support deviation from step requirements.

Include past medication trials and dates, reason for discontinuation (inefficacy, intolerance, contraindication)
Office notes, medication lists, and relevant lab results

Background

Prucalopride (Motegrity) is a selective 5‑HT4 receptor agonist indicated by the FDA for the treatment of chronic idiopathic constipation (CIC) in adults. Typical adult dosing for CIC is 2 mg PO once daily, with available tablet strengths of 1 mg and 2 mg. For purposes of this policy, coverage criteria apply to adults aged ≥ 18 years and any approved authorization is limited by the dosing threshold of 2 mg per day.

Definitions

inv-18: Prucalopride (Motegrity) — definition / drug class

Drug classSerotonin-4 (5-HT4) receptor agonist

Brand nameMotegrity

Typical adult dosing (CIC)2 mg PO once daily

inv-19: CIC — chronic idiopathic constipation definition

DefinitionChronic idiopathic constipation (CIC)

AbbreviationCIC = chronic idiopathic constipation

Context in policyCIC is the indicated condition for prucalopride coverage per initial and continuation criteria