CurrentCentenePolicy CP.PMN.87

Plecanatide (Trulance) (PDF)

Defines medical necessity criteria, prior authorization expectations, continuation criteria, non-covered indications, dosing limits, contraindications, and therapeutic alternatives for plecanatide (Trulance) for Medicaid line of business.

Policy Summary

PayerCentene

PolicyPlecanatide (Trulance) (PDF)

Policy CodePolicy CP.PMN.87

Change TypeRevisions and annual reviews (including line-of-business removals)

Effective DateFeb 1, 2017

Next Review Date

Key ActionProvider must submit documentation supporting that member meets all approval criteria for initial and continued therapy.

SourceLink

POLICY UPDATE CHANGES

Per March SDC: removed commercial line of business; for CIC and IBS-C, removed step through Linzess.

Per December SDC, removed HIM line of business as PA is no longer required.

4Q 2024 annual review: no significant changes; references reviewed and updated.

4Q 2025 annual review: no significant changes; references reviewed and updated.

2Covered Indications

18+Minimum Age (years)

3 mg/dayMaximum Dose

12 monthsApproval Duration

Coverage Summary

Plecanatide (Trulance) is a guanylate cyclase-C agonist FDA-approved for adults for chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Coverage stance: covered with criteria for these adult indications. Prior authorization is required and the policy enforces specific prior-treatment failures and documentation requirements. Approval is limited to members aged ≥ 18 years, with a maximum daily dose of 3 mg (1 tablet) per day. Contraindications include patients less than 6 years of age and those with known or suspected mechanical gastrointestinal obstruction. The policy includes a boxed warning regarding the risk of serious dehydration in pediatric patients. This summary reflects the scope of the policy for the Medicaid line of business.

Quick reference - key thresholds/values

Minimum Age>= 18 years

Maximum Dose<= 3 mg/day (1 tablet)

Approval Duration12 months

Covered IndicationsChronic Idiopathic Constipation (CIC); Irritable Bowel Syndrome with Constipation (IBS-C)

Initial Therapy Criteria

Initial Therapy - Chronic Idiopathic Constipation (CIC)

ALL of the following

Diagnosis of CIC
Age ≥ 18 years
Failure of one bulk-forming laxative (e.g., psyllium, methylcellulose, calcium polycarbophil), unless clinically significant adverse effects or contraindications
Failure of one stimulant laxative (e.g., bisacodyl, senna), unless clinically significant adverse effects or contraindications
Failure of polyethylene glycol (MiraLax) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects

Continuation Therapy Criteria

Continued Therapy - All Indications in Section I

ALL of the following

Member status
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy
Dose limit: If request is for a dose increase, new dose does not exceed 3 mg (1 tablet) per day

Diagnoses / Indications NOT Authorized

Diagnoses/Indications NOT authorized

Non-FDA approved indications which are not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety according to off-label use policies CP.PMN.53 for Medicaid or evidence of coverage documents

Provider Actions & Authorization Details

Documentation Required

Submit documentation supporting approval criteria

Provider must submit documentation supporting that the member meets all approval criteria for initial and continued therapy. Attach office chart notes, laboratory results, and any other relevant clinical information to substantiate diagnosis, prior treatment trials, dosing, and response.

Prior Authorization

Approval duration

Approvals for both initial and continued therapy are granted for 12 months.

Applicable Codes & Product Dosing

Product availability / dosingmixed

N/A	Tablet: 3 mg (product strength)

Clinical Evidence & References

Key prescribing information: Trulance Prescribing Information (Synergy Pharmaceuticals Inc.; March 2024) lists the approved adult indications (CIC and IBS-C), dosing as 3 mg PO once daily, product availability as a 3 mg tablet, and a maximum dose of 3 mg/day. The prescribing information and policy require documentation of prior treatment failures (bulk-forming laxative, stimulant laxative and polyethylene glycol for CIC; bulk-forming laxative for IBS-C) and generic lubiprostone as specified in the approval criteria.

Clinical guideline and trial citations: The policy references ACG/AGA guidelines and multiple clinical trials and reviews supporting use and management of CIC and IBS-C (for example, ACG/AGA clinical practice guideline references and Phase III trials of plecanatide).

Relevant boxed warning/contraindications from the background: the prescribing information and policy state a boxed warning for the risk of serious dehydration in pediatric patients, and list contraindications including patients less than 6 years of age (due to dehydration risk) and patients with known or suspected mechanical gastrointestinal obstruction.

Background & Definitions

Plecanatide is a guanylate cyclase-C agonist FDA-approved in adults for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). The drug is dosed as 3 mg PO once daily (tablet formulation).

Contraindications include patients less than 6 years of age due to the risk of serious dehydration, and patients with known or suspected mechanical gastrointestinal obstruction. The policy includes a boxed warning highlighting the risk of serious dehydration in pediatric patients.

Scope applicability: this clinical policy defines medical necessity criteria, prior authorization expectations, continuation criteria, non-covered indications, dosing limits, contraindications, and therapeutic alternatives for plecanatide (Trulance) specifically for the Medicaid line of business.

Term	Definition
CIC
chronic idiopathic constipation
IBS-C
irritable bowel syndrome with constipation

Revision History

07.14.25annual_review

4Q 2025 annual review: no significant changes; references reviewed and updated.

03.11.25material_changeLatest

Per March SDC: removed commercial line of business; for CIC and IBS-C, removed step through Linzess. P&T Approval Date = 05.25

12.02.24line_of_business_change

Per December SDC, removed HIM line of business as prior authorization is no longer required. P&T Approval Date = 02.25

Policy Summary

PayerCentene

PolicyPlecanatide (Trulance) (PDF)

Policy CodePolicy CP.PMN.87

Change TypeRevisions and annual reviews (including line-of-business removals)

Effective DateFeb 1, 2017

Next Review Date

Key ActionProvider must submit documentation supporting that member meets all approval criteria for initial and continued therapy.

SourceLink

On This Page

Failure of generic lubiprostone, unless contraindicated or clinically significant adverse effects

Dose limit: Dose does not exceed 3 mg (1 tablet) per day≤ 3 mg/day

Maximum daily dose enforced

Initial Therapy - Irritable Bowel Syndrome with Constipation (IBS-C)

ALL of the following

Diagnosis of IBS-C
Age ≥ 18 years
Failure of one bulk-forming laxative (e.g., psyllium, methylcellulose, calcium polycarbophil), unless clinically significant adverse effects or contraindications
Failure of generic lubiprostone, unless contraindicated or clinically significant adverse effects
Dose limit: Dose does not exceed 3 mg (1 tablet) per day≤ 3 mg/day
Maximum daily dose enforced

Other diagnoses/indications (Initial)

ANY of the following

Label change guidance: If this drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, refer to: CP.PMN.255 (for formulary/PDL drugs, Medicaid) or CP.PMN.16 (for non-formulary drugs, Medicaid)
Off-label routing: If requested use is NOT specifically listed under section III AND criterion 1 above does not apply, refer to the off-label use policy CP.PMN.53 for Medicaid

Maximum daily dose enforced

Continued Therapy - Other diagnoses/indications

ANY of the following

Label change guidance: If drug has recently (within last 6 months) undergone a label change not yet reflected in this policy, refer to CP.PMN.255 (Medicaid) for formulary drugs or CP.PMN.16 (Medicaid) for non-formulary drugs
Off-label routing: If requested use is NOT listed under diagnoses for which coverage is NOT authorized AND criterion 1 above does not apply, refer to off-label use policy CP.PMN.53 for Medicaid

Documentation Required

Therapy response for continuation

For continuation of therapy, the provider must document that the member is responding positively to treatment.

Billing Rule

Dose limit enforcement

Dose must not exceed 3 mg (one 3 mg tablet) per day. Requests for dosing above 3 mg/day will be denied.

Step Therapy

Prior failures required

Providers must document failure (or intolerance/contraindication) of the required prior agents before approval: one bulk-forming laxative (e.g., psyllium, methylcellulose, calcium polycarbophil), one stimulant laxative (e.g., bisacodyl, senna) and polyethylene glycol (MiraLax) for CIC, and generic lubiprostone (for CIC and IBS-C). Allowance is made if agents are contraindicated or cause clinically significant adverse effects.

07.12.24annual_review

4Q 2024 annual review: no significant changes; references reviewed and updated.