CurrentColorado Rocky Mountain Health PlansPolicy N/A

Step therapy for prescription constipation agents (constipation agents coverage criteria)

Defines step-therapy prior authorization requirements for several prescription agents used to treat chronic idiopathic constipation, irritable bowel syndrome with constipation, and opioid-induced constipation; affects providers prescribing these drugs and pharmacy benefit adjudication.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy for prescription constipation agents (coverage criteria for CIC, IBS-C, OIC)

Policy CodePolicy N/A

Change TypeNew step therapy program (added) — material change

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization demonstrating documented prior failure, contraindication, or intolerance to the required comparator agents and include drug names and dates of trials.

SourceLink

POLICY UPDATE CHANGES

New step therapy program for constipation agents (Program 2025 P 3193-1) establishing required prior trials and approvals for branded agents.

12 monthsauthorization duration for approved agents

2prior failures required CIC

2prior failures required OIC

bothprior trials required for IBS-C

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clinical approval date

Coverage Criteria

Initial Therapy - Chronic Idiopathic Constipation

Covered when ALL of the following are met

CIC - prior therapy requirement: Patient has history of failure, contraindication, or intolerance to two of the following: (a) lubiprostone (Amitiza), (b) prucalopride (Motegrity), (c) linaclotide (Linzess). Document drug and date tried.2 of list

Authorization will be issued for 12 months.

Initial Therapy - IBS-C

Covered when ALL of the following are met

IBS-C - prior therapy requirement: Patient has history of failure, contraindication, or intolerance to both of the following: (a) lubiprostone (Amitiza), (b) linaclotide (Linzess). Document date tried.both

Approval applicable to Ibsrela or Trulance per criteria.

Initial Therapy - Opioid-induced Constipation

Covered when ALL of the following are met

OIC - prior therapy requirement: Patient has history of failure, contraindication, or intolerance to both of the following: (a) lubiprostone (Amitiza), (b) naldemedine (Symproic). Document date tried.both

Approval applicable to Movantik or Relistor tablets per criteria.

The program generally treats branded agents including Ibsrela, Movantik, Relistor tablets, Trulance, Brand Amitiza, and Brand Motegrity as excluded from routine coverage unless specific step-therapy criteria are met. The step-therapy program establishes conditions under which these brands may be approved (for example, documented prior trials or documented contraindication/intolerance to specified comparator agents).

Providers should anticipate that requests for the listed branded products will require prior authorization and supporting documentation of prior medication trials (drug name(s) and dates) or documented contraindication/intolerance to the required comparators for the patient’s indication. Absent that documentation, requests risk denial.

Initial Therapy Criteria (By Indication)

Initial therapy - CIC

CIC initial approval

CIC initial: Approval of Motegrity (brand only) or Trulance requires documented failure, contraindication, or intolerance to two of: lubiprostone, prucalopride, linaclotide. Document drug and date tried.2 of list

Authorization will be issued for 12 months.

Initial therapy - IBS-C

IBS-C initial approval

IBS-C initial: Approval of Ibsrela or Trulance requires documented failure, contraindication, or intolerance to both lubiprostone and linaclotide. Document date tried.both

Re-authorization / Continuation Criteria

Re-authorization rules

Re-authorization

Re-authorization: Authorizations will be issued for 12 months; physicians and patients should periodically assess need for continued treatment.12 months

UnitedHealthcare may also use claims/medication history or diagnosis codes for automated re-authorization; state mandates and member-specific benefit plan coverage may impact continuation.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Step therapy prior authorization is required and is indication-specific. Prior authorization must document the applicable indication and that required step-therapy trials (or documented contraindication/intolerance) have been attempted before coverage of the requested agent is approved.

Prior authorization required for Motegrity (brand only), Trulance, Ibsrela, Movantik, and Relistor tablets for the indications below.
Authorizations are issued for up to 12 months when criteria are met.

Step Therapy

Step Therapy Program Overview

This step therapy program requires that members try and fail (or have documented contraindication/intolerance to) specified comparator agents for each covered indication before the request for the preferred/limited agent will be approved. Approval decisions may use prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic as supporting evidence when available.

Program applies to constipation agents listed in the plan's step therapy: Ibsrela (tenapanor), Motegrity (prucalopride) brand only, Movantik (naloxegol), Relistor (methylnaltrexone) tablets, and Trulance (plecanatide).

Step Therapy Rules

Covered Agent(s)	Required prior trials (document drug name and date tried)	Coverage status
Movantik (naloxegol) or Relistor (methylnaltrexone) tablets
History of failure, contraindication, or intolerance to both of: (a) lubiprostone (Amitiza), (b) naldemedine (Symproic). Document date tried.
Covered with criteria — prior trials required

Definitions

OIC — Opioid-induced constipation definition/key term

TermOpioid-induced constipation (OIC)

DefinitionConstipation occurring in adult patients receiving opioid therapy (chronic non-cancer pain or chronic pain related to prior cancer or its treatment) for which opioid antagonists are indicated.

Typical pharmacologic class usedPeripherally acting mu-opioid receptor antagonists (PAMORAs) — e.g., Movantik (naloxegol), Relistor (methylnaltrexone) tablets, Symproic (naldemedine).

Clinical noteIndications described apply to adults who do not require frequent (e.g., weekly) opioid dosage escalation; reassess need for continued treatment periodically.

CIC — Chronic idiopathic constipation definition/key term

TermChronic idiopathic constipation (CIC)

Background

This policy addresses prescription agents used to treat chronic idiopathic constipation (CIC), irritable bowel syndrome with constipation (IBS-C), and opioid‑induced constipation (OIC). It summarizes indications consistent with product labeling and describes the step-therapy requirements that apply to branded guanylate cyclase‑C agonists, serotonin 4 receptor agonists, and peripherally acting mu‑opioid receptor antagonists (PAMORAs).

Authorizations for approved agents under this program are issued for 12 months. State mandates, federal regulatory requirements, and the member’s specific benefit plan may also affect coverage and any additional utilization management rules.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy for prescription constipation agents (coverage criteria for CIC, IBS-C, OIC)

Policy CodePolicy N/A

Change TypeNew step therapy program (added) — material change

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization demonstrating documented prior failure, contraindication, or intolerance to the required comparator agents and include drug names and dates of trials.

SourceLink

On This Page

Initial therapy - OIC

OIC initial approval

OIC initial: Approval of Movantik or Relistor tablets requires documented failure, contraindication, or intolerance to both lubiprostone and naldemedine (Symproic). Document date tried.both

Automated approval/re-approval processes or supply limits may be applied by the plan.

Documentation Required

Required Documentation of Prior Therapies

Document prior therapies by listing the drug name(s) and the dates of the trial(s), or provide documentation of a medical contraindication or intolerance to the required agents. Incomplete documentation of prior trials may result in denial.

For chronic idiopathic constipation: document history of failure, contraindication, or intolerance to two of: lubiprostone (generic Amitiza), prucalopride (generic Motegrity), Linzess.
For IBS with constipation: document history of failure, contraindication, or intolerance to both: lubiprostone (generic Amitiza), Linzess.
For opioid‑induced constipation: document history of failure, contraindication, or intolerance to both: lubiprostone (generic Amitiza), Symproic.
Include dates tried for each prior agent and any supporting clinical notes.

Note

Plan and Regulatory Considerations

State mandates, federal regulatory requirements, and the member's specific benefit plan may modify coverage and step therapy requirements. Other utilization management programs or exclusion policies (for certain brand products) may also apply and affect approval.

Some listed brand products (Ibsrela, Movantik, Relistor tablets, Trulance, Brand Amitiza and Brand Motegrity) are typically excluded from coverage — check member benefit plan for specifics.
State mandates or federal regulations may override or alter step therapy or prior authorization requirements.
Other plan policies (e.g., quantity limits, supply limits) may apply.

Denial Risk

Missing Required Prior Trials

If the required prior trials or adequate documentation (drug names and dates, or contraindication/intolerance evidence) are not provided, the request will be denied. Denials may be issued where documentation is missing, or when trials do not meet the step therapy requirements for the specific indication.

Missing trial dates or missing documentation of failure/intolerance may lead to denial.
Denials may be overridden if adequate medical justification or alternative evidence is submitted supporting medical necessity.

DefinitionA chronic constipation disorder in adults without identifiable underlying cause for which specific agents are indicated (e.g., lubiprostone, linaclotide, prucalopride, plecanatide).

Representative approved therapiesMotegrity (prucalopride) — indicated for CIC in adults; Trulance (plecanatide); Linzess (linaclotide); Amitiza (lubiprostone).

Clinical notePhysicians and patients should periodically assess the need for continued treatment with these agents.

IBS-C — Irritable bowel syndrome with constipation definition/key term

TermIrritable bowel syndrome with constipation (IBS-C)

DefinitionA subtype of irritable bowel syndrome in adults characterized predominantly by constipation; specific treatments include agents such as Ibsrela (tenapanor), linaclotide, plecanatide, and lubiprostone (in women).

Representative approved therapiesIbsrela (tenapanor) — indicated for IBS-C in adults; Trulance (plecanatide); Linzess (linaclotide); Amitiza (lubiprostone) for IBS-C in women aged ≥18 years.

Clinical noteTherapy choice and continuation should be periodically reassessed by physicians and patients.