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    v1.0.28
    OpenPayerPolicy UpdatesGastroenterologyMass General Brigham Health Plan GC‑C Coverage Upd…
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    CurrentMass General Brigham Health PlanPolicy N/A

    GC-C agonists and other prescription therapies for chronic constipation and IBS-C (linaclotide, lubiprostone, prucalopride, plecanatide)

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    Pharmacy prior authorization policy governing coverage criteria, quantity limits, and continuation requirements for linaclotide (Linzess), lubiprostone (Amitiza), prucalopride (Motegrity), and plecanatide (Trulance) for Commercial/Exchange members.

    Policy Summary
    PayerMass General Brigham Health Plan
    PolicyGC-C agonists and other prescription therapies for chronic constipation and IBS-C (linaclotide, lubiprostone, prucalopride, plecanatide)
    Policy CodePolicy N/A
    Change TypeMaterial updates and clarifications
    Effective DateMay 1, 2026
    Last ReviewFeb 11, 2026
    Next Review DateN/A
    Key ActionObtain prior authorization and document indication, prior laxative trial, and for reauthorization attest to positive clinical response.
    SourceLink
    POLICY UPDATE CHANGES

    Added supplemental pediatric indication for Linzess for IBS-C in children 7-17 years of age.

    Updated policy to reflect generic availability of Amitiza (lubiprostone) and Motegrity (prucalopride).

    Updated reauthorization criteria to require attestation of positive clinical response.

    Clarified that only lubiprostone, Linzess, and Trulance are approved for IBS-C.

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    12 monthsauthorization duration
    1 laxativerequired prior laxative trial
    Commercial/Exchangeapplicable plan
    appliedquantity limits

    Coverage Criteria for GC-C Agonists and Related Therapies

    Initial Authorization

    Authorization may be granted when ALL of the following criteria are met:

    Initial Authorization criteria: 1. ONE of the following indications: a. Member is 18 years or older with one of the following: (i) chronic idiopathic constipation (CIC); (ii) irritable bowel syndrome with constipation (IBS-C) — lubiprostone, linaclotide (Linzess), and plecanatide (Trulance) only; (iii) opioid-induced constipation (OIC) in adults with chronic noncancer pain, including chronic pain related to prior cancer or its treatment who do not require frequent opioid dose escalation — lubiprostone only; (iv) chronic constipation not otherwise specified after other causes (medication-induced constipation, GI motility disorders, GI obstruction, etc.) have been ruled out. b. Member age 6–17 years with functional constipation (Linzess only). c. Member age 7–17 years with IBS-C (Linzess only). 2. Member has failed dietary and lifestyle modifications. 3. Member has experienced an allergy or side effect with, or has had at least a 1-week trial resulting in treatment failure or inadequate response with, at least one laxative agent (examples: saline, stimulant, bulk, or osmotic laxatives such as milk of magnesia, lactulose, polyethylene glycol [PEG], psyllium, methylcellulose, magnesium citrate, senna, bisacodyl). 4. For prucalopride only: diagnosis of chronic idiopathic constipation and prior treatment with either lubiprostone or linaclotide (Linzess).

    Follow age- and drug-specific indication rules; lubiprostone OIC indication limited as specified.

    Continuation Therapy

    Requests for reauthorization will be approved when ALL of the following are met:

    Reauthorization criteria: 1. Member demonstrates a positive clinical response to therapy (attestation or documentation required).

    Authorizations approved for 12 months when criteria are met.

    The policy notes that lubiprostone is indicated for opioid‑induced constipation (OIC) in adults with chronic non‑cancer pain, but includes an important limitation: effectiveness has not been established for OIC in patients taking diphenylheptane opioids (e.g., methadone). This limitation means that requests for lubiprostone to treat OIC in patients on methadone should be evaluated with caution and may not meet the policy’s coverage rationale.

    Coverage under this policy requires specific prior steps and documented indications before authorization will be granted. For initial approvals the policy requires: (1) an eligible diagnosis and age per the drug‑specific rules; (2) failure of dietary and lifestyle modifications; and (3) a trial of at least one laxative for ≥1 week with documented failure, intolerance, or allergy. Additionally, prucalopride requires prior treatment with either lubiprostone or linaclotide (Linzess) before approval will be considered.

    Items not explicitly addressed in the policy are treated as not covered or not medically necessary unless they meet the stated criteria. Prior authorization is required for these products under the Commercial/Exchange pharmacy benefit, and members new to the plan within the past 90 days who are already receiving therapy may be reviewed for continuation.

    Provider Requirements and Actionable Rules

    Prior Authorization

    Prior authorization required for Commercial/Exchange pharmacy benefit

    Prior authorization is required for linaclotide (Linzess), lubiprostone (Amitiza), prucalopride (Motegrity), and plecanatide (Trulance) when billed under the Commercial/Exchange pharmacy benefit. Members who are new to the plan within the past 90 days and are currently receiving the requested medication may be reviewed for continuation (prior authorization review applies).

    • Program Type: Prior Authorization applies (Commercial/Exchange pharmacy benefit).
    • Members new to the plan within the past 90 days who are currently receiving treatment may be reviewed for continuation instead of new-initiation criteria.
    Step Therapy

    No step therapy requirement

    No formal step therapy program applies to these products; the Step Therapy option is unchecked in the program settings.

    • Program Type section shows Step Therapy box unchecked.

    Definitions

    Chronic idiopathic constipation (CIC)
    DefinitionChronic idiopathic constipation (CIC): a diagnosis for which several prescription agents are indicated (e.g., lubiprostone, linaclotide, prucalopride, plecanatide) for adults; linaclotide also indicated for CIC in adults and for pediatric FC as specified.
    Typical patient ageAdults (≥18 years) for primary CIC indications noted in this policy.
    Therapies includedAgents indicated for CIC in this policy: lubiprostone, linaclotide (Linzess), prucalopride (Motegrity), plecanatide (Trulance).
    Related notesAuthorizations require prior trial of dietary/lifestyle measures and failure/intolerance to ≥1 laxative (≥1 week).
    Irritable bowel syndrome with constipation (IBS-C)
    DefinitionIrritable bowel syndrome with constipation (IBS‑C): an indication for agents in this policy, with drug- and age-specific approvals (e.g., lubiprostone for women ≥18; linaclotide for adults and children ≥7; plecanatide for adults).

    Background and Clinical Context

    Lubiprostone is a chloride channel activator approved for adult chronic idiopathic constipation (CIC), adult opioid‑induced constipation (OIC) in patients with chronic non‑cancer pain, and for IBS‑C in adult women. The policy also calls out the limitation that lubiprostone’s effectiveness for OIC in patients taking diphenylheptane opioids (for example, methadone) has not been established.

    Linaclotide (Linzess) and plecanatide (Trulance) are guanylate cyclase‑C agonists used for CIC and IBS‑C (linaclotide additionally has pediatric indications: CIC in children ≥6 years and IBS‑C in children ≥7 years). Prucalopride is a 5‑HT4 receptor agonist indicated for CIC in adults. These agents have distinct labeled indications and age ranges that determine which diagnoses and patient groups are eligible under the policy.

    Policy Summary
    PayerMass General Brigham Health Plan
    PolicyGC-C agonists and other prescription therapies for chronic constipation and IBS-C (linaclotide, lubiprostone, prucalopride, plecanatide)
    Policy CodePolicy N/A
    Change TypeMaterial updates and clarifications
    Effective DateMay 1, 2026
    Last ReviewFeb 11, 2026
    Next Review DateN/A
    Key ActionObtain prior authorization and document indication, prior laxative trial, and for reauthorization attest to positive clinical response.
    SourceLink
    On This Page
    Coverage Criteria for GC-C Agonists and Related TherapiesProvider Requirements and Actionable RulesDefinitionsBackground and Clinical Context
    Documentation Required

    Required documentation to support authorization and reauthorization

    Document the patient’s specific indication and prior conservative measures, and record prior laxative use and response; for reauthorization, document a positive clinical response (attestation required).

    • Document the patient’s indication (age- and drug-specific: e.g., CIC, IBS-C, OIC for lubiprostone, pediatric indications for linaclotide where applicable).
    • Document failure of dietary and lifestyle modifications.
    • Document at least a 1-week trial with failure, intolerance, or allergy to at least one laxative agent (examples: milk of magnesia, lactulose, PEG, psyllium, methylcellulose, magnesium citrate, senna, bisacodyl).
    • For prucalopride, document prior treatment with either lubiprostone or linaclotide.
    • For reauthorization, document/attest to a positive clinical response to therapy.
    Denial Risk

    Denial triggers for authorization or reauthorization

    Requests missing the required indication, lacking documentation of a prior laxative trial (≥1 week), or without evidence/attestation of positive clinical response at reauthorization may be denied; requests exceeding stated quantity limits may also be denied.

    • Absence of a covered indication per age- and drug-specific rules (e.g., IBS-C limited to certain agents; OIC limited for lubiprostone) can trigger denial.
    • No documentation of failure/intolerance to at least one laxative after a ≥1-week trial is a denial trigger.
    • Failure to demonstrate or attest to a positive clinical response on reauthorization is a denial trigger.
    • Requests that exceed the policy’s quantity limits (per-product daily limits) may be denied.
    Drug-specific age limitsLinzess (linaclotide): indicated for IBS‑C in adults and pediatric patients 7 years and older; Lubiprostone: indicated for IBS‑C in women 18 years or older; Plecanatide: indicated for IBS‑C in adults.
    Authorization considerationCoverage requires documentation of prior nonpharmacologic measures and failure/intolerance to at least one laxative agent (≥1 week).
    Functional constipation (FC)
    DefinitionFunctional constipation (FC): a constipation diagnosis seen in pediatric patients for which linaclotide has an indication (pediatric FC ≥6 years).
    Pediatric age thresholdLinzess (linaclotide) is indicated for functional constipation in pediatric patients 6 years of age and older.
    Related therapiesOther agents in this policy are primarily indicated for CIC/IBS‑C in adults; consult drug-specific indications for FC in other age groups.