Loading...

    Explore
    • Policy Monitoring
    • Live Policy Feed
    • Billing Codes
    • NPI Medicare & Medicaid
    • Healthcare Providers
    • Health Insurance Payers
    • States
    • Service Lines
    • Taxonomy Codes
    Lookup tools
    • Billing Code Lookup
    • CPT Modifier Lookup
    • Provider Taxonomy Code Lookup
    • Healthcare Provider & Facility Lookup
    • Health Insurance Payer Lookup
    • Payer Contact Directory

    Policy & Benchmark Tools

    • Prior Authorization Lookup
    • Coverage Criteria Lookup
    • Timely Filing Lookup
    • Billing Code Reimbursement Rates
    • Payer Comparison Dashboard
    • Facility Comparison Dashboard
    • All tools

    Company

    • About OpenPayer
    • Data Sources
    • Trek Health
    OpenPayerby Trek Health
    LinkedInYouTube

    © 2026 Trek Health. All rights reserved.

    OpenPayer is built and maintained by Trek Health.

    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsMass General Brigham Health Plan Daybue Coverage |…
    Ask Trek AI about this page
    CurrentMass General Brigham Health PlanPolicy N/A

    Daybue (trofinetide) oral solution and Daybue STIX coverage criteria

    Customize your policy alerts

    Sign up for all Mass General Brigham Health Plan policy alerts

    Know when Mass General Brigham Health Plan releases new policies or updates existing guidance.

    Monitor payer policy activity

    Receive email alerts as soon as relevant payer policies are published or updated.

    Defines prior authorization, coverage criteria, quantity limits, and specialty pharmacy requirements for Daybue (trofinetide) oral solution and Daybue STIX for commercial/exchange members age 2 and older.

    Policy Summary
    PayerMass General Brigham Health Plan
    PolicyDaybue (trofinetide) oral solution and Daybue STIX coverage criteria
    Policy CodePolicy N/A
    Change TypeAdded product and updated quantity limits
    Effective DateJun 1, 2026
    Last ReviewMar 11, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization with medical records (e.g., chart notes) confirming MECP2 mutation and clinical manifestations to support approval.
    SourceLink
    POLICY UPDATE CHANGES

    Added Daybue Stix to the policy.

    Updated quantity limits and added explicit per-day packet limits for Daybue STIX products.

    Replaced general term 'documentation' with 'submission of medical records (e.g., chart notes)' throughout the policy.

    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.

    ≥2Minimum age
    12 moApproval length
    120 mL/dayOral solution limit
    4 pkt/daySTIX 5k/6k limit
    2 pkt/daySTIX 8k limit

    Coverage Criteria for Daybue (trofinetide)

    Initial Authorization

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

    Initial Authorization Criteria: Diagnosis of Rett Syndrome.
    Initial Authorization Criteria: Submission of medical records (e.g., chart notes) confirming diagnosis by a mutation in the MECP2 gene.

    Evidence must be medical records/chart notes.

    Initial Authorization Criteria: Submission of medical records (e.g., chart notes) demonstrating that member exhibits clinical manifestations of disease (e.g., hand wringing, apraxia, gait abnormalities, development delays).

    Evidence must be medical records/chart notes.

    Initial Authorization Criteria: Member is 2 years of age or older.>= 2 years

    Continuation of Therapy

    Reauthorization is approved when ALL of the following are met:

    Continuation/Reauthorization Criteria: Member is experiencing benefit from therapy (e.g., stabilization or improvement in repetitive movements, mood dysfunction/disruptive behavior, vocalization, ambulation).clinical benefit documented

    Approval length is 12 months per Limitations.

    The policy does not list any explicit clinical exclusion conditions. No diagnoses or clinical scenarios are specified as universally ineligible for Daybue (trofinetide) oral solution or Daybue STIX in the coverage criteria.

    No additional coverage clarifications or "not medically necessary" statements are provided in the policy text.

    Initial Therapy Requirements

    Initial Therapy

    Initial coverage criteria

    Initial: Diagnosis of Rett Syndrome; MECP2 mutation confirmed by medical records; documentation of clinical manifestations (e.g., hand wringing, apraxia, gait abnormalities, development delays); age ≥ 2 years.all required

    For members new to plan, medical records demonstrating current treatment may also be required.

    Reauthorization / Continuation Criteria

    Reauthorization

    Reauthorization criteria and duration

    Reauthorization: Member demonstrates clinical benefit (stabilization or improvement in defined symptoms).clinical benefit documented

    Approvals granted for 12 months; quantity limits continue to apply.

    Coding and Identifiers

    Drug NDCs (not specified)NDC
    NDC not specifiedDaybue oral solution and Daybue STIX products (specific NDCs not listed in document)
    Quantity limits — Daybue oral solution and STIX packets
    Daybue oral solution120 mL per day
    Daybue STIX 5,000 mg packet4 packets per day
    Daybue STIX 6,000 mg packet4 packets per day
    Daybue STIX 8,000 mg packet2 packets per day

    Quantity Limits and Dispensing

    Daybue oral solution — per-day limit
    Limit120 mL per day
    Approval lengthInitial and reauthorizations granted for 12 months
    Applicable populationCommercial/Exchange members age ≥ 2 years
    Daybue STIX 5,000 mg packet — per-day limit
    Limit4 packets per day
    Packet strength5,000 mg per packet
    Approval lengthInitial and reauthorizations granted for 12 months

    Provider Requirements and Actions

    Prior Authorization

    Prior Authorization Required

    Prior Authorization Required: Prior authorization is required for Commercial/Exchange members for trofinetide (Daybue/Daybue STIX).

    • Affected plan: Commercial/Exchange
    • Program type: Prior Authorization
    • Specialty pharmacy fill required
    Step Therapy

    Step Therapy

    Step therapy: No step therapy requirements are listed for this medication in the policy.

    Key Definitions

    MECP2-confirmed Rett syndrome — required confirmation
    DefinitionDiagnosis must be confirmed by a mutation in the MECP2 gene
    Supporting documentationSubmission of medical records (e.g., chart notes) confirming the MECP2 mutation is required
    Associated clinical criteriaDocumentation should demonstrate clinical manifestations (e.g., hand wringing, apraxia, gait abnormalities, developmental delays)

    Background and Clinical Context

    Rett syndrome is described in the policy context as a neurodevelopmental disorder characterized by regression in development and loss of previously acquired skills; it is associated with pathogenic variants in the MECP2 gene. Trofinetide (Daybue) is indicated to treat Rett syndrome in patients aged ≥ 2 years, and the policy requires submission of medical records confirming diagnosis and clinical manifestations (for members new to the plan, records must document current receipt of the requested drug when applicable).

    Site of Care and Dispensing

    Billing Rule

    Dispense only via contracted specialty pharmacy

    This medication is designated specialty and must be dispensed by a contracted specialty pharmacy (must be filled at a contracted specialty pharmacy).

    Policy Revision History

    2026-06-01material_updateLatest

    Added Daybue STIX products to the policy and specified packet-level quantity limits for Daybue STIX; administrative wording clarified to replace 'documentation' with 'submission of medical records (e.g., chart notes).',

    2025-11-01material_update

    Added quantity limits to the Limitations section and updated language regarding members new to the plan;

    2023-09-01review
    Policy Summary
    PayerMass General Brigham Health Plan
    PolicyDaybue (trofinetide) oral solution and Daybue STIX coverage criteria
    Policy CodePolicy N/A
    Change TypeAdded product and updated quantity limits
    Effective DateJun 1, 2026
    Last ReviewMar 11, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization with medical records (e.g., chart notes) confirming MECP2 mutation and clinical manifestations to support approval.
    SourceLink
    On This Page
    Coverage Criteria for Daybue (trofinetide)Initial Therapy RequirementsReauthorization / Continuation CriteriaCoding and IdentifiersQuantity Limits and DispensingProvider Requirements and ActionsKey DefinitionsBackground and Clinical ContextSite of Care and DispensingPolicy Revision History
    Daybue STIX 6,000 mg packet — per-day limit
    Limit4 packets per day
    Packet strength6,000 mg per packet
    Approval lengthInitial and reauthorizations granted for 12 months
    Daybue STIX 8,000 mg packet — per-day limit
    Limit2 packets per day
    Packet strength8,000 mg per packet
    Approval lengthInitial and reauthorizations granted for 12 months
    Documentation Required

    Required Medical Records and Denial Risk

    Documentation Required: Submission of medical records (e.g., chart notes) is required to confirm diagnosis and clinical manifestations. For members new to the plan (coverage effective date ≤ 90 days), medical records must document that the member is currently receiving treatment with the requested drug (excluding samples or manufacturer patient assistance). Authorization may be denied if required medical records confirming diagnosis or clinical manifestations are not provided.

    • Required records to confirm MECP2 mutation and Rett syndrome diagnosis
    • Documentation of clinical manifestations (e.g., hand wringing, apraxia, gait abnormalities, developmental delays)
    • For new-to-plan members (≤ 90 days), documentation that member is currently receiving the requested drug (excluding samples or manufacturer assistance)

    Reviewed at July P&T with changes effective 09/01/2023;