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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty Drugscareoregon Soliqua Prior Auth Coverage | OpenPayer
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    CurrentcareoregonPolicy N/A

    Soliqua (insulin glargine/lixisenatide) prior authorization

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    Prior authorization requirements for coverage of Soliqua (insulin glargine/lixisenatide) for members, including initial authorization and reauthorization clinical criteria and documentation expectations.

    Policy Summary
    Payercareoregon
    PolicySoliqua (insulin glargine/lixisenatide) prior authorization
    Policy CodePolicy N/A
    Change TypeAdministrative — no material clinical changes
    Effective DateJul 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization with documentation of Type 2 diabetes, required prior therapy trials (including metformin and additional agents), basal insulin dose where required, and HbA1c results or medical rationale when HbA1c ≥10%.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    6 moinitial approval length
    12 moreauthorization approval length
    >7% and <10%A1c pathway
    ≥10%A1c threshold w/ rationale

    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.

    Coverage Criteria for Soliqua (insulin glargine/lixisenatide)

    inv-01: Initial Therapy — Covered when ALL of the following are met

    Covered when ALL of the following are met

    Initial Authorization Criteria: Diagnosis of Type 2 Diabetes
    Metformin trial: Trial and failure, intolerance, or contraindication to metformin
    Additional therapy trials or contraindication: Either: (a) Trial and failure of at least TWO of the following: sulfonylurea; pioglitazone; alogliptin (PA required); Steglatro (PA required) OR (b) Patient has a contraindication to all of the following: sulfonylurea; pioglitazone; alogliptin; Steglatro

    alogliptin and Steglatro require prior authorization

    Basal insulin requirement: Patient has tried and failed basal insulin at a dose of at least 40 units>= 40 units
    A1c requirements: Either: (a) Patient has an HbA1c greater than 7% and less than 10% OR (b) Both: HbA1c greater than or equal to 10% AND submission of medical records confirming an acceptable medical rationale for why mealtime insulin cannot be usedsee text

    Required documentation when HbA1c >= 10%

    inv-02: Reauthorization — Reauthorization criteria

    Reauthorization criteria

    First renewal: For first renewals, patient has been adherent and one of the following: at least a 10% reduction in HbA1c OR HbA1c less than 7%>=10% reduction or A1c <7%
    Subsequent renewals: For subsequent renewals, at least one A1c has been obtained in the previous 6 monthsA1c within 6 months

    No explicit exclusions are listed in this guideline.

    Requests are not medically necessary when the patient does not meet the stated clinical criteria. Specifically, coverage requires a documented diagnosis of Type 2 Diabetes, evidence of trial and failure (or intolerance/contraindication) to metformin, completion of the required additional therapy steps (either trial and failure of at least two agents from the list or documented contraindications), demonstration of prior basal insulin use at a dose of at least 40 units where required, and meeting the HbA1c criteria (either >7% and <10%, or ≥10% with submission of medical records explaining why mealtime insulin cannot be used). Absence of these elements may result in a determination that the request is not medically necessary.

    Initial Authorization Requirements

    inv-14: Initial authorization — Initial authorization requirements for Soliqua

    Initial authorization requirements for Soliqua

    Diagnosis of Type 2 Diabetes
    Metformin trial: Trial and failure, intolerance, or contraindication to metformin
    Additional therapy trials or contraindication: Either trial and failure of at least TWO of: sulfonylurea; pioglitazone; alogliptin (PA required); Steglatro (PA required) OR patient has contraindication to all of these agents

    alogliptin and Steglatro require prior authorization

    Basal insulin: Tried and failed basal insulin at a dose of at least 40 units>= 40 units

    Reauthorization / Continuation Criteria

    inv-15: Reauthorization criteria — Reauthorization (continuation) requirements

    Reauthorization (continuation) requirements

    First renewal response: Patient adherence plus either >=10% reduction in HbA1c or HbA1c <7%>=10% reduction or A1c <7%
    Subsequent renewals monitoring: At least one A1c obtained in the previous 6 monthsA1c within 6 months

    Step Therapy Requirements

    StepRequired trial(s) or documentationNotes
    3
    HbA1c criteria — either HbA1c >7% and <10%, OR HbA1c >=10% plus submission of medical records confirming an acceptable medical rationale for why mealtime insulin cannot be used
    When HbA1c >=10%, medical records (e.g., chart notes) explaining why mealtime insulin cannot be used must be submitted

    Clinical Thresholds and Dosing

    HbA1c thresholds (inv-05)
    HbA1c range for routine approvalGreater than 7% and less than 10%
    HbA1c pathway requiring additional documentationHbA1c greater than or equal to 10% AND submission of medical records confirming an acceptable medical rationale for why mealtime insulin cannot be used
    Documentation type required when HbA1c >=10%Medical records (e.g., chart notes) explaining why mealtime insulin cannot be used
    Basal insulin dose (inv-06)
    Minimum basal insulin dose for prior trialAt least 40 units
    Context for basal insulin requirementPatient has tried and failed basal insulin at a dose of at least 40 units as part of initial criteria

    Provider Actions, Documentation, and Denial Triggers

    Prior Authorization

    Prior authorization required; initial 6 months, reauthorization 12 months

    Prior authorization is required for Soliqua. Initial approvals are for 6 months and reauthorizations are for 12 months; initial authorization requires meeting the policy's clinical criteria including diagnosis, prior therapy trials, basal insulin dose where specified, and HbA1c thresholds.

    Step Therapy

    Therapy step requirements: metformin → additional agents → basal insulin where required

    Providers must document sequential therapy trials: trial and failure (or intolerance/contraindication) to metformin, then either trial/failure of at least two of sulfonylurea, pioglitazone, alogliptin, or Steglatro, or documented contraindication to all listed agents; certain pathways also require trial and failure of basal insulin at ≥40 units.

    • Metformin: trial and failure, intolerance, or contraindication (required).
    • Then either: trial/failure of at least two of {sulfonylurea, pioglitazone, alogliptin*, Steglatro*} OR contraindication to all listed agents.

    Definitions and Required Documentation

    Diagnosis required (inv-12)
    Required diagnosisType 2 Diabetes
    Indication in policySoliqua considered only for members with a diagnosis of Type 2 Diabetes
    Placement in criteria setDiagnosis is the first required element in initial authorization criteria
    Trial/failure/intolerance/contraindication (inv-13)
    Definition of trial and failure/intolerance/contraindicationDocumentation that the member tried the agent and either failed to achieve control, had intolerance, or has a contraindication to the listed agent(s)
    Prior therapy examplesApplies to metformin and to subsequent required trials of agents such as sulfonylurea, pioglitazone, alogliptin, Steglatro (or documented contraindication)

    Background on Soliqua

    Soliqua is a combination product that pairs a basal insulin (insulin glargine) with a GLP‑1 receptor agonist (lixisenatide) to improve glycemic control in patients with Type 2 Diabetes. The policy is focused on ensuring appropriate prior therapy trials and specified HbA1c thresholds before authorizing use.

    Policy Summary
    Payercareoregon
    PolicySoliqua (insulin glargine/lixisenatide) prior authorization
    Policy CodePolicy N/A
    Change TypeAdministrative — no material clinical changes
    Effective DateJul 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization with documentation of Type 2 diabetes, required prior therapy trials (including metformin and additional agents), basal insulin dose where required, and HbA1c results or medical rationale when HbA1c ≥10%.
    SourceLink
    On This Page
    Coverage Criteria for Soliqua (insulin glargine/lixisenatide)Initial Authorization RequirementsReauthorization / Continuation CriteriaStep Therapy RequirementsClinical Thresholds and DosingProvider Actions, Documentation, and Denial TriggersDefinitions and Required DocumentationBackground on Soliqua
    A1c requirements: Either HbA1c >7% and <10% OR HbA1c >=10% with submission of medical records explaining why mealtime insulin cannot be usedsee text

    Submission of medical records required when HbA1c >=10%

    NotesBasal insulin trial is listed as required (see initial authorization criteria)
  1. Where specified, patient must have tried and failed basal insulin at a dose of at least 40 units.
  2. *alogliptin and Steglatro require prior authorization per policy notes.
    3. Documentation Required

    Require medical-record justification when HbA1c ≥10%

    If the patient's HbA1c is ≥10%, submit medical records (for example, chart notes) that confirm an acceptable medical rationale explaining why mealtime (meal time) insulin cannot be used.

    Denial Risk

    Potential denial triggers: missing diagnosis, required trials, or documentation

    Requests missing required documentation or required clinical elements may be denied.

    • No documented diagnosis of Type 2 Diabetes.
    • No documentation of trial/failure, intolerance, or contraindication to metformin.
    • No documentation of trials of the required additional agents or documented contraindications to them.
    • When required, no documentation of prior basal insulin trial at ≥40 units.
    • When HbA1c ≥10%, absence of medical-record justification for why mealtime insulin cannot be used.
    When PA is required for listed agentsAlogliptin and Steglatro are noted as requiring prior authorization when used in step therapy trials