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    v1.0.30
    OpenPayerPolicy UpdatesObstetrics/GynecologyTexas Children's Progesterone Prior Auth | OpenPay…
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    CurrentTexas Children's Health PlanPolicy 6198

    17 alpha-hydroxyprogesterone caproate Therapy Guidelines

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    This guideline governs prior authorization and medical-necessity review for 17 alpha-hydroxyprogesterone caproate therapy intended to prevent recurrent preterm delivery for Texas Children's Health Plan members. It specifies required submission documentation, eligible pregnancy and treatment criteria, dosing limits, and denial conditions.

    Policy Summary
    PayerTexas Children's Health Plan
    Policy17 alpha-hydroxyprogesterone caproate Therapy Guidelines
    Policy CodePolicy 6198
    Change TypeNo material change
    Effective DateJul 19, 2021
    Next Review DateN/A
    Key ActionObtain prior authorization for all 17 alpha-hydroxyprogesterone caproate therapy intended to prevent preterm delivery.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    100%Prior authorization required
    16 yearsMinimum patient age
    16w0d-26w6dTreatment initiation window
    21 dosesMaximum treatment course

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    250 mg IM or 275 mg SCWeekly dose

    Medical Necessity and Exclusion Criteria

    Covered Initial Therapy Criteria

    Covered when ALL of the following criteria are met for weekly 17 alpha-hydroxyprogesterone caproate therapy to prevent preterm delivery:

    ALL of the following

    • Patient is age 16 years or older.≥ 16 years
    • Pregnancy is singleton.

    • ONE of the following prior-delivery circumstances

      • History of a prior spontaneous singleton preterm delivery before 37 weeks of gestation due to spontaneous preterm labor.
      • History of a prior spontaneous singleton preterm delivery before 37 weeks of gestation due to premature rupture of membranes.
    • Treatment is initiated between 16 weeks, 0 days and 26 weeks, 6 days of gestation.
    • Recommended dose is 250 mg intramuscularly or 275 mg subcutaneously once weekly.
    • Weekly injections begin between 16 weeks, 0 days and 26 weeks, 6 days and continue until 36 weeks, 6 days of gestation, for a maximum of 21 doses.≤ 21 doses

    Coverage is not medically necessary when the patient has a current or prior history of thrombosis or a thromboembolic disorder.

    Coverage is not medically necessary for unapproved indications, including amenorrhea, endometrial carcinoma, multifetal gestation, short cervix without a history of preterm birth, testing for endogenous estrogen production, or any diagnosis other than a singleton pregnancy in a woman with a history of spontaneous singleton preterm birth.

    Requests may be denied for medical necessity when the patient is younger than 16 years, 0 days; treatment exceeds 21 weeks, 0 days; or the dose exceeds 250 mg intramuscularly or 275 mg subcutaneously once weekly.

    Requests may also be denied for medical contraindications, including known or suspected breast cancer or other hormone-sensitive cancer or a history of these conditions; undiagnosed abnormal vaginal bleeding unrelated to pregnancy; cholestatic jaundice of pregnancy; benign or malignant liver tumors or active liver disease; uncontrolled hypertension; or an allergic reaction to any MAKENA ingredient (hydroxyprogesterone, castor oil, benzyl benzoate, or benzyl alcohol).

    Requests that do not meet the established criteria will be referred to a Texas Children’s Health Plan Medical Director or Physician Reviewer for review. The Denial Policy will be followed.

    Prior Authorization and Submission Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for all 17 alpha-hydroxyprogesterone caproate therapy intended to prevent preterm delivery. Requests are submitted to the Utilization Management Department through online submission, fax, phone, or mail during normal business hours and are evaluated for eligible-service and medical-necessity support.

    Documentation Required

    Required Prior Authorization Documentation

    Submit the following information with every prior authorization request for 17 alpha-hydroxyprogesterone caproate therapy:

    • Patient identifying information
    • Documentation of medical necessity
    • Prescription information, including drug, strength, quantity, directions, and expected therapy duration
    • Prescriber information and signature

    Therapy Overview

    This guideline addresses 17 alpha-hydroxyprogesterone caproate therapy intended to prevent recurrent spontaneous preterm delivery. Coverage is limited to a singleton pregnancy in a woman with a history of spontaneous singleton preterm delivery before 37 weeks, due to spontaneous preterm labor or premature rupture of membranes. When criteria are met, treatment is initiated between 16 weeks, 0 days and 26 weeks, 6 days gestation at the recommended dose of 250 mg intramuscularly or 275 mg subcutaneously once weekly.

    Policy Summary
    PayerTexas Children's Health Plan
    Policy17 alpha-hydroxyprogesterone caproate Therapy Guidelines
    Policy CodePolicy 6198
    Change TypeNo material change
    Effective DateJul 19, 2021
    Next Review DateN/A
    Key ActionObtain prior authorization for all 17 alpha-hydroxyprogesterone caproate therapy intended to prevent preterm delivery.
    SourceLink
    On This Page
    Medical Necessity and Exclusion CriteriaPrior Authorization and Submission RequirementsTherapy Overview
    Denial Risk

    Clinical Criteria and Contraindications

    Weekly therapy is considered medically necessary only when the applicable clinical criteria are met. Requests may be denied for age, duration, dose, or contraindication-related medical-necessity concerns.

    • Patient is 16 years of age or older.
    • Pregnancy is singleton.
    • Patient has a history of a prior spontaneous singleton preterm delivery before 37 weeks gestation due to spontaneous preterm labor or premature rupture of membranes.
    • Treatment is initiated between 16 weeks, 0 days and 26 weeks, 6 days gestation.
    • Weekly injections begin between 16 weeks, 0 days and 26 weeks, 6 days and continue until 36 weeks, 6 days of gestation, for a maximum of 21 doses.
    • Recommended dose is 250 mg intramuscularly or 275 mg subcutaneously once weekly.
    • Medical-necessity denial conditions include age less than 16 years, 0 days; treatment exceeding 21 weeks, 0 days; or dosing greater than 250 mg intramuscularly or 275 mg subcutaneously once weekly.
    • Contraindications include current or prior thrombosis or thromboembolic disorders; known or suspected breast cancer, other hormone-sensitive cancer, or a history of these conditions; undiagnosed abnormal vaginal bleeding unrelated to pregnancy; cholestatic jaundice of pregnancy; benign or malignant liver tumors or active liver disease; uncontrolled hypertension; or allergic reaction to any MAKENA ingredient (hydroxyprogesterone, castor oil, benzyl benzoate, or benzyl alcohol).
    • Requests that do not meet the criteria may be referred to a TCHP Medical Director/Physician Reviewer, and the Denial Policy will be followed.
    Denial Risk

    Unapproved Indications

    Therapy is not covered or is considered medically unnecessary when requested for an unapproved indication or for a diagnosis other than singleton pregnancy in a woman with a history of spontaneous singleton preterm birth.

    • Amenorrhea
    • Endometrial carcinoma
    • Multifetal gestation
    • Short cervix without a history of preterm birth
    • Testing for endogenous estrogen production
    • Any diagnosis other than singleton pregnancy in a woman with a history of spontaneous singleton preterm birth