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    v1.0.28
    OpenPayerPolicy UpdatesEndocrinologyNeighborhood Health Plan RI Palsonify Coverage | O…
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    CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

    Palsonify (paltusotine) — Coverage Criteria for Acromegaly

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    Covers medical necessity and authorization criteria for Palsonify (paltusotine) tablets for treatment of adults with acromegaly, including initial and continuation authorization and quantity limits; applies to Medicaid members of Neighborhood Health Plan of Rhode Island.

    Policy Summary
    PayerNeighborhood Health Plan of Rhode Island
    PolicyPalsonify (paltusotine) — Coverage Criteria for Acromegaly
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateMay 1, 2026
    Last ReviewFeb 1, 2026
    Next Review DateFeb 1, 2026
    Key ActionSubmit prior authorization with required documentation showing endocrinologist involvement, diagnostic confirmation, and prior inadequate response to lanreotide or octreotide.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    6 monthsinitial or continuation authorization length
    20mg/30mgtablet strengths available

    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.

    2/day
    maximum daily quantity limit
    AdultsFDA-approved population

    Coverage Criteria for Palsonify (paltusotine)

    Initial Therapy

    Authorization of 6 months may be granted for the treatment of acromegaly when ALL of the following are met:

    Initial authorization criteria: 1. The requested drug is prescribed by or in consultation with an endocrinologist; 2. Documentation that the diagnosis of acromegaly has been confirmed by one of the following: (a) serum GH level > 1 ng/mL after a 2-hour OGTT at time of diagnosis; OR (b) elevated serum IGF-1 above the age- and gender-adjusted normal range per the physician's laboratory at diagnosis; 3. Documentation that the member has a recent high pretreatment IGF-1 level for age and/or gender based on the laboratory reference range; 4. Documentation that the member had an inadequate or partial response to surgery OR there is a clinical reason why the member has not had surgery; 5. Documentation that Palsonify will not be taken concomitantly with a strong or moderate CYP3A4 inducer; 6. Documentation that the member has had an inadequate treatment response, intolerance, or contraindication to Somatuline Depot (lanreotide acetate) OR Sandostatin LAR Depot (octreotide acetate).n/a

    All conditions required for initial approval

    Continuation Therapy

    Authorization of 6 months may be granted for continuation of therapy when ALL of the following are met:

    Continuation authorization: Documentation that the member's IGF-1 level has decreased or normalized since initiation of therapy.IGF-1 decreased or normalized

    Required for renewal

    Use of Palsonify (paltusotine) for indications other than the FDA‑approved population is not covered. The policy limits use to the treatment of adults with acromegaly who have had an inadequate response to surgery or for whom surgery is not an option.

    Requests for Palsonify for any other diagnoses or clinical indications are considered experimental/investigational and not medically necessary, and therefore will not be approved.

    Provider Actions and Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for Palsonify for acromegaly; initial and continuation approvals may be granted for up to 6 months when all documented criteria are met.

    • Authorization duration: up to 6 months for initial or continuation requests
    • Prescriber requirement: prescribed by or in consultation with an endocrinologist
    • Drug interaction: Palsonify must not be taken concomitantly with strong or moderate CYP3A4 inducers
    Step Therapy

    Step Requirement — Somatostatin Analogs

    Step requirement: member must have documentation of inadequate response, intolerance, or contraindication to a somatostatin analog prior to approval of Palsonify.

    • Required step therapies: Somatuline Depot (lanreotide acetate) OR Sandostatin LAR Depot (octreotide acetate) — documentation of inadequate response, intolerance, or contraindication to one of these is required

    Diagnostic and Eligibility Definitions

    Diagnostic criteria — Acromegaly
    Confirmed diagnostic threshold (OGTT)Serum GH level > 1 ng/mL after a 2-hour oral glucose tolerance test at time of diagnosis.
    Alternate diagnostic markerElevated serum insulin-like growth factor-1 (IGF-1) above the age- and gender-adjusted normal range at diagnosis (per physician's lab).
    Pretreatment disease activityDocumentation of a recent high pretreatment IGF-1 level for the member's age and/or gender based on laboratory reference range.
    Continuation criterionFor continuation of therapy, documentation that the member's IGF-1 level has decreased or normalized since initiation of therapy.

    Background on Palsonify (paltusotine)

    Palsonify (paltusotine) is an oral therapy indicated for the treatment of adults with acromegaly who have had an inadequate response to surgery and/or for adults for whom surgery is not an option. Coverage under this policy is limited to that FDA‑approved indication.

    Policy Summary
    PayerNeighborhood Health Plan of Rhode Island
    PolicyPalsonify (paltusotine) — Coverage Criteria for Acromegaly
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateMay 1, 2026
    Last ReviewFeb 1, 2026
    Next Review DateFeb 1, 2026
    Key ActionSubmit prior authorization with required documentation showing endocrinologist involvement, diagnostic confirmation, and prior inadequate response to lanreotide or octreotide.
    SourceLink
    On This Page
    Coverage Criteria for Palsonify (paltusotine)Provider Actions and RequirementsDiagnostic and Eligibility DefinitionsBackground on Palsonify (paltusotine)
    Documentation Required

    Documentation Requirements — Initial Authorization

    For initial authorization, provide documentation of endocrinologist involvement and diagnostic confirmation of acromegaly, including elevated GH or IGF‑1, and evidence of prior surgery response or clinical reason surgery was not performed.

    • Diagnostic confirmation: GH > 1 ng/mL after 2‑hour OGTT OR elevated serum IGF‑1 above age/gender reference range at diagnosis
    • Recent pretreatment IGF‑1: document a recent high pretreatment IGF‑1 level for age/gender based on laboratory reference range
    • Surgery documentation: evidence of inadequate or partial response to surgery OR clinical reason why surgery was not performed
    • Drug interaction check: documentation that Palsonify will not be taken with a strong or moderate CYP3A4 inducer
    Note

    FDA‑Approved Indication / Non‑Covered Uses

    Palsonify is FDA‑approved for adults with acromegaly who had inadequate response to or are not candidates for surgery. Use for other indications is considered experimental/investigational and not medically necessary.