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    Pretomanid

    Drug - Pretomanid tablet [Mylan Specialty L.P.]

    April 2020

    Therapeutic area - Tuberculosis

    Initial approval criteria

    • Patient is ≥ 18 years old AND
    • Patient has pulmonary extensively drug resistant (XDR) or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB) AND
    • Patient is concomitantly taking bedaquiline and linezolid as part of the recommended dosing regimen and use of bedaquiline and linezolid are not contraindicated in patient AND
    • Dosing regimens follows duration for each agent as indicated in the prescribing information AND
    • Patient meets prior authorization criteria for bedaquiline AND
    • If patient meets prior authorization criteria for pretomanid, bedaquilline will be approved for the same treatment duration as pretomanid AND
    • Patient is receiving the combination regimen by directly observed therapy (DOT) as documented in chart notes AND
    • Prescriber attests that patient has been counseled on the need for compliance with the full course of therapy AND
    • Patient has been assessed for symptoms and signs of liver disease and laboratory tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase, and bilirubin) AND
    • A complete blood count has been obtained at baseline and prescriber attestation that it will be monitored throughout treatment course AND
    • Serum potassium, calcium, and magnesium levels have been obtained and corrected if abnormal AND
    • Electrocardiogram (ECG) is obtained prior to initiation of treatment and throughout treatment course AND
    • Patient is not receiving strong CYP3A4 inducers (e.g., rifampin, efavirenz) AND
    • If patient is receiving an OAT3 substrate, dosage of the OAT3 substrate has been reduced accordingly, as needed AND
    • If patient has moderate hepatic impairment or moderate to severe renal impairment, dosing has been adjusted accordingly

    Renewal criteria

    • Patient must continue to meet the above criteria AND
    • Patient has NOT experienced any treatment regimen-restricting adverse effects (e.g., hepatotoxicity, myelosuppression peripheral and optic neuropathy, QT prolongation, lactic acidosis) and remains compliant

    Quantity limits

    • 30 tablets/30 days
    • Duration of approval: 26 weeks

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

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