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    Retevmo™

    Drug - Retevmo™ (selpercatinib) [Eli Lilly and Company]

    September 2020

    Therapeutic area - Oncology, Oral - Lung

    Initial approval criteria

    Patient is ≥ 18 years of age (unless otherwise specified) AND

    Universal Criteria

    • Selpercatinbib must be used as a single agent AND
    • Patient does not have uncontrolled hypertension AND
    • Patient does not have clinically significant active cardiovascular disease or a recent myocardial infarction (e.g., within 6 months prior to start of therapy) AND
    • Patient does not have a history of prolongation of the QT-interval > 470 msec AND
    • Patient has not had recent major surgery within the previous 14 days AND
    • Patient does not have neurologically unstable central nervous system (CNS) metastases AND
    • Selpercatinib will not be used concomitantly with other RET-type targeted therapies (e.g., cabozantinib, vandetanib) AND
    • Patient will avoid concomitant therapy with any of the following:
      • Coadministration with acid-reducing agents (e.g., proton pump inhibitor [PPI], histamine 2 [H2] receptor antagonist, and locally-acting antacid); if concomitant therapy is unavoidable, the patient will be monitored closely for adverse reaction and/or dose modifications OR
      • Coadministration with strong or moderate CYP3A4 inhibitors (e.g., fluconazole, itraconazole); if concomitant therapy is unavoidable, the patient will be monitored closely for adverse reaction and/or dose modifications OR
      • Coadministration with strong and moderate CYP3A inducers (e.g., rifampin, carbamazepine, St. John’s wort) OR
      • Coadministration with CYP3A substrates (e.g., amitriptyline, carbamazepine); if concomitant therapy is unavoidable, the patient will be monitored closely for adverse reaction and/or dose modifications OR
      • Coadministration with CYP2C8 substrates (e.g., paclitaxel, dabrafenib, pioglitazone, repaglinide); if concomitant therapy is unavoidable, the patient will be monitored closely for adverse reaction and/or dose modifications AND

    Non-Small Cell Lung Cancer (NSCLC)

    • Patient disease has the presence of a RET gene fusion as detected by an FDA-approved or Clinical Laboratory Improvement Amendments (CLIA) ompliant test* AND
    • Patient has metastatic disease OR

    Thyroid Cancer

    • Patient is ≥ 12 years of age AND
    • Patient disease has the presence of a RET gene fusion (thyroid cancer) or specific RET gene mutation (medullary thyroid cancer) as detected by an FDA-approved or CLIA compliant test* AND
      • Patient has advanced or metastatic medullary thyroid cancer (MTC) AND
        • Patient requires systemic therapy OR
      • Patient has advanced or metastatic papillary thyroid cancer , poorly differentiated thyroid cancer, anaplastic thyroid cancer or Hürthle cell thyroid cancer AND
        • Patient requires systemic therapy AND
        • Patient has radioactive iodine (RAI)-refractory disease, if RAI was an appropriate treatment option (Note: anaplastic thyroid cancer typically exhibits inadequate RAI uptake)
    • Initial approval is for 6 months

    * If confirmed using an immunotherapy assay - https://www.fda.gov/medical-devices/vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-vitro-and-imaging-tools

    † Note: Requests for specific RET-gene mutations in MTC tumor specimens other than the following will be reviewed on a case-by-case basis: M918T, extracellular cysteine mutations (involving cysteine residues 609, 611, 618, 620, 630, and 634), V804M or V804L, K666N, D631, L633delinsV, D631_L633delinsE, D378_G385delinsE, D898_E901del, A883F, E632_L633del, L790F, 636_V637insCRT, and D898_E901del+D903_S904DelinsEP

    Renewal criteria

    • Patient must continue to meet criteria above AND
    • Patient experienced disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread AND
    • Patient is absent of unacceptable toxicity from the drug. Examples of unacceptable toxicity include severe hepatotoxicity, severe hypersensitivity, QT interval prolongation, impaired wound healing, severe or life-threatening hemorrhagic events, uncontrolled hypertension, etc.
    • Renewal approval is for 6 months

    Quantity limits

    • 320 mg per day
    • Patient’s weight (in kg) must be provided at time of request

    Questions?

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

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