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Self-Administered Oncology Prior Authorization (with Quantity Limit*) Criteria - Medicare Part D
Medicare Utilization Management Policy
Last Review: 03/31/2025

The following formulary medications are included in this program:

abiraterone 250 mg, Akeega, Alecensa, Alunbrig, Augtyro, Ayvakit, Balversa, Besremi, bexarotene capsule, Bosulif, Braftovi, Brukinsa, Cabometyx, Calquence, Caprelsa, Cometriq, Copiktra, Cotellic, Danziten, dasatinib, Daurismo, Erivedge, Erleada, erlotinib, everolimus, everolimus tablet for oral suspension, Exkivity, Fotivda, Fruzaqla, Gavreto, gefitinib, Gilotrif, Gomekli, Ibrance, Iclusig, Idhifa, imatinib mesylate tablet, Imbruvica, Imkeldi, Inlyta, Inqovi, Inrebic, Itovebi, Iwilfin, Jakafi, Jaypirca, Kisqali, Kisqali Femara, Koselugo, Krazati, lapatinib, Lazcluze, lenalidomide, Lenvima, Lonsurf, Lorbrena, Lumakras, Lynparza, Lytgobi, Matulane, Mekinist, Mektovi, Nerlynx, Ninlaro, Nubeqa, Odomzo, Ogsiveo, Ojemda, Ojjaara, Onureg, Orgovyx, Orserdu, pazopanib, Pemazyre, Piqray, Pomalyst, Qinlock, Retevmo, Revuforj, Rezlidhia, Romvimza, Rozlytrek, Rubraca, Rydapt, Scemblix, sorafenib, Stivarga, sunitinib, Tabrecta, Tafinlar, Tagrisso, Talzenna, Tasigna, Tazverik, Tepmetko, Thalomid, Tibsovo, Torpenz, tretinoin capsule, Truqap, Tukysa, Turalio, Vanflyta, Venclexta, Verzenio, Vitrakvi, Vizimpro, Vonjo, Voranigo, Welireg, Xalkori, Xospata, Xpovio, Xtandi, Yonsa, Zelboraf, Zejula tablets, Zolinza, Zydelig, and Zykadia

PA applies to new starts only

Prior Authorization Criteria for Approval

The requested medication will be approved when ALL of the following are met:

  1. The patient has an FDA labeled indication or an indication that is supported in CMS approved compendia for the requested medication
    AND
  2. ONE of the following:
    1. There is evidence of a claim that the patient is currently being treated with the requested medication within the past 180 days
      OR
    2. The prescriber states the patient is currently being treated with the requested medication
      OR
    3. ALL of the following:
      1. Genetic testing has been completed, if required, for therapy with the requested medication and results indicate the requested medication is appropriate
        AND
      2. The patient does NOT have any FDA labeled contraindications to the requested medication
        AND
      3. ONE of the following:
        1. The requested medication is FDA labeled or supported by compendia as a first-line therapy for the requested indication
          OR
        2. The patient has tried appropriate FDA labeled or compendia supported therapy that are indicated as first-line therapy for the requested indication
          OR
        3. The patient has an intolerance or hypersensitivity to the first-line therapy for the requested indication
          OR
        4. The patient has an FDA labeled contraindication to the first-line therapy for the requested indication
          AND
      4. The patient does NOT have any FDA labeled limitations of use that are not otherwise supported in NCCN guidelines
        AND
      5. ONE of the following:
        1. The requested medication is not Bosulif
          OR
        2. The requested medication is Bosulif AND ONE of the following:
          1. The patient’s medication history indicates use of imatinib OR dasatinib for the requested indication (if applicable)
            OR
          2. The patient has an intolerance or hypersensitivity to imatinib OR dasatinib
            OR
          3. The patient has an FDA labeled contraindication to imatinib OR dasatinib
            OR
          4. CMS approved compendia does not support the use of imatinib OR dasatinib for the requested indication
            OR
          5. The prescriber has provided information in support of use of Bosulif over imatinib OR dasatinib for the requested indication
            AND
      6. ONE of the following:
        1. The requested medication is not Calquence
          OR
        2. The requested medication is Calquence AND ONE of the following:
          1. The patient’s medication history indicates use of Brukinsa OR Imbruvica for the requested indication (if applicable)
            OR
          2. The patient has an intolerance or hypersensitivity to Brukinsa OR Imbruvica
            OR
          3. The patient has an FDA labeled contraindication to Brukinsa OR Imbruvica
            OR
          4. CMS approved compendia do not support the use of Brukinsa OR Imbruvica for the requested indication
            OR
          5. The prescriber has provided information in support of use of Calquence over Brukinsa OR Imbruvica for the requested indication
            AND
  3. ONE of the following:
    1. The requested quantity (dose) does NOT exceed the program quantity limit
      OR
    2. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit
        AND
      2. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit
        AND
      3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months

*The following medications do NOT have a quantity limit: bexarotene capsules, Matulane, and tretinoin capsules

FDA Approved Genetic Tests

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