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Diclofenac Sodium (Actinic Keratoses) 3% gel — Blue Cross Blue Shield of Oklahoma

actinic (solar) keratoses of the trunk and/or extremities

Preferred products

  • generic imiquimod 5% cream
  • fluorouracil solution

Initial criteria

  • 1. If the patient has an FDA labeled indication, then ONE of the following:
  • A. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
  • B. There is support for using the requested agent for the patient’s age for the requested indication AND
  • 2. ONE of the following:
  • A. BOTH of the following:
  • 1. The patient has a diagnosis of actinic (solar) keratoses of the face and/or scalp; AND
  • 2. The requested agent is diclofenac 3% gel, Carac (Fluorouracil) 0.5% cream, Efudex (Fluorouracil) 5% cream, Fluoroplex, Tolak, imiquimod 5%, Zyclara (imiquimod) 3.75% cream, Zyclara 2.5% cream, OR Klisyri OR
  • B. BOTH of the following:
  • 1. The patient has a diagnosis of actinic (solar) keratoses of the trunk and/or extremities; AND
  • 2. The requested agent is diclofenac 3% gel, Efudex (Fluorouracil) 5% cream, OR Fluoroplex OR
  • C. BOTH of the following:
  • 1. The patient has a diagnosis of superficial basal cell carcinoma AND
  • 2. The requested agent is imiquimod 5% OR Efudex (Fluorouracil) 5% cream OR
  • D. BOTH of the following:
  • 1. The patient has a diagnosis of external genital and/or perianal warts (EGW) / condyloma acuminata AND
  • 2. The requested agent is imiquimod 5% OR Zyclara (imiquimod) 3.75% cream AND
  • 3. ONE of the following:
  • A. BOTH of the following:
  • 1. ONE of the following:
  • A. Prescriber has stated or documented that the patient has stage four advanced, metastatic cancer and the requested agent is being used to treat the cancer OR
  • B. Documentation that the requested agent is used to treat an associated condition of stage four advanced, metastatic cancer [chart notes required] AND
  • 2. The use is consistent with best practices for the treatment of stage four advanced, metastatic cancer, supported by evidence-based literature, and approved by US FDA OR
  • B. For diagnosis of actinic keratoses or superficial basal cell carcinoma, ONE of the following:
  • 1. Patient is currently stable and being treated with requested agent [chart notes required] OR
  • 2. Patient has tried and had an inadequate response to generic imiquimod 5% cream or fluorouracil solution [chart notes required] OR
  • 3. Generic imiquimod 5% cream or fluorouracil solution was discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR
  • 4. Patient has intolerance or hypersensitivity to therapy with generic imiquimod 5% cream or fluorouracil solution [chart notes required] OR
  • 5. Patient has FDA labeled contraindication to generic imiquimod 5% cream AND fluorouracil solution [chart notes required] OR
  • 6. Generic imiquimod 5% cream or fluorouracil solution expected to be ineffective or inappropriate based on patient characteristics, adherence issues, comorbidities, or adverse risk [chart notes required] OR
  • 7. Generic imiquimod 5% cream or fluorouracil solution not in the best interest of the patient based on medical necessity [chart notes required] OR
  • 8. Patient has tried another drug in the same pharmacologic class or mechanism and it was discontinued due to lack of efficacy or adverse event [chart notes required] OR
  • C. For diagnosis of external genital warts and/or perianal warts (EGW) / condyloma acuminata, ONE of the following:
  • 1. Patient is currently being treated and stable on requested agent [chart notes required] OR
  • 2. Patient has tried and had an inadequate response to generic imiquimod 5% cream [chart notes required]

Approval duration

180 days