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Pennsaid — Blue Cross Blue Shield of Texas

FDA approved diagnosis for the requested agent

Preferred products

  • generic topical diclofenac 1.5% solution
  • generic topical diclofenac 1% gel
  • brand or generic topical over the counter (OTC) NSAID

Initial criteria

  • Target Agent(s) will be approved when ALL of the following are met:
  • 1. ONE of the following:
  • A. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
  • B. BOTH of the following:
  • 1. ONE of the following:
  • A. The prescriber has stated that the patient has been diagnosed with stage four advanced, metastatic cancer and the requested agent is being used to treat the cancer OR
  • B. The prescriber has submitted documentation that the patient has been diagnosed with stage four advanced, metastatic cancer and the requested agent is being used to treat an associated condition related to stage four advanced metastatic cancer [chart notes are required] AND
  • 2. The use of the requested agent is consistent with best practices for the treatment of stage four advanced, metastatic cancer, or an associated condition; supported by peer-reviewed, evidence-based literature; and approved by the United States Food and Drug Administration OR
  • C. The patient is currently being treated with the requested agent and the patient is currently stable on the requested agent [chart notes are required] OR
  • D. The patient has tried and had an inadequate response to generic topical diclofenac 1.5% solution or generic topical diclofenac 1% gel OR a brand or generic topical over the counter (OTC) NSAID [chart notes are required] OR
  • E. Generic topical diclofenac 1.5% solution or generic topical diclofenac 1% gel OR a brand or generic topical OTC NSAID was discontinued due to lack of efficacy, diminished effect, or an adverse event [chart notes are required] OR
  • F. The patient has an intolerance or hypersensitivity to generic topical diclofenac 1.5% solution or generic topical diclofenac 1% gel OR a brand or generic topical OTC NSAID that is NOT expected to occur with the requested agent [chart notes are required] OR
  • G. The patient has an FDA labeled contraindication to generic topical diclofenac 1.5% solution AND generic topical diclofenac 1% gel AND ALL brand and generic topical OTC NSAIDs that is not expected to occur with the requested agent [chart notes are required] OR
  • H. Generic topical diclofenac 1.5% solution or generic topical diclofenac 1% gel OR a brand or generic topical OTC NSAID is expected to be ineffective based on known clinical characteristics, cause a barrier to adherence, worsen a comorbid condition, decrease functional ability, or cause harm [chart notes are required] OR
  • I. Generic topical diclofenac 1.5% solution or generic topical diclofenac 1% gel OR a brand or generic topical OTC NSAID is not in the best interest of the patient based on medical necessity [chart notes are required] OR
  • J. The patient has tried another prescription drug in the same pharmacologic class or mechanism as generic topical diclofenac 1.5% solution or generic topical diclofenac 1% gel OR a brand or generic topical OTC NSAID and that prescription drug was discontinued due to lack of efficacy or adverse event [chart notes are required]
  • 2. The patient has an FDA approved diagnosis for the requested agent AND
  • 3. ONE of the following:
  • A. The patient is not currently being treated with a topical lidocaine product within the past 30 days OR
  • B. There is support for appropriate use of topical lidocaine with the requested agent for a different indication (e.g., Lidoderm for post-herpetic neuralgia, Flector for acute pain)

Approval duration

12 months