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Subsys (fentanyl sublingual spray)Medical Mutual

Breakthrough pain in patients with cancer

Initial criteria

  • The patient is unable to swallow, has dysphagia, esophagitis, mucositis, or uncontrollable nausea/vomiting; OR the patient is unable to take two other short-acting narcotics (for example: immediate-release formulations of oxycodone, morphine sulfate, hydromorphone, etc.) secondary to allergy or severe adverse events; AND
  • The prescriber verifies no concurrent substance abuse treatments are being prescribed (examples include but are not limited to: Suboxone, Vivitrol, oral naloxone, buprenorphine); AND
  • The patient will be using or continuing use of an oral or transdermal long-acting narcotic (for example: Duragesic, OxyContin, morphine extended-release) or the patient is on intravenous, subcutaneous, or spinal (intrathecal, epidural) narcotics (for example: morphine sulfate, hydromorphone, fentanyl citrate) for around-the-clock pain coverage; AND
  • The patient is not opioid naïve (is opioid tolerant, taking an opioid for one week or longer); AND
  • The requested product is prescribed by or in consultation with an oncologist or pain management specialist; AND
  • For Actiq and generic fentanyl citrate, the patient must be age ≥ 16 years OR for all other transmucosal fentanyl products, the patient must be age ≥ 18 years

Reauthorization criteria

  • Response to therapy is required for continuation of therapy

Approval duration

initial 3 months, renewal 1 year