Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Abdominal pain. 
Treatment: Fentora 800 micrograms (mcg) #63/7 Day. 

The insurer denied the Fentora 800 micrograms (mcg) #63/7 Day. 
The denial is upheld. 

The patient is a male. The request is for Fentora (fentanyl) 800 micrograms (mcg) #63/7 Day for abdominal pain. The patient has tried methadone and morphine. The patient has a history of removal of J tube, esophagectomy, pyloroplasty, and Barium swallow study. The request for Fentora 800 mcg (micrograms) #63/7 was denied by the health plan, as this medication is indicated for treatment of breakthrough cancer pain. 

Per a note, the patient has history of eosinophilic esophagitis, mast cell syndrome and chronic epigastric and abdominal pain. He had increased need for ITP (intrathecal pump) refills with sufentanyl and shortened pump life. Trial with methadone and morphine was not tolerated. Discussed adjusting oral medications and ITP (intrathecal pump) medications. The patient was also taking hydromorphone 12mg (milligrams) every 4 hours and Fentora 2 times a day. His total MME (Morphine Milligram Equivalents) was 496 mg (milligrams) per day. 

No, the requested Fentora lollipop 800 micrograms (mcg) #63/7 Day is not medically necessary. 

This medication is indicated for treatment of breakthrough cancer pain in patients who are receiving and tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. 

This request is not in accordance with generally accepted standards of medical practice, and not clinically appropriate in terms of type, frequency, site, extent and duration and considered effective for the patient's illness, injury or disease. 

The patient has history of chronic abdominal pain status post abdominal surgeries. The patient is able to eat comfortably and sustain proper nutrition. While it is noted that lack of pain control may lead to failure to thrive, the patient is maintained on ultra-high doses of chronic opiate therapy with Intrathecal pump with sufentanyl, oral hydromorphone 12mg (milligrams) every 4 hours a day, and Fentora tabs 600mcg (micrograms) 2 times a day. 

Therefore, given the above, the requested Fentora lollipop 800 micrograms (mcg) #63/7 Day is not medically necessary. 

Peer-reviewed literature supports the use of Fentora for cancer pain. Fentora 800mcg (micrograms) is indicated for treatment of breakthrough cancer pain and who are receiving and tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. 

A review by Wang (2) provided very limited clinical evidence to support long-term opioid use for chronic abdominal pain. 

Given recent CDC (Centers for Disease Control and Prevention) report of opioid epidemic, it is prudent to use the best medical practice with appropriate evaluation of psychological comorbidities, urine drug screening, prescription drug monitor, and opioid treatment agreements to minimize adverse side effects related to opioids. Furthermore, well-designed clinical trials are needed to evaluate the effectiveness of long-term use of opioid medications, and more clinical research on which opioid medication is more effective for chronic abdominal pain. 

Per a CDR (common drug review) clinical review (3), "The CADTH (Canadian Agency for Drugs and Technologies in Health) Canadian Drug Expert Committee (CDEC) recommends that Fentora not be reimbursed for the management of breakthrough pain in patients with dysphagia or a lack of adequate pain relief or intolerable opioid-related toxicities or adverse events or contraindication to morphine, oxycodone, or hydromorphone." Furthermore, "There is no evidence available to evaluate the efficacy and safety of Fentora in the population specified in the request for reimbursement; specifically, patients with dysphagia and/or a lack of adequate pain relief and/or intolerable opioid-related toxicities or adverse events or contraindication to morphine, oxycodone, or hydromorphone. There is no evidence that patients who are unable to achieve pain relief with the pain management strategies that are currently available would benefit from treatment with Fentora."