Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Fibromyalgia. 
Treatment: Formulary Exception for Cymbalta. 
The insurer denied coverage for formulary exception for Cymbalta. 

The denial is overturned. 

This patient was taking Cymbalta for chronic pain. She has diagnoses of fibromyalgia and generalized anxiety disorder. She has a past medical history of breast cancer, hypertension, hypothyroidism, neuropathy, gastroesophageal reflux disease (GERD), and anemia. It was reported that she had increased stress mostly related to work. She reported some depression and worsened anxiety. Notes reported that the provider wanted to increase Cymbalta from 30 milligrams (mg) per day to 30 mg twice per day to better target pain due to fibromyalgia flares. This also targeted anxiety. 
    
This reviewer disagrees with the decision to deny coverage for Cymbalta as the medical records provided did report that she had adverse side effects to Duloxetine which is the generic version of Cymbalta which is the brand name. It was reported that she had visual hallucinations when taking Duloxetine. The Food and Drug Administration (FDA) approved Cymbalta (Duloxetine) for the treatment of major depressive disorder and generalized anxiety disorder. The maximum approved daily dosage is 120 mg per day and the request was for 30 mg twice per day which is 60 mg per day which is within range for FDA approval.  It is FDA approved for the treatment of diabetic neuropathy, fibromyalgia, and chronic musculoskeletal pain. This patient had reports of pain due to fibromyalgia as well as worsened anxiety due to generalized anxiety disorder. 

According to an article in Focus: The Lifelong Journal in Psychiatry: Anxiety Disorders patients with generalized anxiety disorder cognitive behavioral therapy, pharmacotherapy, and other psychotherapies were not only indicated but also have been shown to result in reduction of symptoms. The standard pharmacological treatment for generalized anxiety disorder and panic disorder is serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors such as Duloxetine (Cymbalta), Venlafaxine, and Desvenlafaxine, and also benzodiazepines. This patient was reportedly taking Cymbalta with efficacy in anxiety as per notes. 

Notes reported that the anxiety increased mostly due to work stressors and also her pain increased due to fibromyalgia flare ups, so the recommendation was to increase the dosage of Cymbalta from 30 mg per day to 30 mg twice per day to better target anxiety and pain due to fibromyalgia flare ups. This patient had a significant reported adverse effect when taking generic Duloxetine as she had reported visual hallucinations, so she required the brand name Cymbalta which is the brand name version of Duloxetine. 

Desvenlafaxine and Venlafaxine were not FDA approved for fibromyalgia though approved for generalized anxiety disorder. The formulary medication would not likely be effective for her pain and fibromyalgia flare ups and she reportedly had efficacy with 30 mg of Cymbalta for anxiety and pain but due to stressors reported the need for an increase in dosage to 30 mg twice per day to better target anxiety and pain and fibromyalgia flare ups. Also, if her pain and fibromyalgia flare ups were less it likely would also lessen her anxiety so Cymbalta appeared to be a more effective medication for her than the generic other formulary medications. Cymbalta was more likely to be effective than other formulary medications and she did have a serious adverse effect from generic Duloxetine which is formulary. 

The insurer's denial for Formulary Exception for Cymbalta is overturned.