Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1The patient is a 58-year-old woman with a history of fibromyalgia with associated chronic fatigue syndrome and depression since the early 1990s. The patient has been prescribed many medications including Trazadone, Nortriptyline, Flexeril, Celexa, Zoloft, Ultram, Voltaren, etodolac, and Neurontin. Treatment with these medications provided the patient with significant pain relief but resulted in minimal increase in her energy level. Since initiating Provigil in June 2003 the patient has noted marked improvement in her energy level and quality of life. She has also been able to stop use of Neurontin while taking Provigil. The patient has requested authorization and coverage for continued treatment with Provigil. The Health Plan indicates the efficacy of Provigil for the patients diagnosis has not been established in peer-reviewed medical literature.Review of the submitted records demonstrates that the patient has noted significant benefit since starting treatment with Provigil. The patient has been able to discontinue treatment with Neurontin, thus reducing her overall use of medications. Additionally, there does not appear to be severe side effects with Provigil and the patient has been tolerating the medication well. Although Provigil is not specifically FDA approved for fibromyalgia, it has been effective in similar cases of extreme fatigue and is FDA approved for treatment of narcolepsy. Thus, use of Provigil by this patient is medically reasonable and appropriate.Based upon the information set forth above, I have determined that the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 2The patient is a 58-year-old woman with a history of fibromyalgia with chronic fatigue syndrome and depression. The patients medications include Trazadone, Nortriptyline, and Flexeril. Provigil was subsequently added to the patients regimen. The patient found Trazadone and Nortriptyline quite useful in lessening her pain though her fatigue only improved with the addition of Provigil. The submitted records indicate the patient noticed an increase in her energy level within a few days of commencement of Provigil. The patient has requested authorization and coverage for Provigil. The Health Plan has denied the patients request indicating that Provigil is considered investigational for this indication.Standard treatment of fibromyalgia is not particularly well defined to the extent that one antidepressant provides a definitive gain over another. Therefore, a medication that does help and for which there is some support in the literature, is medically appropriate. The patient has noticed a vast improvement in her functional status since initiating Provigil. Furthermore, the patient has already pursued treatments such as tricyclics and SSRIs and found them only partially effective. Adjunctive agents to antidepressants are often considered in cases in which there has been an incomplete response. Therefore, I have determined that the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 3The patient is a 58-year-old woman who has fibromyalgia with severe fatigue. The patient has been treated with multiple medications in the past. The submitted records indicate the patients energy level has significantly improved since Provigil was added to her treatment regimen. The patient has requested authorization and coverage for Provigil. The Health Plan has denied the patients request on the basis that Provigil is considered investigational for treatment of fibromyalgia related fatigue.The Health Plans denial should be overturned. The submitted records provide documented evidence of the superiority of Provigil over standard treatment for this patient. There have been anecdotal reports of Provigil helping fatigue of fibromyalgia. This patient has realized clear subjective benefit from Provigil and therefore, continued use of Provigil is medically appropriate. Therefore, I have determined that the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.