Appeal type: Experimental/Investigational
Decision: Overturned

Physicain 1The patient is a 17-year-old female who has had daily headaches since May 2004 that have seriously impacted her quality of life. She has undergone extensive diagnostic imaging. The patient has tried a variety of medications without relief. Her neurologist has diagnosed her with classic migraine. A request has been made for authorization and coverage for Botox injections for treatment of the patients headaches. The Health Plan has denied the request on the basis that Botox is considered experimental for treatment of the patients medical condition.This young female appears to have status migrainosis or transformed migraine. To date, the efficacy of Botox for treatment of migraines has not been established in the medical literature. Though there is great interest in Botox and studies are in progress, there are no randomized, controlled trials. In addition, the long-term safety risks of Botox therapy are not known. One report documents that Botox caused severe intractable headaches after use for dermatologic reasons (Alam, et al.). Given the lack of long-term data on Botox therapy, standard treatment modalities are likely to be more beneficial for treatment of this patients migraines.Based upon the information set forth above, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 2The patient is a 17-year-old female with acute onset of persistent unilateral headache, which has not responded to multiple acute and preventive therapies including Depakote, Topamax, and Periactin. The patient is significantly disabled and is being closely followed by a neurologist. It has been recommended that the patient receive Botox therapy. The Health Plan has denied coverage for Botox on the basis it is considered investigational for treatment of the patients headaches.It is likely that this patients condition does not represent migraine, but meets criteria for new onset daily persistent headache, which is a recent addition to the International Headache Society Criteria. However, it may also represent hemicrania continua, an indomethacin responsive headache disorder, in which case a therapeutic trial of indomethacin may provide relief. Based upon the information provided, it does not appear the patient has undergone a trial of indomethacin. If there is documented evidence the patient has failed indomethacin, a trial of Botox therapy would be medically appropriate as continued attempts at standard therapies are not likely to be successful. Based upon the information set forth above, I have determined that if it is documented that the patient has failed a trial of indomethacin, the requested therapy 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 17-year-old female with intractable headaches (migraine and possibly muscle tension type) and comorbid depression. The extensive notes from her neurologist reveal that the appropriate diagnostic tests were performed to determine the cause of her headaches. The test results were negative. The notes indicate that the patient was prescribed a large number of different medications and treatment modalities, to no avail. It has been recommended that the patient undergo Botox injections. The Health Plan has denied coverage for Botox on the basis it is considered investigational for patients such as this patient.Although Botox is not yet considered a standard therapy for the treatment of headache, there is a growing body of significant evidence demonstrating its efficacy in the treatment of intractable migraines. Many patients with migraines have benefited from Botox. In the case of this patient the submitted records indicate she has failed to respond to many appropriate medications. Since multiple medications have failed to provide her with relief, Botox therapy is likely to provide a better clinical outcome than further trials of standard therapies. Therefore, I have determined that the requested therapy 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.