Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1The patient is a 47-year-old woman who has experienced severe headaches for the past 20 years. She has been treated by a neurologist with a variety of prophylactic and acute medications that have only been partially helpful. The patients neurologist has suggested the use of Botox injections. The Health Plan has denied authorization for Botox therapy on the basis that it is considered experimental. There is limited scientific data available for adequate evaluation of the use of Botox for headache relief. Further critical studies of Botox for the treatment of mixed headache patterns await approval by the Food and Drug Administration. In the case of this patient, it does not appear that standard therapy has been exhausted. Though the patients recent regimen of Vioxx prophylactically with Amerge or Imitrex for breakthrough headaches has not been completely effective, other pharmacologic combinations are available. Given that the patient has not exhausted conservative treatment and due to the lack of long-term data on Botox therapy, 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 47-year-old female with over a 20-year history of migraines. Her headaches have been difficult to control. The patient has been on a regimen consisting of prophylactic use of Vioxx with Amerge or Imitrex for breakthrough headaches. The patient is requesting Botox therapy to potentially decrease the amount of oral medications that she currently requires. The Health Plan had denied authorization for Botox therapy on the basis that it is considered experimental.Although the patients migraine headaches have been difficult to control thus requiring multiple drug regimens, there is not yet sufficient scientific literature to establish the efficacy of Botox therapy over standard therapy for migraine headaches. The safety and efficacy of the long-term use of Botox therapy has not been reported as yet. As such, it cannot yet be determined whether Botox is likely to be of greater benefit than standard prophylactic therapy. Therefore, 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 3The patient is a 47-year-old woman with a long-standing history of migraine headache. She has had frequent headaches of a throbbing quality with associated nausea, photophobia, phonophobia, and smell sensitivity. At times the headaches have been incapacitating. The submitted records indicate the patient has tried and essentially failed numerous prophylactic medications including all of the Food and Drug Administration approved headache prophylactic medications and a number of other off-label medications. The patients recent status appeared unchanged with daily Vioxx usage, and Amerge or Imitrex. The patients provider has recommended the use of Botox injections. The Health Plan has determined that the requested therapy is experimental.The patient clearly has a diagnosis of migraine without aura. She continues to require treatment with Vioxx 50mg. The chronic use of this dose of Vioxx is not well studied but does potentially pose risks of hypertension and renal disease. Other prophylactic medications have failed. Despite all measures, the patient is still experiencing two to three migraines per month. Though the data on the use of Botox therapy is not perfect, there is strong support for the trial of Botox therapy in cases of refractory migraine that has not responded to conventional treatment. In light of this patients history of various medication trials, there is sufficient probability of positive results to warrant the use of Botox injections. Based upon the information set forth above, 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.