Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1:  The patient is a 48-year-old female who suffers from chronic migraine headaches, which began to increase in frequency and severity in spite of on-going treatment. She is followed by a neurologist and has been treated with a number of medications, including triptans, which have only been partially effective and have produced side effects. The patient began treatment with Botox injections and reports a reduction in the frequency of her headache episodes. She underwent a complete neurological evaluation which revealed no abnormalities. Of note, the patient is also receiving spironolactone, a drug that occasionally exacerbates headaches. The Health Plan has denied the patients request for authorization of continued Botox injections citing the experimental nature of the therapy.The long-term safety and efficacy of Botox for the treatment of migraine headaches has not been clearly established. There is insufficient scientific data available to adequately evaluate the role of Botox in migraine headache relief. Additionally, the submitted clinical evidence does not demonstrate the patient has exhausted all conservative treatment modalities. Therefore, I have determined that the therapy at issue 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 2:  The patient is a 48-year-old woman with long-standing migraine-type headaches. She reports prior treatment with beta blockers, nortriptyline, Celexa, Depakote, Neurontin and Topamax was ineffective. The patient consulted with a neurologist who reviewed the history of her headache management and recommended Botox therapy. The patient has demonstrated that Botox therapy has decreased the frequency and severity of her headache activity through the maintenance of a headache diary. The Health Plan considers Botox therapy experimental/investigational, and denied the patients request for authorization and coverage.It is apparent from the record the patient had had adequate trials of all major categories of preventative therapy commonly used in the treatment of migraine-type headaches. Botox, under these circumstances is appropriate. Botox therapy has been studied in double-blinded placebo-controlled trials with proven efficacy and the therapy is no longer considered experimental or investigational for patients such as this one. For these reasons, 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.Physician 3:  This patient is a 48-year-old female with chronic intermittent migraine who failed treatment with multiple abortive and prophylactic medications. She has responded well to Botox therapy with a 60-70% reduction in headache frequency. The Health Plan denied the patients request for continued authorization of Botox based upon their determination that the therapy is investigational.Botox is an accepted treatment for various types of headaches in patients who have failed standard therapies. It is generally appropriate for the patient to have tried and failed three to four prophylactic agents and various abortive medications prior to a trial of Botox. The evidence in this case indicates the patient has failed to respond to conventional medical management. As such, Botox therapy is medically indicated and has been shown to be effective for the patient.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.