Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1The patient is a 17-year-old female with migraine headaches. The patient has been tried on multiple medications without lasting relief. The patient reports that her migraines have improved after treatment with Botox therapy. She wishes to obtain authorization for additional Botox therapy. The Health Plan has denied the patients request on the basis that Botox therapy is considered experimental for treatment of migraines headaches. The use of Botox in the treatment of migraines is considered off-label at this time and is not the standard of care. Limited scientific data are available for adequate evaluation. There are no prospective randomized studies documenting the efficacy of this therapy. The literature is limited with only small studies and case reports. 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 2The patient is a 17-year-old female with debilitating migraine headaches. According to the submitted records the patient has been treated with multiple medications (for acute episodes and prophylaxis) with no relief. Botox injections have provided relief. The patient has requested authorization for additional Botox injections. The Health Plan has denied the patients request indicating that Botox therapy is considered investigational.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. Similarly, Botox has been beneficial for this patient and her records indicate that there is little likelihood that other available treatments would be beneficial given that she has failed to respond to a long list of appropriate medications. 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. However, the patient should be reevaluated in 12 months to ascertain whether Botox injections are still necessary since many patients with migraine headaches improve once the chronic cycle is interrupted.Physician 3The patient is a 17-year-old female with a history of severe migraine headaches since 2000. The submitted records indicate the patient has been tried on a total of 22 different medications, including both abortive and prophylactic medications, without significant relief from her headaches. The patient received Botox injections in January 2002 and July 2003 and experienced significant relief, which allowed her to participate in normal school activities. The patient has requested authorization for further Botox injections. The Health Plan has denied the patients request indicating that Botox injections are considered investigational.The current body of scientific evidence supports the use of botulinum toxin as a last resort for patients with intractable or recalcitrant migraines and chronic daily headaches. In the case of this patient, she either did not respond or was unable to tolerate any of the 22 medications she had been tried on. She has had two treatments using Botox and responded positively to both treatments. Given the patients favorable response to Botox and the failure of other therapy, it is likely that further Botox therapy will be of greater benefit to the patient than additional standard therapy. 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.