Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 63-year-old female who experiences headaches and possibly has comorbid depression. The patients provider indicates the patient has failed treatment with Pamelor, Midrin, Paxil, Effexor, Tylenol and ibuprofen. The patient wishes to pursue treatment with Botox. The Health Plan has denied coverage for the requested therapy on the basis it is considered investigational.The documentation provided suggests the patient has muscle tension type headaches rather than migraine headaches. In addition, it appears the patient has comorbid depression. In cases such at this, patients receive the most benefit from prophylactic headache medications such as Depakote, calcium channel blockers or Topamax combined with Paxil for depression. There are a number of effective and well tolerated medications for the treatment of muscle tension headaches. Botox therapy is not likely to result in a superior clinical outcome over standard medications. 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 2: The patient is a 63-year-old woman with a diagnosis of chronic tension type headaches. When her neurologist last saw her in October 2004, the patient had achieved headache control with a MIDAS (migraine disability assessment score) of 7, indicating minimal disability, and was responding to Pamelor. Additionally, the patient indicated she experienced only 5 headaches in 90 days.  Pamelor was discontinued in November 2004. There is no recent record of chronic daily headaches. A request has now been made for authorization and coverage of Botox injections. The Health Plan has denied this request indicating the efficacy of Botox for the treatment of the patients condition has not been established.Upon review of the submitted records it appears the patient has chronic tension type headaches. Her headaches had been controlled and were minimally disabling with some worsening in November 2004, but no follow-up. If, in fact, the patient does have migraines rather than tension type headaches, there is no evidence the patient has tried any of the usual chronic migraine medications such as Topamax, Depakote or beta-blockers. While recent evidence suggests Botox has a role in the treatment of chronic migraine, studies show no positive effects versus placebo in chronic tension type headaches. The patient should follow-up with her neurologist if her headaches have changed character and worsened, as she will likely need re-evaluation with imaging. 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 3: The patient is a 63-year-old female with diagnoses of chronic daily headaches, chronic tension headaches and fibromyalgia syndrome. She has had daily headaches for many years now. She has been tried on several medications including amitriptyline and various anti-depressants. There is no mention in the provided records of standard prophylactic medication use such as beta-blockers, valproate or topiramate. The patients neurological exam and brain imaging studies are normal. She has not been seen by her neurologist in one year.The patient has requested authorization and coverage for Botox therapy. The Health Plan has denied this request citing a lack of peer-reviewed evidence demonstrating the efficacy of Botox in this clinical setting.Review of the submitted clinical information reveals the patient has not yet received the benefit of approved prophylactic therapy with medications such as topiramate, valproate or beta-blockers. While she carries diagnoses of fibromyalgia, chronic daily headache, and chronic tension headache, there is no firm diagnosis of migraine mentioned in the submitted records. Furthermore, studies on Botox therapy demonstrate conflicting results and a very large placebo effect. Further studies are needed to determine if Botox is ultimately going to be useful in the treatment of chronic tension headaches. Moreover, the efficacy of Botox injections for the treatment of fibromyalgia syndrome remains unproven. 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.