Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1The patient is a 64-year-old woman who has been experiencing headaches, cervical muscle spasms, occipital neuralgia, and cervical pain due to cervical spine degenerative disc disease. A number of treatment modalities have been tried without providing satisfactory relief.  Injections of botulinum toxin have provided effective relief of pain and muscle spasms. The patient wishes to continue treatment with botulinum toxin. The consultations with her pain specialist indicate that a variety of medications and treatments have been tried since 1/5/04 without significant relief. The patient reports that injections of botulinum toxin provide relief for two months. She wishes to receive additional botulinum toxin injections. The Health Plan has denied coverage for the requested therapy on the basis it is considered investigational for treatment of patients such as this patient.The medical literature is replete with cases involving patients such as this patient who have been successfully treated with botulinum toxin injections. However, the therapy remains unproven and has not yet been approved by the Food and Drug Administration for treatment of patients such as this patient. Many patients seek surgery for symptomatic cervical degenerative disease, in the hope of obtaining relief of pain muscle spasm and occipital neuralgia. Surgery is a poor and frequently devastating option for the treatment of cervical degenerative disease. Botulinum toxin injections are generally safe and well tolerated and provide relief of symptoms. As such, continued use of botulinum toxin is likely to be more effective than any other available 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.Physician 2The patient is a 64-year-old woman with at least a two-year history of cephalgia related to spasm, occipital neuralgia, migraines, and cervical spine pain related to cervical degenerative disc disease. The patient has tried and failed multiple treatment modalities, including pain medication, muscle relaxants, cervical epidural steroid injections, and occipital nerve blocks. The patient has also received four trigger point injections with temporary pain relief, ranging from one week to three weeks. Additionally, the patient received two botulinum toxin injections, on 6/10/04 and 6/29/04, with pain relief lasting two weeks and two months respectively. She is seeking authorization for further botulinum toxin injections. The Health Plan has denied the patients request on the basis the requested therapy is considered investigational for treatment of the patients medical condition.Review of the submitted clinical evidence indicates the patients cephalgia does not appear to respond consistently to the numerous treatment modalities attempted, including botulinum toxin injections. The duration of pain relief from each botulinum toxin injection does not appear to last long enough to warrant continued courses of treatment with botulinum toxin injections. Thus, there is not sufficient evidence to support the continued use of botulinum toxin in the treatment of this patient. 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 64-year-old woman with facial suboccipital pain for two years. The records show she previously responded quite well to occipital nerve block and trigger point injections with nearly 100% relief of pain, but it was short lived. She subsequently received botulinum toxin injections with immediate relief of pain, which recurred within two weeks, but did improve after a second injection. The submitted records do not support a diagnosis of migraine, cervical dystonia, or occipital neuralgia. It does not appear that the patient has seen a neurologist. She currently has ongoing pain and has requested authorization for continued botulinum toxin injections. The Health Plan has denied the request on the basis that botulinum toxin is experimental for treatment of patients such as this patient.The submitted documentation does not provide sufficient evidence that the patient had a true physiologic response to previous botulinum toxin injections given the report of immediate relief of pain, with a recurrence in two weeks. The patient did respond to previous occipital nerve block and trigger point injections though also with recurrence within two weeks. Based upon the submitted records, the patient has not undergone adequate trials of standard medical treatments. Usual treatments might include a trial of higher dose Zanaflex, amitriptyline, Neurontin, and Flexeril. Given the patients response to previous botulinum toxin injections, she is likely to experience superior results with standard therapies.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.