Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Physician 1: The patient is a 34-year-old female with chronic headache and neck pain for two years after a motor vehicle accident. She has been followed by a pain management specialist who has treated her with narcotics, muscle relaxants, trigger point injections, occipital nerve blocks and botulinum toxin type B (Myobloc) injections. The patient has continued to experience moderate to severe pain. The Myobloc injections on several occasions resulted in modest and short-lasting pain relief. The patient wishes to receive additional Myobloc injections. The Health Plan has denied coverage for Myobloc on the basis it is considered investigational for treatment of migraine headaches.There are very limited studies involving Myobloc in the treatment of headache or neck pain with no placebo-controlled studies. The documentation provided indicates the patient responds to Myobloc for only six to eight weeks. The patients headaches suggest migraine and the patient is receiving no preventive therapy and inadequate triptan therapy. Furthermore, the patient appears to also respond quite effectively to occipital nerve block, though for a shorter period of time. For these reasons, 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 34-year-old female with neck, head, and lumbosacral pain of two years duration most likely resulting from a motor vehicle accident. The patient has been followed by a pain management specialist who has been treating her with medications including narcotics, Zanaflex, and epidural injections without success. Botulinum toxin type B injections appear to have provided some modicum of relief and the patient wishes to continue its use. The Health Plan has denied coverage for botulinum toxin type B citing a lack of established efficacy for treatment of migraine headaches.Review of the submitted information demonstrates the patient is most likely experiencing muscle tension type headaches. Such headaches are best treated by relaxation techniques, acupuncture, exercise, and mild non-steroidal anti-inflammatory medications. Upon review of the medical literature, there is not sufficient evidence of the safety and efficacy of botulinum toxin type B for treatment of muscle tension type headaches. The patient is likely to experience greater benefit from standard treatment modalities. Therefore, I have determined the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Accordingly, the Health Plans denial should be upheld.Physician 3: The patient is a 34-year-old female with chronic neck and head pain after a motor vehicle accident. Her diagnosis is listed as occipital nerve headaches. This symptom description in April 2004 would suggest possible migraine. The effect of preventive medications such as Neurontin is not included in the materials provided. Nor is there evidence the dose of Neurontin has been titrated to optimal. Exam description suggests there may also be myofacial pain and trigger injections have been performed as well.The patient has received several injections of Myobloc (botulinum toxin type B) at relatively low doses/high dilution and reported experiencing immediate relief. The Health Plan has denied coverage for botulinum toxin type B citing a lack of established efficacy for treatment of migraine headaches.The patient has diagnoses of headache, muscle spasm and occipital neuralgia. Botox (botulinum toxin type A) has substantiated evidence-showing benefit for chronic migraine, and cervicogenic/myofacial pain and is approved for cervical dystonia. Botulinum toxin type B is a different protein complex with a different side effect profile, shorter duration of outcome, and very little data to suggest efficacy for headaches, and in fact, none for occipital neuralgia. Review of the medical literature reveals no support for use of botulinum toxin type B in this patient. The report of immediate relief upon injection suggests a possible needling effect since botulinum neurotoxins takes several days to start to work, and typically show peak effect in one to two weeks. Based upon the information provided, the patients diagnosis remains unclear and details regarding her attempts at standard therapies are unknown. There is insufficient evidence botulinum toxin type B is superior to standard therapies for treatment of this patients condition. Accordingly, 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.