Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for 155 units of Botox injected into 31 specific sites according to the Botox protocol.The issue to be decided is whether the requested Botox injections,155 units injected into 31 specific sites according to the Botox protocol, are medically necessary for treatment of the patients medical condition.OnabotulinumtoxinA (Botox) has been approved for the treatment of chronic migraine. The lack of need for slow dose escalation, the rapid onset of therapeutic benefits, and the favorable tolerability profiles are advantages that injectable therapies have in common (American Headache Society). In 2016, the American Academy of Neurology updated its 2008 guidelines on using botulinum neurotoxin for brain disorders. Botulinum toxin A is now recommended for the management of chronic migraine, defined as attacks lasting four or more hours on at least 15 days each month for three months. Frampton and Silberstein performed a review of the current evidence of onabotulinumtoxinA (in the prevention of chronic migraine. The authors reported, The totality of evidence from clinical trials and real-world studies indicates that onabotulinumtoxinA is an effective and generally well-tolerated option for the prevention of chronic migraines that may be particularly useful for patients who have previously failed to respond to or are intolerant of commonly prescribed oral prophylactics. (Frampton, J. and Silberstein, S.). OnabotulinumtoxinA was originally approved on the basis of pooled data from two phase III studies. In these studies, injection of up to five cycles of onabotulinumtoxinA at 12-week intervals was generally well-tolerated and effective in producing statistically significant and clinically meaningful improvements in headache symptoms, acute headache pain medication usage, headache impact and health-related quality of life in adults with chronic migraine (Frampton, J. and Silberstein, S.). Per the Botox prescribing information, the recommended dose for treating chronic migraine is 155 units administered intramuscularly using a sterile 30-gauge, 0.5 inch needle as 0.1 mL (5 units) injections per each site. Injections should be divided across seven specific head/neck muscle areas (total of 31 different sites). (U.S. Food and Drug Administration). In this case, the patient has a history of chronic migraines and has not responded to multiple oral preventive medications. Based on the American Academy of Neurology guideline and study noted above, the patient is a candidate for prophylactic treatment with botulinum toxin therapy. The dosage of 155 units injected into 31 sites is based on clinical trials and is the standard dosage currently recommended per the Botox prescribing information. Therefore, 155 units of Botox injected into 31 specific sites according to the Botox protocol are medically necessary for the treatment of the patients medical condition.Final Result: The reviewer determined that the requested service is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in neurology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.