Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer # 2:

This is a female patient with a history of chronic migraines. She presented to her treating physician's office with complaints of headache, bilateral ocular pressure, bilateral forehead pressure, nasal congestion, and postnasal drip. An anterior rhinoscopy was performed that revealed a deviated septum. She had been given Dyazide and Imitrex 100 mg after the onset of the migraine; no improvement in her symptoms was noted. It was recommended she be treated with onabotulinum toxin A injections. 

The patient suffers from chronic migraines and scientific evidence in peer-reviewed literature supports an improvement in the frequency of chronic migraines.

Per Escher CM, Paracka L, Dressler D, Kollewe K. (2017), "Chronic migraine (CM) is a severely disabling neurological condition characterized by episodes of pulsating unilateral or bilateral headache. The United States Food and Drug Administration (FDA) approved onabotulinumtoxinA (Botox) for the prophylactic treatment of CM in 2010. It has been shown that onabotulinumtoxinA is effective in the reduction of headache frequency and severity in patients with CM. Treatment is well tolerated by the patients. This review reports on the history of botulinum neurotoxin (BoNT) in CM and presents the current clinical evidence for the use of onabotulinumtoxinA in the treatment of CM."

Per Frampton JE, Silberstein S. (2018), "An intramuscular formulation of onabotulinumtoxinA (onabotA; Botox) is currently the only therapy specifically approved for the prevention of headaches in adults with chronic migraine (CM) in the EU and North America."

Bruloy et al indicated that "This meta-analysis reveals that botulinum toxin type A injections are superior to placebo for chronic migraines after 3 months of therapy."              

In 10/2010, the US Food and Drug Administration (FDA) approved onabotulinumtoxinA (Botox; Allergan Inc) for headache prophylaxis in patients with adult chronic migraines who suffer headaches on 15 or more days per month, each lasting more than 4 hours.     

The patient is a good candidate for J0585 Injection, onabotulinum toxin A, 1 unit for chronic migraines.  She has chronic migraines and has failed medical therapy. Chronic migraine is defined as 15 or more days of headache per month, at least eight of those days being migraine. People with episodic migraines have fewer than 15 headache days per month. Botulinum toxin type A has been FDA approved for chronic migraine treatment.     

Botox is approved as a preventative medication for those who have failed oral medications. Therefore, the J0585 Injection, onabotulinum toxin A, 1 unit for chronic migraines is the best available treatment for this patient at this time.  She has failed oral medications and Botox is approved as a preventative medication for those who have failed oral medications to treat chronic migraines.  Therefore, it is likely to be more beneficial for this patient than any standard treatment/procedures.                                                  

The carrier's denial of J0585 Injection, onabotulinum toxin A, 1 unit for chronic migraines should be reversed.