Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Migraine Headaches

Treatment: Botox (onabotulinumtoxin A) Injection

The insurer denied coverage for Botox (onabotulinumtoxin A) Injection

The denial is overturned

This case involves a patient with a request for Botox (onabotulinumtoxin A) Injection.

The patient was seen and was referred for neurologic consultation for headaches. The patent has a history of cystic fibrosis and headaches since a young age which were nondisabling, occurring once every 2-3 months and would improve with acetaminophen. The patient then developed more severe headaches around the age of 20. The patient reported worsening headaches of more than 15 days a month that were disabling in nature. The headaches were associated with photophobia, phonophobia, nausea and emesis. The pain was located primarily at the forehead between her eyebrows. Current acute medication includes eletriptan, ondansetron, and acetaminophen. Other medication includes mirtazapine, diphenhydramine, Diflucan, alprazolam and tobramycin. The patient was not taking any preventive medications for their migraine headaches. Prior headache medications include: Sumatriptan, Naproxen, Excedrin, ibuprofen, intravenous (IV) prochlorperazine, IV ketorolac, and venlafaxine. The provider recommended starting Botox (onabotulinumtoxin A) Injection during the visit.

According to the U.S Food and Drug Administration, Botox is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for prophylaxis of headaches in adult patients with chronic migraine (>=15 days per month with headache lasting 4 hours a day or longer).  Contraindications include hypersensitivity to botulinum toxin, infection at the proposed injection site, and urinary tract infection or retention for intradetrusor injection.  The medication should be used with caution in patients with compromised respiratory function.  Per the cited references, there is risk of fetal toxicity with topiramate and Depakote.  There is risk of fetal harm during 2nd and 3rd trimester with candesartan use.  Amitriptyline, due to its alpha-adrenergic receptor blockade, can cause orthostatic hypotension, dizziness, sedation.  Metoprolol is contraindicated in patients with sick sinus syndrome, second or third-degree heart block (in the absence of pacemaker), decompensated heart failure, hypotension, and documented hypersensitivity to the drug or components. Since the main effect of propranolol is to decrease heart rate, it is contraindicated in those who have bradycardia (less than 60 beats per minute).  Venlafaxine may cause serotonin syndrome.  

In this case, the patient was recommended for Botox injections for migraine prevention.  The patient had 15+ migraine days per month.  A prior request for Botox was denied as the patient did not have poor response or Food and Drug Administration contraindication to the preferred formulary medications.  However, the documentation detailed that the patient had chronic migraines that have been refractory to other treatments.  The documentation supports that the patient has contraindications to the formulary recommended medications.  The patient is of childbearing age and there are several medications on the formulary that may cause fetal toxicity including Topamax, Depakote, and candesartan.  The patient could not utilize metoprolol, propranolol, or candesartan due to baseline low blood pressure.  Amitriptyline and venlafaxine could not be used due to risk of serotonin syndrome.  

Based on the above, the insurer's denial must be reversed. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Botox (onabotulinumtoxin A) Injection is substantiated.