Onabotulinumtoxina denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee’s parent has requested authorization and coverage for Botox injections (200 units every 12 weeks). Medical literatures describe botulinum toxin as a potent muscle relaxant that has been found to have analgesic effects in patients with a variety of pain syndromes. The authors further state, “Both in vitro and in vivo studies showed the ability of the toxin to block the release of pain neurotransmitters, such as substance P, glutamate, and calcitonin gene-related peptide. The effect of the toxin, and specifically of one of its serotypes, botulinum neurotoxin type A, on headaches, has been extensively studied. This serotype is available in the United States in three forms, including as onabotulinumtoxinA.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Botox injections.The American Headache Society (AHS) recommends preventive treatment when attacks significantly interfere with patients’ daily routines despite acute treatment; a patient has four or more attacks per month; or a patient has contraindication to, failure, or overuse of acute treatment. Currently, Botox (onabotulinumtoxinA) is approved by the U.S. Food and Drug Administration for the treatment of chronic migraines. In 2016, the American Academy of Neurology (AAN) updated its 2008 guidelines on using botulinum neurotoxin for brain disorders. OnabotulinumtoxinA 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.

Where the denial was upheld

Nature of Statutory Criteria/ Case Summary: The enrollee is requesting authorization and coverage for onabotulinumtoxinA (Botox) in conjunction with Aimovig. The enrollee has chronic migraines, intractable to multiple medications. The enrollee reported partial response to the anti-calcitonin gene-related peptide (CGRP), Aimovig. Enrollee began Aimovig at a dosage of 70mg, for a total of seven injections. The dosage was then increased to 140mg, which reduced headache frequency to two per week from an average of four per week. The enrollee has failed traditional migraine preventative options, including amitriptyline, Depakote, propranolol, venlafaxine, topiramate, gabapentin, and verapamil. Headache frequency is currently at about five per month. The neurologist recommended the inclusion of Botox as an adjunctive therapy to Aimovig in order to provide a more aggressive treatment.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Botox injections every 90 days. The American Headache Society (AHS) recommends preventive treatment when attacks significantly interfere with patients’ daily routines despite acute treatment, when a patient has four or more attacks per month, or when a patient has contraindication to, failure, or overuse of acute treatment. The U.S. Food and Drug Administration (FDA) approves the use of onabotulinumtoxinA (Botox) for the treatment of chronic migraine. Injectable therapies do not require slow dose escalation, allow for the rapid onset of therapeutic benefits, and have favorable tolerability profiles.

Put this treatment in the complete diagnosis-and-drug graph, with the migraine-only denominator disclosed separately: migraine, CGRP drug and Botox denial evidence guide.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Onabotulinumtoxina, then check the rights and deadlines that apply to your plan.