Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Frequent migraine headaches.

Treatment: botulinum toxin A per unit (botox injection) (code J0585).

The insurer denied coverage for botulinum toxin A per unit (botox injection) (code J0585).

The denial is overturned.
 
This is a teenage female who has a diagnosis of frequent migraine headaches. The treating provider has requested therapy with botulinum toxin A per unit (botox injection) (code J0585), which is under review.

Although the health care plan did act reasonably and with sound medical judgment it was not in the best interest of the patient. 

While Botox is not Food and Drug Administration (FDA)-approved for use in children less than 18 years old for headaches/migraines; Botulinum toxin A per unit (botox injection) (code J0585) is considered medically necessary for this patient.

The use of both calcitonin gene-related peptide (CRGP) antagonists and Botox are off-label in patients this age, and the combination is unknown regarding safety and efficiency. Although there is no contraindication to their use in that medications can be used in combination and off-label, there is insufficient medical literature to support their use in this age. The provided literature does provide support that the combination could be more effective and thus warrants approval.

Therefore, the request for botulinum toxin A per unit (botox injection) (code J0585) is medically necessary and is approved. 

"Pharmacological treatment of chronic migraine (CM) is based on two pillars: abortive treatment of acute migraine attacks and prophylactic treatment. The substances most commonly used for the abortion of migraine attacks are nonsteroidal anti-inflammatory drugs (NSAIDs) and triptanes. There is good clinical evidence, that both substance groups are effective in the abortive treatment of acute migraine attacks. On the other hand, it has been shown, that both NSAIDs and triptanes may lead to medication overuse headaches. Therefore, the challenge is to restrict migraine-abortive substances to the least amount necessary. This observation highlights the special importance of prophylactic treatment in patients with CM. Generally, prophylactic medication can be given as soon as the diagnosis of CM is established. The choice of which substance is applied should be made with regard to the patient's comorbidities"(Escher CM, et al 2017)

"Botulinum toxin type A and human monoclonal antibodies targeting calcitonin gene-related peptide receptor were beneficial in reducing monthly migraine days and >=(greater than or equal) 50% (percent) response rate, but uncertainties remained for Botulinum toxin type A regarding response rate. The effect size for human monoclonal antibodies was greater with a relatively lower drop-out rate. High-quality randomized trials are required to evaluate the effect of topiramate in chronic migraine patients with medication overuse headache."(Giri S, et al 2023)

"For the prevention of chronic migraine, several pharmacological therapies are available, including oral medications, botulinum toxin type A, and the newly approved monoclonal antibodies targeting calcitonin gene-related peptide or its receptor. However, monotherapy does not yield benefits in some affected individuals, which raises the question of whether dual therapy with monoclonal antibodies and botulinum toxin type A hold promise in patients with treatment-resistant chronic migraine.

Preclinical data suggest that anti-calcitonin gene-related peptide monoclonal antibodies and botulinum toxin type A have synergistic effects within the trigeminovascular system. Of note, findings indicate that fremanezumab - an antibody targeting the calcitonin gene-related peptide - mainly prevents the activation of A-fibers, whereas botulinum toxin type A prevents the activation of C-fibers."(Pellesi L, et al 2020)        

Based on the above, the insurer's denial must be overturned. 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 botulinum toxin A per unit (botox injection) (code J0585) is substantiated.