Emgality denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Emgality. Many patients with migraines can benefit from preventive migraine treatment. While there are no strict definitions for the precise frequency or duration of migraine headaches that would prompt preventive therapy, more than four headaches per month or headaches that last longer than 12 hours are generally considered reasonable thresholds. The goals of preventive therapy are to reduce the frequency, severity, and duration of headaches, to improve treatment responsiveness of acute attacks, and to improve overall function or reduce the risk of neurologic impairment.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Emgality. According to the American Headache Society (AHS), there are four injectable preventive therapies available for the treatment of migraine including Botox and three monoclonal antibody (mAb) targeting calcitonin gene-related peptide (CGRP) agents, such as Emgality, or targeting the CGRP receptor. Emgality is U.S. Food and Drug Administration (FDA) approved for episodic and chronic migraine. Emgality 120 mg is for monthly use following an initial loading dose of 240 mg. In this case, the patient has a history of chronic migraines that have not adequately responded to oral preventative medications. The use of Botox has been effective in reducing the number of headache days though her headaches have recently become more severe.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The enrollee has requested authorization and coverage for Emgality 120 mg/ml auto injector.The International Classification of Headache Disorders defines chronic migraine as “headache occurring on 15 or more days per month for more than three months, which, on at least eight days per month, has the features of migraine headache.” (Headache Classification Committee of the International Headache Society). Prophylactic treatments should be initiated in patients with chronic migraine. Evidence-based prophylactic medications for episodic migraine are often used for chronic migraine. These agents include topiramate, gabapentin, tizanidine, fluoxetine, amitriptyline, and valproate.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Emgality. The International Headache Society (IHS) defines chronic migraine as when a patient experiences 15 or more headaches per month for three or more months, with eight or more headaches per month meeting the criteria for migraine with and without aura, or that respond to migraine-specific treatment. Every chronic migraine treatment plan should include both prophylactic treatment for reduction of headache days and severity of headaches and as-needed treatment for exacerbations. Prophylactic treatments should be initiated in patients with chronic migraine. Evidence-based prophylactic medications for episodic migraine including topiramate, gabapentin, tizanidine, fluoxetine, amitriptyline, and valproate are often used to treat chronic migraine.

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 Emgality, then check the rights and deadlines that apply to your plan.