Ajovy denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Ajovy. As noted in the records provided for review, this patient presents with a history of chronic daily migraines which are adversely impacting her ability to perform her activities of daily living and her quality of life. The provider noted that the patient has tried and failed two classes of abortive medications and prophylactic medications. According to the provider’s notes, the patient has been managing her chronic migraines with a combination of Botox injections, Ajovy injections, and oral Ubrelvy. The patient’s provider has recommended continued treatment with Ajovy to prevent chronic migraines given its current success.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient requested Ajovy autoinjector for treatment of migraines. Current headache expert recommendations indicate “if the medical risk from a trial of two or more established preventive treatments outweighs the possible benefits, an attestation by the prescribing clinician should take precedence over prospectively defined plans and allow patients access to whatever treatment(s) are deemed medically necessary”.

Where the denial was upheld

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Ajovy autoinjector pen. Ajovy is a monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) for the prevention of episodic or chronic migraine in adult patients. Per the American Headache Society (AHS), calcitonin gene‐related peptide (CGRP) monoclonal antibodies, such as Ajovy, have demonstrated efficacy, safety, and patient tolerability, for the prevention and treatment of episodic and chronic migraine in randomized placebo‐controlled trials. The AHS reported that CGRP monoclonal antibodies may achieve rapid treatment effects over a period of days to weeks and are effective in patients who have failed prior preventive treatment, as well as those who are on concurrent oral preventive treatment.

Findings: The physician reviewer found that The patient has requested authorization and coverage for Ajovy injections. As noted in the medical literature and by the American Headache Society (AHS), Ajovy injections are indicated for patients who have demonstrated failure of at least two medications such as topiramate, divalproex sodium, a beta blocker, a tricyclic antidepressant, or a serotonin norepinephrine reuptake inhibitor. Goadsby and colleagues reported that their study demonstrated the long-term safety, tolerability, and efficacy of Ajovy in the management of patients with migraine. However, the records provided for review do not adequately document failure of two or more medications from this list of preventative treatments for migraines. Thus, the patient does not meet the criteria for treatment with a calcitonin gene related peptide (CGRP) monoclonal antibody.

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