Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Migraine headaches.
Treatment: Emgality 120 milligrams per milliliter (mg/ml) subcutaneous solution auto-injector (SC SOAJ).

The insurer denied coverage for Emgality 120 milligrams per milliliter (mg/ml) sub cutaneous solution auto-injector (SC SOAJ).
The denial is overturned.

The patient is a female with a history of hypothyroidism, migraines, polycystic ovarian syndrome, and vitiligo. The letter by the doctor noted that the patient suffered from migraine headaches and was having more than 15 days of headaches. He noted that the patient failed beta-blockers, amitriptyline, nortriptyline, topiramate, and other antidepressants. He noted that Aimovig is not a good option for the patient as it can cause constipation and aggravate the patient's gastrointestinal (GI) distress and for this reason Emgality was chosen.

Based on the information provided by the treating provider, Emgality is medically necessary as the patient failed multiple preventative medications and is not a candidate for Aimovig due to her GI issues.      

Emgality 120 milligrams per milliliter (mg/ml) sub cutaneous solution auto-injector (SC SOAJ) is considered medically necessary for this patient.

The patient has chronic migraine and failed numerous medications and is not a candidate for Aimovig which makes Emgality medically necessary.

"Both doses of galcanezumab were superior to placebo in reducing the number of monthly headache days . Galcanezumab appears efficacious, safe, and well tolerated for the preventive treatment of chronic migraine." (Detke, H. C. et al. 2018).

"This leads to trigeminocervical complex (TCC) activation and a headache episode, modulated by calcitonin gene-related peptide (CGRP). Galcanezumab (Emgality) is a monoclonal antibody targeting CGRP that is given in a monthly injection for the prevention of migraines. Its safety was previously shown in phase 1 and 2 trials, and recent phase 3 trials showed efficacy, with up to 50 percent (%) reduction in monthly migraine days and improved functional capacity in migraineurs. Studies show that the drug is well tolerated and safe. Migraine headache is a common neurological syndrome that causes great pain and suffering. Treatment options today are limited. Galcanezumab does not prevent migraines, but it is effective in decreasing their frequency and length. It is also much better tolerated than the currently existing therapies. While it is unlikely to provide monotherapy for migraines, it is a novel therapy that may be added for cases of severe or frequent migraines." (Urits, I. et al. 2020).

"Galcanezumab was superior to placebo in the preventive treatment of migraine and was safe and well tolerated in patients for whom multiple previous standard-of-care preventive treatments had failed. Galcanezumab might represent an important treatment option for patients who have not benefited from or tolerated previous standard-of-care treatments." (Urits, I. et al. 2020).

"CGRP receptor antagonists and monoclonal antibodies against CGRP and its receptor are medications used in the management and treatment of migraine, which is the sixth-highest cause worldwide of years lost due to disability as per the Global Burden of Disease Study (2013).

Currently, Food and Drug Administration (FDA)-approved drugs acting on the CGRP, or its receptor, are those used in the treatment or prophylaxis of migraine. This group includes monoclonal antibodies (erenumab, eptinezumab, galcanezumab, fremanezumab) against the CGRP receptor and CGRP receptor antagonists (rimegepant and ubrogepant). In addition, Atogepant and vazegepant are other receptor antagonists undergoing clinical trials and are yet to receive FDA approval." (Rashid, A., & Manghi, A. 2021).                                                         

The insurer's denial of coverage for Emgality 120 mg/ml SC SOAJ is overturned. Medical Necessity is substantiated.