Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Migraine headaches

Treatment: Qulipta 60 milligram (mg) tablets

The insurer denied coverage for Qulipta 60 milligram (mg) tablets

The denial is upheld

The patient is a teenager diagnosed with tension type headaches and migraines without aura not intractable without status migrainous. The patient presented for neurology consultation for recurrent headaches. The patient reported headaches were described as feeling of pressure located in the temporal or occiput. The patient reports that the more severe throbbing headaches probably occur once or twice per week and are sometimes associated with photophobia and nausea. Headaches may last up to hours. The patient has used Excedrin Migraine when needed for severe headaches. The headaches improved after sleep. Severe headaches seem to happen more frequently around the menstrual period. The patient has also been taking magnesium supplements which has noted possible improvement in the severity of the headaches. The encounter diagnosis was tension type headache unspecified. Neurological examination was normal. Treatment plan: preventative treatment medication prescribed sertraline 25 milligrams (mg) a day, topiramate 25 mg 1 tablet daily for 1 week then 1 tablet twice daily. 

The requested medication is not a Food and Drug Administration (FDA) approved drug for pediatric use; therefore, Qulipta 60 mg tablets are not considered medically necessary for this patient. 

Per the cited reference, in human studies, increased levels of Calcitonin gene-related peptide (CGRP) were observed in childhood and adolescent migraine patients. Therefore, it can be assumed that remedies based on influencing CGRP metabolism are also working in that age group. Furthermore, it is not unlikely that children and adolescents need higher body weight adjusted doses of anti-CGRP drugs compared to adults.  For triptans, it has already been shown that they work in younger ages, for gepants drugs, no data are available, and for CGRP ligand/receptor antibodies, positive evidence is only available from case series (Evers, 2022).

Per the cited reference, preventive treatment of episodic migraine includes nonspecific and migraine-specific drugs. While medications from several pharmacological classes-such as anticonvulsants, beta-blockers, and antidepressants-have an established efficacy in migraine prevention, they are associated with a number of side effects (Wilbanks, 2022). 

Per the cited references and the FDA, calcitonin gene-related peptide have not been approved for the treatment migraines in patient under 18 years of age. The documentation notes that the patient is under 18 years of age and diagnosed with tension type headaches and migraines without aura not intractable without status migrainous. The patient reported headaches pressure located in the temporal or occiput once or twice per week that are sometimes associated with photophobia and nausea.  Initially the patient was treated with Excedrin Migraine for severe headaches with reported improvements. The patient has tried sertraline 50 mg a day, topiramate 25 mg, lamotrigine 50mg twice daily and has tried Qulipta samples in office. The requested medication Qulipta 60 mg tablets is not considered medically necessary for this patient.  Other treatment options may include non-pharmacological migraine preventions, triptans, and non-steroidal anti-inflammatory drugs (NSAIDs). As such, the denial of coverage for Qulipta 60 mg tablets is upheld as not medically necessary.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Qulipta 60 mg tablets is not substantiated.