Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Migraine headache
Treatment: Nurtec ODT (oral disintegrating tablet) 75 mg (milligrams) tab (tablet)
The insurer denied coverage for Nurtec ODT 75 mg tab.
The denial is upheld.
 
According to the medical records, the patient is a teenager who was prescribed Nurtec oral disintegrating tablet (ODT). A recent office note stated the patient was a teenager with a diagnosis of chronic migraine without aura. The patient responded to Emgality with a reduction in headache intensity, with return of headaches to a frequency of daily after a few months. The patient was using almotriptan and Zofran and was also being treated for postural orthostatic tachycardia syndrome. She was using Aleve 440 milligrams (mg) daily for other pains and was on lamotrigine and gabapentin. Previous imaging of the brain was negative for intracranial pathology other than sinus disease. At that time, Emgality was continued, and almotriptan with Zofran was prescribed as acute therapy. The patient was considered for Cambia. Nurtec was the only rescue medication that worked well as acute therapy. The patient underwent an Emgality injection on that date.

A letter of medical necessity indicates that the patient previously tried acute therapy with Excedrin migraine, ibuprofen, Tylenol, sumatriptan that was ineffective, rizatriptan that worked inconsistently, ondansetron that worked inconsistently, zolmitriptan nasal spray that made headaches worse before making them better, almotriptan that was ineffective, Cefaly (electrical stimulator) that she was unable to tolerate.  Nurtec worked for her when provided through a manufacturer assistant program.  Naproxen had minimal efficacy. The patient also been tried on multiple preventives that were also not effective. It was noted that being a teenager should not preclude her from receiving the requested medication, and it was noted that the patient was at an adult height / weight, and that her biology was not much different than those older.

Nurtec ODT (oral disintegrating tablet) has not been shown to be safe and effective in the pediatric population. There have been no clinical trials of Nurtec in this population to show safety and efficacy. A clinical trial (NCT04743141) is in progress to assess the safety of Nurtec in patients aged 6-17.  No results are available from this trial. A search of Pubmed using "Rimegepant and children" or rimegepant and adolescent yielded no information. The patient is using an injectable monoclonal antibody in the form of Emgality; the safety, but not efficacy, of injectable monoclonal antibodies has been demonstrated. (Szperka, C. L. et al.). However, there is no evidence in the peer-reviewed medical literature, based on open label or randomized clinical trials, that medications such as Nurtec and Ubrelvy are safe in the pediatric population, and there has been no randomized clinical trial to show efficacy as noted. Therefore, Nurtec ODT (oral disintegrating tablet) 75 mg (milligrams) is not considered medically necessary for the patient.

"The diagnosis and management of migraine headaches can be challenging in children and adolescents. The description of migraine in this population may include symptoms that are not typically described in adults. Treatment options for pediatric migraine is increasing, however remain limited. (Green, A. et al.).

"Migraine is one of the top reasons for consulting a pediatric neurologist. Although the majority of children and adolescents who receive evidence-based first-line interventions for migraine will improve substantially, a subset of patients develop resistant or refractory migraine." (Marshall, A. et al.). 

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 Nurtec ODT (oral disintegrating tablet) 75 milligrams (mg) tab is not substantiated.