Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Migraine
Treatment: Indocin
The health plan denied the requested Indocin as a formulary exception.
The health plan's determination is overturned.

The patient is a female who has been diagnosed with paroxysmal hemicrania. Her neurologist describes that the patient developed headaches over 10 years ago. She started to have watering of the eyes, puffiness of the cheeks and eyes, inflammation of the forehead and numbness of the fingers followed by a right parietal headache. She sometimes has a runny nose in association with the headache. Associated symptoms include nausea and vomiting, but no photophobia or phonophobia. The headaches may wake her from sleep. There are no apparent triggers. Abortive medications have included ibuprofen, Tylenol, migraine cocktails, and naproxen. These have not been effective in relieving her pain. Prophylactic medications have included topiramate, verapamil, and propranolol. These have been ineffective, although the patient's headaches became worse when she tried to wean off propranolol.

There is a family history of migraines and cluster headaches on the father's side of the family. A brain magnetic resonance imaging (MRI) was abnormal. The patient has a history of hypertension and hidradenitis. Her medications include Emgality, levalbuterol, mupirocin, propranolol, and senna. She takes ondansetron as needed for nausea.

The examination was significant for hypertension [a blood pressure of 166/121 millimeters of mercury (mmHg)] a weight of 201 pounds, and a body mass index (BMI) of 32.44. The neurological examination was normal.

The doctor prescribed Emgality for prophylaxis and indomethacin 25 milligrams (mg) three times daily as a treatment trial for paroxysmal hemicrania.

At issue is whether the formulary drugs diclofenac sodium, diflunisal, etodolac, ibuprofen, meloxicam tablet, nabumetone, naproxen [except naproxen controlled release (CR) or naproxen suspension], naproxen sodium, oxaprozin, sulindac will be or have been ineffective, would not be as effective as the non-formulary drug, indocin (indomethacin) or would have adverse effects.

The health plan's determination is overturned in whole.

With strong support of the medical literature, the formulary drugs would not be as effective as the non-formulary drug, indomethacin, which is well established as the most effective drug and standard of care in the treatment of paroxysmal hemicrania.

Hameed and Sharman describe "Hemicrania continua (HC) is a primary headache disorder with a pathognomonic treatment response to indomethacin. It presents clinically with a baseline continuous unilateral headache for months that intermittently exacerbates with associated autonomic features." They note "A complete response to indomethacin is one of the pathognomonic features of hemicrania continua. Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) that reversibly inhibits prostaglandin-forming cyclooxygenase (COX) enzyme, similar to ibuprofen and naproxen. It is proposed that indomethacin is more effective than other NSAIDs, probably due to the highest central nervous system penetration, central serotonergic effects, and inhibition of nitrous oxide-dependent vasodilation." [1]

Clinical guidelines for the management of hemicrania continua recommend the use of indomethacin. A beneficial response to indomethacin is regarded as being pathognomonic for hemicrania continua. [1] 

In a review of patients diagnosed with paroxysmal hemicrania, Bemanalizadeh found that "almost all patients benefited from indomethacin and showed complete responses to treatment, while some needed combination treatment of indomethacin with other medications." [4]

Therefore, the formulary drugs would not be as effective as the non-formulary drug, indomethacin.