Non-FDA Approved Use denials: what the review data shows

Where the denial was overturned

The patient is a 36-year-old man with Crohn’s disease of the ileocolon for at least four years with a diagnosis established at surgery. He has been treated with Asacol, prednisolone, methonidazole, mercaptopurine, Entocort, and, most recently, infliximab. In September 2004, the patient underwent a small bowel resection and stricturoplasty and the specimen was examined by the pathologist who thought this again represented active Crohn’s disease. Although the patient had some initial response to infliximab, the response has waned with time. Citing theoretical reasons including antibody production to this agent, the enrollee and his providers have requested that the Health Plan approve adalimumab (Humira) as treatment for Crohn’s disease.

Physician 1: The patient is a 42-year-old female with over a 15-year history of chronic migraines. She experiences migraines more than 15 days per month. The patient’s headaches have been unresponsive to betablockers, several tricyclic antidepressants, Depakote, Topamax, and Zonegran. The patient has used Botox for over three years with moderate improvement. She is currently experiencing disabling headaches in the absence of Botox. The Health Plan has denied authorization and coverage for Botox on the basis it is considered investigational for treatment of migraine headaches.The patient has a history of significant chronic migraine headaches. She has tried and failed more than six preventive agents and has tried essentially all standard therapies. She has used Botox for several years with documented improvement.

Where the denial was upheld

Physician 1: The patient is a 63-year-old man with thin bones (osteopenia), documented on a bone density (DEXA) scan 8.5 years ago. He was treated with Aredia, an intravenous bisphosphonate for an unknown amount of time. There is no evaluation as to the cause of the osteopenia. The patient was apparently unable to tolerate the oral bisphosphonates, Fosamax and Actonel. There is no documentation of any response to treatment. The patient’s primary care physician decided to restart the Aredia, apparently based on the findings of osteopenia on a lumbar spine x-ray finding performed a year before. Based upon the documentation provided, it is not known if the patient’s condition is progressive. It is not known if the patient was offered Forteo, which is FDA approved for severe primary osteoporosis in men.

Physician 1The patient is a 64-year-old woman who has been experiencing headaches, cervical muscle spasms, occipital neuralgia, and cervical pain due to cervical spine degenerative disc disease. A number of treatment modalities have been tried without providing satisfactory relief. Injections of botulinum toxin have provided effective relief of pain and muscle spasms. The patient wishes to continue treatment with botulinum toxin. The consultations with her pain specialist indicate that a variety of medications and treatments have been tried since 1/5/04 without significant relief. The patient reports that injections of botulinum toxin provide relief for two months. She wishes to receive additional botulinum toxin injections.

These are outcomes from California’s external review program — an independent physician panel that binds the insurer. Every state has an equivalent process, and internal appeals succeed even more often. Cite the outcome record for Non-FDA Approved Usewhen you appeal: reviewers routinely find that denials like yours didn’t hold up.