Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

The patient is a 41-year-old male with chronic eye pain and chronic rhinosinusitis. The records provided include multiple notes from several physicians with different specialties. He has had problems with chronic bilateral eye pain (also referred to variously as retro-orbital pain and atypical facial pain) for many years. He has had several surgeries, received neuro-ganglion blocks, and takes oral analgesics on a regular basis for this problem. There are detailed notes related to possible adverse affects experienced by the patient with the use of Neurontin and gabapentin. There are two physician dictations regarding this patients sinus disease history. In October 2004 it is noted that the patient had a history of nasal and paranasal sinus polyposis. He had undergone three surgeries for this problem, the last having been helpful in alleviating his symptoms of midfacial pain, chronic rhinitis and intermittent low-grade fevers. Plans for a repeat CT scan are stated at the end of this note, but no follow-up is given in this regard. The other note from an otolaryngologist is dated 8/16/05. It states that the patient did well with the use of Tobramycin irrigations, but that he claims to be reinfected. Sporanox was then prescribed. It is stated that the patients disease is absolutely incurable-need to try fungal treatment. There is no mention of any cultures having been performed.There are several dictations related to a problem with toenail fungus. This has been treated with temporary success in the past through the use of Sporanox and Diflucan. It has recurred after each treatment.There is also an allergy/immunology evaluation. Applicable conclusions were that the patient most likely had underlying allergic rhinitis, recurrent viral versus bacterial infections of the respiratory tract, and an onychomycosis of the left greater toe. Lastly, there is a consultation by an infectious disease specialist from September 2005. The conclusions in this report are that the patient has allergies, chronic sinusitis, no evidence of systemic fungal infection and no apparent underlying systemic illness. While this physician stated he did not feel strongly one way or the other about the use of anti-fungal therapy in this patient, he did state that since there is no evidence of invasive fungal infection, he would not continue it as a long-term therapy.At issue in this case is whether Sporanox is medically necessary for treatment of the patients condition.This disease entity, chronic sinusitis (or rhinosinusitis or chronic hyperplastic eosinophilic sinusitis) encompasses a wide range of symptomatology and physical findings. The American Academy of OtolaryngologyHead and Neck Surgery (AAO-HNS) has made great efforts through its task force to better define this disease and to explore its etiologies, pathophysiology and treatments options. Unfortunately, there are still many unknown/uncertain factors regarding this common disease process. A search of the literature regarding the use of antifungal medications in patients with chronic rhinosinusitis yields conflicting viewpoints. As is mentioned by this patient, the Mayo study indicates that a large proportion of chronic rhinosinusitis patients may have detectable fungal elements in their sinuses. Whether this is clinically significant remains to be seen. This type of fungal involvement may be normal colonization, or may elicit either a true allergic reaction or result in an infectious process. Treatment approaches for this fungal element and their results are varied as well. Fungal sinus disease that is not invasive has been treated with surgical extirpation, steroid nasal sprays, immune therapy and antifungal agents. Treatment of chronic rhinosinusitis without proven fungal disease traditionally has been with saline lavage, allergy medications (oral and nasal sprays), antibiotics, immune therapy, systemic steroids and surgery as necessary. The use of antifungal agents in this latter group of patients is relatively new. The most commonly cited drug in this regard is intra-nasal amphotericin. When administered by lavage its use has met with varied results. The use of oral Lamisil was not successful in the one study found in the literature search. The use of fluconazole nasal spray did yield positive results when used in conjunction with systemic steroids and itraconazole. At this time there is no consensus as to the possible role of fungal involvement in chronic rhinosinusitis and no clear evidence that antifungal medications are efficacious in its treatment. In this case, there is no identified fungal component in the patients sinusitis as no cultures have been performed.  Finally, it is known that antifungal agents may be hepatotoxic or may increase a patients risk for congestive heart failure (CHF). Based upon the information set forth above, I have determined that the requested medication is not medically necessary for treatment of the patients medical condition. The Health Plans denial should be upheld.