Lamisil denials in California external review

What the reviewers wrote

Where the denial was overturned

A 28-year-old female enrollee has requested Lamisil for treatment of her onychomycosis. Findings: The physician reviewer found that the patient’s medical condition, onychomycosis, would be most effectively treated with oral Lamisil. The relative efficacy and safety profiles of this drug, compared to other systemic antifungal drugs, justify the choice of continuous terbinafine therapy in this case. Onychomycosis is a common nail ailment associated with significant physical and psychological morbidity. Various treatment modalities including topical, systemic and surgical have been used for onychomycosis. Topical drugs are delivered through specialized transungual drug delivery systems ensuring high concentration and prolonged contact. Commonly used oral therapeutic agents include Lamisil, fluconazole, and itraconazole.

The patient is a 41-year-old man who saw his physician for painful, swollen toes secondary to thickened, crumbling toenails. The physician’s diagnosis was onychomycosis. The Health Plan denied coverage for Lamisil. A fungus culture grew out coagulase-negative staph and no fungus. Liver function tests were normal. The condition worsened to the extent that the patient’s mobility was impaired. The patient then took Lamisil tablets for 180 days. During the course of the treatment, the nails improved, the pain and swelling disappeared, and the patient’s mobility was no longer impaired.The submitted clinical information is sufficient to support the diagnosis of onychomycosis. A toenail condition such as this patient’s with irregular crumbling and thickening and resultant painful swelling of the toe does not improve on its own.

Where the denial was upheld

The patient is a 55-year-old woman who has had lifting of the left first toenail with resultant pain for at least 1.5 years. In June 2004, Lamisil was prescribed, after which improvement was noted. Treatment was discontinued because the patient indicated she was having a reaction to Lamisil. The painful toenail problem has persisted. In August 2005, Lamisil was again prescribed, but the Health Plan denied authorization on the basis that the drug is no longer a formulary medication. Fungus cultures were negative. The patient was offered surgical removal of the toenail, which she refused. At issue is whether Lamisil is medically necessary for treatment of the patient’s condition.The submitted information indicates the patient has been receiving treatment for her nail condition from her primary care physician.

The patient is a 42-year-old female who was seen by a podiatrist in February 2005 for thickening of the right hallux nail. The patient states the toenail is painful and cracked. She also reports the toe is red and swollen with resultant pain and difficulty with walking and wearing shoes. Chart notes indicate severe thickening and yellow discoloration of the toenail. Lamisil has been recommended. The Health Plan has denied authorization because the diagnosis of onychomycosis has not been confirmed through appropriate testing.The Health Plan’s denial is correct. Although the patient’s clinical presentation is strongly suggestive of onychomycosis, further testing (KOH, fungal culture or nail biopsy) is necessary to confirm the diagnosis and establish the need for Lamisil. If appropriate testing confirms a diagnosis of onychomycosis, Lamisil should be authorized.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Lamisil, then check the rights and deadlines that apply to your plan.