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202106-138641

2021

CVS Caremark

Self-Funded

Genitourinary/ Kidney Disorder

Pharmacy/ Prescription Drugs

Medical necessity

Overturned

Case Summary

Diagnosis: Peyronie's disease.
Treatment: Xiaflex.
The insurer denied the Xiaflex.
The determination is overturned.

The patient has a diagnosis of Peyronie's disease. The records document a curvature of 30-40 degrees and a palpable plaque. He is noted to have stable disease. He does not have erectile dysfunction (ED). Xiaflex treatments have been recommended. At issue is the medical necessity of Xiaflex.
The Xiaflex is medically necessary for this patient. The patient has intact erectile function. The Food and Drug Administration (FDA) Prescribing Information is as follows: "The treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy (1)." The FDA criteria for coverage were met. Criteria regarding degree of curvature, palpable plaque and stability of disease were met. The records document a curvature of 30-40 degrees and a palpable plaque. Therefore, the Xiaflex is medically necessary.

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