Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Vitiligo 
Treatment: Formulary Exception for Elidel 1% cream 

The insurer denied coverage for Formulary Exception for Elidel 1% cream. The denial is upheld. 

This patient is a female with vitiligo on the face. The patient has used Elidel for a long time. The provider requests coverage for Elidel. The plan denied as not necessary as the patient did not meet the criteria of not being able to use the formulary alternatives. 

"Vitiligo, an acquired depigmentation disorder, manifests as white macules on the skin and can cause significant psychological stress and stigmatization. Recent advances have shed light on key components that drive disease onset and progression as well as therapeutic approaches. Vitiligo can be triggered by stress to the melanin pigment-producing cells of the skin, the melanocytes. The triggers, which range from sunburn to mechanical trauma and chemical exposures, ultimately cause an autoimmune response that targets melanocytes, driving progressive skin depigmentation. The most significant progress in our understanding of disease etiology has been made on three fronts: (1) identifying cellular responses to stress, including antioxidant pathways and the unfolded protein response (UPR), as key players in disease onset, (2) characterizing immune responses that target melanocytes and drive disease progression, and (3) identifying major susceptibility genes. The current model for vitiligo pathogenesis postulates that oxidative stress causes cellular disruptions, including interruption of protein maturation in the endoplasmic reticulum (ER), leading to the activation of the UPR and expression of UPR-regulated chemokines such as interleukin 6 (IL-6) and IL-8. These chemokines recruit immune components to the skin, causing melanocytes to be targeted for destruction." 

"Clinicians should be aware that vitiligo is not merely a cosmetic disease and that there are safe and effective treatments available for vitiligo. It is important to recognize common and uncommon presentations and those with active disease, as well as their implications for clinical management; these were discussed in the first article in this continuing medical education series. Existing treatments include topical and systemic immunosuppressants, phototherapy, and surgical techniques, which together may serve to halt disease progression, stabilize depigmented lesions, and encourage repigmentation. We discuss how to optimize the currently available treatments and highlight emerging treatments that may improve treatment efficacy in the future" (Rodrigues et al 2017). 

"Pathogenic causes are likely multifactorial, including genetic influences, dysfunctional biochemical pathways, autoimmune processes, melanocyte adhesion deficits, and nervous system imbalances.Traditional vitiligo treatments include topical and oral immunomodulators and phototherapy. On rare occasions, depigmentation creams may also be used when repigmentation therapies prove inadequate and greater than 50 percent of body surface area (BSA) is involved" (Dillion et al 2017). 
                                                
The formulary medications would not likely cause the patient to have an adverse reaction. The records do not indicate that the formulary options have been ineffective.  The provider states the patient failed generic. There is no mention made of a trial and failure with generic alternatives which were not effective in the medical records.  

There is no evidence that the requested medication would be more effective than formulary options. 

The carrier's denial of request for Formulary Exception for Elidel 1% cream is upheld.