Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Hidradenitis suppurativa, Hurley stage II.  
Treatment: Cosentyx.  

The insurer denied coverage for Cosentyx.  

The denial is upheld.  

This is a male patient with hidradenitis suppurativa, Hurley stage II. The patient's condition failed treatment with isotretinoin and doxycycline. The request is for Cosentyx (secukinumab).  

As per Russo and Alikhan (2016), hidradenitis suppurativa (HS) is a chronic, painful, inflammatory disorder of hair follicles and manifests with several cutaneous findings, including double comedones, papules, cysts, nodules, draining abscesses, and sinus tracts.  It is associated with tremendous morbidity and decreased quality of life. Treatment of HS is challenging.  Recently, there have been mixed reports regarding the efficacy of anakinra, an interleukin 1 receptor antagonist, in the management of HS. Their case study of severe HS proved refractory to anakinra, and found that tolerance of this therapy may be a limiting factor for some patients due to the necessity for daily injections.  

As per Kohorst et al. (2017), HS "is a progressive, recurrent inflammatory disorder...Hidradenitis suppurativa surgical management was well regarded by patients and should be considered by future patients to limit the morbidity of HS."  
                                         
As per Lee and Eisen (2015), "Given the absence of significant improvement in the treatment of hidradenitis suppurativa (HS) with traditional medical and surgical therapies, biologics have piqued the interest of research investigators.  The efficacy of biologics in the treatment of inflammatory conditions like psoriasis and rheumatoid arthritis is well-documented.  More recently, success with biologics has been demonstrated in atopic dermatitis, another dermatological condition associated with inflammatory states.  Researchers have begun to probe the utility of biologic agents in less prevalent conditions that feature inflammation as a key characteristic, namely, hidradenitis suppurativa.  Five agents in particular adalimumab, anakinra, etanercept, infliximab, and ustekinumab, have been explored in the setting of HS. Results to date put forward adalimumab and infliximab as biologic treatments that can safely be initiated with some expectant efficacy. Other biologic agents require more rigorous examination before they are worthy of addition to the treatment armamentarium."  

In this case, the patient has not tried and failed the Food and Drug Administration (FDA) approved medication, adalimumab (Humira).  The patient does not have a demyelinating disorder, congestive heart failure (CHF), lupus-like syndrome or active infection.  The patient has no medical contraindication or previous trial and failure to adalimumab (Humira).  Thus, a medical exception for Cosentyx is not been established.  

Cosentyx is not considered medically necessary for this patient.  Secukinumab is a human monoclonal antibody that inhibits interleukin-17A.  Data is limited to small, open-label studies for treatment of hidradenitis suppurativa.  

The health plan acted reasonably with sound medical judgment, and in the best interest of the patient.  

The carrier's denial of coverage for Cosentyx should be upheld.  The medical necessity is not substantiated.