Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Hidradenitis Suppurativa (HS). 
Treatment: Cosentyx Pen (2 Pens) 150 milligrams/milliliters (mg/ml) pen injector. 

The insurer denied coverage for Cosentyx Pen (2 Pens) 150 mg/ml pen injector. 

The denial is overturned. 

According to the medical records, the patient is an adult with a history of hidradenitis suppurativa (HS), who has failed topical and oral antibiotics, phototherapy, intralesional kenalog, surgical intervention, and Humira. Her provider is requesting approval for Cosentyx. 

Although Cosentyx is not Food and Drug Administration (FDA) approved for HS, there are several case series and open-label trials supporting its safety and efficacy. HS is a difficult to treat condition for which there is no gold standard therapy. Since the patient has failed standard therapies as well as the only FDA approved biologic for HS (Humira), it would be appropriate to allow approval for Cosentyx. 

It should be approved for this patient who has already failed Humira. 

Since this patient has failed other standard treatments, as well as Humira, she is a good candidate for Cosentyx in order to minimize any futher morbidity from her HS. 
  
There are no other available treatment options left for this patient, as she has exhausted the standard treatments of antibiotics, steroids, and Humira. 

There are no other standard treatments to compare Cosentyx to. When properly managed as in the case series and open-label trials, it is associated with minimal risk.   

Cosentyx would be beneficial to this patient. Without it, she can have non-healing absesses and infections that can lead to hospitalization and further morbidity. 

"The treatment of HS has remained challenging because of the many knowledge gaps regarding etiology. However, recent studies into the pathogenesis of HS have enabled the investigation of newer therapies. The second article in this continuing medical education series reviews the evidence for established therapies for HS, including anti-inflammatories, antibiotics, and surgery. New and emerging therapies that specifically target cytokines involved in HS pathogenesis will be covered. The potential therapeutic roles of anticytokine therapies, including both the expanded application of existing molecules as well as the specific development of novel therapies for HS are discussed. With increased attention on HS and with numerous clinical trials currently underway, we hope that the variety of treatment options for HS will be expanded." (Goldburg, S. R. et al. 2020) 

"HS is an inflammatory skin disease that is challenging to treat. Patients with HS have imbalances in the T-helper 17 cell (Th17) axis that are similar to those in patients with psoriasis. They have high serum levels of the proinflammatory cytokine interleukin (IL) 17A, which leads to neutrophil recruitment and provides positive feedback to maintain the population of proinflammatory Th17 cells. These imbalances improve with antitumor necrosis factor- (antiTNF-) biologics.3 It is hypothesized that by reducing circulating IL-17A, antiIL-17A biologics such as secukinumab may also treat HS.2,3 Secukinumab (Cosentyx, Novartis, Basel, Switzerland) is a human monoclonal immunoglobulin G1 kappa antibody that selectively binds to IL-17A. Our study aimed to look at the effects of secukinumab on lesions in patients with moderate to severe HS." (Goldburg, S. R. et al. 2020). 

In summary, the denial of Cosentyx Pen (2 Pens) 150 mg/ml pen injector and coverage for the requested treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.