Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Hidradenitis suppurativa. 
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. 

Per medical records, the patient is an adult with hidradenitis suppurativa.  The patient has significant and noticeable lesions on bilateral axillae and the umbilicus. She has failed numerous topical agents, oral antibiotics, phototherapy, surgical intervention, intralesional Kenalog and Humira.  The medication under review is Cosentyx Pen (2 Pens) 150 mg/ml pen injector. 

All available medical documentation was reviewed. 

The scientific evidence in peer-reviewed literature does support a result of improvement in health outcome. Based on the current peer-reviewed literature and accepted standards in the specialty's medical community, treatment with Cosentyx is considered essential for this particular individual. Use of Cosentyx is considered standard of practice after treatment failure of Humira for this member's diagnosis of hidradenitis suppurativa.  The patient has failed all other conventional topical and systemic therapies (including doxycycline, and Humira).  Hidradenitis suppurativa is a scarring, debilitating and disfiguring skin disease.   The evidence is strong enough for Cosentyx to be used for treatment for hidradenitis suppurativa in this patient.  There are several reports in the dermatology peer-reviewed literature that show that Cosentyx is effective for the management of hidradenitis suppurativa in some patients. Given that this patient has failed all the conventional therapies, Cosentyx is warranted for this patient. 

Prussick, L., et al. (2019), writes in "Open-label, investigator-initiated, single-site exploratory trial evaluating secukinumab, an anti-interleukin (IL)-17A monoclonal antibody, for patients with moderate-to-severe hidradenitis suppurativa" that Cosentyx was effective.  Casseres et al writes in "Secukinumab in the treatment of moderate to severe hidradenitis suppurativa: Results of an open-label trial" that "Seventy percent (n = 14) of all patients achieved  hidradenitis suppurativa clinical response (HiSCR) by week 24". 
  
Ribero, S. et al. (2021), writes in "Effectiveness of Secukinumab in the treatment of moderate-severe hidradenitis suppurativa: results from an Italian multicentric retrospective study in a real-life setting" that Cosentyx was effective. 

 Kashetsky, N. et al. (2022),  write in "Treatment Outcomes of IL-17 Inhibitors in Hidradenitis Suppurativa: A Systematic Review" that "IL-17 inhibitors may serve as an effective therapeutic target in approximately two-thirds of patients with hidradenitis suppurativa (HS) and can be considered in those who are refractory to other treatment modalities". 

Cosentyx Pen (2 Pens) 150 mg/ml pen injector does not have final approval from the appropriate regulatory bodies for this diagnosis. 

This patient is a good candidate for Cosentyx Pen (2 Pens) 150 mg/ml pen injector. 

Cosentyx Pen (2 Pens) 150 mg/ml pen injector is the best available treatment for this patient at this time. 

The adverse risks are not increased over standard treatment/services.  The patient has already failed the standard treatments. 

In summary, the denial of Cosentyx Pen (2 Pens) 150 mg/ml pen injector 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.