Appeal type: Experimental/Investigational
Decision: Overturned

The patient has hidradenitis suppurativa and multiple sclerosis treated by her dermatologist and has failed topical therapies, oral anti androgens, oral antibiotics (triple oral antibiotics), intralesional steroids and surgical drainage.  Sites involved included bilateral axillae, bilateral breasts, and genital/pubic areas.  Multiple sclerosis is an absolute contraindication for anti-TNF therapies.  The treating provider is requesting Cosentyx on the patient's behalf.

Secukinumab (Cosentyx) has been shown to be an effective treatment for hidradenitis suppurativa.  While not currently approved for this indication, it has shown to be efficacious and safe in the available medical literature.  It has been shown to objectively reduce lesion counts/inflammation and has improved patient reported/quality of life outcomes.

Prussick et al. demonstrated that seven out of nine patients (78%) achieved Hidradenitis Suppurativa Clinical Response (HiSCR). Based on the last observation recorded, eight patients (80%) achieved HiSCR out of ten who completed Week 24 in both arms of the study.  Five patients (83%) achieved HiSCR out of the six who had failed previous anti-TNF therapy.  It took an average of seven weeks to achieve HiSCR. Eight out of 18 patients (44%) achieved HiSCR during the loading dose period.  In one case report after 12 weeks of treatment with secukinumab, the number of lesions reported by the patient within the period of the previous four weeks was reduced from 23 to seven, his pain visual analogue scale (VAS) score was reduced from five to three and pain/utility/handicap VAS score was reduced from seven to four (Thorlacius et al. 2018).

Marasca, C. et al. (2019), indicate "Adalimumab (Humira) constitutes the only biologic therapy for Hidradenitis Suppurativa (HS) approved by the US Food and Drug Administration. However, lack of efficacy and adverse events may also be associated with this therapy.  Increased IL-17 serum concentrations has been seen in patients with HS as well as a significantly increased number of IL-17producing cells in lesional and in perilesional HS skin compared with healthy subjects. Therefore, IL-17 pathway may play a key role in HS pathogenesis.  Currently, four case reports described a significant improvement of lesion activity and inflammation with secukinumab (Cosentyx) in HS patients.  Furthermore, secukinumab is now in phase I trial for HS treatment."

Jorgensen, A. R. et al. (2018) indicate "Furthermore, 12 months with secukinumab and a single CO2-laser treatment provided sustained and on-going therapeutic response, which expands upon results from previous reports that have shown only short term efficacy of secukinumab in HS."      

Cosentyx has shown to be efficacious and safe in the available medical literature. Given that the patient has failed typical first and second line therapies and is contraindicated for anti TNF therapies due to her multiple sclerosis, Cosentyx 300 mg Dose 2 pens is likely to be more beneficial to treat her condition.  This dosing has shown to be effective and safe for hidradenitis in smaller studies and in psoriasis in large studies leading to its approval by the FDA for the treatment of moderate to severe plaque psoriasis in adults.     

The patient cannot use the standard therapy of anti TNF's which are contraindicated in a patient with multiple sclerosis.  Cosentyx is an IL-17 inhibitor which acts on the same pathway (TH17 mediated inflammation) as an anti TNF and this treatment is not contraindicated in a patient with multiple sclerosis.                                                    

The carrier's denial of coverage for Cosentyx 300mg Dose - 2 pens should be reversed since this medication is likely to be more beneficial than any other existing standard health service