Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Hidradenitis suppurativa and multiple sclerosis
Treatment: Cosentyx 300mg Dose - 2 pens

The insurer has denied coverage for Cosentyx - 300 mg Dose - 2 pens. The denial was reversed.

This case involves a female with a medical history of hidradenitis suppurative and multiple sclerosis.  She has been treated with intralesional injections, topical therapy, Stelara, antibiotics, spironolactone, oral contraceptives, pain medications, and surgery. The office visit of in mid 2019 indicates the patient was to utilize chlorhexidine/clindamycin gel, dual antibiotics including levofloxacin/metronidazole, spironolactone, and oral contraceptive pills (OCPs). The provider indicated they would be ordering secukinumab (Cosentyx).

The provider letter in mid-2019 indicates the patient has been on topical and oral antibiotics and anti-androgen therapies with suboptimal results.  Additionally, because the patient had a well-established diagnosis of multiple sclerosis, which is an absolute contraindication for anti-TNF drug therapies (etanercept, adalimumab, infliximab, golimumab, certolizumab), there was a need for an alternative drug, secukinumab (Cosentyx).The provider requested treating the patient's psoriasis with a starter dose of 300 mg at week 0, 1, 2, 3, and 4 and maintenance dosing 300 mg every two weeks, thereafter.

According to current literature from the US Food and Drug Administration (FDA), Cosentyx is a human interleukin-17A antagonist which is indicated for the treatment of moderate to severe plaque psoriasis in adult patients. The recommended dose is 300 mg by subcutaneous injection at week 0, 1, 2, 3 and 4 followed by 300 mg every four weeks.  The medication was the subject of a phase 1 clinical trial for patients with hidradenitis suppurativa to determine the safety of the medication.  The study was completed in December of 2018. No results for this clinical study were posted as of 6/3/19. Ingram J. R. (2019) states, "Ustekinumab, anakinra, and canakinumab are biologic therapies that may be of benefit for patients with severe and refractory Hidradenitis suppurativa [HS] based upon limited dataPositive responses to ustekinumab, an interleukin (IL)-12/23 inhibitor given via subcutaneous injection, have been reported in patients with moderate to severe refractory HS." 

The scientific evidence and peer-reviewed literature was sparse and did not allow for conclusions to be drawn regarding improvements of health outcomes related to the use of an IL 17A inhibitor.  The requested medication, Cosentyx 300 mg dose-2 pens, does not have final approval from the appropriate regulatory bodies for this diagnosis.  Cosentyx 300 mg dose-2 pens is not the best available treatment for this patient at this time since the safety and efficacy for the patient's diagnosis has not been proven.  The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient.

The carrier's denial of coverage for Cosentyx 300mg Dose - 2 pens should be upheld since this medication is not likely to be more beneficial than any other existing standard health service.