Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Hidradenitis Suppurativa

Treatment: Cimzia Starter Kit

The insurer denied Cimzia Starter Kit.

The denial was upheld.

This is a female patient with a history of hidradenitis suppurativa (HS). The patient reported that she had not been taking her medication per HS protocol as prescribed because of bizarre arthritis flare and probable hypersensitivity reaction. Her provider noted that the patient was on monthly infusions until early 2020 when a severe inflammatory arthritis developed (generalized) that required prednisone, presumptive hypersensitivity reaction given this patient's previous shortness of breath symptom during an infusion in late 2019. The patient reported draining in the upper right axilla and left breast associated with 2 cm ulcer. On video examination, the patient was noted to have inflammatory nodules in the bilateral axillae, left inframammary skin and much less involving the groin and buttocks. The patient reported pain score of 3/10 and HS-PGA: 5. The patient's treatment plan included topical therapy with chlorhexidine/clindamycin gel, triple antibiotics with levofloxacin/rifampin/metronidazole; plan for trial of intravenous (IV) ertapenem for 6 weeks, infliximab 7.5 mg/kg, finasteride 5 mg daily, triamcinolone acetonide (KENALOG-40) and trial of Cimzia (certolizumab). Dr. Cohen is requesting authorization for Cimzia 200 mg/ml Starter Kit.

As per Savage et al (2019), "[Hidradenitis suppurativa (HS)] is notoriously difficult to treat. The efficacy of adalimumab and [infliximab (IFX)] in HS is encouraging despite some limitations. Adalimumab has the highest quality evidence supporting its use in HS, and should be considered as first line therapy. IFX represents another reasonable treatment option, with primary drawbacks including an inconvenient infusion schedule, less robust data, and difficulty obtaining insurance approval. As surgery offers a more permanent solution and may increase time to HS relapse, concomitant use of anti-TNF- agents in the setting of surgery is an intriguing concept. The etanercept literature lacks convincing data that it can offer benefit in HS. Evidence for golimumab and certolizumab is even further limited. In summary, adalimumab and IFX are mainstays in the treatment of HS; however, as neither offers complete or long-lasting disease remission, continued pursuit of clinical trials investigating novel treatment strategies is paramount." And according to Santillan et al (2000), "Adalimumab is currently the only FDA-approved HS biological therapy. Some patients do not experience treatment efficacy with adalimumab at 40 mg/week, which may result in increasing the dose or seeking other treatments. Infliximab is the next line of HS treatment with demonstrated efficacy. 

Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition that is also known as acne inversa and affects 1% of the population. The primary sites of involvement are the intertriginous skin areas of the axillary, groin, perianal, perineal, and inframammary regions, trough HS can occur in any skin area that contains follicular pilosebaceous units. The associated pain, malodor, drainage, and disfigurement contribute to a profound psychosocial impact of the disease on many patients. The goal of treatment is systemic control of inflammation. A combination of medical and surgical intervention in some cases is required to treat existing lesions and scarring. Medical treatment is based on the use of antibiotics, retinoids and antiinflammatory drugs, in which TNF-alpha inhibitors agents play a central role. Adalimumab is the only drug approved in the summary of product characteristics for the treatment of this disease. 
The health plan acted reasonably with sound medical judgment, and in the best interest of the patient.

Based on the above, the medical necessity for Cimzia 200 mg/ml Starter Kit is not substantiated.  The insurer's denial should be upheld.