Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Atopic Dermatitis.
Treatment: Dupixent (dupilumab) 300 mg every week.
The insurer denied the Dupixent (dupilumab) 300 mg every week.
The denial is overturned.

The patient is an adult female with moderate to severe atopic dermatitis who has been on Dupixent 300 mg previously. The request is to continue this treatment. Prior to this therapy, she has tried and failed methotrexate, cyclosporine, phototherapy, and topical steroids. 

Yes, the Dupixent (dupilumab) 300 mg every week is medically necessary.

Dupilumab is a monoclonal antibody that inhibits IL (interleukin)-4 and IL (interleukin)-13 signaling by blocking the shared IL (interleukin)-4Ra and originally demonstrated efficacy in phase II clinical trials.  In 03/2017, it was approved by the United States (US) Food and Drug Administration (FDA) for adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.  It is a subcutaneous injection administered initially at a dose of 600 milligrams (mg) and then every two weeks thereafter. Approval of dupilumab was based on clinical trials investigating dupilumab as monotherapy (SOLO 1 and SOLO 2) and in concomitant administration with topical corticosteroids (CHRONOS). Results from the SOLO 1 (n=671) and SOLO 2 (n=708) trials showed 36-38% of patients who received dupilumab had scores of zero or one (clear or almost clear) on the Investigator's Global Assessment scale compared with placebo (8-10%) (P< .001).  Additionally, improvement from baseline to week 16 of at least 75% on the Eczema Area and Severity Index (EASI) was reported in significantly more patients who received each regimen of dupilumab than in patients who received placebo (P < .001).  Given its unprecedented efficacy, dupilumab is now a first-line therapeutic for moderate-to-severe atopic dermatitis (AD).

The patient has failed topical steroids, methotrexate, cyclosporine and phototherapy.  There is evidence in the peer-reviewed published medical literature that supports weekly dosing of dupilumab in patients with severe atopic dermatitis as safe and effective. In SOLO-CONTINUE, treatment-emergent ADA (antidrug antibody) incidences were lowest with dupilumab weekly or every two weeks and were slightly higher with less frequent treatment regimens.  In SOLOCONTINUE, monotherapy with dupilumab, 300 milligrams, weekly or every two weeks for 36 weeks maintained the clinical efficacy achieved in SOLO and was significantly better than placebo across all outcomes.  Less frequent administration (every four weeks or every eight weeks) resulted in reduced efficacy, no safety advantages, and numerically higher treatment emergent ADA (antidrug antibody) incidences, whereas weekly administration had no apparent benefit over administration every two weeks. This study supports the use of 300 mg of dupilumab weekly or every two weeks as effective regimens in adults with moderate to severe atopic dermatitis (AD) for long-term maintenance of treatment response. Furthermore, a prospective survey study assessed 23 patients with atopic dermatitis (AD) on dupilumab with standard every-other-week dosing who were transitioned to every-week (EW) dosing.  The average time from starting standard every-other-week (EOW) dupilumab to transitioning to every week dosing was 8.6 months.  Overall, five of the 23 patients (22%) had Investigator Global Assessment (IGA) scores of clear or almost clear on every-other-week dupilumab, while 12 of the 23 (52%) had IGA of clear or almost clear on every-week dosing.  Of the 17 who responded to the survey, 12 (71%) reported symptom recurrence prior to their next dupilumab dose on the every-other-week dosing, and all patients claimed that increasing to every-week dosing controlled their symptoms.  Weekly dosing of dupilumab may be beneficial to patients who experience recurrence of atopic dermatitis (AD) symptoms on the standard of every other week.

The patient has been stable on weekly dosing for the past several years and for the reasons above, and as continuation of care for this patient, Dupixent (dupilumab) 300 mg weekly injections are medically necessary.