Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Eczema.
Treatment: Dupixent 300mg per week (Pre-service).
The insurer denied the Dupixent 300mg per week (Pre-service).
The denial is overturned. 

The patient is a female with severe atopic dermatitis that is not well controlled on Dupixent every two weeks.  She started this therapy approxmately three months ago.  Prior to that, the patient had tried and failed various topical medications including mometasone, fluticasone, and Protopic.  She is still significantly itchy with dermatitis on her breasts and hands.  Her provider is requesting an increase in dosing frequency to weekly in hope to relieve the patient's symptoms.

Yes, the proposed treatment with Dupixent is medically necessary.
The patient has severe atopic dermatitis affecting multiple areas of the body. She has improved with dupilumab. Increasing the dosage to weekly administration is within the standard of care based on published literature.

Dupilumab is a monoclonal antibody that inhibits IL-4 (interleukin 4) and IL-13 (interleukin 13) signaling by blocking the shared IL-4Ra (interleukin 4 receptor) and originally demonstrated efficacy in phase II clinical trials. 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 (number =671) and SOLO 2 (number =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).

Given its unprecedented efficacy, dupilumab is now a first-line therapeutic for moderate-to-severe atopic dermatitis (AD). The patient has failed topical steroids and calcineurin inhibitors.

Cyclosporine, azathioprine, methotrexate, and mycophenolate mofetil are not Food and Drug Administration (FDA) approved for use in atopic dermatitis (Insufficient data exists to firmly recommend optimal dosing, duration of therapy, and precise monitoring protocols for any systemic immunomodulating medication. Strength of Recommendation: B Level of Evidence: I or II, depending on agent), while Dupixent is.

Systemic steroids and cyclosporine are not a reasonable long term treatment for moderate to severe atopic dermatitis due to their severe side effect profile.

Furthermore, a prospective survey study assessed 23 patients with atopic dermatitis (AD) on dupilumab with standard every-other-week (EOW) dosing who were transitioned to every-week (EW) dosing. The average time from starting standard every-other-week 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 (Investigator Global Assessment )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.

For the reasons above, Dupixent weekly injections are medically necessary.