Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Hydradenitis Suppurative.
Treatment: Humira Pen 80 mg (milligrams)/0.8 ml (milliliters) SC (subcutaneous) PNKT (pen kit) weekly.
The insurer denied: Humira Pen 80 mg (milligrams)/0.8 ml (milliliters) SC (subcutaneous) PNKT (pen kit) weekly.
The denial is overturned.

The patient is an adult female with hidradenitis, treated with topical and oral antibiotics, Humira and Remicade. Her provider is requesting Humira 80 mg (milligrams) weekly. The health plan denied coverage for the increased dosing. The denial is being appealed.

The requested weekly Humira is medically necessary.
Dose optimization of biologics is commonly performed in diseases for which these medications are used and has been studied in general for rheumatologic and autoimmune diseases. It has been known since their early inception that obese patients required higher doses of biologics, and many patients treated with anti-tumor necrosis factor (TNF) therapies suffer from loss of response over time and require dose escalation.

There are observational studies performed on inflammatory bowel disease that show that patients on high-dose adalimumab had a lower treatment failure rate when compared to patients on the standard regimen (Greener, 2021). The study by Martinez-Cutillas et al concluded that the practice of optimization of dose regimens in patients with rheumatic diseases under treatment with anti-TNF (tumor necrosis factor) is spreading among professionals, resulting in annual cost reduction in the treatment of rheumatic arthropathies.

Therefore given this patient's severe disease, risk of flare upon discontinuation or lowering of the dose, and support in current medical literature for dose optimization, the request is medically necessary.

Specific to hidradenitis suppurativa, Kimball et al. note that it is a painful, chronic inflammatory skin disease with few options for effective treatment. "PIONEER I and II were similarly designed, phase 3 multicenter trials of adalimumab for hidradenitis suppurativa, with two double-blind, placebo-controlled periods. In period 1, patients were randomly assigned in a 1:1 ratio to 40 mg [milligrams] of adalimumab weekly or a matching placebo for 12 weeks. In period 2, patients were reassigned to adalimumab at a weekly or every-other-week dose or to placebo for 24 weeks. The primary endpoint was a clinical response, defined as at least a 50% reduction from baseline in the abscess and inflammatory-nodule count, with no increase in an abscess or draining-fistula counts, at week 12. Results: We enrolled 307 patients in PIONEER I and 326 in PIONEER II. Clinical response rates at week 12 were significantly higher for the groups receiving adalimumab weekly than for the placebo groups: 41.8% versus 26.0% in PIONEER I (P=0.003) and 58.9% versus 27.6% in PIONEER II (P<0.001). Patients receiving adalimumab had significantly greater improvement than the placebo groups in rank-ordered secondary outcomes (lesions, pain, and the modified Sartorius score for disease severity) at week 12 in PIONEER II only. Serious adverse events in period 1 (excluding worsening of underlying disease) occurred in 1.3% of patients receiving adalimumab and 1.3% of those receiving placebo in PIONEER I and in 1.8% and 3.7% of patients, respectively, in PIONEER II. In period 2, the rates of serious adverse events were 4.6% or less in all the groups in both studies, with no significant between-group differences. Conclusions: Treatment with adalimumab (40 mg weekly), as compared with placebo, resulted in significantly higher clinical response rates in both trials at 12 weeks; rates of serious adverse events were similar in the study groups."

The patient has already been on 80 mg (milligrams) every other week, and therefore a trial of weekly dosing is appropriate.