Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #2

Diagnosis: Crohn's disease

Treatment: Adalimumab/Humira [citrate-free (cf)] 80 milligrams (mg)

The insurer denied coverage for Adalimumab/Humira (cf) 80 mg

The denial is overturned 

This is the case of male with a history of Crohn's disease with complication. Per the appeal letter from the provider, the patient has inflammatory bowel disease (IBD). The patient was started on adalimumab at a dose of 40 mg every 14 days. The dose was increased to weekly to provide therapeutic dosing, and he was started on prednisone. The patient is having diarrhea with blood. An adalimumab level was not detected. An increase to 80 mg weekly is therefore requested in order to achieve remission and avoid severe complications.

The requested dose is supported by current medical literature, that the requested drug be covered instead of the available products on the plan's formulary, or at the standard dosing, for continuity of care based on established clinical results as noted by the patient's provider. This is the standard of medical care and is the best available treatment for the patient.

Change in therapy from that requested by the provider, discontinuation, or de-escalation would result in a serious risk of harm to the patient, as supported by current medical literature.

The patient exhausted other appropriate treatment options indicated for Crohn's Disease.

The coverable dose and frequency have been tried and failed, as supported by available and/or therapeutic drug level monitoring and antibody detection.

Adalimumab (HUMIRA) for the treatment of Crohn's disease is established in regard to efficacy and being cost-effective. Anti-tumor necrosis factor (TNF)-alpha therapy (adalimumab or infliximab) typically are held for patients with failure or intolerance to a course of glucocorticoids and/or immunosuppressive agents, those who are steroid-dependent despite immunosuppressants, failed glucocorticoids, or are unable to wait for the potential beneficial effects of methotrexate or azathioprine.

Induction therapy (160 mg at week 0 and 80 mg at week 2) and maintenance treatment with adalimumab (40 mg subcutaneously every two weeks). Both are more effective than the placebo. Adalimumab results in mucosal healing at rates similar to other anti-TNF agents.

There is Food and Drug Administration (FDA)-approved dosing for Humira for ulcerative colitis also that begins with an initial dose of 160 milligrams, a second dose two weeks later of 80 mg, and a maintenance dose of 40 mg every other week, thereafter.

Data from Crohn's Trial of the Fully Human Antibody Adalimumab for Remission Maintenance (CHARM), a 56-week, randomized controlled trial of adalimumab for patients with moderately to severely active Crohn's disease, were used to evaluate outcomes of adalimumab dosage adjustment. At >=12 weeks, patients with flares or lack of response versus baseline (including patients who responded and then lost response) could move sequentially to open-label (OL) adalimumab EOW and then to OL adalimumab weekly. Of 260 patients randomized to adalimumab conclusions were that weekly therapy was associated with clear clinical benefits and a small cost increase. 

In case of a loss of response to adalimumab, some patients with Crohn's disease may derive benefit from increasing the dosing frequency to 40 mg weekly. The efficacy and safety of adalimumab 80 mg weekly remain unknown. The conclusion was that "adalimumab 80 mg weekly seems to be well-tolerated and may be effective in inducing clinical remission in patients with luminal Crohn's disease who failed to respond to 40 mg weekly or 80 mg every other week."

The requested service is likely to be more beneficial than any of the standard treatments/procedures for this patient.                                                 

The carrier's denial of Adalimumab/Humira [citrate-free (cf)] 80 milligrams (mg) should be overturned.