Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Ankylosing Spondylitis (AS).
Treatment: Humira (CF [citrate-free]) Pen 40MG (milligrams)/0.4ML (milliliters) Pen Injector weekly injections.

The insurer denied the Humira (CF [citrate-free]) Pen 40MG (milligrams)/0.4ML (milliliters) Pen Injector weekly injections. The denial is upheld. 

The patient is a woman with diagnoses of Ankylosing Spondylitis and recurrent uveitis. The patient failed therapy with Enbrel. The patient has some response to Humira as in the past, however the effects of Humira on the patient's arthritis wears off prior to the next dose two weeks later. The provider is seeking authorization to treat with weekly Humira rather than Humira every two weeks. Weekly Humira was denied by plan as being experimental and investigational and is the subject of this review.    

No, the health plan should not cover the proposed treatment with weekly Humira. 

No, weekly Humira is not likely to be more beneficial than alternative therapies such as other anti-TNF (tumor necrosis factor) agents or drugs such as Humira in combination with DMARDS (disease-modifying antirheumatic drugs), Cosentyx or Taltz. 

The issue being addressed right now is the patient's ankylosing spondylitis flare despite Enbrel and Humira dosed every two weeks, and not the iritis, which is stable. The requested weekly Humira exceeds the FDA (Food and Drug Administration)-recommended dose of Humira for the treatment of Ankylosing Spondylitis. The prescribing information for Humira states, "The recommended dose of Humira for adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) is 40 mg [milligrams] administered every other week. Methotrexate (MTX), other non-biologic DMARDS [disease-modifying antirheumatic drugs], glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with Humira. In the treatment of RA [rheumatoid arthritis], some patients not taking concomitant MTX [methotrexate] may derive additional benefit from increasing the dosing frequency of Humira to 40 mg [milligrams] every week." It does not include a recondition of weekly Humira in the treatment of Ankylosing Spondylitis. 

Also, a review of the current peer-reviewed literature does not support the utility of weekly Humira to treat ankylosing spondylitis as it does in Rheumatoid Arthritis patients who are on monotherapy with Humira. As per Van de Heidge, et. al., "After 6 weeks of weekly adalimumab therapy, 14 of 61 (23.0%) patients had an ASAS20 [Assessment in Ankylosing Spondylitis response criteria 20] response, six of 61 (9.8%) patients had an ASAS40 [Assessment in Ankylosing Spondylitis response criteria 40] response and eight of 61 (13.1%) had a BASDAI [Bath Ankylosing Spondylitis Disease Activity Index] 50 response. After 1 year of receiving adalimumab 40 mg [milligrams] weekly, 18 of 53 patients (34.0%) achieved an ASAS20 [Assessment in Ankylosing Spondylitis response criteria 20] response, eight of 53 (15.1%) achieved an ASAS40 [Assessment in Ankylosing Spondylitis response criteria 40] response and eight of 53 (15.1%) achieved a BASDAI [Bath Ankylosing Spondylitis Disease Activity Index] 50 response (observed data); these 53 patients were ASAS [Assessment in Ankylosing Spondylitis response criteria] non-responders before being switched to weekly adalimumab treatment." As per the same author there were no additional safety concerns using Humira weekly in this AS (ankylosing spondylitis) population. 

Unfortunately, there are no other large, randomized controlled studies looking at the efficacy or safety of Humira weekly in this patient population and, therefore, the FDA (Food and Drug Administration) has not recommended weekly use of Humira in patients with Ankylosing spondylitis alone or in combination with Methotrexate.