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 female.

Document describes the patient with history of AS (ankylosing spondylitis) and recurrent iritis.  The patient had been on Enbrel, and this was switched to Humira every two weeks. The patient has had increased "lumbar stiffness" three to four days after the Humira injection, and thus attending requested weekly Humira.  

Denial of weekly Humira coverage, per letter, states the requested frequency is not supported by the literature or the Humira labeling. There is only data from an open label extension of a study of Humira in AS (ankylosing spondylitis).

Office note a couple of months later states that the patient was feeling worse three days after dosing of Humira.  The patient had been on Humira previously, then Enbrel again, but switched back to Humira due to iritis flares while on Enbrel.  Methotrexate at 25 mg (milligrams) caused a decrease in platelets.  The patient is also on Celebrex.

Ophthalmology note describes quiescent uveitis at that time.  It was suggested that the patient could be switched to Remicade, as that would help with musculoskeletal and eye issues, or add MTX (methotrexate) to the Humira.

No, the health plan should not cover the Humira (CF [citrate-free]) Pen 40MG (milligrams)/0.4ML (milliliter) Pen Injector weekly injections.

There are no robust published data supporting the dose of Humira 40 mg (milligrams) weekly for AS (ankylosing spondylitis).  FDA (Food and Drug Administration)-approved labeling only allows for dosing every two weeks for this condition.

No, the Humira (CF [citrate-free]) Pen 40MG (milligrams)/0.4ML (milliliter) Pen Injector weekly injections is not likely to be more beneficial.

There have been no robust studies published involving weekly Humira for AS (ankylosing spondylitis).  If this the patient is having increased AS (ankylosing spondylitis) symptoms three days after the Humira injection, one could conclude that she is failing Humira.  There are other options, as discussed by the ophthalmologist (see above):  MTX (methotrexate) could be added to the regimen (the decrease in platelets may not be seen in a dose lower than what she was on in the past--and may help her when used in combination with the Humira every two weeks).  Or the provider could switch biologic agents.

In patients with AS (ankylosing spondylitis), switching to a second biological DMARD (disease-modifying antirheumatic drug), such as a TNFi (tumor necrosis factor inhibitor) or IL-17i (interleukin-17 inhibitor) after prior TNF (tumor necrosis factor)-inhibitor (Enbrel and Humira being examples of TNF (tumor necrosis factor)-inhibitors) use is efficacious. Switching TNF (tumor necrosis factor) inhibitors was beneficial for a substantial proportion of patients with AS (ankylosing spondylitis) who failed to respond to initial or even second TNF (tumor necrosis factor) inhibitor therapy, and adverse effects were not enhanced.