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 overturned. 

The patient is a female with ankylosing spondylitis (AS) and recurrent iritis.  She failed treatment with prednisone, methotrexate and Advil.  She was then treated with Enbrel 50 mg (milligrams) weekly, which led to control of her musculoskeletal symptoms.  However, she developed recurrent flares of iritis on Enbrel.  

Enbrel was switched to Humira 40 mg (milligrams) every other week.  Humira controlled the patient's iritis symptoms, but she developed worsening axial arthritis symptoms (i.e., low back stiffness and costochondral pain).  Per attached documentation, Humira would only help her musculoskeletal symptoms for three to four days when dosed every two weeks.  

The patient was switched to Humira 40 mg (milligrams) dosed weekly via the use of samples, and the physician reports resolution of musculoskeletal symptoms and continued control of her iritis.  

The appeal is for Humira (CF [citrate-free]) Pen 40MG (milligrams)/0.4ML (milliliters) Pen Injector weekly injections for the treatment of AS (ankylosing spondylitis) associated with recurrent iritis.

Yes, the health plan should cover the Humira (CF [citrate-free]) Pen 40MG (milligrams)/0.4ML (milliliters) Pen Injector weekly injections.

Humira is FDA (Food and Drug Administration)-approved for both the treatment of AS (ankylosing spondylitis) and uveitis at a dose of 40 mg (milligrams) every other week.  Humira is not FDA (Food and Drug Administration)-approved for either of these indications at a dose of 40 mg (milligrams) weekly, as requested for this patient.  However, Humira is FDA (Food and Drug Administration)-approved for the treatment of rheumatoid arthritis at a maximum dose of 40 mg (milligrams) weekly if given as monotherapy, and the safety and efficacy of this dosing regimen has been established for this indication.  

This patient was treated with Humira 40 mg (milligrams) every other week, which led to adequate control of her iritis (i.e., anterior uveitis), but insufficient control of her musculoskeletal symptoms.  Per attached documentation, escalation of Humira to weekly dosing via the use of samples led to control of both musculoskeletal and ocular symptoms.  There are published case series supporting the safety and efficacy of weekly Humira dosing for refractory ocular disease, referenced below.  Therefore, given the established safety and efficacy of Humira 40 mg (milligrams) weekly for various inflammatory indications, along with this patient's documented clinical response to weekly Humira dosing, the health plan should cover Humira (CF [citrate-free]) Pen 40MG (milligrams)/0.4ML (milliliters) Pen Injector weekly injections for the treatment of AS (ankylosing spondylitis) and uveitis in this specific patient.

Yes, the Humira (CF [citrate-free]) Pen 40MG (milligrams)/0.4ML (milliliters) Pen Injector weekly injections are likely to be more beneficial.

There are other potential treatment options for this patient with AS (ankylosing spondylitis) and iritis, who is not responding completely to Humira 40 mg (milligrams) dosed every other week.  As indicated by her ophthalmologist at her office visit, methotrexate may be added to Humira dosed every other week.  However, methotrexate is not typically effective for axial arthritis symptoms, as seen in this patient.  Another option is switching to an alternate TNF (tumor necrosis factor) inhibitor, Remicade, in combination with methotrexate.  However, it has been documented by the physician that this patient is already responding appropriately to Humira 40 mg (milligrams) weekly, with resolution of both musculoskeletal and ocular symptoms and no untoward side effects.  Thus, this patient would be put at unnecessary risk of disease flare if her regimen is changed from weekly Humira dosing.