Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Ankylosing Spondylitis (not clear to expert reviewer); Rheumatoid Arthritis; Lupus; Uveitis.
Treatment:  Humira.

The health plan denied coverage for the prescription Humira.  The health plan's determination is upheld in whole. 

The prescribed medication of Humira weekly is not medically necessary for this patient.
The patient  has been assigned a diagnosis of ankylosing spondylitis.  The progress notes and clinical history suggest that the member has Antinuclear antibody positive Lupus.  There are also points in the medical records where the patient was assigned a diagnosis of Rheumatoid arthritis.  The patient states that patient also had positive double stranded deoxyribonucleic acid (DNA) antibody, which is unique to Lupus and not Ankylosing spondylitis.  The member was sub-maximally responsive to Methotrexate 25 milligrams (mg) weekly and steroids.  Hair loss resulted in discontinuation of Methotrexate in the past.  Inability to use Methotrexate necessitated the use of additional therapy. (It should be noted Lupus can be associated with hair loss.)  Because the patient has joint pain, Humira was started.  The patient has also been diagnosed with uveitis; however it is not clear if the uveitis is anterior, posterior or panuveitis.  Additionally the member has had orbital inflammatory disease as well.  It is not clear if Sarcoidosis or IgG4 related disease, which may have overlapping features, have been ruled out, indicating questionable compliance in the past.  The patient has no history of sacroiliac or back pain or radiographic evidence of spondyloarthropathy affecting the axial skeleton.  The patient states that when a decrease in Humira to q 2 weeks or even monthly in the past out of convenience when traveling, the patient developed more joint pain. 

A treatment which is medically necessary meets all of the following criteria:  1)  Is clinically appropriate in terms of type, frequency, extent, site, and duration and considered effective for targeted condition, 2)  Are required for direct care and treatment of targeted condition, 3)  Condition would be adversely affected if not provided, and 4)  Is provided in accordance with generally accepted standards of medical practice.

The requested therapy with weekly Humira does not meet any of the above medical necessity requirements.  The administration of weekly Humira may exacerbate the patient's condition.  For multiple reasons, weekly Humira is not medically necessary. First, the diagnosis of Ankylosing spondylitis is not clear.  The patient has no documented back pain, sacroiliitis or evidence of axial involvement with the condition.  Patient has not tested positive for HLAB27 but tested positive for antinuclear antibodies and possibly anti double stranded DNA antibodies, which are not features of Ankylosing spondylitis.  Raychaudhuri et. al. describe the features of Ankylosing spondylitis.  This patient does not appear to have those features.  Some of the medical records included for review assign a diagnosis of Lupus, and some also assign a diagnosis of rheumatoid arthritis.  Additionally, the patient is said to have uveitis, but it is not clear if the uveitis is anterior, posterior or panuveitis.  Humira is only approved for posterior or panuveitis (See reference 4).  It is important to address the positive ANA and established Lupus diagnosis in the medical records, as it is well reported that Humira even dosed q 2 weeks can exacerbate or cause a Lupus-like syndrome.

As per Shovman, et.al. "The induction of autoantibodies is common following therapy with anti-TNF-agents. However, anti-TNF-induced lupus (ATIL) is rare.  We assessed the clinical characteristics of three patients with inflammatory bowel disease (IBD) who were treated with infliximab and developed distinct subsets of ATIL.  Also, we searched for similar cases in the published literature.  We describe three patients with ATIL.  The first patient had a classical drug-induced lupus (DIL) presented by thrombocytopenia that resolved after infliximab discontinuation.  The second case experienced symmetric polyarthritis of 14 joints in rheumatoid arthritis (RA)-like distribution accompanied by lymphopenia.  The third one had a severe serositis including ascites and pleural and pericardial effusions along with pancytopenia. In this patient, ATIL coexisted with anti-TNF-induced hepatitis.  The second and third patients met the American College of Rheumatology classification criteria for SLE.  Nevertheless, all three cases exhibited ANA and anti-dsDNA positivity, and only the second patient had anticardiolipin (aCL IgG) and anti-histone antibodies.  The coexistence of both lupus-like syndrome and hepatitis following anti-TNF-therapy in the same patient is very rare, and to the best of our knowledge, only four such case reports are mentioned in literature. Patients with mild ATIL may tolerate another anti-TNF-agent without recurrence of the disease.  Rheumatologists should be aware of the distinct clinical presentations of ATIL and its coexistence with other rare anti-TNF-alpha complications, such as hepatitis. "This patient already has features of Lupus.  Increasing the dose to q week may exacerbate this autoimmune condition.  Weekly Humira is not medically necessary in this case.