Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Atopic Dermatitis, Alopecia Areata
Treatment: Rinvoq
The insurer denied the Rinvoq.
The determination is upheld.

The patient has severe atopic dermatitis and alopecia areata. The patient was being treated with topical fluocinonide and clobetasol solutions, as well as clobetasol shampoo for his alopecia areata; intralesional Kenalog was administered. The patient, at this same visit, was noted to have atopic dermatitis of the flexural elbows and knees, as well as the cheeks. Rinvoq was noted to be effective for alopecia areata on the visit. The patient was noted to have steroid injection fatigue for his alopecia areata, and was frustrated with new spots developing. Rinvoq was concluded to be the best form of treatment for this patient.
At issue is whether the Rinvoq is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

No. The Rinvoq is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The patient has no physically disabling condition or disease, because after reviewing the patient's clinical records, the primary condition for which Rinvoq is being prescribed is not atopic dermatitis but alopecia areata. Alopecia areata is a condition with significant social/psychological impacts on affected patients, and does appear to have potential treatment with Janus Kinase (JAK) inhibitors based on studies [6-9] focusing on Xeljanz (tofacitinib). However, Xeljanz has neither Food and Drug Administration (FDA)-approval nor sufficient consensus/literature support for treatment of alopecia areata. At this time, Xeljanz is only Food and Drug Administration (FDA)-approved for rheumatoid arthritis patients who have failed methotrexate, for juvenile idiopathic arthritis, for psoriatic arthritis, and for ulcerative colitis--all four conditions have indications whereby the safety risks of not using treatment are significantly greater than treatment itself. On a related note, Xeljanz has been recommended to be used with lower dosing in rheumatoid arthritis patients because of concerns about excessive blood clotting.
The janus kinase (JAK) inhibitor Rinvoq has even less clinical experience overall, as well as decreased literature support and consensus, than Xeljanz, and is FDA-approved for moderate to severe rheumatoid arthritis, psoriatic arthritis, moderate to severe atopic dermatitis, moderate to severe ulcerative colitis, and active ankylosing spondylitis. However, for all of these indications Rinvoq is FDA-approved as second-line, and not first-line, systemic therapy for patients who have tried and failed (or could not tolerate) standard first-line therapies. Rinvoq is only FDA-approved for psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, and ankylosing spondylitis when Tumor Necrosis Factor inhibitors have failed (or could not be tolerated), and is only FDA-approved for moderate to severe atopic dermatitis when oral and biologic medications such as Methotrexate, Mycophenolate Mofetil, Cyclosporine, Azathioprine, Dupixent or Adbry have failed (or could not be tolerated).
It does appear, therefore, that the FDA has significant concerns about JAK inhibitors being used as first-line therapy for atopic dermatitis (or any other condition) despite current interest and literature [1,2,4,5] support for use of JAK inhibitors overall in the treatment of atopic dermatitis. Therefore, consistent with consensus and literature [1-5] supporting oral/traditional and biologic therapies for moderate to severe atopic dermatitis, it can be concluded that Rinvoq, Xeljanz, and other JAK inhibitors are not appropriate for this patient, who has tried no systemic therapies to date for his eczematous dermatitis.
The lack of medical necessity for Rinvoq in this patient is particularly problematic for its use in alopecia areata, which is psychologically impacting but not physically/functionally impairing for this patient, and which appears to be the primary reason why Rinvoq is being prescribed.
Accordingly, Rinvoq is not recommended as medically necessary for either the patient's alopecia areata or atopic dermatitis.