Diagnosis: Psoriasis and Psoriatic Arthritis Treatment: Pharmacy/Prescription Drugs Summary: This patient with psoriasis and PsA (psoriatic arthritis) has mechanical knee pain and inflammatory back pain. There is no synovitis and some clearing of skin lesions of the left elbow and knees is noted. Osteoarthritis of multiple sites and psoriasis is noted. A history of hair loss with methotrexate (MTX) is noted. The plan is for Humira at psoriasis dosing. The prior approval form indicates that the request is for the treatment of psoriasis. There is no indication that the patient has gotten Humira yet. In a letter accompanying the appeal request the MD notes that the patient has ongoing PsA and that weekly Humira can be used when the patient is not on MTX. The insurer has denied coverage for Humira Pen 40mg/0.4ml SC PNKT. The denial was upheld. Humira treats both psoriasis and PsA. The FDA-labeling for Humira indicates one vial SQ every other week for PsA. This can be increased to every week if needed, if the patient is not on MTX. The dosing for psoriasis is 80 mg followed by one vial SQ every other week. The documentation in this case is inconsistent. The office note and Prior Approval request indicate that the Humira is for the psoriasis, but the medical doctor (MD) appeal letter notes it is needed for PsA. If the request is for the use of Humira in the treatment of psoriasis then the insurer is correct in denying every week as the indication is for every other week. If in fact the request is for the treatment of PsA then the insurer's denial is still valid, as there has not been any trial of the every other week dosing. The weekly dosing is used if every other week fails. No synovitis is noted at the office visit, and there is no documentation that supports the need to bypass the standard every other week dosing and going straight to every week. Humira Pen 40mg/0.4ml SC PNKT once weekly is not considered medically necessary for this patient. As noted above, the every other week dosing is appropriate. The patient's clinical condition does not meet national criteria for weekly dosing of Humira Pen 40mg/0.4ml SC PNKT. Every week is not indicated for psoriasis, and there has been no trial of the standard every other week for PsA.

1) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s410lbl… 2) Adalimumab: drug information.Lexicomp https://www.uptodate.com/contents/adalimumab-including-biosimilars-of-a…-