Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Rheumatoid arthritis

Treatment: Rinvoq

The insurer denied coverage for Rinvoq

The denial is upheld

 
This case involves an adult patient regarding the continued use of Rinvoq.  The patient was seen regarding rheumatoid arthritis involving both elbows with negative rheumatoid factor.  Since her last visit, she developed fevers and was feeling unwell.  The physician advised the patient to stop medications for one week and resume Rinvoq only after resolution.  At the time, the patient was in the second week of Rinvoq and feeling well.  Without Rinvoq, she felt more stiffness.  She had mild limitation in extension in the right elbow with noticeable but lessened swelling of the left knee.  The report stated the patient was taking sulfasalazine 1500 milligrams (mg) oral 2 times daily.  On physical examination, the right elbow was slightly limited in extension and slightly swollen.  The left elbow had returned to normal.  The left knee was swollen but improved significantly from prior examination.  The progress notes stated the patient was seen via telemedicine visit.  She was using Rinvoq for about 2 months via samples from her physician's office.  She took a 2-week break during these 2 months due to side effects but was also on sulfasalazine.  It was determined that the side effects were associated with the sulfasalazine and there were no issues since restarting Rinvoq alone.  She has one tablet remaining at that time.  She continued to take prednisone 5 mg tablets, 1 tablet daily via oral route.  


The Food and Drug Administration states that Rinvoq is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have an inadequate response or intolerance to one or more TNF blockers.  Rinvoq is not recommended for use in combination with other Janus kinase (JK) inhibitors, biologic Disease-modifying antirheumatic drugs (DMARDS) or with potent immunosuppressant such as azathioprine and cyclosporine.  The recommended dose for treating rheumatoid arthritis is 15 mg once daily.  The documentation provided for the review noted the patient had previously trialed sulfasalazine, prednisone, naproxen, ibuprofen, and Tylenol for treating rheumatoid arthritis.  The patient was given samples of Rinvoq and reported benefits with the use of the medication to include improvements in stiffness and swelling.  However, the treating physician failed to specify why the patient was not recommended to try Cimzia, Humira, or Simponi given that these are preferred products under the patient's healthcare plan.  There were no records indicating the patient had an intolerance or lack of response to any of these drugs and given that she had only taken Rinvoq sporadically (via samples), it would be reasonable for the patient to switch to one of the preferred products to determine if she has a similar response before recommending resumption of Rinvoq for treating her rheumatoid arthritis.  Furthermore, this is consistent with the recommendation for initial treatment in Up to Date. "In patients unable or unwilling to take methotrexate (MTX), we use leflunomide, sulfasalazine, hydroxychloroquine, or a tumor necrosis factor (TNF) inhibitor (e.g., etanercept or adalimumab). Tofacitinib, baricitinib, and upadacitinib are also effective in such patients. There are insufficient data to identify the optimal initial therapy in patients who are unable to take MTX."

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Rinvoq is not substantiated.