Xeljanz Xr denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/ Case Summary: The enrollee has requested authorization and coverage for Xeljanz XR for the treatment of psoriatic arthritis. The Health Plan denied this request as not medically necessary on the basis that he has not tried two of the preferred (formulary) drugs to treat his condition. They assert that studies do not show that Xeljanz XR works better than other drugs to treat the enrollee’s condition.Findings: The physician reviewer found that a review of the medical record indicates the enrollee was diagnosed with psoriatic arthritis that has involved his scalp, fingers, ankles, and other joints. He has tried other medication with no change in his condition. He has been taking Xeljanz XR for several months and reports it is very effective for his condition and has no side effects.

Nature of Statutory Criteria/Case Summary: he enrollee has requested authorization and coverage for Xeljanz XR (extended release) for treatment of the enrollee’s rheumatoid arthritis.Findings: The physician reviewer found that the 2015 American College of Rheumatology (ACR) Guideline for treatment of rheumatoid arthritis recommends methotrexate (MTX) with or without tumor necrosis factor inhibitor (TNFi) as the next treatment option in patients who have failed MTX alone. There is evidence that a second TNFi is effective in those who have tried and failed a previous TNFi or have had adverse reactions to other TNFi. In this patient’s case, the documentation provided indicates failure of multiple disease-modifying antirheumatic drugs. Previous treatments have included methotrexate 17.5 mg, which was stopped in February 2017 because the patient was not able to tolerate the therapy.

Where the denial was upheld

Findings: The physician reviewer found that this enrollee has a history of rheumatoid arthritis. Previous therapy has included Arava and Remicade. Treatment with Remicade was stopped due to a lack of efficacy and because of side effects. The patient complained of pain, and physical examination identified proximal interphalangeal (PIP) joint swelling on the right and metacarpophalangeal (MCP) joint swelling on the left. The patient is noted to have been taking Xeljanz samples, which have been effective. The 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis (the 2015 ACR Guideline) recommends methotrexate (MTX) +/- Tumor Necrosis Factor inhibitor (TNFi) as the next treatment for patients who have failed MTX alone.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Xeljanz XR 11 mg daily. In regards to the use of Xeljanz (tofacitinib) for the treatment of rheumatoid arthritis (RA), the 2015 American College of Rheumatology (ACR) Guideline for the Treatment of Rheumatoid Arthritis recommends methotrexate (MTX)+/- TNF inhibitor (TNFi) as the next treatment in those who have failed MTX alone. There are also multiple studies demonstrating efficacy and safety with TNFi over the years in treating moderate to severe RA. There is evidence that a second TNFi is effective in those who have tried and failed a previous TNFi or have had adverse reactions to other TNFi.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Xeljanz Xr, then check the rights and deadlines that apply to your plan.