Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Arthropathic Psoriasis
Treatment: Xeljanz five milligrams (mg).
The insurer denied the Xeljanz five milligrams (mg).
The denial is upheld

The patient is a female with longstanding psoriasis and severe, deforming psoriatic arthritis with arthritis mutilans. She has failed treatment with Indomethacin, Enbrel, methotrexate, Remicade, Humira, Simponi, Cimzia, Otezla, Stelara, Cosentyx (which led to the onset of Crohn's disease a few years ago), Actemra, Rinvoq and Tremfya. She started treatment with Xeljanz on two different occasions. Xeljanz was given in combination with Stelara, and Stelara was changed to Enbrel approximately two years ago.

The attached physician's appeal letter states the patient has been doing well on the combination of Enbrel 50 milligrams (mg) weekly and Xeljanz five milligrams (mg) daily. The physician asserts that Xeljanz must be continued for this patient's inflammatory bowel disease (IBD), while Enbrel is used to treat her arthritis and skin disease.

The patient has failed all other biologics that can be used for her bowel, joint and skin disease. Per her most recent progress note, she had been doing well on Enbrel and Xeljanz five milligrams (mg) daily for approximately several months but ran out of Xeljanz and developed a joint and skin flare. The patient's inflammatory bowel disease (IBD) was quiescent at this time.

Xeljanz was denied for this patient because it was prescribed in combination with the biologic Enbrel. The appeal if for Xeljanz five milligrams (mg) daily in combination with Enbrel 50 milligrams (mg) weekly for the treatment of psoriasis and severe, deforming psoriatic arthritis with arthritis mutilans in a patient with inflammatory bowel disease (IBD) (Crohn's disease).

No, the proposed treatment, Xeljanz five milligrams daily in combination with Enbrel 50 milligrams weekly, is not medically necessary.
Both Xeljanz and Enbrel are Food and Drug Administration (FDA) approved for the treatment of psoriasis and psoriatic arthritis, as seen in this patient. Xeljanz is additionally Food and Drug Administration (FDA) approved for the treatment of ulcerative colitis, but is being continued and requested for the management of Cosentyx-induced Crohn's disease in this patient.

This patient has tried and failed non-steroidal anti-inflammatory drugs (NSAIDs), as well as numerous biologics, conventional disease-modifying antirheumatic drugs (DMARDs), and targeted synthetic disease-modifying antirheumatic drugs (DMARDs), as enumerated above.

At the patient's recent office visit, she experienced a joint and mild skin flare while off of Xeljanz five milligrams once a day, and while on Enbrel 50 milligrams (mg) weekly. Although there are a few case reports and retrospective case series examining the use of various dual biologic therapies for the treatment of refractory inflammatory bowel disease (IBD) and psoriasis/psoriatic arthritis, such combination therapy is not clinically appropriate, nor in accordance with standard of care in the rheumatology community.

"Higher quality combination of therapies with a significant improvement in the quality of data is required prior to more widespread use." (2).

"Safety concerns should always be at the forefront of decision-making, and larger studies are needed to help confirm the preliminary safety data observed" (1).

Furthermore, there is no specific documentation of lack of response to biologic or targeted synthetic disease-modifying antirheumatic drug (DMARD) therapy in combination with conventional disease-modifying antirheumatic drug (DMARD) therapy for this patient. The Plan states that Xeljanz cannot be used with any biologics or targeted synthetic disease-modifying antirheumatic drugs (DMARDs).  However, Xeljanz can be used with conventional disease-modifying antirheumatic drugs (DMARDs), and Food and Drug Administration (FDA) guidelines stipulate that Xeljanz should be combined with a conventional disease-modifying antirheumatic drug (DMARD) such as methotrexate for the treatment of psoriatic arthritis. Targeted synthetic disease-modifying antirheumatic drugs (DMARDs) and conventionaldisease-modifying antirheumatic drugs (DMARDs) are not the same. Prior to consideration of off-label combination therapy of Xeljanz with Enbrel (and long-term safety concerns of this combination), it would be appropriate to demonstrate failure of standard of care combination therapy with a conventional disease-modifying antirheumatic drug (DMARD).   Many of these disease-modifying antirheumatic drugs (DMARDs) are also used for the treatment of inflammatory bowel disease (IBD).

Therefore, the proposed Xeljanz five milligrams daily in combination with Enbrel 50 milligrams weekly is not medically necessary for this specific patient.

Yes, the health plan did act reasonably, with sound medical judgment and in the best interest of the patient.