Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Preferred Agents:
Axial Spondyloarthritis/Ankylosing Spondylitis (AS)
TNF Inhibitors
adalimumab-adaz
adalimumab-adbm - labeler 00597
adalimumab-fkjp
AVSOLA (infliximab-axxq)
CYLTEZO (adalimumab-abdm)
ENBREL (etanercept)
HULIO (adalimumab-fkjp)
HUMIRA (adalimumab)
RENFLEXIS (infliximab-abda)
SIMLANDI (adalimumab-ryvk)
SIMPONI (golimumab) subcutaneous
YUSIMRY (adalimumab-aqvh)
Interleukin (IL) - 17 Inhibitors
TALTZ (ixekizumab)
Janus Kinase (JAK) Inhibitor
XELJANZ IR (tofacitinib) 5mg tablet, oral solution
RINVOQ ER (upadacitinib)
Polyarticular Juvenile Idiopathic Arthritis (PJIA)
TNF Inhibitors
adalimumab-adaz
adalimumab-adbm - labeler 00597
adalimumab-fkjp
CYLTEZO (adalimumab-abdm)
ENBREL (etanercept)
HULIO (adalimumab-fkjp)
HUMIRA (adalimumab)
SIMLANDI (adalimumab-ryvk)
YUSIMRY (adalimumab-aqvh)
Janus Kinase (JAK) Inhibitor
XELJANZ IR (tofacitinib) 5mg tablet, oral solution
RINVOQ ER (upadacitinib)
T-cell Costimulation Blocker
ORENCIA (abatacept) - 125 mg/mL syringe subcutaneous
Psoriatic Arthritis (PsA)
TNF Inhibitors
adalimumab-adaz
adalimumab-adbm - labeler 00597
adalimumab-fkjp
AVSOLA (infliximab-axxq)
CYLTEZO (adalimumab-abdm)
ENBREL (etanercept)
HULIO (adalimumab-fkjp)
HUMIRA (adalimumab)
RENFLEXIS (infliximab-abda)
SIMLANDI (adalimumab-ryvk)
SIMPONI (golimumab) subcutaneous
YUSIMRY (adalimumab-aqvh)
Janus Kinase (JAK) Inhibitor
RINVOQ ER (upadacitinib)
Interleukin (IL)-23p19 Inhibitor
SKYRIZI (risankizumab-rzaa)
TREMFYA (guselkumab)
Interleukin (IL)-17 Inhibitor
TALTZ (ixekizumab)
Rheumatoid Arthritis (RA)
TNF Inhibitors
adalimumab-adaz
adalimumab-adbm - labeler 00597
adalimumab-fkjp
AVSOLA (infliximab-axxq)
CYLTEZO (adalimumab-abdm)
ENBREL (etanercept)
HULIO (adalimumab-fkjp)
HUMIRA (adalimumab)
RENFLEXIS (infliximab-abda)
SIMLANDI (adalimumab-ryvk)
SIMPONI (golimumab) subcutaneous
YUSIMRY (adalimumab-aqvh)
Janus Kinase (JAK) Inhibitor
RINVOQ ER (upadacitinib)
T-cell Costimulation Blocker
ORENCIA (abatacept) - 125 mg/mL syringe subcutaneous
Interleukin (IL)-6 Inhibitor
ACTEMRA (tocilizumab)
TYENNE (tocilizumab-aazg)
The use of golimumab (Simponi Aria) may be considered medically necessary when ALL of the following criteria are met:
-
The individual must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route);
and
-
Golimumab (Simponi Aria) must be prescribed by, or in consult with, a specialist in the area of the individual's treated diagnosis;
and
-
Clinical justification must be provided why a self-administered agent cannot be used (subject to clinical review);
AND
- If diagnosis is AS, the individual must have failed a 30-day trial of Xeljanz and Rinvoq ER, and a 90-day trial of a TNF inhibitor, and a 90-day trial of Taltz, as evidenced by paid claims or pharmacy printouts.
- If diagnosis is PJIA, the individual must have failed a 30-day trial of Rinvoq ER, and Xeljanz and a 90-day trial of a TNF inhibitor and Orencia, as evidenced by paid claims or pharmacy printouts.
- if diagnosis PsA or RA, the individual must have had a 90-day trial of a preferred agent from each class approved for the individual's diagnosis, as evidenced by paid claims or pharmacy printouts and clinical justification must be provided why a self-administered agent cannot be used (subject to clinical review).
Reauthorization Criteria
The continues use of golimumab (Simponi Aria) may be considered medically necessary when
ALL
of the following criteria are met:
-
The individual has previously been approved for golimumab (Simponi Aria) through Blue Cross Blue Shield of North Dakota's precertification process;
and
-
The prescriber has provided documentation that the individual has demonstrated disease stability or beneficial response to therapy;
and
- The individual must continue to meet applicable initial criteria.
The use of golimumab (Simponi Aria) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
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