When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.
This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.
The FDA approved the intravenous (I.V.) form of golimumab (Simponi Aria®), on October 20, 2017 for the treatment of adults with active psoriatic arthritis.
The safety and efficacy of golimumab (Simponi Aria®) was studied in a phase III, randomized, double-blind, placebo-controlled trial in 480 adults with active psoriatic arthritis (Kavanaugh, et al, 2017). Participants had previous received DMARD therapy (≥3 months) and/or NSAID therapy (≥4 weeks) or demonstrated intolerance to these agents. Participants were randomized (1:1) to receive golimumab (Simponi Aria®) or placebo at weeks 0, 4, 12, and 20. The primary outcome of the study was the percentage of participants who met the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at week 14. The results showed a statistically significant improvement in the golimumab (Simponi Aria®) group (75% of participants) when compared to the placebo group (22% of participants) (p<0.001).
RHEUMATOID ARTHRITIS (RA)
Rheumatoid arthritis (RA) is an autoimmune disease that results in a chronic and systemic inflammatory disorder that affects tissues and organs. RA can cause pain, stiffness, swelling, and limited motion and function of many joints. In RA, the focus of the inflammation is in the synovium, the tissue that lines the joint. Immune cells release inflammation-causing chemicals. These chemicals can damage cartilage (the tissue that cushions between joints) and bone.
The FDA approved an intravenous (I.V.) form of golimumab (Simponi Aria®) on July 18, 2013 for the treatment of adult individuals with moderately to severely active RA, in combination with methotrexate (MTX). The FDA's approval of golimumab (Simponi Aria®) is based upon a double-blind, placebo-controlled clinical study involving 592 individuals. The study participants were 18 years and older, with moderately to severely active RA, who were simultaneously treated with MTX. The individuals in the study were diagnosed with RA according to the American College of Rheumatology (ACR) classification criteria three months prior to the start of the study. All participants were required to have at least six swollen and six tender joints. These individuals were randomized into either the treatment group (n=395) or the placebo group (n=197). Individuals in the treatment group received golimumab (Simponi Aria®) with MTX. The golimumab (Simponi Aria®) dose regimen administered was 2 mg/kg given as an intravenous infusion at weeks 0 and 4, then every 8 weeks thereafter. The placebo group received a placebo with MTX up until week 24. After week 24, individuals in the placebo group, while still blinded, received golimumab (Simponi Aria®) and MTX through week 52.
All participants completed 52 weeks of treatment. Participants were able to continue stable doses of concurrent low-dose corticosteriods (less than or equal to 10 mg of prednisone a day). The use of other disease-modifying antirheumatic drugs (DMARDS), including cytotoxic agents or other biologics, was prohibited.
The clinical response was measured using the American College of Rheumatology (ACR) response criteria for RA. The ACR criteria are used, in most clinical trials, to assess efficacy of the treatment for RA. The results are reported as a percentage of study participants who achieve ACR20 (20 percent improvement in swollen joints), ACR50 (50 percent improvement), and ACR70 (70 percent improvement) in three of the five criteria:
Policy: 08.00.15e:Off-label Coverage for Prescription Drugs and/or Biologics
Policy: 08.00.34m:Infliximab and Related Biosimilars
Policy: 08.00.50s:Rituximab (Rituxan®) Infusion and Related Biosimilars, and Rituximab/Hyaluronidase Human for Subcutaneous Injection (Rituxan Hycela®)
Policy: 08.00.62i:Abatacept (Orencia®) for Injection for Intravenous Use
Policy: 08.00.82j:Ustekinumab (Stelara®)
Policy: 08.00.85h:Tocilizumab (Actemra®) for Intravenous Infusion