Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Crohn's disease. 
Treatment: Remicade (J1745-Injections). 

The insurer denied the Remicade (J1745-Injections). 
The denial is upheld. 

The patient is a male with CD (Crohn's disease). He has been on Remicade 10 mg/kg (milligrams per kilogram) every 8 weeks since adolescence. 

Per office visit note, the patient was evidenced to be in clinical remission. Colonoscopy was unremarkable including biopsies of the terminal ileum as well as the colon. 

The patient and the provider are requesting for the patient to stay on Remicade due to concerns about worsening CD (Crohn's disease) control and the possibility of development of antibodies against Remicade. 

No, the requested Remicade is not medically necessary. 

The plan denied Remicade because it is not documented that the patient has tried Inflectra before. The health plan is offering the preferred product Inflectra. Inflectra is one of the biosimilars which have been developed as a replacement for Remicade (infliximab). 

The provider is requesting for the patient to stay on Remicade due to concerns about worsening CD (Crohn's disease) control upon switching to Inflectra. 

Several clinical data are available in IBD (inflammatory bowel disease) patients treated with IFX (infliximab)-biosimilar or who were switched from Remicade with satisfactory outcomes, sustained efficacy and no sign of increased immunogenicity or any other safety concerns. In the clinical review by Deiana et al, multiple studies have been discussed without evidence of worsening outcome upon switching. (1)  

Another review by Bhat et al, concluded that current data support the efficacy and safety of biosimilars for the treatment of IBD (inflammatory bowel disease). In their article, they discussed the successful systematic switching from infliximab to biosimilar in two US (United States) based healthcare systems, Boston Medical Center (BMC) and Cleveland Clinic Foundation (CCF). (2) 

Multiple studies have shown no evidence of worsening disease control upon switching from brand name Remicade to Inflectra (infliximab-dyyb) biosimilar. In the study by Ho el al, using the Kaiser Permanente system data, they compared 1409 patients in the infliximab-dyyb group versus 1409 patients in the Remicade group using propensity score matched case control design. The authors found that 347 patients (24.6%) in the infliximab-dyyb group compared to 375 patients (26.6%) who remained Remicade who experienced disease worsening requiring acute care or treatment failure. The authors concluded that there was no increased risk of disease worsening requiring acute care or treatment failure in patients with IBD (inflammatory bowel disease) who switched from Remicade to Infelctra (infliximab-dyyb ) when compared to patients who remained on Remicade (3). 

Regarding the question of antibodies formation after switching, currently there is no evidence in the literature regarding this being an issue upon switching to biosimilar from infliximab brand Remicade as evident by the lack of clinically meaningful worsening of disease activity. In the study by Hoeve et al, in the pediatric age group that specifically investigated the immunogenicity and drug levels upon switching in 42 children (26 Crohn disease and 16 ulcerative colitis), it was found that there were no significant differences in drug level or antibody formation risk in this group. Given lack of comparable specific study among adults, it is safe to conclude that they will follow the same pattern given the abundance of studies that showed no change in disease activity upon switching (4). 

Yes, the health plan did act reasonably, with sound medical judgment and in the best interest of the patient. 
There is no clinical evidence that biosimilars are inferior to the Remicade in maintaining deep remission in this patient.