Ulcerative colitis (UC) is associated with a substantial economic burden in the United States, largely driven by outpatient, inpatient, and treatment costs. The annual estimated cost related to UC ranges from $8.1 to $14.9 billion (in 2008 U.S. dollars). Ustekinumab and adalimumab are therapeutics approved by the FDA to treat UC, but there are no head-to-head clinical trials comparing these agents.
Researchers developed a cost per responder and remitter model to compare annual costs for ustekinumab versus adalimumab in patients with moderate-to-severe UC and found that ustekinumab had a lower annual cost than adalimumab at one year.
The results of the study were presented during AMCP Nexus 2020 Virtual in a poster presentation titled “Cost Per Responder and Cost Per Remitter Analysis of Ustekinumab Versus Adalimumab Among Patients with Moderate-To-Severe Ulcerative Colitis that have Failed Conventional Therapy in the United States.”
Researchers constructed the model using efficacy results from a network meta-analysis and accounted for differences in study design between the ULTRA II trial for adalimumab and the UNIFI trial for ustekinumab. Cost inputs included the number of doses per year and the cost per dose for each treatment. The study population comprised patients with moderate-to-severe UC who had failed conventional therapy (non-biologic failure population).
Differences between treatment and placebo groups in one-year response and remission rates were used as the final efficacy inputs for cost calculations. The one-year clinical response rate (delta versus placebo) was 43.0% for ustekinumab and 12.6% for adalimumab. The one-year clinical remission rate (delta versus placebo) was 28.1% for ustekinumab and 9.6% for adalimumab.
Drug costs were based on Big Four prices (a brand-name drug discount program for the four largest federal purchasers of pharmaceuticals) as of May 2020: $1,153.92 per ustekinumab 130 mg vial, $12,384.50 per ustekinumab 90 mg syringe, and $1,872.16 per adalimumab 40 mg syringe.
The total cost (calculated as induction plus maintenance therapy) was $71,576.51 for ustekinumab compared with $56,164.80 for adalimumab for one year.
The annual cost per responder was $166,457 for ustekinumab and $445,752 for adalimumab, and the annual cost per remitter was $254,721 for ustekinumab and $585,050 for adalimumab in the non-biologic failure population of patients with moderate-to-severe UC.
The study was limited by key differences in the two clinical trials that were compared, which complicated comparisons between these studies.
The study was sponsored by Janssen Scientific Affairs.
Ding Z, Obando C, Ni W, Muser E. Cost Per Responder and Cost Per Remitter Analysis of Ustekinumab Versus Adalimumab Among Patients with Moderate-To-Severe Ulcerative Colitis that have Failed Conventional Therapy in the United States. Poster K5. AMCP Nexus 2020 Virtual.