P0572 - Costs for Treating Patients With Ulcerative Colitis With Vedolizumab or Adalimumab Based on Endoscopic Improvement Data From the VARSITY Trial

Jesse Ortendahl, MS¹, Sabyasachi Ghosh, MS², Ninfa Candela, MD³, Tao Fan, PhD, MS², Kandavadivu Umashankar, PharmD, MS^2
1Partnership for Health Analytic Research, LLC, Beverly Hills, CA; ²Takeda Pharmaceuticals USA, Inc., Lexington, MA; ³Takeda Pharmaceuticals USA, Inc., Wellesley, MA

Introduction: Ulcerative colitis (UC) is a chronic inflammatory disease that affects approximately 1 million people in the USA. Long-term medication, intermittent periods of hospitalization and, in the most severe cases, the need for colectomy, are all factors that contribute to the high costs associated with treating UC. Endoscopic improvement (EI) has been linked to reduced colectomy rates and, in the VARSITY trial, a greater proportion of patients treated with vedolizumab (VDZ) experienced EI than those treated with adalimumab (ADA);¹ however, the cost implications of treating with either VDZ or ADA are unknown.

Methods: Using a Monte Carlo simulation model, we projected the mean cost for treating patients with moderate to severe UC who received either VDZ or ADA. The inputs were EI rates as reported in the VARSITY trial (ClinicalTrials.gov identifier: NCT02497469), with EI defined as a Mayo endoscopic subscore of 0 or 1 at week 52;¹ drug cost, including wholesale acquisition cost, administration cost and wastage; colectomy cost based on a claims analysis;² and colectomy rates deduced from a meta-analysis of UC-related surgery-free status with or without EI³ (Table). The model calculated the mean cost for a US patient from a cohort of 10,000 over a 1-year period from a payer’s perspective, and accounted for discontinuation of treatment due to lack of response, with response defined as EI.

Results: The mean annual cost for a patient treated with VDZ is less than that for a patient treated with ADA (Figure). The cost consists of drug and colectomy costs, both of which are lower for a patient treated with VDZ ($37,515 and $10,062 respectively) than with ADA ($50,559 and $11,841 respectively). The data reflect a total saving of $14,823 associated with use of VDZ versus ADA.

Discussion: The high economic burden associated with UC highlights the need for cost-effective management strategies. The simulation presented here suggests a cost saving associated with the use of VDZ over the course of a year versus ADA. Cost savings are, in part, due to the higher EI rate and lower need for colectomy with VDZ compared with ADA. Furthermore, the data support the financial benefit of targeting EI in addition to clinical remission as a critical endpoint in managing patients with UC.



1. Sands BE et al. N Engl J Med 2019;381:1215–26.
2. Pilon D et al. Curr Med Res Opin 2020;36:1285–94.
3. Shah SC et al. Clin Gastroenterol Hepatol 2016;14:1245–55.




Figure: Figure. Mean total cost per patient treated with vedolizumab or adalimumab over 1 year. Error bars indicate the range across 10,000 individual simulated patients.

Proportion of patients with EI,1 %	Vedolizumab	39.7
	Adalimumab	27.7
Drug cost per patient,* US$	With EI	Vedolizumab†	60,133
		Adalimumabǂ	89,523
	Without EI	Vedolizumab†	22,550
		Adalimumabǂ	35,809
Colectomy cost per patient,2,§ US$	90,858
Proportion of surgery-free patients,3 %	With EI	96.5
	Without EI	86.1

Table: Table. Monte Carlo simulation model input variables.

*Drug cost is presented as wholesale acquisition cost (based on PriceRx, as of April 22, 2021) + administration cost (based on the Physicians’ Fee and Coding Guide).

†Intravenous administration of vedolizumab in a clinic over 30 minutes has been assumed. Patients received 300 mg at 0, 2 and 6 weeks and those with EI received 300 mg every 8 weeks from week 14.

ǂSelf-administration of subcutaneous adalimumab has been assumed. Patients received 160 mg on day 1, 80 mg on day 15 and 40 mg on days 29 and 43 and those with EI received 40 mg every 14 days for the remainder of the year.

§Colectomy cost calculated as the difference between the annual cost of patients requiring UC-related surgery and those not requiring UC-related surgery. Colectomy cost was reported in 2017 and has been inflated to 2020 US$.

EI, endoscopic improvement; UC, ulcerative colitis.


Disclosures:
Jesse Ortendahl: Partnership for Health Analytic Research, LLC – Employee. Takeda Pharmaceuticals U.S.A., Inc – Other Financial or Material Support, Jesse is an employee of PHAR, LLC, who received payment for conducting the research described in this abstract.
Sabyasachi Ghosh: Takeda Pharmaceuticals U.S.A., Inc – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Ninfa Candela: Takeda Pharmaceuticals U.S.A., Inc – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Tao Fan: Takeda Pharmaceuticals U.S.A., Inc – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Kandavadivu Umashankar: Takeda Pharmaceuticals U.S.A., Inc – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).


Jesse Ortendahl, MS¹, Sabyasachi Ghosh, MS², Ninfa Candela, MD³, Tao Fan, PhD, MS², Kandavadivu Umashankar, PharmD, MS². P0572 - Costs for Treating Patients With Ulcerative Colitis With Vedolizumab or Adalimumab Based on Endoscopic Improvement Data From the VARSITY Trial, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.