Yale University School of Medicine and PACT-Gastroenterology Center Westport, CT, United States
Paul Feuerstadt, MD1, Mei Lu, MSc, MD2, Emi Terasawa, PhD3, Brian Terreri, PharmD, MBA4, Shawn Du, PhD3, Rajeev Ayyagari, PhD5, Brooks D. Cash, MD, FACG6, Anthony Lembo, MD7, Baha Moshiree, MD8, Philip Schoenfeld, MD, MSEd, MSc (Epi), FACG9, Mena Boules, MD4, Linda Nguyen, MD10 1Yale University School of Medicine and PACT-Gastroenterology Center, Hamden, CT; 2Takeda Development Center Americas, Inc., Lexington, MA; 3Analysis Group, Inc., New York, NY; 4Takeda Pharmaceuticals USA, Inc., Lexington, MA; 5Analysis Group, Inc., Boston, MA; 6University of Texas Health Science Center at Houston, Houston, TX; 7Beth Israel Deaconess Medical Center, Boston, MA; 8Atrium Health, Charlotte, NC; 9John D. Dingell VA Medical Center, Redwood City, CA; 10Stanford University, Redwood City, CA
Introduction: Prucalopride is a selective high-affinity serotonin type-4 receptor agonist approved for the treatment of chronic idiopathic constipation in adults. Healthcare costs before and after the initiation of prucalopride in the USA have not been studied.
Methods: An observational retrospective cohort analysis of data from the MarketScan Commercial Claims and Encounters database (2015–Q2 2020) was performed for patients aged 18–64 years with ≥1 prescription filled for prucalopride and a diagnosis of constipation based on ICD-10 codes, who were continuously enrolled from ≥6 months before (baseline) to ≥6 months after (study period) prucalopride initiation. Patients were excluded if they had a diagnosis of irritable bowel syndrome with constipation, drug-induced constipation or post-operative ileus, opioid use or had a capitated health plan. Healthcare costs were estimated from a third-party payer perspective and adjusted to 2020 US dollars and included pharmacy costs and medical costs (from inpatient, emergency room and outpatient encounters). All-cause and constipation-related healthcare costs (identified using ICD-10 codes) were compared at baseline and during the study period using a Wilcoxon signed-rank test.
Results: A total of 564 patients were included in the analysis. There was a reduction in all-cause medical costs in the study period versus baseline (total $11 679 vs $13 393; p< 0.001; Image). Total all-cause healthcare costs were numerically lower during the study period than baseline ($20 263 vs $21 145); however, this difference was not statistically significant. There was a significant reduction in constipation-related medical costs in the study period versus baseline (total $580 vs $876; p< 0.001; Image), primarily driven by reduced constipation-related outpatient costs ($385 vs $550; p< 0.001). Constipation-related pharmacy costs increased over the study period; however, when the cost of prucalopride was excluded, total constipation-related healthcare costs decreased from $1497 (SD, $2732) at baseline to $949 (SD, $2913) in the study period (p< 0.001)
Discussion: Although pharmacy costs increased, constipation-related and all-cause medical costs were both significantly reduced after the initiation of prucalopride, mostly due to reduction of outpatient costs. As healthcare costs typically increase when a new treatment is initiated, additional studies with a longer follow-up are warranted to further investigate the cost impact of prucalopride.
Figure: Image. Mean all-cause (A) and constipation-related (B) healthcare costs in the 6 months before (baseline) and 6 months after (study period) the initiation of prucalopride treatment in patients aged 18–64 years without a capitated health plan (N=564)
*Significant difference at the 5% confidence level. Medical costs are defined as the sum of the medical costs at different settings (ER, inpatient, outpatient office/clinic/urgent care, outpatient hospital/surgical center and other outpatient setting). Outpatient costs are the sum of the costs presented for outpatient/office/clinic/urgent care, outpatient hospital/surgical center and outpatient other (i.e., laboratory tests and outpatient home health services). Total healthcare costs are the sum of the medical costs at all settings and pharmacy costs. Constipation-related medical costs are defined as costs associated with healthcare resource use for which a diagnosis code for constipation was found in one of the first three positions for the corresponding claim. Constipation-related pharmacy costs were defined as costs associated with constipation-related treatments. ER, emergency room.
Mei Lu: Takeda Development Center Americas, Inc. – Employee. Takeda Pharmaceutical Company Limited – Stockholder/Ownership Interest (excluding diversified mutual funds).
Emi Terasawa: Analysis Group Inc. – Employee. Takeda Pharmaceuticals USA, Inc. – Grant/Research Support.
Brian Terreri: Takeda Development Center Americas, Inc. – Employee. Takeda Pharmaceutical Company Limited – Stockholder/Ownership Interest (excluding diversified mutual funds).
Shawn Du: Analysis Group Inc. – Employee. Takeda Pharmaceuticals USA, Inc. – Grant/Research Support.
Rajeev Ayyagari: Analysis Group Inc. – Employee. Takeda Pharmaceuticals USA, Inc. – Grant/Research Support.
Mena Boules: Takeda Development Center Americas, Inc. – Employee. Takeda Pharmaceutical Company Limited – Stockholder/Ownership Interest (excluding diversified mutual funds).
Paul Feuerstadt, MD1, Mei Lu, MSc, MD2, Emi Terasawa, PhD3, Brian Terreri, PharmD, MBA4, Shawn Du, PhD3, Rajeev Ayyagari, PhD5, Brooks D. Cash, MD, FACG6, Anthony Lembo, MD7, Baha Moshiree, MD8, Philip Schoenfeld, MD, MSEd, MSc (Epi), FACG9, Mena Boules, MD4, Linda Nguyen, MD10. P1441 - Healthcare Costs Before and After the Initiation of Prucalopride Treatment: A Real World Study in Patients With Constipation in the U.S., ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.