Budget Impact of Oral Semaglutide Intensification versus Sitagliptin among US Patients with Type 2 Diabetes Mellitus Uncontrolled with Metformin

Abstract

Background Oral semaglutide was approved in 2019 for blood glucose control in patients with type 2 diabetes mellitus (T2DM) and was the first oral glucagon-like peptide 1 receptor agonist (GLP-1 RA). T2DM is associated with substantial healthcare expenditures in the US, so the cost of a new intervention should be weighed against clinical benefits. Objective This study evaluated the budget impact of a treatment pathway with oral semaglutide 14 mg daily versus oral sitagliptin 100 mg daily among patients not achieving target glycated hemoglobin (HbA1c) level despite treatment with metformin. Methods This study used the validated IQVIA™ CORE Diabetes Model to simulate the treatment impact of oral semaglutide 14 mg and sitagliptin 100 mg over a 5-year time horizon from a US healthcare sector (payer) perspective. Trial data (PIONEER 3) informed cohort characteristics and treatment effects, and literature sources informed event costs. Population and market share data were from the literature and data on file. The analysis evaluated the estimated budget impact of oral semaglutide 14 mg use for patients currently using sitagliptin 100 mg considering both direct medical and treatment costs to understand the impact on total cost of care, given underlying treatment performance and impact on avoidable events. Results In a hypothetical plan of 1 million lives, an estimated 1993 patients were treated with sitagliptin 100 mg in the target population. Following these patients over 5 years, the incremental direct medical and treatment costs of a patient using oral semaglutide 14 mg versus sitagliptin 100 mg was $US16,562, a 70.7% increase (year 2019 values). A hypothetical payer would spend an additional $US3,300,143 (7.1%) over 5 years for every 10% of market share that oral semaglutide 14 mg takes away from sitagliptin 100 mg. Univariate and scenario analyses with alternate inputs and assumptions demonstrated consistent results. Conclusions Use of oral semaglutide 14 mg in patients currently receiving sitagliptin 100 mg substantially increases the budget impact for patients with T2DM whose blood glucose level is not controlled with metformin over a 5-year time horizon for US healthcare payers. Plain Language Summary Patients with type 2 diabetes mellitus (T2DM) have many treatment options. Choices depend on factors such as cost, preference, and patient characteristics. Oral semaglutide was recently approved for the treatment of T2DM as the first oral therapy Digital Features To view digital features for this article go to

Budget Impact Analysis of Diabetes Drugs: A Systematic Literature Review

“…The discounting rate was not always clearly reported in the included BIA studies. Four studies reported the discounting rate ranging from 3 to 5% (16,(23)(24)(25), eight studies (11,15,(17)(18)(19)(20)(21)27) did not consider the discounting rate in compliance with the ISPOR Task Force guidelines (7). Meanwhile, six studies (10, 12-14, 22, 26) did not mentioned the discounting rate in the articles.…”

“…Seven studies only calculated treatmentrelated costs only (10,(13)(14)(15)(21)(22)(23). Eleven studies took into account both treatment-related costs and condition-related costs (11,12,(16)(17)(18)(19)(20)(24)(25)(26)(27), of which nine studies considered the cost of hypoglycemia which was further classified into minor and severe hypoglycemia (11,12,16,18,20,(24)(25)(26)(27), six studies considered the cost of diabetes-related complications (11,16,17,19,25,27) (mainly including myocardial infarction (MI), stroke, heart failure, heart disease) and only one took the cost of adverse event (including dizziness, vomiting, fatigue and loss of appetite) into account (12).…”

“…Among the five basal insulin BIA studies, one of them was about insulin glargine biosimilar (13). The rest of BIA studies targeted GLP-1 RA (n = 4, including once-weekly semaglutide, oral semaglutide, and benaglutide) (12,14,25,27), DPP-4i (n = 3, including vildagliptin, saxagliptin, and linagliptin) (10,15,23), SGLT-2i (n = 2, both were dapagliflozin) (11,17) and metformin (n = 1) (19).…”

“…The majority of studies (n = 13) (10-12, 14-17, 19, 22-25, 27) restricted the target population on type 2 diabetes patients while some targeted type 1 diabetes patients (n = 2) (18,21), or type 1 and type 2 diabetes patients (n = 2) (20,26), and one study did not specify the target population (13). Six studies estimated the eligible population size based on a hypothetical health plan (20,(23)(24)(25)(26)(27), of which the assumed size varied widely ranging from 1 million to 35 million. All but one (23) of these studies reported the specific number of target population.…”

“…It is worth noting that one study applied the patient-years instead of patient number to measure the size of target population (10). Two other characteristics were checked: nine studies (16, 18, 20-24, 26, 27) reported conflict of interests (50%), 12 studies (14,(16)(17)(18)(19)(20)(22)(23)(24)(25)(26)(27) reported pharmaceutical company funding (66.7%), and three studies (10)(11)(12) contained no details of conflicts of interests or funding sources (16.7%).…”