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The American Journal of Managed Care March 2020
Gender Differences in Newly Separated Veterans’ Use of Healthcare
Laurel A. Copeland, PhD; Erin P. Finley, PhD; Dawne Vogt, PhD; Daniel F. Perkins, PhD; and Yael I. Nillni, PhD
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Klaus W. Lemke, PhD; Kiemanh Pham, MD, MPH; Debra M. Ravert, MD; and Jonathan P. Weiner, DrPH
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Glenn Melnick, PhD; and Katya Fonkych, PhD
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Patrick Liu, AB; Sanket S. Dhruva, MD, MHS; Nilay D. Shah, PhD; and Joseph S. Ross, MD, MHS
Care Management Reduced Infant Mortality for Medicaid Managed Care Enrollees in Ohio
Alex J. Hollingsworth, PhD; Ashley M. Kranz, PhD; and Deborah Freund, PhD
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Brant Morefield, PhD; Lisa Tomai, MS; Vladislav Slanchev, PhD; and Andrea Klemes, DO
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Cost-effectiveness of Diabetes Treatment Sequences to Inform Step Therapy Policies
Anna Hung, PharmD, PhD; Bhavna Jois, BS; Amy Lugo, PharmD; and Julia F. Slejko, PhD
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Richard L. Sheer, BA; Richard L. Barron, MS; Lavanya Sudharshan, MS; and Margaret K. Pasquale, PhD
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Cost-effectiveness of Diabetes Treatment Sequences to Inform Step Therapy Policies

Anna Hung, PharmD, PhD; Bhavna Jois, BS; Amy Lugo, PharmD; and Julia F. Slejko, PhD
This study assesses the cost-effectiveness of adding a sodium-glucose cotransporter 2 inhibitor versus switching to a glucagon-like peptide-1 receptor agonist in patients with diabetes on metformin and a dipeptidyl peptidase-4 inhibitor.
ABSTRACT

Objectives:
Cost-effectiveness estimates are useful to a health plan when they are specific to a utilization management policy question. To help inform a step therapy policy decision, this study assessed the 3-year cost-effectiveness of adding a sodium-glucose cotransporter 2 (SGLT2) inhibitor versus switching to a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in patients with type 2 diabetes who are on metformin and a dipeptidyl peptidase-4 (DPP-4) inhibitor from both private and public payer perspectives in the United States.

Study Design: Cost-effectiveness analysis.

Methods: A decision-analytic model was built incorporating goal glycated hemoglobin (A1C) achievement as the effectiveness measure, as well as adverse effect and discontinuation rates from clinical trial data. One-way, scenario, and probabilistic sensitivity analyses were performed.

Results: In a cohort of 1000 patients, adding an SGLT2 inhibitor led to $3.9 million more in spending and 93 more patients reaching goal A1C compared with switching from a DPP-4 inhibitor to a GLP-1 RA. This resulted in an incremental cost-effectiveness ratio (ICER) of $42,125 per patient to achieve goal A1C from the private payer perspective. Using a public payer perspective led to an ICER of $103,829. These results were most sensitive to changes in drug costs and the proportion of patients achieving A1C goal or discontinuing.

Conclusions: Assuming a $50,000 willingness-to-pay threshold, adding an SGLT2 inhibitor was cost-effective compared with switching from a DPP-4 inhibitor to a GLP-1 RA from a private payer perspective but not from a public payer perspective. This study highlights how differences in payer reimbursement rates for medications can lead to contrasting results.

Am J Manag Care. 2020;26(3):e76-e83. https://doi.org/10.37765/ajmc.2020.42639
Takeaway Points

This study assesses the cost-effectiveness of adding a sodium-glucose cotransporter 2 (SGLT2) inhibitor versus switching from a dipeptidyl peptidase-4 (DPP-4) inhibitor to a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in patients with type 2 diabetes already on metformin and a DPP-4 inhibitor.
  • Cost-effectiveness estimates are especially useful to a health plan when they are specific to a utilization management policy question.
  • Several health plans had step therapy policies for SGLT2 inhibitors that required metformin and a DPP-4 inhibitor before use of an SGLT2 inhibitor. An alternative step therapy policy that was under consideration in 2017 was to additionally require switching from a DPP-4 inhibitor to a GLP-1 RA before adding an SGLT2 inhibitor.
  • Adding an SGLT2 inhibitor was cost-effective compared with switching from a DPP-4 inhibitor to a GLP-1 RA from a private payer perspective but not from a public payer perspective.
  • The results from this study differed by payer type (public payer vs private payer) due to differences in drug prices.
Type 2 diabetes (T2D) is estimated to affect approximately 27 million Americans and cost approximately $327 billion.1,2 Of this, $237 billion is spent on direct medical care and $90 billion is due to reduced productivity.2 Metformin has increasingly become the first-line agent for T2D; it was prescribed for approximately 60% to 77% of all patients using first-line antidiabetic treatment from 2005 to 2016.3 During this time period, sulfonylureas were the most commonly prescribed second-line agents, but their use has decreased (from 60% to 46%).3 Over the same time frame, the use of dipeptidyl peptidase-4 (DPP-4) inhibitors as second-line agents has increased from 0.4% to 21%.3

In 2013, a new antidiabetic drug class called sodium-glucose cotransporter 2 (SGLT2) inhibitors entered the US market. Canagliflozin was the first drug in the class approved by the FDA, followed by dapagliflozin and empagliflozin in 2014 and ertugliflozin in 2017.4 SGLT2 inhibitors enhance urinary excretion of glucose by blocking transport proteins that help reabsorb glucose systemically.5 SGLT2 inhibitors safely and effectively reduce glycated hemoglobin (A1C) levels by 0.5% to 1.0%,5 reduce body weight by 1 to 3 kg,6 and reduce systolic blood pressure by 3 to 5 mmHg.7,8 Common adverse effects (AEs) include urinary tract infections (UTIs), genital mycotic infections (GMIs), and polyuria.6

In 2018, the American Association of Clinical Endocrinologists guidelines suggested the preferential use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) before SGLT2 inhibitors as the second-line or third-line agent after metformin.9 GLP-1 RAs are injectables that include exenatide, liraglutide, albiglutide, dulaglutide, lixisenatide, and semaglutide, as well as an oral formulation of semaglutide most recently approved. Whereas exenatide and liraglutide have been on the US market since 2005 and 2010, respectively, albiglutide, dulaglutide, lixisenatide, and semaglutide (injectable) entered the US market more recently, between 2014 and 2017.4 The efficacy of these agents in reducing A1C and body weight has been well established.10-14 Common AEs include gastrointestinal events and hypoglycemia.12

In 2014, several health plans had a step therapy requirement to use metformin and a DPP-4 inhibitor before the initiation of SGLT2 inhibitors.15-19 However, given that GLP-1 RAs are also efficacious in lowering A1C, health plans were considering an alternative step therapy requirement that would switch members from a DPP-4 inhibitor to a GLP-1 RA before use of SGLT2 inhibitors. This is because DPP-4 inhibitors and GLP-1 RAs have similar mechanisms of action, but GLP-1 RAs generally lead to larger A1C reductions. Given that GLP-1 RAs are also more expensive than SGLT2 inhibitors, it would be helpful for health plans to assess the cost-effectiveness of switching from a DPP-4 inhibitor to a GLP-1 RA versus adding on an SGLT2 inhibitor in members on metformin and a DPP-4 inhibitor who need further reduction of A1C. This study aims to assess the cost-effectiveness of these specific treatment sequences using both private and public payer perspectives over a 3-year time horizon.

METHODS

Model Description

A decision-analytic model (Figure 1) was constructed for a hypothetical cohort of 1000 patients with T2D who were currently using metformin and a DPP-4 inhibitor but required additional glycemic control. Patients could then either add an SGLT2 inhibitor or replace the DPP-4 inhibitor with a GLP-1 RA. The model determined whether patients reached a goal of A1C less than 7% at 3 years and whether patients experienced UTIs, GMIs, or hypoglycemia. Due to the short time horizon and specific decision context, this model did not include longer-term complications from diabetes and was focused on the comparison of adding an SGLT2 inhibitor or replacing the DPP-4 inhibitor with a GLP-1 RA in patients on metformin and a DPP-4 inhibitor who need further glycemic control. Patients who discontinued either an SGLT2 inhibitor or a GLP-1 RA were assumed to switch to insulin as fourth-line treatment.

Clinical Input Data

Population. The cost-effectiveness of an SGLT2 inhibitor as an add-on to metformin and a DPP-4 inhibitor versus replacing a DPP-4 inhibitor with a GLP-1 RA was analyzed in adults 18 years or older with T2D uncontrolled on metformin and a DPP-4 inhibitor alone. A literature review was conducted in PubMed to identify phase 3 clinical trials with the sequence of interest (metformin and DPP-4 inhibitor switching to GLP-1 RA or adding SGLT2 inhibitor). Search terms included canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, exenatide, exenatide extended-release, liraglutide, dulaglutide, albiglutide, lixisenatide, semaglutide, metformin, gliptin, efficacy, and safety. Search filters included clinical trial as the article type. References of identified articles were searched through to find other similar articles. We also worked with a formulary manager at a health plan who had recently reviewed the SGLT2 inhibitor and GLP-1 RA drug classes to ensure that we were not missing any clinical trials with the treatment sequence of interest. Baseline characteristics of the model population were based on the characteristics of the patients from those identified clinical trials.20-28 The majority of these clinical trials included adult patients with T2D with a range of baseline A1C levels from 7% to 11% and a baseline body mass index of less than 45 kg/m2. Most trials required previous treatment with at least metformin, and trial durations varied from 24 weeks (short term) to 260 weeks (long term).


 
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