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The American Journal of Managed Care May 2019
Evaluation of Value-Based Insurance Design for Primary Care
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The Presurgical Episode: An Untapped Opportunity to Improve Value
Erika D. Sears, MD, MS; Rodney A. Hayward, MD; and Eve A. Kerr, MD, MPH
Clarification of References to Medication Adherence Scale
Open Doors to Primary Care Should Add a “Screen” to Reduce Low-Value Care
Betsy Q. Cliff, MS; and A. Mark Fendrick, MD
From the Editorial Board: Daniel B. Wolfson, MHSA
Daniel B. Wolfson, MHSA
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Cost-Effectiveness of DPP-4 Inhibitor and SGLT2 Inhibitor Combination Therapy for Type 2 Diabetes
Manjiri Pawaskar, PhD; S. Pinar Bilir, MS; Stacey Kowal, MS; Claudio Gonzalez, MD; Swapnil Rajpathak, MD; and Glenn Davies, DrPH
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Cost-Effectiveness of DPP-4 Inhibitor and SGLT2 Inhibitor Combination Therapy for Type 2 Diabetes

Manjiri Pawaskar, PhD; S. Pinar Bilir, MS; Stacey Kowal, MS; Claudio Gonzalez, MD; Swapnil Rajpathak, MD; and Glenn Davies, DrPH
This study evaluates the long-term cost-effectiveness of treatment involving combination therapy with dipeptidyl peptidase 4 (DPP-4) inhibitors and sodium-glucose cotransporter 2 (SGLT2) inhibitors compared with an alternative with sulfonyureas prior to insulin initiation on a background of metformin.

Objectives: Maintaining glycemic control limits costly health risks in patients with type 2 diabetes (T2D), but accomplishing this may require individualized strategies. Generic medications (eg, sulfonylureas [SU], insulin) are common in T2D management due to their efficacy and costs; however, relatively new drug classes (eg, dipeptidyl peptidase 4 [DPP-4] inhibitors, sodium-glucose cotransporter 2 [SGLT2] inhibitors) have demonstrated clinical benefits in combination therapy. The objective of this study was to evaluate the long-term cost-effectiveness of a strategy involving branded combination therapy with DPP-4 inhibitors and SGLT2 inhibitors (pathway 1) compared with a generic alternative with SU and insulin (pathway 2) on a background of metformin.

Study Design: Cost-effectiveness analysis using the validated IQVIA CORE Diabetes Model from the US payer perspective.

Methods: Cost-effectiveness analysis. Lifetime clinical and economic outcomes (discounted 3%/year) were modeled for a T2D cohort failing to achieve glycemic goal on metformin monotherapy. Patient baseline data and treatment effects reflect results of clinical trials. Direct medical cost inputs are from multiple published sources. Scenario analyses on key intervention effects and assumptions tested robustness of results.

Results: Pathway 1 had higher direct medical costs compared with pathway 2, yet also increased total quality-adjusted life-years (QALYs) by 0.24. Increased costs were partially offset by a reduction in diabetes-related complications and delayed insulin initiation. The incremental cost-effectiveness ratio (ICER) for pathway 1 is favorable at $64,784/QALY. Scenario analyses showed limited impact; nearly all ICERs were less than $100,000/QALY.

Conclusions: In the United States, sequential addition of SGLT2 inhibitors to DPP-4 inhibitors may be considered cost-effective compared with traditional treatment with generic medications for patients who fail to achieve glycemic goal on metformin.

Am J Manag Care. 2019;25(5):231-238
Takeaway Points
  • Generic medications (eg, sulfonylureas followed by insulin) are commonly used as therapy intensifies after metformin, but a pathway of newer medications (eg, dipeptidyl peptidase 4 [DPP-4] inhibitors and sodium-glucose cotransporter 2 [SGLT2] inhibitors prior to insulin) may be cost-effective over a lifetime.
  • Evaluation of this sequence revealed that it increased costs compared with a generic pathway, yet also improved quality-adjusted life-years (QALYs) by 0.24 for an incremental cost-effectiveness ratio of $64,784/QALY.
  • Costs were partially offset by a reduction in diabetes-related complications and delayed insulin initiation.
  • In the United States, sequential addition of SGLT2 inhibitors to DPP-4 inhibitors may be cost-effective compared with traditional treatment using generic medications for patients not at glycemic goal on metformin.
Of 23 million diabetes diagnoses in the United States, approximately 21.9 million are type 2 diabetes (T2D).1 T2D is known to increase the risk of various complications and comorbidities throughout a patient’s lifetime; in addition to generally raised mortality, patients with diabetes face higher risks of specific chronic conditions, such as cardiovascular disease (CVD), kidney disease, and blindness, as well as costly events, such as amputation, myocardial infarction, and stroke.1,2 Maintaining glycemic control has a direct relationship with mitigating risk,3 and patients with glycated hemoglobin (A1C) of 7.0% or less have been shown to have lower rates of comorbidities.4

Appropriately managing glycemic levels will help minimize economic burden as well. A study by the American Diabetes Association (ADA) estimated total direct diabetes-related expenditures at $237 billion for 2017,5 and other evidence has shown that higher A1C levels were linked with higher healthcare costs (for A1C levels >7.5%).6,7 Past data have also shown that patients with diabetes without comorbidities may have annual healthcare costs that are only one-fourth as large as those of patients with cardiovascular complications.8 Considering healthcare costs from the opposite perspective, more than 25% of total national costs to manage ophthalmological, renal, and cardiovascular conditions are incurred by patients with diabetes.5

Although initial medical treatment includes metformin monotherapy when tolerated, ADA guidelines recommend intensification with a sodium-glucose cotransporter 2 (SGLT2) inhibitor or liraglutide (a glucagon-like peptide 1 [GLP-1] receptor agonist) in patients with established CVD due to evidence of cardiovascular benefit.9 In patients without established CVD or heart failure, the first intensification may combine metformin with therapies such as a dipeptidyl peptidase 4 (DPP-4) inhibitor, an SGLT2 inhibitor, a thiazolidinedione, a sulfonylurea (SU), a GLP-1 receptor agonist, or basal insulin. Subsequent intensification includes triple therapies composed of these options.9

Commonly used therapies for intensification after metformin failure may include generic medications like SU or, later, insulin, due to a combination of established efficacy and relative costs compared with branded medications.10-12 However, the American College of Physicians has noted that evidence indicates potential safety differences with these therapy choices, including a higher risk of hypoglycemia and weight gain for metformin + SU compared with metformin combinations with DPP-4 inhibitors or SGLT2 inhibitors.10 Insulin likewise conveys increased risks of hypoglycemia and weight gain,13-15 whereas both SU and insulin may be associated with increased CVD risk.16-18 In addition to the negative impact to patient health, the additional costs associated with managing downstream complications can be substantial; both clinical and financial factors may be relevant to consider when making therapeutic choices.

At the same time, findings of recent clinical trials of triple-therapy combinations with newer (and thus branded) medications, such as DPP-4 inhibitors and SGLT2 inhibitors, have demonstrated significant clinical benefit over the use of each individual component when on a background of metformin.19,20 Multiple SGLT2 inhibitors have also been shown to convey CVD protective effects in this population, including reduced risk of heart failure, myocardial infarction, and stroke.16,21,22 Additionally, recent evidence suggests that remaining on DPP-4 inhibitor therapy provides significant improvement in A1C without increasing the risk of hypoglycemia compared with stopping it when initiating insulin.23 Clinicians may therefore find it valuable to consider these newer therapies in combination prior to further intensification.

Given available clinical evidence, this study sought to model the overall impact on a lifetime of patient health outcomes, costs, and cost-effectiveness of a specific intensification pathway utilizing branded medications alone and in combination, sequentially. In this pathway, US patients with T2D that is poorly controlled on metformin alone transition from DPP-4 inhibitor to DPP-4 inhibitor + SGLT2 inhibitor on a background of metformin prior to insulin initiation. This pathway is compared against a more generic pathway in which patients intensify to metformin + SU, followed by initiation of insulin.

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