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CME / ABIM MOC / CE

Are SGLT2 and GLP-1 Receptor Agonists Cost Prohibitive as First-Line Diabetes Therapies?

  • Authors: News Author: Marlene Busko; CME Author: Laurie Barclay, MD
  • CME / ABIM MOC / CE Released: 11/23/2022
  • Valid for credit through: 11/23/2023
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  • Credits Available

    Physicians - maximum of 0.25 AMA PRA Category 1 Credit(s)™

    ABIM Diplomates - maximum of 0.25 ABIM MOC points

    Nurses - 0.25 ANCC Contact Hour(s) (0 contact hours are in the area of pharmacology)

    Pharmacists - 0.25 Knowledge-based ACPE (0.025 CEUs)

    Physician Assistant - 0.25 AAPA hour(s) of Category I credit

    IPCE - 0.25 Interprofessional Continuing Education (IPCE) credit

    You Are Eligible For

    • Letter of Completion
    • ABIM MOC points

Target Audience and Goal Statement

This activity is intended for diabetologists/endocrinologists/metabolism clinicians, cardiologists, nephrologists, family medicine/primary care clinicians, internists, nurses, pharmacists, physician's assistants, and other members of the health care team for patients with type 2 diabetes.

The goal of this activity is for learners to be better able to describe the lifetime cost-effectiveness of a strategy of first-line sodium-glucose cotransporter-2 inhibitor or glucagon-like peptide-1 agonist therapy in medication-naive US patients with type 2 diabetes identified from the National Health and Nutrition Examination Survey (2013-2016), using a population simulation model based on the United Kingdom Prospective Diabetes Study, Outcomes Model version 2 for diabetes-related complications and mortality, with added information about hypoglycemic events, quality of life, and US costs.

Upon completion of this activity, participants will:

  • Assess the lifetime cost-effectiveness of a strategy of first-line sodium-glucose cotransporter-2 inhibitor or glucagon-like peptide-1 agonist therapy in medication-naive US patients with type 2 diabetes identified from the National Health and Nutrition Examination Survey (2013-2016), using a population simulation model
  • Evaluate the clinical implications of the lifetime cost-effectiveness of a strategy of first-line sodium-glucose cotransporter-2 inhibitor or glucagon-like peptide-1 agonist therapy in medication-naive US patients with type 2 diabetes identified from the National Health and Nutrition Examination Survey (2013-2016), using a population simulation model
  • Outline implications for the healthcare team


Disclosures

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News Author

  • Marlene Busko

    Freelance writer, Medscape

    Disclosures

    Marlene Busko has no relevant financial relationships.

CME Author

  • Laurie Barclay, MD

    Freelance writer and reviewer
    Medscape, LLC

    Disclosures

    Laurie Barclay, MD, has the following relevant financial relationships:
    Formerly owned stocks in: AbbVie Inc.

Editor/Nurse Planner

  • Stephanie Corder, ND, RN, CHCP

    Associate Director, Accreditation and Compliance, Medscape, LLC

    Disclosures

    Stephanie Corder, ND, RN, CHCP, has no relevant financial relationships.

Compliance Reviewer

  • Amanda Jett, PharmD, BCACP

    Associate Director, Accreditation and Compliance, Medscape, LLC

    Disclosures

    Amanda Jett, PharmD, BCACP, has no relevant financial relationships.

Peer Reviewer

This activity has been peer reviewed and the reviewer has no relevant financial relationships.


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This activity was planned by and for the healthcare team, and learners will receive 0.25 Interprofessional Continuing Education (IPCE) credit for learning and change.

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CME / ABIM MOC / CE

Are SGLT2 and GLP-1 Receptor Agonists Cost Prohibitive as First-Line Diabetes Therapies?

Authors: News Author: Marlene Busko; CME Author: Laurie Barclay, MDFaculty and Disclosures

CME / ABIM MOC / CE Released: 11/23/2022

Valid for credit through: 11/23/2023

processing....

Clinical Context

In the US, type 2 diabetes prevalence is more than 30 million people; annual costs of approximately $327 billion increased from $174 billion in 2007, partially from high costs of sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists. These drugs have been shown to reduce atherosclerotic cardiovascular disease (ASCVD), microvascular disease, and mortality while improving glycated hemoglobin (HbA1c) and cardiovascular risk factors.

The 2020 American Diabetes Association and European Association for the Study of Diabetes guidelines therefore recommended SGLT2 inhibitors or GLP-1 receptor agonists as second-line therapy, after lifestyle intervention and metformin, in patients with type 2 diabetes without ASCVD, and as first-line therapy with metformin for patients with or at high risk for ASCVD, heart failure, or chronic kidney disease. However, American Diabetes Association guidelines do not recommend SGLT2 inhibitors and GLP-1 receptor agonists as second-line therapy if cost is a major issue.

Study Synopsis and Perspective

To be cost-effective compared with metformin for initial therapy for type 2 diabetes, prices for a sodium-glucose cotransporter-2 (SGLT2) inhibitor or a glucagon-like peptide-1 (GLP-1) agonist would have to fall by at least 70% and at least 90%, respectively, according to estimates.

The study, modeled on US patients, by Jin G. Choi, MD, and colleagues, was published online October 3 in the Annals of Internal Medicine.

The researchers simulated the lifetime incidence, prevalence, mortality, and costs associated with 3 different first-line treatment strategies (metformin, an SGLT2 inhibitor, or a GLP-1 agonist) in US patients with untreated type 2 diabetes.

Compared with patients who received initial treatment with metformin, those who received one of the newer drugs had 4.4% to 5.2% lower lifetime rates of congestive heart failure, ischemic heart disease, myocardial infarction, and stroke.

However, to be cost-effective at less than $150,000 per quality-adjusted life-years (QALY), SGLT2 inhibitors would need to cost less than $5 a day ($1800 a year) and GLP-1 agonists would have to cost less than $6 a day ($2100 a year), a lot less than now.

Knowing how expensive these drugs are, "I am not surprised" that the model predicts that the price would have to drop so much to make them cost-effective compared with first-line treatment with metformin, senior author Neda Laiteerapong, MD, told Medscape Medical News in an interview.

"But I am disappointed," she said, because these drugs are very effective, and if the prices were lower, more people could benefit.

"In the interest of improving access to high-quality care in the United States, our study results indicate the need to reduce SGLT2 inhibitor and GLP-1 receptor agonist medication costs substantially for patients with type 2 [diabetes] to improve health outcomes and prevent exacerbating diabetes health disparities," the researchers conclude.

One way that the newer drugs might be more widely affordable is if the government became involved, possibly by passing a law similar to the Affordable Insulin Now Act, speculated Dr Laiteerapong, who is associate director at the Center for Chronic Disease Research and Policy, University of Chicago, Illinois.

Current Prices Too High to Encourage First-Line Adoption

Guidelines recommend the use of SGLT2 inhibitors and GLP-1 agonists as second-line therapies for patients with type 2 diabetes, but it has not been clear whether clinical benefits would outweigh costs for use as first-line therapies.

"Although clinical trials have demonstrated the clinical effectiveness of these newer drugs, they are hundreds of times more expensive than other. . .diabetes drugs," the researchers note.

In contrast, costs may fall in the coming years when these new drugs come off-patent.

The current study was designed to help inform future clinical guidelines.

The researchers created a population simulation model based on the United Kingdom Prospective Diabetes Study, Outcomes Model version 2 (UKPDS OM2) for diabetes-related complications and mortality, with added information about hypoglycemic events, quality of life, and US costs. 

The researchers also identified a nationally representative sample of people who would be eligible to start first-line diabetes therapy when their A1c reached 7% for the model. 

Using National Health and Nutrition Examination Survey (NHANES) data (2013-2016), the researchers identified about 7.3 million US adults aged 18 years and older with self-reported diabetes or an A1c more than 6.5% with no reported use of diabetes medications.

Patients were an average age of 55 years, and 50% were women. They had had diabetes for an average of 4.2 years, and 36% had a history of diabetes complications.

The model projected that patients would have an improved life expectancy of 3.0 and 3.4 months from first-line SGLT2 inhibitors and GLP-1 agonists, respectively, compared with initial therapy with metformin as a result of reduced rates of macrovascular disease.

"However, the current drug costs would be too high to encourage their adoption as first line for usual clinical practice," the researchers report.

Disparities Could Remain for Decades

Generic SGLT2 inhibitors could enter the marketplace shortly because 1 of 2 dapagliflozin patents expired in October 2020, and approval for generic alternatives has been sought from the Food and Drug Administration, Dr Choi and colleagues note.

However, it could still take decades for medication prices to drop low enough to become affordable, the group cautions. For example, a generic GLP-1 agonist became available in 2017, but costs remain high.

"Without external incentives," the group writes, "limited access to these drug classes will likely persist (for example, due to higher copays or requirements for prior authorizations), as will further diabetes disparities--for decades into the future--because of differential access to care due to insurance (for example, private vs public), which often tracks race and ethnicity."

The study was supported by the American Diabetes Association. Dr Choi was supported by a National Institutes of Health, National Institute on Aging grant. Dr Laiteerapong and other coauthors are members of the National Institute of Diabetes and Digestive and Kidney Diseases Chicago Center for Diabetes Translation Research at the University of Chicago, Illinois. Dr Choi and Dr Laiteerapong have reported no relevant financial relationships. Disclosures for the other authors are listed with the article.

Ann Intern Med. Published online October 3, 2022.[1]

Study Highlights

  • Data sources for this individual-level Monte Carlo–based Markov model included randomized trials, Centers for Disease Control and Prevention databases, RED BOOK, and NHANES {2013-2016).
  • Researchers identified approximately 7.3 million US adults aged at least 18 years with self-reported diabetes or A1c higher than 6.5% with no reported use of diabetes medications.
  • Base-case analysis showed that among drug-naive US patients with type 2 diabetes, first-line SGLT2 inhibitors and GLP-1 receptor agonists had lower lifetime rates of congestive heart failure, ischemic heart disease, myocardial infarction, and stroke compared with metformin.
  • Life expectancy would improve by 3.0 and 3.4 months from first-line SGLT2 inhibitors and GLP-1 agonists, respectively, vs metformin, because of reduced rates of macrovascular disease (24.4%-25.2% cumulative absolute reduction).
  • First-line SGLT2 inhibitors cost $43,000 more and added 1.8 quality-adjusted months versus first-line metformin ($478,000 per QALY).
  • First-line injectable GLP-1 receptor agonists cost more and reduced QALYs compared with metformin.
  • Sensitivity analysis showed that by removing injection disutility, first-line GLP-1 receptor agonists were no longer dominated (incremental cost-effectiveness ratio [ICER], $327,000 per QALY).
  • Oral GLP-1 receptor agonists were not cost-effective (ICER, $823,000 per QALY).
  • To be cost-effective at less than $150,000 per QALY, costs would need to be less than $5 per day for SGLT2 inhibitors and less than $6 per day for oral GLP-1 receptor agonists.
  • The investigators concluded that as first-line agents, SGLT2 inhibitors and GLP-1 receptor agonists would improve type 2 diabetes outcomes by lowering risk for macrovascular events, but their costs would need to fall by 70% for SGLT2 inhibitors and 90% for oral GLP-1 receptor agonists to be cost-effective.
  • Current drug costs are too high to encourage adoption as first-line for usual clinical practice.
  • The model suggests that compared with the 2021 American Diabetes Association and European Association for the Study of Diabetes guidelines, first-line SGLT2 inhibitors and GLP-1 receptor agonists are not cost-effective for the US population, mainly because of high medication costs.
  • Costs may soon fall when these new drugs become off-patent, but this cost reduction may be insufficient, and it could still take decades for medication prices to drop low enough to become affordable.
  • Without external incentives and/or government involvement, possibly by passing a law similar to the Affordable Insulin Now Act, limited access to these drug classes will likely persist.
  • Diabetes disparities are also likely to persist for decades because of differential access to care based on insurance, which often tracks race and ethnicity.
  • To improve high-quality type 2 diabetes care access in the US, improve health outcomes and prevent exacerbating diabetes health disparities, SGLT2 inhibitor and GLP1 receptor agonist medication costs need to decrease substantially.
  • Study limitations include lack of international generalizability of US population and costs; UKPDS model limitations, including overestimation of macrovascular complications; and incomplete demographic and heart failure history and limited sample of NHANES participants precluding additional analyses.
  • In addition, the NHANES population included patients with an extensive history of diabetes without self-reported diabetes medication, a potentially socioeconomically disadvantaged group, affecting generalizability and reflecting a population of interest given the economic barrier to adequate treatment.

Clinical Implications

  • First-line SGLT2 inhibitors and GLP-1 receptor agonists are not cost-effective for the US population, mainly because of high medication costs.
  • It could take decades for medication prices to drop low enough to become affordable.
  • Implications for the Health Care Team: Diabetes disparities are also likely to persist for decades because of differential access to care based on insurance, which often tracks race and ethnicity.

 

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