Newer Drugs Not Cost-Effective for First-Line Diabetes Therapy

Marlene Busko

October 04, 2022

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 three different first-line treatment strategies — metformin, an SGLT2 inhibitor, or a GLP-1 agonist — in US patients with untreated type 2 diabetes.

Compared to 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 under $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 to 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 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 if 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.

On the other hand, 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 and older with self-reported diabetes or an A1c > 6.5% with no reported use of diabetes medications.

Patients were an average age of 55 and 55% 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 to initial therapy with metformin due to 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 one of two dapagliflozin patents expired in October 2020 and approval for generic alternatives has been sought from the US Food and Drug Administration, 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. Choi was supported by a National Institutes of Health, National Institute on Aging grant. Laiteerapong and other co-authors 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. Choi and 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. Abstract

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