Equitable Access to Medicines Underpins Diabetes and CKD Directive

The 2022 guideline update published by the KDIGO organization for the care of people with diabetes and chronic kidney disease (CKD) highlighted the safety and evidence-based expanded role of agents from three drug classes: SGLT2 inhibitors, GLP-1 receptor agonists, and nonsteroidal mineralocorticoid receptor antagonists .

But this key part of the guideline also underscored the challenges in ensuring equitable and affordable access for American patients to these practice-changing drugs.

The impact of the widespread adoption of these three drug classes in the routine management of people with diabetes and CKD in the United States “will be determined by the effectiveness of the healthcare system and its patients and clinicians at overcoming individual and structural barriers,” write Milda Saunders, MDand Neda Laiteerapong, MDin an editorial that accompanied the January 9 release of a synopsis of the 2022 update to the guidelines in Annals of Internal Medicine.

The synopsis is an 11-page digest of the 128-page comprehensive guide released by the Kidney Disease: Improving Global Outcomes (KDIGO) in 2022.

The recommendations in the 2022 guideline update “are exciting for their potential to alter the natural history of CKD and diabetes, but their effect may be severely limited by multilevel barriers,” write Saunders and Laiteerapong, two interns at the University of Chicago.

“Without equitable implementation of the KDIGO 2022 guidelines, clinical practice variation may increase and widen health inequities for minority people with CKD and diabetes,” they warn.

Generics to the rescue

A potentially effective, and likely imminent, way to level the prescription field for patients with CKD and diabetes is to use sodium-glucose cotransporter 2 (SGLT2) inhibitor agents, the agonist of the Glucagon-like peptide-1 (GLP-1) and classes of nonsteroidal mineralocorticoid receptor antagonists will be available in generic formulations.

This should lower prices and thus expand access and will likely happen quite soon for at least two of the three drug classes, Laiteerapong predicts.

Some GLP-1 receptor agonists have already escaped patent exclusivity or will do so in 2023, she notes, including the anticipated ability of a drugmaker to launch generic drug marketing in the United States. liraglutide by the end of 2023.

However, whether that manufacturer, Teva, proceeds with generic liraglutide “is a big question,” Laiteerapong said in an interview. She cited the story of Teva failing to introduce a generic formulation of exenatide to the US market even though he got a green light doing so since 2017.

The only non-steroidal mineralocorticoid receptor antagonist currently on the market is finerenone (Kerendia), which will not be patented for several years, but for some brand name SGLT2 inhibitors, US patents will expire in 2025. Moreover, remogliflozin is an SGLT2 inhibitor which “may have already lost patent exclusivity,” Laiteerapong noted, although it also never received marketing clearance in the United States.

Laiteerapong expressed optimism about the overall progress of access. “A lot of people have Type 2 diabetesand these drugs are in demand,” she noted. She also highlighted recent progress on insulin affordability. “Things will get better as long as people stand up for and stand up for fairness,” she asserted.

Encourage form sign-ups

Laiteerapong cited other approaches that could boost access to these drugs, such as “creating incentives for pharmaceutical companies to ensure that [these drugs] appear on formularies” of major government-affiliated U.S. health insurance programs, such as Medicare Advantage, Medicare Part D plans, state Medicaid plans, and coverage by U.S. Veterans Affairs and the Tricare health insurance plans available to serving members of the US military.

The op-ed she co-wrote with Saunders also calls for future collaborations between various medical societies to create “a more unified and streamlined set of recommendations” that benefits patients with diabetes, CKD and several other diseases. chronicles.

“Over the past decade, we have seen more companies willing to present cooperative guidelines, as well as an increase in research on patients living with multiple chronic conditions. There is a momentum that will allow these different companies to work together,” Laiteerapong said.

Laiteerapong and Saunders have disclosed no relevant financial relationship.

Ann Intern Med. Published on January 9, 2023.

Mitchel L. Zoler is a reporter for Medscape and MDedge based in the Philadelphia area. @mitchelzoler

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