MMIT Reality Check on Type 2 Diabetes (GLP-1 and Combo)

Payer Coverage:

A review of market access for type 2 diabetes (GLP-1 and combo) treatments shows that under the pharmacy benefit, about 47% of the lives under commercial formularies are covered with utilization management restrictions. Around 12% of the lives under Medicare formularies are not covered for at least one of the drugs.

For about 64% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, 24% require multiple steps. Around 28% of payer-controlled pharmacy benefit covered lives require prior authorization, with 30% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

Use of Pricey New Diabetes Drugs Is Higher Among Traditional Medicare Enrollees

Compared to Medicare Advantage members, seniors enrolled in Original Medicare are more likely to be prescribed costly new diabetes medications, according to a recent study in the American Journal of Managed Care. While metformin remains the standard of care for both populations, researchers found that overall use of newer medications, such as glucagon-like peptide-1 (GLP-1) receptor agonists, was 5.1% higher among Original Medicare beneficiaries, which likely contributed to higher total costs and out-of-pocket spending for that cohort. Despite their high cost, GLP-1s are picking up steam on Medicare formularies, according to data from MMIT, AIS Health’s parent company.

Diabetes Med Access May Be Better for Commercial Patients

A new study published in JAMA Network Open suggests commercial insurance members have better access to newer diabetes drugs than members of Medicare Advantage plans — especially MA members with low incomes. The study reviewed a cohort of 382,574 patients with type 2 diabetes between the ages of 58 and 66 and their utilization of glucagonlike peptide-1 receptor agonists (GLP-1RA), sodium-glucose cotransporter-2 inhibitors (SGLT2i) and dipeptidyl peptidase-4 inhibitors (DPP-4i).

The study found that “in addition to differences in initiation of medication by health plan, we found that older patients were less likely to start treatment with each of the examined medications than were younger patients,” and that “compared with White patients, all non-White patients were less likely to start GLP-1RA treatment.”

Express Scripts Coverage, FDA Label Update Boost Rybelsus

Access to Novo Nordisk’s Rybelsus (semaglutide) — the first oral glucagon-like peptide-1 receptor agonist (GLP-1) to treat adults with type 2 diabetes — got a major boost in January 2020 when Novo said Express Scripts, part of Cigna Corp., would cover the agent. “The GLP-1s are looked at as high efficacy products,” said Jeffrey Casberg, M.S., R.Ph., director of clinical pharmacy at IPD Analytics, although they do have gastrointestinal side effects, he added.

Key Findings:

Market Events Drive Changes

In September 2019, Novo Nordisk’s Rybelsus (semaglutide) was approved as the first and only glucagon-like peptide-1 (GLP-1) analog in a pill and a new option for adults with type 2 diabetes who are not achieving their A1C goal with current antidiabetic treatment. There has not been a new GLP-1 agent released since that product. Eli Lilly and Co.’s Trulicity (dulaglutide) added higher strength dose forms, and Intarcia Therapeutics, Inc. is still attempting to gain FDA approval for ITCA 650, but otherwise the market space has been quiet. There are currently only two agents (aside from ITCA 650) in late-stage trials. Hanmi Pharmaceutical Co., Ltd.’s efpeglenatide is in Phase III, but progress has been suspended after interim data was released for the AMPLITUDE trial in June 2021. The second agent, tirzepatide, from Eli Lilly has been submitted to the FDA for approval and has an estimated Prescription Drug User Fee Act (PDUFA) date of May 30, 2022.

Competitive Market Landscape

This is truly a heavyweight market, with four of the biggest pharma companies — Eli Lilly and Co., Novo Nordisk, AstraZeneca plc and Sanofi — vying for supremacy. Novo is currently the king of the mountain with a lineup that includes Victoza (liraglutide), one of the first in the class; Ozempic (semaglutide), the first once-weekly injectable in the class; and Rybelsus, the first and currently only oral agent in the class. Lilly had closed the revenue gap on the back of their only agent in the class, Trulicity; however Novo has maintained the top spot thanks to its diverse lineup.

Pharmacy, Medical Benefit Implications

Coverage for the drugs is via the pharmacy benefit. The majority of payers cover Novo’s Victoza and Ozempic and Lilly’s Trulicity. AstraZeneca’s Bydureon (exenatide) and Byetta (exenatide injection) take the middle ground. Sanofi’s standalone GLP-1 Adlyxin (lixisenatide injection) came after its combo brother Soliqua (insulin glargine and lixisenatide). Soliqua has good coverage, but Adylxin’s uptake remains slim compared to the other products in class.

Key Players in Market:

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