A review of market access for type 2 diabetes GLP-1 and combo treatments shows that under the pharmacy benefit, about 55% of the lives under commercial formularies are covered with utilization management restrictions. Around 26% of the lives under Medicare formularies are not covered for at least one of the drugs.
For about 60% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, 30% require multiple steps. Around 42% of payer-controlled pharmacy benefit covered lives require prior authorization, with 25% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.
While the FDA may not have approved the most drugs in a year in 2022, it still gave the green light to a number of agents, many of them specialty medications, as well as granted additional indications to existing therapies. The FDA’s Center for Drug Evaluation and Research (CDER) approved 39 new molecular entities in 2022, and the Center for Biologics Evaluation and Research (CBER) approved 12 biologic license applications, including four new gene therapies in the second half of the year. AIS Health, a division of MMIT, asked some industry sources what the most notable 2022 FDA approvals were and why they were so important.
Arash Sadeghi, Pharm.D., clinical pharmacist at Optum Rx, Inc.: Mounjaro (tirzepatide) [from Eli Lilly and Co.] was the first dual acting GIP/GLP-1 receptor agonist approved by the FDA for the treatment of type 2 diabetes. While many other drugs are available for type 2 diabetes, including other GLP-1 receptor agonists, this is a growing category because of the use of these drugs for chronic weight management, and that trend is potentially going to continue if tirzepatide is eventually approved for this use as well.
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.
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.”
Market Events Drive Changes
In May 2022, the FDA approved Eli Lilly and Company’s Mounjaro (tirzepatide) injection, a new once-weekly glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1 ) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. It is the first and only FDA-approved GIP and GLP-1 receptor agonist. In September 2019, Novo Nordisk’s Rybelsus (semaglutide) was approved as the first and only 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.
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 (dulaglutide); however, Novo has maintained the top spot thanks to its diverse lineup.
Pharmacy 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) 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 the class.
Key Players in Market: