MMIT Reality Check on Type 2 Diabetes (SGLT2 and Combo) (2Q2022)

Payer Coverage:

A review of market access for type 2 diabetes (SGLT2 and combo) treatments shows that under the pharmacy benefit, about 43% of the lives under commercial formularies are covered with utilization management restrictions. Around 20% of the lives under Medicare formularies are not covered for at least one of the drugs.

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For about 57% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 69% of the lives require a single step. Around 16% of payer-controlled pharmacy benefit covered lives require prior authorization, with 74% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

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Trends:

FDA Approves Trijardy XR

In January 2020, the FDA approved Trijardy XR (empagliflozin/linagliptin/metformin hydrochloride extended-release tablets) to lower blood sugar in adults with type 2 diabetes, along with diet and exercise. The drug is marketed by Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Co., and it is the first triple combination product with Jardiance for the indication.

Diabetes Med Access May Be Better for Commercial Patients

A 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.

“Better understanding of nonclinical factors contributing to treatment decisions and efforts to promote greater equity in diabetes management appear to be needed,” the study concluded.

The study, which was authored by researchers including Rozalina McCoy, M.D., a National Institutes of Health-funded researcher at the Mayo Clinic, 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).

Zynquista Shows Positive Outcomes

In 2020, Lexicon Pharmaceuticals Inc. said its Zynquista (sotagliflozin) was found to lower A1C, a measure of blood glucose levels, in patients with type 2 diabetes, in four late-stage studies. But the company said it did not intend to seek FDA approval until it finds a partner for commercialization.

Key Findings:

Market Events Drive Changes

In January 2020, the FDA approved Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Co.’s Trijardy XR (empagliflozin/linagliptin/metformin hydrochloride extended-release tablets) to lower blood sugar in adults with type 2 diabetes, along with diet and exercise. The drug is the first triple combination product with Jardiance for the indication.

Competitive Market Landscape

Eli Lilly and Co./Boehringer Ingelheim Pharmaceuticals, Inc. and AstraZeneca are the two largest players on the marketplace, though Johnson & Johnson and Merck & Co., Inc. are not far behind them. Now that many of the agents in this class also provide the additional benefit of a reduction in the risk of cardiovascular death, there is less of a difference among the therapeutic benefits of each agent. Competition is largely driven by contracts, with each company seeking to edge out the competitors by gaining the most widespread preferred coverage status.

Pharmacy Benefit Implications

Coverage for the drugs is via the pharmacy benefit. Overall the agents in this indication enjoy widespread coverage by a majority of payers. Most patients will have numerous options to choose from depending on their formulary, though which agents are considered preferred will depend on contracts and rebates. Eli Lilly and Co./Boehringer Ingelheim Pharmaceuticals, Inc.’s Jardiance (empagliflozin) and AstraZeneca’s Farxiga (dapagliflozin) are the most common agents to enjoy preferred status on major formularies, which is likely linked to their length on the market and additional benefit of reducing the risk of cardiovascular death. Many of the other agents, including several of the extended-release combo agents, have sporadic preferred status, though this appears to be on the rise.

Key Players in Market:

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AIS Health Staff

AIS Health Staff

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