A review of market access for type 2 diabetes (DPP4 and combo) treatments shows that under the pharmacy benefit, about 39% of the lives under commercial formularies are covered with utilization management restrictions. Around 21% of the lives under Medicare formularies are not covered for at least one of the drugs.
For about 57% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, 37% require multiple steps. Around 19% of payer-controlled pharmacy benefit covered lives require prior authorization, with 72% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.
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. 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).
“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.
Mortality Risk of Antidiabetic Agents for Type 2 Diabetes With COVID-19: A Systematic Review and Meta-Analysis
A review of research published in Frontiers in Endocrinology found that there were significant associations between mortality and the antidiabetic agents metformin, sulfonylurea and insulin. In contrast, mortality did not significantly differ between DPP-4 inhibitor users and non-users. The research findings were based on a meta-analysis of 18 studies with 17,338 patients with type 2 diabetes who had COVID-19.
With the cost of diabetes drugs still growing, PBMs and payers are looking for more innovative strategies to hold down costs. For some, that might include a strategy similar to the one recently unveiled by CVS Health Corp.’s Caremark unit. The plan, called RxZERO, offers a slimmer formulary for the diabetes drug class but with no out-of-pocket costs for members. CVS says employers or insurers that pick this plan should expect to save about $30 annually per member.
Market Events Drive Changes
This is the oldest of the classes that came after metformin, starting with Merck & Co., Inc.’s Januvia (sitagliptin) in the fall of 2006. Combination products using DPP-4s first with metformin and then with the newer SGLT2 agents came next as studies showed these offered additional benefits.
Competitive Market Landscape
Merck was first to market in the DPP-4 class with Januvia and clearly continues to dominate. The main competition is between Merck and Eli Lilly & Co./Boehringer Ingelheim Pharmaceuticals, Inc. (BI), with AstraZeneca plc further behind and Takeda Pharmaceutical Company Limited all but out of the running. This is a heavily contracted class; costs are high, but so are rebates.
Pharmacy, Medical Benefit Implications
Merck’s Januvia and combos have the best coverage. Lilly/BI is second best here overall, with Tradjenta (linagliptin) and combos. AstraZeneca’s Onglyza (saxagliptin) and combos are a distant third. Takeda, the last to launch a DPP-4, never got a lot of traction, and Nesina (alogliptin) and combos are a distant fourth. Coverage is under the pharmacy benefit. Step therapy restrictions are common, either alone or as part of prior authorization. Failure on metformin is often required as expected, but trial of preferred DPP-4 agent(s) is commonly seen as well.
Key Players in Market: