PharmaLogic® Spotlight communications explore evolving pharmacy dynamics and emerging trends that influence drug utilization and cost, supporting informed benefits decision-making.
Clinical research continues to produce new drug innovations and uncover new uses for existing medications. The Food and Drug Administration (FDA) has approved 41 new drugs and 2 new gene/cell therapies so far in 2025. Significant advancements in the treatment of rare diseases are offering new hope to patients, while also posing financial challenges for plans as they manage expenses. In 2024, specialty medications accounted for approximately 70% of all new drug approvals, with over half of newly approved drugs in 2025 falling into this category. Notably, one-third of these approvals target various forms of cancer. Additional applications for new drugs are still pending FDA decisions, signaling that this trend is likely to continue.
Recent approvals include:
Approvals pending FDA review:
Drug costs continue to be a prominent concern garnering a tremendous amount of attention from the White House and federal legislators.
Recent decisions made by the FDA, Centers for Disease Control and Prevention (CDC) and the CDC’s Advisory Committee on Immunization Practices (ACIP) are creating uncertainty and confusion about vaccines. In the past there was consensus about vaccine recommendations and schedules between federal agencies, federal and state regulations and specialized medical guidance. Following recent FDA decisions related to COVID-19 vaccines, changes to the ACIP panel membership, hiring and firing decisions at leadership levels of the CDC and decisions made at a recent ACIP meeting there is now discord.
Department of Health and Human Services (HHS) Secretary Kennedy appointed new members to the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), replacing all seventeen members previously holding committee positions. The changes to ACIP membership prompted strong reactions from infectious disease and vaccine specialists in the medical community.
COVID-19 Vaccines
Common state legislative targets include formulary and utilization management restrictions, pharmacy reimbursement mandates and restrictions to pharmacy steerage, regulation of group purchasing organizations (GPOs) and rebate aggregators and not permitting pharmacy ownership by PBMs or insurers. These actions can limit a plan’s flexibility to administer a benefit and restrict use of plan design features that encourage the use of lower-cost options. These new legislative rules can raise prescription benefit and healthcare costs, limit member choice and require that national and regional plans deal with an array of state-specific benefit administration regulations. Most recently, new legislation and laws in AR, AL, CA, CO, IA, IL, IN, KY, LA, NJ, TN, TX are impacting plans.
Use of and expenditures for GLP-1* medications have dominated recent trends for many plans, especially those covering both diabetes and weight-loss GLP-1 drugs. PharmaLogic® data for year-to-date 2025 reveals that 10% of total Rx benefit gross costs are attributed to diabetes GLP-1 medications. For plans that cover GLP-1 drugs for weight loss, the percentage of gross cost is even higher. Plan costs will vary based on factors such as population demographics, diabetes prevalence and other utilization drivers. New uses for GLP-1 drugs continue to be a major focus in clinical trials. As additional therapeutic uses for these drugs are approved, use and costs may continue to increase.
Brown & Brown can assist you in discussions with PBMs and disease management providers to refine your benefit approach to weight loss and other uses for GLP-1 drugs.
Anti-inflammatory drugs continue to be the top category of drugs for many plans based on cost. Most of these medications are specialty biologic drugs such as Humira®, Stelara®, Skyrizi®, Dupixent®, Enbrel® and Rinvoq®. When patents for brand biologic drugs expire, lower cost biosimilar options often become available. Several biosimilars are now available in this class of drugs presenting savings opportunities.
Brand patent litigation or supply chain shortages can impact biosimilar availability. Drug formularies may continue to prefer the original, reference brands along with biosimilars for certain drugs until the market stabilizes.
Consider plan design options that encourage use of biosimilar options, such as:
The mix or blend of drugs changes over time in a prescription benefit as new drugs are introduced, prescribers prefer specific therapies and new patients enter a benefit plan. The increasing use of GLP-1s is an example of changing drug mix that has had a significant impact on many benefit plans.
Injectables are routinely covered in pharmacy benefits, especially those that are self-injectable. As additional injectables are introduced, some replace, or supplement, intravenous medications administered in outpatient hospital clinics and other professional settings. When this happens, a shift in cost from medical to pharmacy benefits is possible.
Recently, four injectable products were introduced to the market and may contribute cost to pharmacy benefits and shift spending from the medical benefit.
Explore injectable drug use: