How to push back on 3 key pharmacy headwinds

Much as generics have long exerted downward pricing pressure on small molecule drugs with expired patent protection, biosimilars are now making inroads as a cost-saving alternative to biologic drugs. Once a brand-name biologic drug faces biosimilar competition prices can drop up to 60%.

Such relief is overdue in the anti-inflammatory category, where expensive biologic medicines have become standard of care in many places. Nothing symbolizes the need for competition quite like Humira® (adalimumab). Indicated for treatment of rheumatoid arthritis, Crohn’s disease, and psoriasis, Humira was approved the Food and Drug Administration (FDA) in 2002 and enjoyed market exclusivity for over two decades due to its patent protections and protracted litigation with biosimilar makers. As a result, branded Humira is the top-selling drug in history, tallying over $200 billion in sales since it was approved.

The once dominant market position of Humira started to change as multiple adalimumab biosimilars entered the market. In February 2023, Optum Rx became the first pharmacy benefit manager to announce it would add an adalimumab biosimilar to formulary at parity to Humira. The impact of this competition on the anti-inflammatory class in particular and prescription drug spending in general was swift and considerable. Analysis indicates that largely due to the introduction of Humira biosimilars net prices in the rheumatoid arthritis category in the U.S. fell by 30% during 2023.

Immunosuppressive drugs such as Humira are not the only biologics facing new competitors. In May the U.S. Food and Drug Administration approved two interchangeable biosimilars options to Eylea®, a drug used to treat macular degeneration and other eye conditions. Looking further ahead, Trulicity, a GLP-1 drug approved in 2014 and indicated for Type 2 diabetes, is expected to lose key patent protections in 2027. Two popular immunotherapy used to treat a variety of cancers, Keytruda and Opdivo, are each expected to lose patent protection in 2028.

Originally prescribed for type 2 diabetes, GLP-1 agonists work by impacting the glucagon-like peptide hormone involved in insulin sensitivity and the regulation of blood glucose. More recently, GLP-1s have become increasingly popular for obesity indications. As a result, GLP-1 drugs are now a primary driver of traditional drug trend.

Moreover, use of these drugs is only expected to increase. According to FDA package labeling, more than half of U.S. adults are eligible for an obesity GLP-1 prescription. GLP-1 drugs are also being examined for indications beyond diabetes and weight loss. In March, the FDA approved a new indication for Wegovy to reduce the risk of cardiovascular events including heart attacks and strokes. GLP-1 drugs are also being studied for indications such as chronic kidney disease, sleep apnea, Alzheimer’s disease, and liver disease. Each new indication could potentially make many more Americans eligible for a GLP-1.

Given this, plan sponsors need a strategic partner with the capabilities to provide options and management strategies to help balance cost and utilization of GLP-1s. To ensure GLP-1 drugs are used responsibly, Optum Rx has added additional rigor to our existing utilization management (UM) and Prior Authorization (PA) processes. We’ve also taken steps to reduce waste, stockpiling and avoid potential duplicate prescriptions of GLP-1 drugs as new indications are approved.

Since they are used to treat chronic disease, Optum Rx has also taken steps to provide guidance for patients taking GLP-1 drugs. This includes creating clinical programs designed to provide ongoing monitoring and motivation for members. For example, Optum Rx Weight Engage helps members achieve and sustain their weight loss goals through behavior modification support such as diet and exercise planning.

In addition to commonly prescribed drugs such as GLP-1s, another reason for the ongoing rise in spending is the growing presence of comparatively rare but ultra-expensive specialty medications entering the market. While the median launch price for a newly marketed drug was $2,115 in 2008, it had risen to $300,000 by 2023.

This trend looks to continue as drug manufacturers fill their development pipelines with increasingly expensive drugs. Orphan drugs, which are intended to treat rare conditions, are constituting a greater share of the pipeline. Despite being aimed at diseases with populations under 200,000 people, orphan drugs outpaced the number of new, non-orphan drugs approved annually by the FDA each of the last four years.

The Optum Rx Orphan Drug Program is a targeted strategy that leverages the clinical expertise of trained pharmacists to detect ineffective therapies and offer personalized clinical support for those members taking orphan drugs we’ve identified as having the greatest opportunity for clinical intervention and cost savings.

First developed for rare genetic diseases with very high unmet needs, gene therapies can have multi-million-dollar price tags and are in some ways the ultimate orphan drugs. Used to treat a rare form of hereditary blindness affecting between 1,000 and 2,000 people in the U.S, Luxturna® was the first gene therapy was approved by the FDA. Since then, a handful of other gene therapies have gained approval including a few therapies aimed at comparatively less rare conditions with larger potential populations including hemophilia and sickle cell disease. A recently approved gene therapy, Lenmeldy, has a wholesale cost of $4.25 million, making it the world's most expensive drug.

As more gene therapies enter the market, the chance that a plan sponsor will encounter a claim for one is only increasing. Our Gene Therapy Risk Protection solution uses a novel risk management approach to manage this risk. Instead of a one-time, multimillion dollar claim, plan sponsors can instead spread out the cost into a manageable, predictable per member per month (PMPM) fee.

We know that patient affordability impacts access and adherence and ultimately overall medical costs. That’s why in addition to client-level solutions, Optum Rx is also taking on affordability challenges at the member level.

Furthering our commitment to lower out of pocket costs for members, the Optum Rx Critical Drug Affordability list helps lower or eliminate copays for members taking life-sustaining medications. There are now almost 300 medications that are part of the program. For example, in 2024 Optum Rx placed all preferred insulin products on tier one of standard commercial formularies, limiting out-of-pocket spend to $35 or less.

Another member-centric affordability solution is Optum Rx Price Edge. This free-to-use price transparency tool scans cash market pricing to deliver aggregate, real-time cost comparison between on-benefit member cost share and off-benefit pricing. When using Price Edge, members save an average $47 per non-covered prescription.*

Costing on average more than $84,000 annually, specialty medications present a true patient affordability challenge. Financial aid, whether through copay cards, foundation grants, manufacturer programs or alternative hardship programs, is often essential to helping patients afford them. Optum Savings IQ^TM technology proactively reviews the financial resources available for every Optum Specialty Pharmacy patient to help them pay for their medication. In 2023, Savings IQ helped connect members with $823.5M in financial aid assistance.*

Modern challenges require modern ideation. Optum Rx is committed to finding innovative ways to help keep the pharmacy benefit affordable and sustainable for plan sponsors and members today and in the years to come. Talk to your Optum Rx representative to learn more.