Harold Carter, who leads pharmaceutical manufacturing contracting and engagement for Express Scripts, carefully monitors the dozens of new therapies moving through the biopharmaceutical pipeline.
We sat down with Carter, senior vice president of trade relations, to discuss how Express Scripts uses its supply chain expertise to help employers and health plans prepare for the next wave of biopharmaceutical innovations long before they hit the market.
The U.S. Food and Drug Administration approved a record-breaking 71 medicines in 2023. With this amount of innovation, how do you prepare clients for new therapies coming to market?
This year is another standout for drug approvals, but all the innovation in the world won’t help if people can’t afford or access these new treatments. With an increase of $142 billion in payer net spend over the past five years, anticipating future pharmaceutical releases and working to blunt the impact of rising drug costs is critical.
That’s where pharmacy benefit experts like Express Scripts come in. We keep a close eye on the biopharmaceutical pipeline – predicting upcoming innovations so we can help our clients keep prescription drug coverage affordable for their members.
What does Express Scripts consider when evaluating new treatments?
PBMs bring value and clinical guidance to a complicated prescription drug landscape. Coverage decisions should always be led with clinical integrity, and Express Scripts carefully weighs the benefits, safety, and efficacy of each therapy when designing formularies.
The PBM role is more important than ever as increasing numbers of experimental, expensive, and high-profile treatments are approved to treat conditions representing a vast unmet need, such as ALS or Alzheimer’s disease, but without clear clinical data that they work as indicated. It’s important to remember that “first” doesn’t always mean best.
Recently, the manufacturer of ALS treatment Relyvrio decided to withdraw the drug from the market after it failed to show it benefited patients living with the disease. Long before the product’s withdrawal, our clients looked to us for clinical guidance. While we support the need for treatments for debilitating conditions like ALS, they must be effective for the patients and plan sponsors we are proud to serve.
How does Express Scripts update its formularies?
When clinically equivalent products are available in a drug class, we focus on driving competition among manufacturers to lower the cost of their products. Lack of competition allows sky-high prescription drug prices to continue, but we can leverage formulary decisions to hold pharma accountable for lowering the prices of their products.
We’ve been criticized by pharma for these strategies, most recently for the price of GLP-1 therapies, but it’s important to remember that manufacturers alone have the authority to set the price of their products. We always welcome efforts from manufacturers to lower the price of their medications, and we stand ready to enable patients to access the medications they need.
What are the top pipeline trends you’re keeping an eye on?
Developments in oncology, gene therapy, and common conditions like diabetes and obesity are the fastest growing pipelines that we are actively preparing our clients for today.
Oncology: Cancer treatments account for more than a third of the research and development now underway. Even though biosimilars and generics provide some relief for total health care budgets, supplemental indications for high-priced cell therapies and second- and third-line treatments launching at premium prices may strain budgets and create challenges in care coordination across the pharmacy and medical benefit.
Gene therapy: Beginning next year, we expect to see 10 to 20 new gene therapies launch annually. What’s groundbreaking is that these therapies, which first treated only very rare diseases, may expand into more common conditions like eye diseases and diabetic complications. Total gene therapy costs are expected to top $25 billion a year in 2026.
Rare specialty drug classes: We continue to see developments in specialty drugs for rare conditions with high unmet needs and larger patient populations. Take Rezdiffra, the sole approved treatment for metabolic dysfunction-associated steatohepatitis (MASH), which is the most severe form of fatty liver disease. The number of adults with MASH is expected to rise along with skyrocketing rates of chronic liver disease in the United States. Despite this unmet need, we’ve seen the manufacturer refuse to partner with payers on affordable pathways to access. It’s part of a pattern, with drugmakers charging as much as they can for medications where no competition exists.
How is Express Scripts helping health plans and employers navigate pipeline development trends?
As fast as new drugs are developed, our team works at the negotiation table with pharma and behind the scenes to ensure patients can benefit from future medicines. As the health care system evolves, so have our strategies. For example, to help our clients tackle the exploding uptake of GLP-1s, we launched the first-ever GLP-1 financial guarantee to provide plans with greater predictability and control of GLP-1 spend and to help ensure the patients who need these drugs most can access them – whether to control their diabetes or achieve a healthier weight. PBMs are coming to the table with solutions like these, while pharma puts profits ahead of patients.
How will Express Scripts continue to help clients navigate the pipeline of costly therapies?
The foresight of PBMs makes it possible for health plans and employers – and millions of Americans – to afford today’s medicines and the lifesaving treatments of the future.
From driving value-based arrangements with manufacturers to pay only for breakthrough treatments that work, to lowering the cost of medications through competition, to improving care coordination across the pharmacy and medical benefit, we provide our clients with greater affordability, certainty, and accessibility in a complicated marketplace.
