The specialty drug pipeline is robust with several new medications anticipated to gain approval in the coming years. Healthcare leaders need to be poised to have a deep understanding of the clinical benefits and harms relative to existing therapies, establish clinical guidelines, anticipate and prepare for costs, and help reduce barriers for patients with complex illnesses that could potentially benefit from these novel drugs.
Approximately 50% of new drug approvals are targeted toward rare conditions with significant unmet needs, according to the U.S. Food & Drug Administration’s Center for Drug Evaluation and Research (CDER), leading to net new spending that did not previously exist. According to IQVIA, specialty medicines now account for more than 50% of medication spending.
To best help patients and caregivers, specialty drug management should focus on cost management to drive affordability while ensuring access and transparency for both clients and members. As pharmacists at CarelonRx, there are three core areas we’re focused on when analyzing trends and strategies within the evolving specialty pharmacy landscape in 2025 and beyond:
1. Adopting a clinical approach: Starting with a clinical mindset is crucial, with drug placement under medical or pharmacy benefits determined by administration method — self-injected and oral drugs under pharmacy benefits, and physician-administered drugs under medical benefits. Strategies and criteria within a class should be consistent across benefits, as treatments often span both categories.
For example, let’s look at chronic obstructive pulmonary disease (COPD), which affects approximately 16 million adults in the United States. The current COPD treatment landscape includes inhaled therapies and oral steroids, but it is evolving with the introduction of Dupixent, the first biologic approved for COPD.
Of those living with COPD in America, about 2% could be potential candidates for biologics. We will be monitoring biologics for better overall patient outcomes with potential cost reductions from fewer exacerbations and hospitalizations. These treatments may also offer better adherence due to less frequent administration.
But with the entry of new biologics into COPD treatment regimens, we anticipate an increase in drug spend due to their high annual price combined with broader adoption of newer inhaled therapies. In fact, the sales of COPD biologics are expected to triple by 2033.
Given this has largely been a condition managed with inhaled therapies, specialty pharmacy programs can help patients and caregivers who may be adopting and administering self-injectables with access and affordability, which are essential for successful clinical outcomes.
A clinical approach that monitors new medications, like those for COPD, is the first step in anticipating the patient population that may benefit, as well as the medication’s placement into treatment guidelines, on formularies, and in clinical practice.
2. Keeping a people-first mindset. The burden of managing a chronic condition with specialty drugs can be emotionally taxing. Providing clear, accessible information about a patient’s disease and treatment can empower them to be active in their care.
This includes educating patients on the importance of communicating with their healthcare team and encouraging them to discuss any barriers to care, such as geographic limitations to receiving specialty medications and/or lack of transportation, to name a few. In addition, educating patients about coverage options, financial assistance programs, and lower cost sites of care, can alleviate financial stress and enhance medication access.
It is also vital to remember those living with complex illnesses often see multiple physicians and manage numerous medications from several pharmacies. In these instances, it’s critical for a patient’s healthcare team to be as integrated as possible across pharmacy, medical, and behavioral health, to avoid fragmented care and promote better health outcomes.
3. Work to reduce costs. The cost of specialty drugs is a pressing concern for patients, providers and benefit managers. With specialty drugs comprising a large percentage of the total drug spend, it’s imperative to find strategies that mitigate financial burden, improve access, and deliver successful clinical outcomes for patients.
Effectively managing specialty drug spending requires a multifaceted strategy that includes clinical management, benefits coordination, cost control, negotiating discounts, and directing care to lower cost sites.
Making biosimilars available to members can also effectively manage costs without compromising efficacy. Biosimilars offer a promising solution and are projected to save an estimated $181 billion through 2027, according to IQVIA. With more than 60 FDA approved biosimilars and more than 100 in development, there is substantial potential for savings across the healthcare system while delivering successful clinical outcomes for patients.
In addition, it’s necessary to utilize predictive analytics to forecast future spending and gaps in care that need to be addressed. Creating a simplified member/patient experience and high-touch care models further contribute to a reduction in costs by improving health outcomes.
Specialty pharmacy stands at the intersection of groundbreaking medical advancements and complex healthcare challenges. By focusing on a clinical approach, maintaining a people-first mindset, and working to reduce costs, we can navigate this landscape more effectively.
Foram Mehta, R.Ph. M.S., is Staff Vice President of Clinical and Specialty Pharmacy at CarelonRx; and Vicki Fisher, Pharm.D., is Director of Clinical Analytic Strategies at CarelonRx.
