News/Blogs

Background

In 2024, the FDA approved 50 novel drugs. A slight decrease from 55 the prior year, these approvals include new molecular entities and biologics only.  Serve You Rx analyzes these approvals to help clients optimize benefit strategies. Read on for 2024 drug approval trends.

Key Trends Shaping Pharmacy Benefits

The drug approval landscape in 2024 highlights several pivotal trends that will shape pharmacy benefits and cost management strategies in the coming years.

• Oncology Innovation: A significant portion (16 drugs) of new approvals targeted oncology. 
• Breakthrough Therapies: Numerous “breakthrough” designations (18 drugs) signal accelerated development. 
• Rare Disease Focus: Orphan drug approvals persist, demanding careful cost management. 

Spotlight: Breakthrough Therapies 

Several notable breakthrough therapies gained FDA approval in 2024, exemplifying the rapid advancements in gene therapy, targeted treatments, and novel mechanisms of action:

• Beqvez: A one-time gene therapy to treat Hemophilia B 
• Winrevair: A novel therapy to treat Pulmonary Arterial Hypertension 
• Rezdiffra: The first therapy to treat Non-alcoholic steatohepatitis (NASH) 
• Crenessity: A corticotropin used to treat congenital adrenal hyperplasia 

The Rare Disease Challenge

Orphan drugs continue to shape the pharmaceutical landscape, particularly in oncology and chronic rare diseases. In 2024:

• 33 drugs received Orphan Drug designation, targeting diseases affecting fewer than 200,000 Americans. 
• These rare disease drugs spanned eight therapeutic areas, with oncology being the most common. 
• The cost of chronic non-oncology rare disease drugs approved ranged from $50,261 to $967,433 annually, averaging $445,394. 
• One-time gene therapies for rare disease averaged $3.9 million, a significant increase from previous years. 

With the rising prevalence of ultra-expensive therapies, managing rare disease drug costs requires a multifaceted approach, including rigorous utilization management, alternative funding strategies, and strategic formulary decisions.

Antibiotic Approvals

Efforts to combat antimicrobial resistance continue, with the FDA’s GAIN (Generating Antibiotics Incentives Now) program supporting the development of new anti-infectives. In 2024, this program contributed to the approval of three new antibiotic treatments, all granted extended exclusivity:

• Orlynvah
• Exbilifep
• Zevtera

These approvals highlight the ongoing need for novel antibiotics, but limited commercial incentives for antibiotic development remain a challenge in the broader pharmaceutical market.

PBM Implications & Serve You Rx Solutions 

The evolving drug landscape underscores the need for pharmacy benefit managers (PBMs) to implement strategic solutions that balance cost management with patient access. Serve You Rx offers targeted programs designed to address these challenges effectively:

• Specialty Drug Management: As specialty drug approvals rise, Serve You Rx provides customized strategies to optimize utilization and manage costs. Our programs ensure members receive the right medications at the right time while mitigating financial strain on plan sponsors.
• Transparency & Cost Control: Serve You Rx champions a transparent PBM model, eliminating hidden fees and providing clear, pass-through pricing. Employers benefit from greater predictability in drug spending and access to 100% pass-through rebates, ensuring cost efficiency.
• Biosimilars Navigation: With biosimilars playing a growing role in cost optimization, Serve You Rx helps clients navigate complex formulary decisions, ensuring the right balance between brand-name drugs and biosimilar alternatives.

By staying ahead of industry trends and leveraging data-driven insights, Serve You Rx empowers clients to make informed, cost-effective decisions in an increasingly complex pharmacy landscape.

Reference: IPD Analytics. (2025, January). Rare Disease Drug Approvals – 2024 Year in Review. 

Discuss 2024 drug approval trends and plans for 2025 and beyond

Meet with our team today to learn more

About Serve You Rx®   
Serve You Rx is a full-service pharmacy benefit manager (PBM) with unquestionable flexibility and an unwavering commitment to doing what's best for its clients. With a fervent focus on those it serves, including insurance brokers, consultants, third-party administrators, and their clients, Serve You Rx delivers exceptional service and tailored, cost-effective benefit solutions. Independent and privately held for nearly 40 years, Serve You Rx can implement new groups in 30 days or less and say "yes" to a wide variety of viable solutions. Known for its adaptability, quality, and client-centricity, Serve You Rx aims to be a benchmark for better client service.