Decoding the Specialty Drug Pipeline: Why Independent Prior Authorization Will Define 2026

Specialty medications continue to dominate the pharmacy landscape. At net prices, drug spend in the United State reached $487 billion in 2024, an increase of 11.4% from the year before.

Perhaps the more surprising aspect is that according to IQVIA 2025, the spike in spend wasn’t driven by price inflation or other economic factors, but rather due to a greater utilization of specialty drugs and high-complexity therapies. Based on that trend, a Vizient 2025 study reports overall pharmacy spend is projected to grow another 3.84% by June 2026, maintaining upward pressure on benefit budgets.

Why Prior Authorization Matters

Prior authorization (PA) is a clinical review process used to confirm that a prescribed medication is medically necessary, evidence-based, and consistent with plan design before it is dispensed. The intent is to ensure appropriate use of high-cost or high-risk therapies, particularly in oncology, immunology, and gene therapy, while promoting safe, effective, and sustainable care.

As the drug pipeline expands, PA has evolved from a transactional checkpoint into a mechanism of clinical governance. Yet, when pharmacy benefit managers (PBMs) oversee both utilization management and dispensing, financial incentives can influence coverage decisions. This overlap has prompted closer attention to how the PA function can maintain neutrality and transparency across stakeholders.

Challenges in Specialty Drug Management

Per-member-per-year specialty drug costs increased from $1,333 in 2023 to $1,641 in 2024, a rise of $308. Specialty trend slowed from 14.4 percent in 2023 to 9.6 percent in 2024, aided by biosimilar adoption yet remaining significant. Specialty utilization rose 4.7 percent, with average claims per user holding steady at 5.9 percent.

Across the market, 84 percent of payers rank specialty cost management as their top priority, while nine percent of employers and 24 percent of health plans have already carved out utilization-management services such as PA, and another 24 percent are considering it.

Pipeline momentum compounds the challenge: the FDA has approved 34 new oncology therapies in the first three quarters of 2025, underscoring how quickly specialty innovation continues to expand.

Oversight and Alignment

The Federal Trade Commission’s Second Interim PBM Report (January 2025) found that PBM-owned pharmacies marked up certain specialty generics by hundreds to thousands of percent, generating $7.3 billion above acquisition cost and $1.4 billion through spread pricing between 2017 and 2022.

These findings highlight the ongoing discussion around how clinical decision-making can remain objective in vertically integrated environments and how oversight frameworks can evolve to safeguard both patients and plan sponsors.

Independent PA: A Modern Solution

Recent models describe the evolution of PA through two key structural lenses:

• Carve-Out Structure: PA can be contractually separated from the PBM and managed by an independent clinical review organization reporting directly to the plan sponsor or coalition. The PBM continues to supply eligibility, claims, and formulary data, while determinations are issued solely on clinical evidence. Integration occurs through secure system connections, ensuring operational continuity under neutral governance.
• Specialty vs. Non-Specialty Framework: Independent reviewers often apply two pathways. Specialty drugs undergo detailed assessment, including indication, dosing, biomarker validation, step-therapy compliance, and site-of-care evaluation, while non-specialty drugs follow streamlined approvals emphasizing generic substitution and adherence monitoring. This approach maintains clinical rigor where spend is highest and ensures efficiency where access and adherence are most important.

Preparing for 2026: What’s Next?

With PMPY specialty costs up $308 year-over-year and an expanding roster of complex therapies, the structure and stewardship of prior authorization will remain a central focus across the industry.

As organizations prepare for 2026, the emphasis is shifting toward transparency, alignment with physicians, integration of patient-support programs, and consistent application of evidence-based criteria—key components in ensuring that prior authorization continues to advance both quality and accountability in pharmacy management.

Key Takeaways

• Specialty drug costs and utilization continue to rise, making effective management critical for payers and plan sponsors.
• Independent prior authorization offers a neutral, evidence-based approach to clinical decision-making, especially as the specialty pipeline expands.
• Regulatory scrutiny and market trends are driving greater transparency and separation of clinical review from dispensing.
• Organizations should focus on aligning PA processes with physicians, integrating patient-support programs, and applying consistent evidence-based criteria.