Why Unpredictable Access Is a Commercial Risk Biopharma Can’t Ignore

Uncertainty has always existed in biopharma. What’s changed is where it shows up and how costly it can become.

Today, even routine access events can quietly derail therapy starts. Annual benefit resets, prior authorization reverifications, shifting coverage rules and unexpected cost exposure all introduce friction into moments that should be predictable. When access breaks down it doesn’t just delay treatment, it undermines launch forecasts, distorts program effectiveness and, most importantly, increases the likelihood that patients never start therapy at all.

At CoverMyMeds, we’ve seen this play out at scale time and time again. Our data highlight nearly two‑thirds of patients experience a delay accessing their medication.¹ Additionally, one‑third of all prior authorizations are still initiated manually, increasing the likelihood of rework, incomplete submissions and avoidable slowdowns.¹ These are structural signals that access predictability must become a core commercialization capability, not a downstream function.

This is especially consequential as innovation moves further into the specialty arena. The 2025 CoverMyMeds Medication Access Report demonstrated that 75% of drug launches are expected to be specialty and 56% of total drug spend is already concentrated in specialty medications.¹ Yet, IQVIA’s latest US medicine use trends report found nearly two-thirds of prescriptions for newly launched drugs go unfilled in the first year on the market.² This makes reliable access especially important for specialty brands, and it helps explain why access and affordability are becoming more central to commercialization conversations.

In fact, this theme surfaced repeatedly at the Asembia AXS26 Summit this spring. Discussions on policy reforms and PBM pressures all landed in the same place. Brands are being asked to perform under tighter constraints with less room for error. Now, more than ever, the market is paying closer attention to how drugs are priced, covered and accessed.

In this context, predictability becomes a competitive advantage. What I mean is that a predictable environment stabilizes brand performance and makes investment decisions easier to defend. It also requires rethinking on how access success is defined. Approval rates and program enrollment still matter, but they don’t fully answer the question leaders are now responsible for answering, “can this model deliver reliable therapy starts at scale when coverage rules, costs and requirements change midstream?”

How Can Pharma Build More Predictable Patient Access?

Predictable access doesn’t come from doing more, rather, we know it occurs from focusing on what matters most and ensuring those efforts work together in practice. We routinely see access friction tend to surface at the same moments when coverage requirements come into view, out‑of‑pocket costs become clear and a claim stalls or fails.

When aspects of the process are managed across disconnected systems, like benefits investigation, medical and pharmacy prior authorization and patient services enrollment, fragmentation sets in and time to therapy stalls. Insightful offerings can connect those moments within a single, embedded workflow so information carries through, momentum is preserved and patients keep moving toward therapy starts. For brands, that connectivity reduces avoidable drop‑offs and supports stronger launch readiness and lifecycle performance.

Reframing access this way shifts the conversation from programs to performance. Once predictability is treated as an operating discipline rather than a collection of initiatives, a path forward becomes clear. The models that succeed align on how they surface issues, reduce friction and measure what moves a patient forward.

• Visibility plays a critical role: Predictability depends on seeing friction early enough to do something about it. That means knowing where prescriptions fall off, where cost becomes a barrier and where administrative steps slow progress. This is about enabling action before abandonment happens. When insight comes too late, that means intervention, patient experience and program effectiveness can also suffer.
• Reliable automation matters: The question in 2026 isn’t whether automation exists, but whether it actually reduces friction without compromising confidence. Predictable access relies on tools that fit real workflows, improve completeness and speed and keep human judgment in control. This is especially important in prior authorization, where scale and clinical discretion must coexist. Done thoughtfully, automation reduces rework and shortens resolution time.
• Measurement must evolve alongside strategy: Time to therapy should reflect what patients experience, not just operational speed. Performance during predictable disruptions such as benefit resets remains one of the clearest indicators of whether an access model is built to hold up under pressure.

How Do You Define Success in 2026?

In 2026, access is no longer a backend function. It sits on the front line of brand performance and patient experience. Leaders who succeed will design for volatility rather than assume stability. They will simplify and streamline, rather than layer more offerings – and they’ll invest where predictability consistently helps patients start and stay on therapy. That consistency is no longer incremental, it’s an advantage.

Nicole Eckl is vice president of biopharma sales at CoverMyMeds.

References:

1. CoverMyMeds. Medication access report 2025: From barriers to bridges. Published March 5, 2025. Accessed May 18, 2026. https://www.covermymeds.health/articles/healthcare-research/medication-access-report
2. IQVIA Institute for Human Data Science. U.S. medicine use trends 2026: Increased use and spending amid access and cost pressures. Published April 28, 2026. Accessed May 18, 2026. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/us-medicine-use-trends-2026