Specialty Pharmaceuticals Face Access Challenges in the AI Era

AXS26 Summit – Asembia held in Las Vegas, NV, sent a clear message to the healthcare sector: Market Access is evolving rapidly and the most successful organizations will be those that consistently think upstream – not those who wait to react. Across conversations, live sessions, and one-on-one meetings, a consistent theme emerged across pharma and specialty healthcare: the industry is moving beyond siloed commercialization approaches toward more integrated, evidence-driven decisions made earlier in the product lifecycle. Artificial Intelligence (AI) has a big part to play but barriers to patient access to advanced therapies exist and innovative solutions are needed to unlock access.

The key themes we saw throughout Asembia were:

• There is increasing pressure on patient access and specialty pharmaceuticals
• The women’s health sector is set for further growth
• Regardless of your sector, you need Artificial Intelligence

Access challenges and specialty pharmaceuticals

Asembia reinforced that payer scrutiny is intensifying – and “access” is increasingly being treated as something that must be engineered early, not negotiated late. Across sessions and side conversations, the consistent message was that manufacturers must think upstream: anticipate policy and utilization management hurdles, pre-empt evidence gaps, and align internal teams earlier so they are not reacting when restrictions hit.

This messaging is seen most clearly in specialty areas where the science is ahead of the system. Cell and gene therapy came up as a good example – the science is already way out in front but everything downstream is holding progress back. These barriers to patient access to innovative solutions include reimbursement complexity, real-world operational lift, and whether payers/providers are willing to absorb the uncertainty that these high-cost treatments bring. The implications are that the access bar is being raised higher, and “good clinical data” alone is no longer enough to secure predictable coverage pathways.

Two Asembia panels addressed critical access challenges in specialty pharmaceuticals, examining cutting-edge cell and gene therapies and opportunities with biosimilar formulations. Both sessions emphasized moving beyond problem identification to actionable solutions for improving patient access while managing costs.

At “Breaking Through Reimbursement Complexities for Cell & Gene Therapies”, a panel led by Joe DePinto (McKesson), Michael A. Evans (Geisinger), Navneet Majhail (HCA Healthcare Sarah Cannon), and Will Shrank (Aradigm Health), discussed a core challenge. Namely, that while cell and gene therapies offer transformative, potentially curative outcomes, access is almost shut down by reimbursement complexities rather than scientific limitations. On average the Food and Drug Administration estimates it can approve 10 to 20 cell and gene therapies per year. But, the systems designed to pay for such innovative therapies are only slowly developing and this is a blunt force blow to patient access.

Among the key Insights:

• The access gap is real: Only 1 in 5 eligible patients receive chimeric antigen receptor T cell therapy (CAR-T therapy), highlighting significant treatment barriers
• Technology solutions: AI-enabled prior authorization processes are accelerating approval timelines
• Care delivery innovation: Emphasis on providing care where patients are located, reducing geographic barriers

The panel moved beyond describing challenges to chart practical pathways forward, examining innovative payment models, risk mitigation strategies, and sustainable reimbursement approaches that could unlock broader access to these breakthrough therapies.

A second panel discussion titled “Rewriting the Playbook: Expanding Biosimilar Access” led by Arpit Patel (MedImpact) addressed the underutilized potential of biosimilars in reducing specialty drug costs. The market reality is that despite representing one of the most powerful cost-reduction opportunities in specialty pharmacy, biosimilar adoption is slow due to market, regulatory, and clinical barriers.

The statistics tell this story well:

• Some 82 biosimilars are available across 20 reference products
• Biosimilars account for only 2% of spend but less than 1% of market share
• Some 7% of US drug spend occurs on reference products with available biosimilar alternatives
• Just 8% of spend targets biologics with upcoming biosimilar competition
• Currently, 32% of biologic spend has no planned biosimilar alternatives

The strategic framework for acceleration is this:

• Open access: Eliminating restrictive formulary barriers
• Direct pharmacy purchasing: Streamlining procurement processes
• Lowest upfront net cost: Transparent pricing models
• Clinical soundness: Evidence-based product selection
• Patient support: Comprehensive assistance and access programs
• Supply chain reliability: Ensuring consistent availability
• Contract optimization: Aligning rebate and contract eligibility
• Economic impact: Biosimilars generate 25% of total gross profits while representing only 7% of wholesaler revenues, demonstrating significant margin opportunities

Both of these panels underscored a common theme: innovative therapies require innovative access, payment and reimbursement solutions. While cell and gene therapies demand new reimbursement models to handle high upfront costs and uncertain long-term outcomes, biosimilars need systematic barrier removal to realize their cost-saving potential. Success in both areas requires coordinated efforts across payers, providers, and manufacturers to align incentives and streamline processes.

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Women’s health is a growth sector

At Asembia, the session “Women’s Health 2030: The Market Opportunity for Biopharmaceutical, MedTech, Consumer Health and Digital Innovation” brought industry leaders together to discuss where women’s health is heading in terms of clinical care and market access. Moderated by Jen Radin (Deloitte), the panel included Joanne Armstrong (CVS Health), Jannine Versi (Elektra Health), and Michael Annichine (Magee-Women’s Research Institute).

Speakers noted that the women’s health space is experiencing significant growth, driven largely by a shift toward medically anchored services and pharmaceuticals that are accelerating diagnosis and treatment. The key drivers that are projected to shift women’s health spending habits are:

• Demographic Shifts: By 2030, 60–70 million women will be over age 45, marking the onset of perimenopause, and women aged 50+ years account for over half of all US consumer expenditures
• Consumer Activation: Over the past 5 years there has been a shift in consumer driven health
• Scientific Innovation and Access: Innovations and expanded access are reducing friction in care. Accelerating diagnosis and treatment and shifting spend to medically anchored services and pharmaceuticals fueling category growth

Speakers noted that three pillars within women’s health will drive further investment and innovation. These are:

• Conditions that present differently in women
• Conditions that disproportionally affect women
• Sex-specific conditions and diseases

Overall, women’s health is estimated to be a $500 billion market, with major opportunity areas in cardiovascular ($49 billion), neurology/neurodegenerative ($44 billion), pelvic diseases ($44 billion), and immune/inflammatory/bone health ($33 billion).

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Everybody needs Artificial Intelligence

Practitioners now use AI to support their work, and 92% of health insurers are using, planning to use, or actively exploring it.

For manufacturers, this raises a strategic question: if payers, providers, and patients are all turning to AI for information, is your content where AI can find it – and pull it accurately? The risk does not just add up to being overlooked, it is in fact having AI misrepresent your product because the right information was not accessible.

In the market access space, this is playing out in real time. AI can help manufacturers prepare for payer negotiations – but payers are building their own AI capabilities too. This means the healthcare sector is becoming an “AI vs AI” dynamic, and manufacturers need to account for both sides of the table.

The session “Charting the AI Path: Current Trends, Status Quo, and Future Outlook for Payers and Providers”, led by Joe DePinto (McKesson), Bret Paulson (Otsuka), and Muna Tuna (Ernst & Young) highlighted high-value use cases worth watching including:

• Shortening diagnosis timelines. Patients often see multiple HCPs, clinics, and hospitals before getting answers. Payers sit on data that could identify patterns earlier – and AI can help connect those dots to accelerate intervention
• Dynamic patient journey mapping. There is no single patient journey – realistically, there are dozens or hundreds. AI can model that complexity and surface where patients face decisions or barriers, helping manufacturers to show up at meaningful moments
• Longitudinal follow-up for gene therapies. Patients need to be tracked for 15 years post-treatment – across state lines, provider changes, and health system shifts. AI offers a path to maintain continuity and learn from long-term clinical outcomes

Conclusion

Asembia 2026 enabled us to explore the specialty pharmacy industry from multiple angles. We saw the challenges, possible solutions and issues that will define healthcare’s future. AI touched all sectors and is reshaping how every stakeholder operates. Equally important though was the whole problem of access – patient access and biosimilar, cell and gene therapy access. Solving all of this is a work in progress for various sectors and we are already looking at possible solutions.