As the pharmaceutical industry continues to evolve, manufacturers must stay ahead of shifting distribution models, regulatory changes, and payer dynamics to ensure patient access and commercial success. In Part 1 of IntegriChain’s Access Insights 2024 panel discussion— “Navigating Market Access Challenges in 2025—industry experts examined how the Inflation Reduction Act (IRA) and emerging payer strategies are reshaping commercialization. 

Building on that discussion, Part 2 explores how innovative distribution models and long-term market access trends will influence pharmaceutical strategy in the years ahead. Moderated by Reena Patel, Partner at Blue Fin Group, an IntegriChain company, the panel brought together industry leaders to discuss the rise of direct-to-consumer models, the increasing influence of payers in traditionally provider-managed markets, and the growing importance of early commercialization planning. As distribution and reimbursement landscapes continue to shift, manufacturers must take a proactive, data-driven approach to ensure sustained market access and profitability. 

Jim Meyers: Chairman of the Board at IntegriChain, former Chief Commercial Officer at Gilead Sciences, and Senior Advisor to BCG. With over 35 years of experience in pharmaceutical commercialization and market access, Jim has been deeply involved in shaping strategies at the intersection of policy, pricing, and patient access.

Cyndi Goss: Head of Policy at Insmed, specializing in government programs, Medicaid, Medicare, and state-level pricing policies. With a career spanning the implementation of the Medicare Modernization Act (MMA) to the latest IRA changes, Cyndi brings extensive expertise in policy analysis and regulatory strategy.

Jose Valdes: Executive Director of Pricing, Channel, Specialty Pharmacy Strategy, and Market Access at Novartis. Jose has led market access strategies across pharma, oncology, and advanced therapies, with a focus on integrating pricing and distribution to optimize product launches.

Patel: How are emerging distribution models affecting market access strategies?

Meyers: We are witnessing a growing trend in direct-to-consumer (DTC) platforms, as seen with examples like LillyDirect and PfizerForAll. These models allow manufacturers to connect more directly with patients, and provides optionality that enables reducing exposure to specific channels like 340B, while offering a more convenient platform for all-cash/non-insurance offerings. The telehealth platform can accelerate patient access to care, which is particularly important with medications like Paxlovid which depend on taking the drug immediately after the onset of symptoms in order to provide a clinical benefit. It’s important to note that the majority of patients who come through these platforms already have a prescription and insurance coverage, and are simply using the platform for convenient delivery options. In other words, they don’t go outside of the PBM’s and payers except in situations where a patient chooses to pay cash (which is typically only the case when the drug is not covered). 

Goss: For smaller biopharmaceutical companies, there’s often more room to experiment with innovative distribution models. However, this flexibility comes with added complexity, particularly around regulatory compliance and financial viability. Specialty drugs still largely rely on the specialty pharmacy model due to the need for high-touch services and reimbursement coordination. Companies must weigh whether shifting to alternative models, such as limited distribution networks or direct specialty distribution, provides a net benefit or introduces unforeseen hurdles.

Valdes: Decisions about distribution models should always be driven by the specific needs of the product. Specialty products require tightly controlled distribution networks to manage therapy initiation, adherence, and reimbursement. On the other hand, broad-market primary care therapies can benefit from wide accessibility, including retail and mail-order channels. Ultimately, manufacturers must align their distribution strategies with payer requirements and patient experience considerations, ensuring that convenience doesn’t come at the cost of access or affordability. 

Patel: Looking ahead, what are the key market access trends for the next 5-10 years?

Meyers: We expect to see increasing payer intervention in traditionally provider-managed spaces, particularly within Medicare Part B and the broader medical benefit landscape. Provider-administered oncology therapies, which historically have faced little to no payer management, may face enhanced payer scrutiny and utilization controls. This shift will necessitate earlier engagement with payers, new pricing strategies, and alternative contract structures to ensure continued market viability. 

Goss: Market access teams will need to closely track evolving state-level regulations, as legislative shifts create a fragmented policy landscape. The broader U.S. healthcare framework oscillates between market-driven dynamics and government intervention, and companies must remain agile in response to potential changes in drug pricing policies, reimbursement mechanisms, and value-based care initiatives. Being proactive in policy advocacy and scenario planning will be crucial. 

Valdes: Speed to market and immediate access optimization will be critical. The historical model of launching and refining access strategies over time is becoming obsolete. Companies must ensure full payer engagement, HEOR (Health Economics and Outcomes Research) readiness, and data-driven contracting strategies from the outset. Additionally, the growing importance of real-world evidence and integrated clinical-economic data will shape future market access planning, requiring closer collaboration between medical affairs, commercial teams, and payers. 

Final Thoughts: Navigating the Future of Market Access with Strategic Agility

The discussions across both parts of this panel underscored that success in today’s rapidly evolving pharmaceutical landscape requires a blend of strategic foresight, data-driven decision-making, and operational agility, requiring manufacturers to adapt in real time. Market access strategies are being reshaped by emerging distribution and dispensing models and shifting reimbursement structures. The rise of direct-to-consumer (DTC) models—exemplified by Lilly Direct and PfizerforAll^TM—offers companies greater control over pricing, reimbursement, and patient engagement. However, panelists emphasized that DTC is not a universal solution. Its viability depends on factors such as therapeutic area, patient population, and regulatory considerations. While smaller biotech firms may have more flexibility to experiment with alternative distribution models, specialty products often necessitate traditional specialty pharmacy and hub partners to ensure proper reimbursement, patient adherence, and seamless provider integration.  

At the same time, payer engagement and reimbursement dynamics are becoming increasingly complex. As Medicare Part B and the broader medical benefit space come under heightened payer scrutiny, manufacturers must reassess their pricing and contracting strategies, particularly for high-cost therapeutic areas like oncology and immunology. Additionally, the continued evolution of state-level policies is creating a fragmented regulatory landscape, requiring manufacturers to engage in more rigorous scenario planning and policy monitoring. Compounding these challenges, the window for profitability post-launch is shrinking. Companies must enter the market with a fully optimized access strategy—one that includes robust health economics and outcomes research (HEOR) data, early payer engagement, and evidence-based contracting strategies to ensure sustainable market success.  

Ultimately, this two-part discussion reinforced that market access is no longer a static function— it is a continuously evolving discipline that demands strategic agility. Manufacturers that can anticipate payer and policy shifts, embrace innovative channel models where appropriate, and execute access strategies with precision will be best positioned for long-term success. As the healthcare ecosystem continues to transform, companies that proactively align their commercialization approach with today’s market realities—from IRA-driven pricing pressures to payer-controlled reimbursement models and emerging distribution pathways—will be the ones that thrive in the years ahead. 

Disclaimer: The views and opinions of the panelists are their own and should not be attributed to their employer. 

Want to learn more? Connect with our experts at IntegriChain to explore how we can help your organization stay ahead of market access trends.