The pharmaceutical industry is facing unprecedented challenges as market access dynamics continue to evolve. The Inflation Reduction Act (IRA), changing payer strategies, and emerging distribution and dispensing models are reshaping how manufacturers approach commercialization. To navigate these complexities, companies must rethink channel, pricing, contracting, and patient access strategies.

At IntegriChain’s Access Insights 2024, industry experts discussed how pharmaceutical manufacturers can adapt to this shifting landscape. Moderated by Reena Patel, a Partner at Blue Fin Group, an IntegriChain company, the panel featured market access leaders from across the industry. This is the first installment of our two-part blog post.

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 SMED, 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.

This discussion provided key insights into how companies are responding to new market access challenges, including IRA implementation, state-level pricing regulations, gross-to-net pressures, and payer-driven changes in reimbursement models. The panelists shared strategies for mitigating financial risks, optimizing commercial execution, and preparing for long-term shifts in policy and industry dynamics.

Patel: What are the biggest market access challenges facing pharmaceutical companies today?

Meyers: The implementation of the Inflation Reduction Act (IRA) has significantly changed the market access landscape. Companies from Round 1 know their negotiated prices, but the challenge lies in effectuating the price in a manner that doesn’t further expose them to duplicate discounts or payer preference for non-negotiated alternatives. The effectuation of the Maximum Fair Price (MFP) is driving concerns about gross-to-net impact and the elimination of traditional PBM/payer rebates. This shift requires careful planning to avoid any adverse impact on net revenue or patient access.

Goss: Small biopharmaceutical companies face unique hurdles in navigating policy changes. The lack of clarity from federal agencies on IRA implementation and duplicate discounting in 340B programs poses a significant risk. Companies must proactively work with legal and compliance teams to develop strategies for mitigating financial risks while ensuring affordability for patients.

Valdes: The entire healthcare system is under pressure, with payers and PBMs adjusting their models. Pharmaceutical manufacturers must take a holistic approach, integrating pricing, channel strategy, and distribution planning. The traditional silos between access, commercial, and financial teams must be dismantled to create agile and responsive market access strategies.

Patel: How are regulatory changes impacting investment decisions and product launches?

Meyers: The IRA has fundamentally altered how companies evaluate assets. In the past, companies had a longer life cycle to maximize product revenue. Now, with negotiated pricing kicking in after a set number of years, manufacturers must ensure rapid market penetration and access from day one. The impact is particularly pronounced for small molecules in therapeutic areas like oncology, where stepwise development is common, making the net present value (NPV) of these assets more uncertain. In contrast, biologics face far less impact from IRA negotiations due to their longer exemption period. As a result, CFOs and CEOs are taking a more active role in market access planning due to the unpredictability of gross-to-net dynamics.

Goss: State-level policy changes are also reshaping investment strategies. With individual states implementing pricing transparency laws, prescription drug affordability boards, and 340B regulations, companies must account for these factors early in product planning. Ignoring these policies could lead to unexpected financial penalties and market access restrictions.

Valdes: Launching a new product today requires meticulous planning. Every decision—from clinical trial design to payer negotiations—must factor in long-term pricing pressures. Companies must be strategic about formulary placement, contracting decisions, and data analytics to optimize access and reimbursement.

Patel: What strategies can companies use to manage gross-to-net impact?

Meyers: Gross-to-net has become a top concern for executives. Companies are issuing RFPs for gross-to-net optimization, something that was traditionally handled within market access teams. The growing complexity of pricing pressures—accumulators, maximizers, specialty carveout, the Part D redesign, direct negotiation with Medicare, and 340B—means that manufacturers need real-time data insights and cross-functional collaboration to avoid revenue leakage.

Goss: Transparency and forecasting are critical. Companies must establish robust internal processes to track payer mix changes, state-level policy shifts, and reimbursement trends. This allows them to anticipate financial risks rather than react to revenue losses.

Valdes: The ability to model different pricing and contracting scenarios is essential. Manufacturers must consider future policy changes when making decisions about product pricing, payer contracts, and access programs. Additionally, having strong partnerships with data providers like IntegriChain ensures that companies can proactively address gross-to-net challenges.

Final Thoughts

Market access is more complex than ever, requiring cross-functional collaboration and strategic foresight. Companies that proactively adapt to regulatory changes, optimize gross-to-net management, and explore innovative distribution and dispensing models will be better positioned for success. As industry leaders emphasized in this discussion, early planning and data-driven decision-making are key to navigating the evolving pharmaceutical landscape.

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.