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At the Informa Medicaid Drug Rebate Program Summit in Chicago on Wednesday, speakers offered a novel perspective on developing a strategic decision framework in relation to the continued implementation of the Inflation Reduction Act (IRA) for 2026 and beyondJeff Baab, Partner, Advisory Services, IntegriChain, observed a fundamental shift in the required approach to new drug commercialization, where a business case is needed even when selecting an initial asset, after which various policy changes and a value story relating to a broader group of stakeholders need to be consideredBaab suggested utilizing game theory to conduct probability assessments: “What are all the permutations of a policy and how might they might impact us or competitors directly or indirectly?”
The U.S. pharmaceutical industry is grappling with supply chain challenges propelled by policies and regulations that favor domestic products over foreign imports—Allison D. Pugsley, Partner, Hogan Lovells, brought attention to the Trade Agreements Act of 1979 which restricts U.S. government product acquisitions to U.S.-made or designated country end products, and the Acetris 2020 federal circuit ruling which creates a a “double standard” between these two categories of productsRegarding U.S. tariffs on imported products, Lovells expects the levies to be applied “sooner rather than later” and believes they will present “serious consequences in terms of price” but sees an opportunity to raise VA FSS prices if tariffs apply to their products under current lawThe expert also alerted the audience to the reintroduction of the Biosecure Act which prohibits entities that use government funding from using biotechnology equipment or services provided by a “biotechnology company of concern”, but the Act has become less clear about which specific foreign companies fall under this designation
Experts are strategizing to navigate the intersection of the 340B program, the Inflation Reduction Act (IRA), and Maximum Fair Price (MFP) at the Informa Medicaid Drug Rebate Program Summit in Chicago, and Katheryne Richardson, Managing Director, Berkeley Research Group, offered largely optimistic insights on the future of discount managementThe expert believes manufacturer appetite will grow for optimized drug discount channel management, and the industry will become intolerant of fragmented rebating without a full channel view and controlBy 2028, she said, a combination of competition, MFP price dynamics, and the need for deduplication will upset demand and predictability, the 340B modifier will decline, and a private, more flexible payment module alternative may present competition for the government payment facilitator
The government’s complex 340B Drug Discount program continues to evolve, and attendees of the Informa Medicaid Drug Rebate Program Summit in Chicago convened to deepen their understanding of its fundamentals and influence340B participants were advised to avoid duplicate discounts (DD), where a drug receives both a 340B discount and Medicaid rebate on the same unit, as well as diversion, where a 340B drug is given to an individual who is not a patient of a covered entityThe latest developments include HRSA’s “somewhat controversial” pilot rebate model program scheduled to launch next year to explore manufacturer rebate models, and new state laws advancing to mandate manufacturer sales at 340B prices to contract pharmacies—Further legislation may arise to limit HRSA telehealth flexibilities across state lines and the prescribing of drugs outside a clinic’s typical scope
New pharmaceutical companies face specific challenges when bringing products to market, and experts at the Informa Medicaid Drug Rebate Program Summit in Chicago presented strategies for navigating them, given the complexity of the compliance and market access environmentDifferent considerations come into play as a product launch date approaches, but strategizing must significantly ramp up between 18 months and two years before launch, said Darnell Turner, Vice President, Pricing, Contracting, Market Access Operations, ExelixisRachael Herrera, EY, Manager, added, “You don't want to ignore the government pricing team while launching your product…The earlier you start collaborating with the government team the better the long-term life of the product”
At the Informa Medicaid Drug Rebate Program Summit in Chicago, an expert panel of attorneys discussed the most pressing issues facing the Medicaid Drug Rebate Program (MDRP) and government pricing, including the upcoming pilot rebate model program to explore manufacturer rebate models—It is on a fast track to begin by January 1, and “no one seems to be planning to raise a legal challenge once they finalize the program,” said John Shakow, Partner, King & Spalding LLPRegarding the move towards Most Favored Nations (MFN) pricing, Meena Datta, Partner, Sidley Austin, suggested planning scenarios informed by the administration’s holistic view on pricing that includes access and care: “This line of thinking can be very useful when thinking about MFN possibilities”Jeff Handwerker, Partner, Arnold & Porter, considered how sales to patients are exempt from best price, and direct-to-patient (DTP) platforms and the consignment model involve possibilities for rationally assuming that a sale is exempt, but added that all assumptions and decisions should be documented thoroughly
A Norwegian delegation from the Directorate for Medical Products (DMP) has visited the Danish Medicines Council to gain insight into Denmark’s model for assessing new medicines"Over the past two years, we have worked purposefully to streamline our assessments of medicines so that we can get new cost-effective medicines to patients as quickly as possible. We are happy to share our experiences with our Norwegian colleagues,” says Søren Gaard, Director General of the Danish Medicines CouncilThe Danish Medicines Council explains it has introduced several measures to be able to assess new medicines more quickly. Among other things, this applies to three 'tracks' for the assessment of new medicines, where the time frame is adapted to the complexity of the assessments
The World Health Organization (WHO) has added GLP-1 receptor agonists like Ozempic, Trulicity, and Mounjaro to its Essential Medicines List for treating type 2 diabetes with obesity and related conditions, marking a U-turn from its decision to omit them for obesity earlier this month In new draft guidelines, open for consultation until September 27, WHO said the response to obesity was often shaped by outdated views that frame it as a lifestyle issueInstead, WHO notes it is a "chronic, progressive and relapsing disease” that affects more than 1 billion people globally in both high- and low-income countries, contributing to millions of preventable deaths; as such, it backs the use of these products to treat obesity for the first time
A new ABPI report has found that the UK is losing the race for investment in R&D, clinical trial delivery, and foreign direct investment, due to increasing drags on competitivenessSince 2018, UK Pharmaceutical R&D investment has underperformed against global trends, with a significant slowdown starting in 2020, when UK growth fell to 1.9% per year, behind the global average of 6.6% annual growth. Further, pharma industry investment in R&D actually fell in 2023 by nearly £100 millionThe report highlights UK life science competitive strengths, such as a world-class research infrastructure, public and charitable spending on R&D, and robust protections for intellectual property (IP). However, weaknesses that stand out include low investment in medicine, poor patient access to medicines, and unpredictable rates from the Voluntary Scheme for Branded Medicines Pricing, Access, and Growth (VPAG)
During the week of September 1st, 2025, several companies announced new partnerships and M&A activityDeals include Eli Lilly signed strategic partnership deal with JD Health, a leading online healthcare platform in China, to bring weight-loss and diabetes products directly to patients.NAVLIN Daily’s roundup of industry deal and agreement activity from the past week is below
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