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While the U.S. Most Favored Nation (MFN) policy tends to steal the spotlight as a current driver of global uncertainty and influence on launch sequencing, China’s industrial development is more influential for investors, according to Diane Munch, PhD, MD, Vice President of Global Pricing, PfizerSpeaking at ISPOR 2026, Munch said, “When you think about some of the innovative arrangements going on in the [Guangdong–Hong Kong–Macao Greater] Bay Area, the speed to access, everything, investors aren’t asking about MFN”Munch also highlighted the limits of reference pricing: “We’re at the precipice where value frameworks don’t work. IRP is reaching its pinnacle. Something has to give. All signs, in all honesty, are pointing to China”
Speaking at ISPOR, Diego Guarin, MPH, MSc, MD, Merck, highlighted the LATAM region’s “structural transformation in healthcare and drug pricing, spearheaded by pricing overhauls in Brazil and administrative price controls in Colombia designed to contain the cost of high-tech medicines”LATAM countries “have the full information for an informed HTA decision,” said Juliana Vallini, MPH, MSc, PAHO. However, she said old medicines are still listed when they should be excluded, and other drugs are not listed because they’re unaffordableMeanwhile, significant price gaps are evident in procurement systems. Vallini observed: “It changes a lot when a medicine is purchased at the central or hospital levels. I’m not talking about less developed countries. In the process of purchasing those medicines, we have huge gaps”
A roadblock in reforming the system to align reimbursement with improvements is the failure to understand the incremental progress in cancer care, said Dana P. Goldman, PhD, USC at ISPOR 2026. He explained that six months of extended survival means a patient could live long enough to see the next new treatment“It needs to be the case that you’re reimbursed on outcomes,” Goldman asserted, “not resources expended”Goldman also stressed the inelastic demand for oncology drugs: “It’s a life-threatening illness, and they need to take these things, and they’re willing to spend all their resources...Cancer drugs should have zero copays”
NAVLIN Daily is on the ground at ISPOR U.S., where Courtney Piron, Novartis, said the general industry consensus is that the Most Favored Nation (MFN) policy is flawed: “The CEOs of major companies have said publicly that MFN disincentivizes launches because it undervalues that medicine”At the conference, experts spoke at length about the complexities of the U.S. healthcare system and the challenges of reforming it. Liz Fowler, PhD, JD, Johns Hopkins Bloomberg School of Public Health, said that legislation addressing multi-level exploitation would prompt system players “to change their business model and maximize the new approach” but added that the direct to consumer model would “get some of that out of the system”Looking at the big picture, Inmaculada Hernandez, PhD, CMS, commented, “What keeps me up at night is, what is going to happen when the cap on the premium goes away? That is going to be a problem”
At ISPOR, researchers scrutinized the CMS Medicare Drug Price Negotiation Program and its lack of transparency. Sean D Sullivan, PhD, University of Washington, pointed out that the summaries that are published after negotiations finish are like a “data dump of information submitted to the CMS,” meaning that the public knows “very little” about how the information was assessedFurthermore, Sullivan explained the problem of “spiraling” prices: “You have ceiling price calculations, but in many cases, there is a therapeutic alternative that has an MFP also, so that MFP is going to play a role. This will continue in the future. It starts to spiral down the price, and none of it is influenced by value at all”The researcher also spoke of confusion around therapeutic alternatives and different indications, noting that DPP-4 inhibitors, SGLT2 inhibitors, and generic metformin were all identified as alternatives to semaglutide, and said the CMS should fine-tune its approach
Last week, NAVLIN Daily brought you key market access developments from across the globe. China unveiled plans to expand eligibility and flexibility for the NRDL and Commercial Insurance Innovative Drug List, while Norway warned that the U.S. MFN drug pricing policy could affect medicine access, pharmaceutical trade, local production, and R&D Across Europe, Spain opened the public hearing for its draft 2026 Reference Price Order, including a list of medicines exempted from the reference pricing system by the CIPM, while the EU reached a provisional agreement on the CMA, aimed at reducing medicine shortages and lowering dependence on non-EU suppliers NAVLIN Daily is preparing to attend a slew of conferences, including ISPOR U.S., FT U.S. Pharma and Biotech Summit, and Pricing & Contracting USA 2026. Stay tuned for our coverage next week!
At the U.S. Pharma and Biotech Summit, Lori Reilly, Chief Operating Officer, PhRMA, critically examined the Most Favored Nation (MFN) policy, noting that drug costs could ironically increase, profits of biopharmaceutical companies will decrease, and China may gain leverageAlice Chen, Associate, Professor, USC Sol Price School of Public Policy, underscored that the MFN policy only tries to deal with list prices, and that there are complicated challenges as one thinks through the rest of the supply chainMeanwhile, the panelists agreed that patients are frustrated with systemic complexity and often abandon their scripts. Reilly summarized the public's desires: simplicity, ease of use, and transparency
In response to China’s rapid growth, Susan Winckler, CEO, Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA), underscored at the U.S. Pharma and Biotech Summit that the FDA “is in the midst of a deep diagnostic effort of what it might do better to facilitate drug development”Winckler noted the potential need to revise the IND process, which may require statutory change, but also observed “very low hanging fruit revisions that we might expect to see,” such as replacing term “clinical hold” with new, less “scary” phrasingAs part of the solution to the complex regulatory structure of the biotechnology landscape, Caitlin Frazer, Executive Director, National Security Commission on Emerging Biotechnology (NSCEB), spoke about the National Biotechnology Initiative Act, a bipartisan bill “to create clear, consistent, durable regulatory pathways…for novel products and biotechnology where there is not currently a regulatory analog”
The fierce demand for weight-loss products has kick-started the momentum for direct patient access to pharmaceuticals, leaving industry leaders at the U.S. Pharma and Biotech Summit to wonder about the implicationsMark Thierer, CEO of the scaled commercialization firm EVERSANA, spoke about his company’s plan to build a new platform to seamlessly connect pharma with payers: “Imagine no formularies. Imagine gross-to-net zero. Imagine no tripwires like prior authorizations, and long term, that is exactly what we're building”Thierer explained: “Every major pharma company we’re talking to about an alternate channel…You cannot blow up the current model. It’s not either-or. It’s a third choice – optionality”
The German Association of Research-Based Pharmaceutical Companies (vfa) has said the ongoing Pharmaceutical Dialogue should specifically address the need for better integration between the EU-HTA and the German Drug Market Reorganization Act (AMNOG) procedure“Europe is at its best when it makes things easier. With the European Health Technology Assessment, we finally have another opportunity to do just that. And it is up to the nation-states not to stand in the way now! The so-called EU HTA is intended to simplify procedures, avoid duplication of effort, and bring innovations to patients more quickly. To achieve this, the European assessment must be consistently utilized in the AMNOG process. It must not become an additional layer of bureaucracy in Europe,” says vfa President Han SteutelThe challenge, according to vfa, is to connect AMNOG with EU-HTA in a way that makes European reports usable in practice. The group identifies three main pressure points: AMNOG deadlines are not yet sufficiently coordinated with the EU-HTA process; European and national dossier requirements do not fully match; and it remains unclear how bindingly EU-HTA results will be taken into account in the German procedure
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