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The European Federation of Pharmaceutical Industries and Associations (EFPIA) has revealed its latest annual W.A.I.T. Indicator for 2025The report reveals that the average time for EU patients to access approved medicines has risen to 597 days, up from 578 days in EFPIA’s previous report. It also found that nearly half (49%) of innovative medicines centrally approved in Europe were not available to patients in 2025, while only 28% were fully available through public reimbursement systems“As in previous years the root causes of unavailability and delay to accessing new medicines are multifactorial, ranging from the speed of regulatory processes to misalignment on evidence requirements to insufficient budgets in Member States,” EFPIA notes. “Industry continues to stress that these barriers can be addressed through collaborative work between Member States, the European Commission, and all relevant stakeholders on proposals to improve availability and reduce delays”
At ISPOR 2026, Dr. Zhiliu Tang, GSK, noted that 24% of submissions for China’s National Reimbursement Drug List (NRDL) from domestic companies and 60% from multinational companies included real-world evidence (RWE), but the impact of the RWE remains unclearHowever, China has spent years piloting RWE-informed decision-making and has released various documents that signify its aim to increasingly embrace RWETang offered several recommendations to take advantage of China’s pro-RWE outlook, including ongoing RWE collection to leverage in NRDL negotiations and early launches in the Hainan Pilot Zone to speed up regulatory approvals and coverage decisions
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”
At ISPOR 2026, Xiaoyan Wang, PhD, Tulane University, highlighted a prediction that AI could shorten drug discovery significantly, while adding that the vast majority of Generative Artificial Intelligence (GenAI) pilots at companies are currently failing“The regulatory space is really pro-technology at this point,” said Wang. The U.S. Food and Drug Administration (FDA) now uses multiple AI tools to streamline its processes, while the Institute for Clinical and Economic Review (ICER) has been conducting various AI pilotsAbigail Wright, Director of Evidence Synthesis, ICER, summarized, “AI-assisted approaches may be effective for some tasks in HTA with human supervision, but not effective for some other tasks, because there is not sufficient evidence that it would perform well enough for widespread adoption”
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
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