NAVLIN Daily NewsCheckout Today’s News
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 PD prescription, 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
The incoming patent cliff is reinvigorating strategic M&A activity in the pharma sector, even amid geopolitical and economic uncertaintyAt the U.S. Pharma and Biotech Summit, E. Eric Tokat, Partner, Centerview Partners, said regarding dealmaking activity, “I feel pretty good, robust about it, and the years ahead—this dynamic of innovation in pharma”Regarding China’s competitive rise, Clive Meanwell, Chairman and Partner, Population Health Partners, observed, “We’ve underweighted China in M&A in the past, and now it’s naturally catching up to where it should be. Although it looks a bit dramatic, I think it’s a natural progression of our industry”
“The scale of what’s happening in China is at the scale of the U.S. and has overtaken Europe,” highlighted Lieven Van der Veken, Senior Partner and Global Leader of QuantumBlack, the artificial intelligence (AI) consulting arm of McKinseyThe expert, who spoke at the U.S. Pharma and Biotech Summit, said global drugmakers must join forces with China, and cross-border partnerships are strategically shifting to earlier stages of developmentAgreements with Chinese companies are rapidly evolving, observed Van der Veken, who suggested exploring different contract types and searching for partners in Chinese cities beyond Shanghai
UnitedHealth’s pharmacy benefit manager (PBM) Optum Rx announced that it will replace its traditional model with a new, fee-based benefit schemeSpecifically, the PBM is introducing a new pricing structure with "monthly, clearly defined fees per member that will be established independent of manufacturer list prices or prescription volume." According to the company, this move will eliminate spread pricing and "similar practices"Every Optum Rx customer will also gain transparency into the new fees, including those associated with Optum Rx’s group purchasing organization (GPO), with disclosure of any payments received from drugmakers
The National Healthcare Security Administration (NHSA) recently published its proposed work plan for this year’s adjustments to the National Reimbursement Drug List (NRDL) and the Commercial Insurance Innovative Drug List. The plan expands eligibility criteria for both lists and introduces flexibility for innovative drugsPrice control rules were also updated to link insurance payment standards with the list prices of competitively bid products, thus addressing notable price differences observed between list prices and reimbursement standards for some competitively priced products on the NRDLFurthermore, renewal rules were clarified, with a two-prong payment standard adjustment mechanism proposed for exclusive products for which agreements have expired after eight years, thereby alleviating past uncertainty about how contracts can be renewed after eight years and how prices will change after shifting to the standard list
The National Healthcare Security Administration (NHSA) published a tentative work plan for updating the National Reimbursement Drug List (NRDL) and the Commercial Insurance Innovative Drug List this yearThe plan proposes expanding eligibility to include drugs that have completed their technical review by the time the finalized work plan is issued. It also introduces NRDL eligibility for drugs that were on last year's commercial list, new generic products, and previously negotiated drugs that later failed the renewal processThe work plan opens the doors to the commercial list for new generics and exclusive products for rare diseases approved in the last five years or that have completed technical review
The European Parliament and Council negotiators have reached a provisional agreement on the Critical Medicines Act (CMA) aimed at reducing shortages of essential medicines, cutting the EU’s dependence on non-EU suppliers and strengthening pharmaceutical manufacturing inside the blocPublic Health Committee Chair Adam Jarubas (EPP, PL) said: "The Critical Medicines Act is closely linked to the pharmaceutical package, the missing piece of the EU's response to medicines shortages following the creation of the critical medicines list and the Critical Medicines Alliance. It implements the Pharmaceutical Strategy for Europe and marks a milestone for the European Health Union. It means greater medicines security for the Europeans, but it will also be an essential support for EU's reindustrialization and competitiveness"A Presidency debriefing on the outcome of the trilogue will take place on May 13, 2026. However, the provisional agreement still needs to be approved by both Parliament and Council before the new rules can enter into force
650+
+99%
<24
4,000+
24x7
99.5%
