NAVLIN Daily NewsCheckout Today’s News
Industry leaders met yesterday at the FT Global Pharma and Biotech Summit in London to discuss dramatically changing policies on both sides of the Atlantic, from Europe’s new pharmaceutical strategy to the U.S.' Most Favored Nation (MFN) pricingWhile the room was packed out with senior industry representatives and payers who all harbor thoughts on these topics, those on stage kept their cards close to their chestsRead on to learn NAVLIN Daily’s learnings from the first day of the Summit
We’re back at the Financial Times’ (FT) Global Pharma and Biotech Summit in London for day two, where Dr Sam Roberts, Chief Executive Officer (CEO) of the National Institute for Health and Care Excellence (NICE), kicked off the day talking about NICE’s transformation journeyThe outgoing CEO, who will be leaving at the end of 2025, addressed the Agency’s closer collaboration with the Medicines and Healthcare products Regulatory Agency (MHRA), the premise of the Voluntary Pricing and Access Scheme (VPAG), and the controversy surrounding the Enhertu (trastuzumab deruxtecan) decision under NICE’s new severity modifierDr Roberts confirmed that the joint working pathway between NICE and the MHRA launched on 1 October, marking what she described as “20 years” of ambition finally realized. “We’ve got the first couple of medicines that are part of that pathway where we’re constantly sharing data with MHRA,” she said. “Our aim is to have NICE advice and MHRA license as close together as possible, ideally on the same day.”
Speaking at the Financial Times’ (FT) Global Pharma and Biotech Summit in London, Patrik Jonsson, Executive Vice President and President, Lilly International, told the crowd, "My understanding is that the [Voluntary Scheme for Branded Medicines Pricing (VPAG)] deadline has probably been postponed for another two weeks, so until the end of November at the earliest.”The deadline is scheduled for this coming Friday, November 14. There has been no public announcement that the VPAG has been delayed by another two weeks, so Jonsson’s remark is just speculation until verifiedCompanies that notify their departure before the new deadline will not be able to reverse their decision, and companies exiting VPAG will instead move onto the statutory scheme for branded medicines. The adjustments have been introduced to give companies additional time to weigh their options amid what the Association of the British Pharmaceutical Industry (ABPI) described as “ongoing global uncertainty.”
Last week, U.S. drug pricing policies continued to make headlines globally as the Centers for Medicare & Medicaid Services (CMS) announced a new voluntary model intended to implement MFN pricing through State Medicaid programs, and Novo Nordisk and Eli Lilly became the fourth and fifth drugmakers to sign MFN deals. If you’re interested in MFN, ask the team about our MFN Tracker or our new Policy Newsletter Across the pond in Europe, Joint Clinical Assessment (JCA was the hot topic at conferences and meetings; NAVLIN Daily attended the World Orphan Drug Congress (WODC) in Amsterdam and European Access Academy (EAA) in Paris, where stakeholders discussed the ups and downs of the first year of the Regulation Meanwhile, China wrapped up its National Reimbursement Drug List (NRDL) and new Commercial Insurance Innovative Drug List, slashing prices by 15-50%. This year is the first time that a separate Innovative List has been developed, and the outcomes will be closely watched
The Centers for Medicare & Medicaid Services (CMS) announced a new voluntary model intended to implement Most Favored Nation (MFN) pricing through State Medicaid programs Under the GENEROUS model, manufacturers can choose to participate and will offer prices based on what other select countries pay for prescription drugs covered by the Medicaid program. The basket of countries that will be referenced by GENEROUS include the United Kingdom, France, Germany, Italy, Canada, Japan, Denmark, and SwitzerlandAccording to CMS, in return for participating in the program, manufacturers will have “standardized coverage criteria for their drugs” across state Medicaid programs. The agency notes that manufacturers who have already agreed to MFN pricing deals with the Trump administration will participate in the GENEROUS Model "as a result of these agreements"
Novo Nordisk has agreed to a price for its semaglutide products (Wegovy, Ozempic, and Rybelsus) under the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation Program, according to executives speaking on the company's third quarter earnings callAlthough Novo did not reveal the negotiated price, the company noted that “the estimated direct impact of semaglutide MFP in Medicare Part D had it been introduced 1 January 2025 would have been a negative low single-digit impact on global sales growth for the full year of 2025." JP Morgan analysts have characterized this as "better than feared"CMS is expected to publish any agreed-upon MFPs resulting from the second cycle of Medicare drug price negotiations by November 30, 2025
Eli Lilly has announced plans to build a new $3 billion manufacturing plant in Katwijk, the Netherlands, to expand its production capacity ahead of launch for orforglipron, its experimental weight-loss pillLilly already has European manufacturing plants in France, Ireland, Italy and Spain, with additional facilities already planned in Germany and IrelandThe move goes against the recent wave of companies leaving Europe to invest in manufacturing sites in the U.S.; Lilly itself recently announced a new $6.5 billion manufacturing facility at Generation Park in Texas, joining the likes of Johnson & Johnson (J&J), AbbVie, Biogen, AstraZeneca, Sanofi, Gilead, Takeda, Roche, and Novartis, who have all recently allocated additional investment to the U.S.
The Drugs Consultative Committee (DCC), India, has approved amendments to Forms 27D, 27DA, 28D, and 28DA under the Drugs Rules, 1945, expanding their scope to include stem cell-derived products, gene therapies, and xenograftsThe move marks a key step toward strengthening the regulatory framework for next-generation therapies in the countryEarlier, these forms were limited to vaccines and recombinant DNA drugs. Following stakeholder consultations and concurrence from the Drugs Technical Advisory Board (DTAB), the forms will also cover advanced therapeutic products
The UK pharma industry and government have, once again, extended the deadline for companies to leave the 2024 Voluntary Scheme for Branded Medicines Pricing (VPAG) to November 14, 2025Cigna’s pharmacy benefit manager (PBM), Evernorth Health Services, announced an initiative to transition from its traditional rebate-based pharmacy benefit model to upfront discountsNovartis CEO Vas Narasimhan told Reuters that the company is considering adding more medicines to its direct-to-patient (DTP) platform
China's annual NRDL negotiations kicked off in Beijing, focusing first on drugs with clear pricing like antivirals, anesthetics, and chronic disease medicines. Oncology drugs and tough-to-negotiate items are saved for last. Talks for the new Commercial Insurance Innovative Drug List will immediately follow, in late October and early NovemberWhile the exact number of drugs entering negotiations is undisclosed, hundreds of drugs that are not currently listed on the NRDL are eligible. Blockbusters from Novartis and Novo Nordisk and multiple CAR-T therapies are likely to enter negotiationsChina launched the Commercial Insurance Innovative Drug List for newer, pricey, cutting-edge drugs. Those that qualify for both lists but fail the basic NRDL talks can pivot here. It's open to rare disease treatments and generics approved in the past five years, offering an alternative for high-cost medicines falling outside basic insurance criteria
650+
+99%
<24
4,000+
24x7
99.5%
