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Johnson & Johnson is suing the federal government over the Health Resources and Services Administration's (HRSA) efforts to block the drugmaker from implementing changes to how it provides discounts under the 340B Drug Pricing ProgramIn August, J&J notified hospital customers that the company intended to stop providing upfront 340B discounts on Stelara (ustekinumab) and Xarelto (rivaroxaban) starting October 15, 2024. Instead, J&J proposed making 340B discounts for the two drugs through a rebate system. However, HRSA threatened to terminate J&J's Pharmaceutical Pricing Agreement (PPA) and impose sanctions on the company if it carried out its rebate planJ&J has responded by initiating a legal challenge against the agency. The drugmaker is asking the court to declare its proposed rebate model legal under 340B statute and to protect it from any related enforcement actions
Donald Trump has officially been elected the 47th president of the United States and Republicans have regained the Senate after flipping key seats in West Virginia, Montana, and Ohio. Read how the election could affect pharma pricing and market access on NAVLIN Daily The UK government plans to relaunch the Innovative Licensing and Access Pathway (ILAP), a scheme designed to speed up the introduction of new medicines to the National Health Service (NHS). Based on stakeholder feedback, the existing ILAP system was seen as too lenient and unclear on entry criteria, with not enough input from the NHS French National Assembly lawmakers approved key amendments to Article 9 of the proposed Social Security Financing Bill (PLFSS) for 2025. Among the adopted adjustments is a two-year cap of the safeguard clause contribution—known as the "M contribution"—for pharmaceutical companies at EUR 1.6 billion
The Egyptian Drug Authority (EDA) announced that all pharmaceutical items for various therapeutic groups, especially diabetes treatments and effervescent medications, have been available in the local market since last July. The Authority has not received any complaints about these items EDA Chairman Dr. Ali Al-Ghamrawy, confirms that nearly 9.5 million packages of diabetes treatments and other essential medications have been distributed so far. This includes over 2.1 million Mixtard (insulin isophane/NPH + human insulin/soluble insulin ) vials, around 350,000 packages of Lantus (insulin glargine), and more than 2.6 million insulin vialsEDA confirms that additionally, over 2.3 million packages of other insulin types have been supplied. For metformin-based diabetes treatments, nearly 2.2 million packages have been distributed, with enough raw materials to produce over 6 million more packages
Donald Trump has officially been elected the 47th president of the United States and Republicans have regained the Senate after flipping key seats in West Virginia, Montana, and Ohio. Although control of the House of Representatives is still up for grabs, Republicans currently need just 12 more House seats to secure a majority, while Democrats need 33The President-elect will now have 75 days to build out his team and consider administrative appointments before Inauguration Day on January 20, 2025. During this transition period, industries will start to prepare for another Trump presidencyNAVLIN Daily's breakdown of how a second Trump presidency could impact the pharmaceutical industry is below
The UK government plans to relaunch the Innovative Licensing and Access Pathway (ILAP), a scheme designed to speed up the introduction of new medicines to the National Health Service (NHS). Based on stakeholder feedback, the existing ILAP system was seen as too lenient and unclear on entry criteria, with not enough input from the NHSAs a result, it is being overhauled with new entry criteria and more collaboration with the NHS - the revamped ILAP will offer a more "bespoke" service, according to the MHRA, with selective entry and increased dialogue between ILAP partner organizations and developers. It will also introduce a simpler roadmap and timelinesFurther details will be released in January 2025 and the MHRA will begin taking applications in March 2025. The current ILAP system will stop accepting applications after 20 November 2024
At the time of publication, 4:30AM ET, Republicans have won control of the U.S. Senate, retaking the chamber for the first time in four years. Control over the House of Representatives has still not been calledFinal results could take days; in 2020, former President Joe Biden was declared the winner four full days after Election Day. However, after claiming a string of crucial swing states overnight, Donald Trump is poised to return to the White House for a second term. He has already delivered a victory speech to his supporters in FloridaFull NAVLIN Daily coverage will follow later today, but here we provide a quick snapshot of pharma-related policies Trump has supported throughout his campaign
On October 25, the Social Affairs Committee of the National Assembly unanimously rejected the Social Security financing bill (PLFSS) for 2025, with a number of amendments being withdrawnGeneviève Darrieussecq, Ministry of Health and Access to Care, made it clear that she opposes the fixed "safeguard clause (M amount)" set by lawmakers under the PLFSS, which determines the baseline pharmaceutical spending level that would trigger clawback payments from drug manufacturers. She emphasized the need for dynamic, year-over-year adjustments"We have no room for error," added Mr. Thibault Bazin, a member of the Republican Right group. "We need a stable framework that encourages investment and an enabling environment to ensure access to medicines. That's what is at stake today”
Korea’s Ministry of Health and Welfare (MoHW) announced a partial revision of the “Standards for Determinations and Adjustment of Pharmaceuticals," introducing significant changes to Health Technology Assessment (HTA) and drug pricing in South Korea Among other changes, the proposed revisions adjust the cost-effectiveness evaluation criteria to account for new products with greater clinical usefulness than their comparators, add two new risk-sharing arrangements to the four existing risk-based agreements, allow post-marketing evaluation for high-priced drugs that have not undergone sufficient health economic evaluation if the conditions for innovation are met, and increase the maximum reduction rate for price-volume agreements from 10% to 12.5% until the end of 2025, and then again to 15% from 2026 onwardsThe proposed revisions will be open to public comments until December 16, 2024
At the World Orphan Drug Congress in Barcelona, emphasis was once again laid on the importance of developing and implementing a European Rare Disease Action Plan Keynote panel members emphasized the need for integrating global, national, and regional initiatives for a comprehensive rare disease strategy. Referring to France, Anne-Sophie Chalandon, of Sanofi, cited the progress France has made on a national rare disease plan, suggesting that other nations could take inspiration. She also highlighted an innovative funding initiative in Italy as examples of successful regional effortsFrom the pharmaceutical perspective, Gabriella Almberg from UCB highlighted the need for the innovation cycle to continue; she pointed out the importance of political will and collective accountability in ensuring the success of an action plan. Ultimately, there was unanimous agreement that any plan should avoid duplicating existing initiatives and should translate into impactful actions at all levels
Sofie Alverlind of Sweden's TLV spoke at the World Orphan Drug Congress about the agency's use of value-based pricing for drug evaluationGovernment-commissioned research from the Agency discovered that while the number of drugs for rare diseases has doubled in the last decade, their costs have quadrupled. Alverlind proposes considering treatment volume as part of the value-based concept, suggesting the use of a "staircase model"Alverlind also acknowledges that potential trade-offs must be addressed if the QALY threshold is raised, ensuring only the most severe conditions get priority. The ultimate aim, she highlights, is to achieve access to effective drugs for both common and rare diseases at sustainable costs
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