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Last week, NAVLIN Daily brought you key market access developments from across the globe In France, CEPS and the pharmaceutical industry signed a new drug pricing framework through 2030, while the EU Council voted in favor of the pharmaceutical reform package to improve patient access, medicine supply security, and regulatory predictability Germany proposed linking manufacturers’ supplementary rebates to local research, production, investment, and employment, while the G-BA warned that planned AMNOG reforms could increase bureaucracy and drug spending, with a special pathway potentially applying to more than 60% of new active substance assessments
At the Medicaid Drug Rebate Program Summit 2026, executives discussed reporting challenges such as lacking claims-level detail, differing state opinions on 340B, the pilot program for ADAPs, and different rules around write-offsThe speakers generally agreed that multi-stakeholder collaboration is needed to address unresolved complexities and ensure that everyone has the information they need when they need itAntoine Nelson, Sr. Director, Rebate Invoice & Audit, Synergie Medication Collective, spoke of the need for alignment between the commercial and government sides: “There are major differences between the two. There shouldn’t be. Commercial needs to be brought into these discussions on the Medicaid side to figure out a more streamlined way of doing things”
At the Medicaid Drug Rebate Program Summit 2026 in Chicago, a Medicaid Working Group discussed balancing the risks and advantages of artificial intelligence (AI), such as the loss of the human workforce’s knowledge and critical thinking to navigate the constantly evolving Medicaid landscape, as well as the ability for AI to automate repeatable tasks, such as sending invoicesThe group also observed that states and vendors all address claims adjudication differently, and stressed the need for alignment between MCL and fee-for-service modelsThe discussion ended with a warning from Antoine Nelson, Sr. Director, Rebate Invoice & Audit, Synergie Medication Collective: The 340B reform will cause costs to grow “exponentially” and disputes will not be diminished
AstraZeneca India got India’s Subject Experts Committee (SEC) permission to import and market camizestrant 75 mg for HR-positive, HER2-negative breast cancer with ESR1 mutations Citing an unmet medical need, the SEC recommended waiving the requirement for a local Phase III clinical trial for the specified indication.The SEC recommended granting permission on the condition that the drug should be sold at retail on the prescription of a medical oncologist, and AstraZeneca must conduct a Phase IV trial and submit the study plan to regulators in three months
The Centers for Medicare & Medicaid Services (CMS) finalized its Medicare Part B Most Favored Nation (MFN) demonstration, the GLOBE Model, but major exemptions and participation carveouts substantially narrow the model’s reachThe final rule excludes biosimilars and their reference biologics, orphan-only drugs, plasma-derived products, certain cell and gene therapies, and any manufacturer participating in the Medicaid-focused GENEROUS ModelReflecting the narrower scope, CMS now expects only four manufacturers to be subject to GLOBE and has reduced its projected savings estimate from $12 billion to $440 million, signaling a more limited impact than originally anticipated
Sweden’s Dental and Pharmaceutical Benefits Agency (TLV) has implemented a package of new rules governing pharmaceutical reimbursement applications, pricing and generic substitutionFrom October 1, three new sets of regulations apply alongside new general reimbursement and pricing guidelines: HSLF-FS 2026:23 on applications for subsidy and pricing, HSLF-FS 2026:14 on the pricing of interchangeable medicines, and HSLF-FS 2026:16 on medicine substitution“The changes are intended to improve access to effective medicines and to ensure that society’s costs for medicines remain reasonable and sustainable over time,” the Agency stated
Japan’s Maruho inked a deal with Taiwan’s Orient EuroPharma (OEP), granting OEP rights to a sweat-reducing treatment for primary axillary hyperhidrosisOEP will market the drug in 10 ASEAN countriesSeveral years ago, Maruho launched the product in Japan under the brand name Rapifort Wipes 2.5%
The industry is bracing for the impact of Korea’s drug pricing reform, which reduces prices for generics and post-patent drugs while rewarding innovationCompanies reliant on generics face steep profit drops, while innovative firms may see relative gains. Profit margins for small and medium-sized firms are at higher risk due to fixed costs and R&D demandsCompanies can offset the reform's impact by exploring overseas markets, licensing technologies, securing CDMO partnerships, launching non-reimbursable products, and leveraging the flexible pricing system, but these strategies involve certain risks
The Council of the European Union adopted the EU pharmaceutical reform package by a 26-0-1 voteThe legislation aims to balance incentives for pharmaceutical innovation with measures to improve patient access, strengthen medicine supply security, and create a more predictable regulatory environment for manufacturersNow that the Council has voted, the European Parliament must formally adopt both the regulation and the directive comprising the package. The Parliament’s vote is expected October 2, 2026
Last week, NAVLIN Daily brought you key market access developments from across the globe In the U.S., new details emerged on MFN drug pricing deals with Pfizer and Eli Lilly, while all 50 states, the District of Columbia, and Puerto Rico applied to join the GENEROUS drug pricing modelIn Japan, the medical insurance system has incorporated Amchepry, the first commercialized iPSC-based treatment for Parkinson’s in the world, while China released its 15th Five-Year Plan for its pharmaceutical industry, which sets ambitious goals, including 20% annual growth for innovative drugs and at least five global blockbusters surpassing $1 billion in sales
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