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Last week, NAVLIN Daily brought you key market access developments from across the globe. Germany moved to replace proposed dynamic drug discounts with fixed discounts after industry opposition, the European Parliament approved legislation implementing the EU-U.S. trade framework, and U.S. Senate Democrats launched a consultation on new proposals to lower drug prices and build on reforms under the IRA China's drug reimbursement list application window has closed after receiving 818 submissions, while four newly approved innovative medicines qualified for potential inclusion in this year's updated NRDL Reports emerged of U.S.-Germany talks on a potential deal linking tariff relief to more flexible pricing for innovative medicines, while Denmark sought at least $12.5 million in compensation from Amgen over its decision to halt supplies of the cholesterol drug Repatha
AstraZeneca is positioning India as a potential future market for its investigational oral GLP-1 treatment for obesity and diabetes, with the company planning to bring the drug to the country once global Phase III trials are completed and regulatory approvals are secured "We hope to bring it to India as soon as we have the right data and regulatory approvals," said Praveen Rao Akkinepally, Managing Director of AstraZeneca Pharma IndiaAkkinepally said India could also play a role in the late-stage development program, noting the country's history of participation in AstraZeneca's cardiovascular and renal clinical trials
Impartial members of Germany’s Federal Joint Committee (G-BA) have emphasized that the draft plan to stabilize the contribution rates in the statutory health insurance (GKV) exhibits a “serious injustice” that is likely to jeopardize its overall acceptanceIn a letter, the group acknowledged that reforms are needed; however, G-BA said the government is shifting EUR 12.5 billion in costs that should be tax-funded onto statutory health insurance, while placing additional burdens on insured people and healthcare providersMeanwhile, the group backed higher manufacturer rebates on medicines and vaccines to curb spending. However, the group warned against automatic adjustments tied to expenditure growth, proposing instead a fixed 13% rebate subject to review every three years, and criticized plans to abolish the combination discount for high-cost therapies
Norway’s Directorate of Medical Products (DMP) has completed a health technology assessment of Leqembi (lecanemab) for the treatment of early Alzheimer's disease, concluding that while the therapy slows disease progression, its clinical benefit is limited, treatment is highly resource-intensive and the overall cost to the Norwegian healthcare system is substantial“Patients who receive the drug take a little longer to reach the same level of memory and functional decline compared to those who do not receive Leqembi. However, the practical significance of this is a matter of debate. For example, it is unclear whether patients experience a better quality of life or whether they are able to care for themselves and live at home longer,” says Senior Physician Sara Viksmoen WatleMeanwhile, DMP points out the cost to hospitals of using Leqembi is estimated at NOK 2.8 billion per year, and due to the drug's limited efficacy, the need for nursing and care is unlikely to be reduced sufficiently to offset the high treatment costs
The EU Council has agreed its negotiating mandate on a directive designed to accelerate biotechnology innovation across the bloc, paving the way for talks with the European Parliament on the proposed European Biotech Act I directiveCyprus’ Health Minister Neophytos Charalambides, speaking on behalf of the Council presidency, said the agreement demonstrated Europe’s determination to remain competitive in a rapidly evolving global biotech landscapeOnce the European Parliament has established its position, the two institutions will enter into negotiations to agree on the final text
The European Parliament has given its final approval to legislation implementing the EU's tariff commitments under the August 2025 EU-U.S. trade framework, paving the way for a new phase in transatlantic commerce while raising fresh questions for the pharmaceutical industry over the future treatment of medicines and supply chainsUnder the August 2025 EU-U.S. trade framework tariffs on pharmaceutical products imported into the U.S. will be capped at 15%However, the European Federation of Pharmaceutical Industries and Associations (EFPIA) cautioned: “It remains to be seen how the 15% tariff cap on innovative medicines would impact patient care, global supply chains, and the sector's footprint in Europe should tariffs be applied”
Last week, NAVLIN Daily brought you key market access developments from across the globe. Discussions at NAVLIN’s PPIC and the EU HTA & Evidence Strategy Forum focused on major trends shaping the healthcare landscape. Roche Chairman Severin Schwan criticized U.S. MFN pricing negotiations as "blackmail" amid tariff threats, while the European Commission published the first-ever JCA under the EU HTA Regulation for Ojemda NAVLIN Daily was on the ground at the World Orphan Drug Congress USA 2026 and PPIC Basel, where experts discussed rare disease access, global regulatory alignment, MFN pricing, AI, and the EU JCA, with the European Commission's first JCA report generating significant interest Eli Lilly and Boehringer Ingelheim announced major investment pullbacks in Germany, citing proposed healthcare reforms, while Novo Nordisk launched its obesity treatment Wegovy in the UAE
NAVLIN Daily is on the ground at World Orphan Drug Congress USA 2026, where Julian Polaris from Manatt highlighted upcoming Medicaid provisions under the One Big Beautiful Bill Act (OBBBA)The OBBBA significantly alters Medicaid by imposing eligibility constraints, including work and community engagement requirements for coverage. While “medically frail” individuals are exempt from this requirement, the CMS left it up to the states to interpret this exemptionEach state is likely to take a slightly different approach and will need to be separately monitored for developments. “It is a challenging time to be advocating for states to expand access,” said Polaris
Secret U.S.-Germany talks are underway to discuss a deal similar to the U.S.-U.K. agreement, which offers relief from U.S. tariffs in exchange for relaxed price limits on innovative drugsTop German officials have been negotiating with the U.S. for months, according to industry insiders. The Berlin-based U.S. embassy has even sent an official to London to learn negotiation strategies from the U.K. playbook, hoping to push Germany toward a favorable dealMeanwhile, big pharma is reacting to German cost-cutting policies, with Eli Lilly, Boehringer Ingelheim, and Pfizer slashing or reconsidering investments in Germany
NAVLIN Daily is on the ground at the World Orphan Drug Congress USA 2026, where experts discussed the latest regulatory updates with emphasis on requirements for confirmatory trialsCompanies must now explicitly address the potential for withdrawal when a confirmatory trial doesn’t pan out, because this possibility has happened, noted Brigid DeCoursey Bondoc, Partner, Morrison FoersterWhen asked if she anticipates any major litigation with the FDA around accelerated approval confirmatory trials and withdrawals, the legal expert answered, “While there is due process, even then, there is an opportunity to litigate against the agency after the decision is made. Is it arbitrary and capricious? Courts are a lot more willing to step in and replace the agency’s reasoning…But after you’ve been through a public hearing process, it might not be your best public-facing campaign”
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