Category
Europe
Health technology assessment, pricing and access across Europe, including EU-level joint clinical assessment and the national systems that still decide funding. Coverage spans the major markets and the smaller systems that often move first.
715 articles in this topic.
Articles in this category
11/12/2026
US MFN Drug Pricing: A 25% German Price Rise Would Cut Medicaid Savings by 3.8%
A preprint led by Thomas Hwang models how German price changes affect US Medicaid MFN savings and German statutory health insurance spending.
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11/12/2026
The EU HTA Regulation: What Latin America Can Learn
A PAHO, RedETSA and HTAi webinar on the EU HTA Regulation: what Latin American agencies can reuse from joint clinical assessments, and which elements may be hard to adapt.
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11/12/2026
Artificial Intelligence in Medicine Regulation: From Concept to Practice
EMA says it is moving artificial intelligence in medicine regulation from concept to practice. Its timeline runs from a 2021 joint workshop to research priorities published in August 2026. #SyenzaNews #MarketAccess #drugregulation
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11/12/2026
EMA Draft Guideline on Predictive Biomarker Assays Opens Public Consultation to 31 March 2027
The European Medicines Agency has opened public consultation on its draft guideline on predictive biomarker assays. Comments are accepted from 9 November 2026 until 31 March 2027.
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11/6/2026
Refixia Nonacog Beta Pegol: INFARMED Recommends Funding for Children Under 12 With Haemophilia B
INFARMED recommends public funding for Refixia nonacog beta pegol in children under 12 with haemophilia B, based on two single-arm trials. #SyenzaNews #MarketAccess
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11/6/2026
Recent Zolgensma safety concerns: what Novartis has reported
SMA Europe has relayed Novartis's figures on tumour reports in patients previously treated with Zolgensma, including two cases of vector DNA integration.
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11/6/2026
Dupilumab Chronic Spontaneous Urticaria: G-BA Finds No Proven Added Benefit
The G-BA has found no proven added benefit for dupilumab in chronic spontaneous urticaria, compared with omalizumab plus second-generation H1 antihistamines.
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11/4/2026
EMA Mid-Year Report 2026: Reform, Supply and the First Joint Clinical Assessment
The EMA mid-year report 2026 records 485 scientific advice requests in the first half, the first joint clinical assessment under the HTA Regulation and progress on the new pharmaceutical law. #SyenzaNews #MarketAccess
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11/4/2026
Truqap prostate cancer withdrawal: AstraZeneca pulls EU bid
"Truqap prostate cancer withdrawal: AstraZeneca pulled its EU bid for newly diagnosed use after EMA raised benefit-risk concerns." #SyenzaNews #MarketAccess
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11/3/2026
Second Cochlear Implant Now Covered for Adults in the Netherlands
The Dutch health institute Zorginstituut Nederland has concluded that a second cochlear implant for adults with severe hearing loss in both ears belongs in the basic health package. #SyenzaNews #MarketAccess
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11/2/2026
EMA Opens Deanxit Safety Review Over Movement and Memory Side Effects
EMA's safety committee has opened a Deanxit safety review at Belgium's request, after reports of movement disorders and memory problems with the flupentixol/melitracen combination. The Belgian agency also questioned the benefit of combining the two substances. #SyenzaNews #Pharmacovigilance #EMA #MentalHealth
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11/2/2026
Migraine Medicines in Portugal: Patients Pay 61% of the Outpatient Bill
Infarmed's first Deep Dive looks at migraine medicines in Portugal. In 2025, more than 73,000 people used SNS-reimbursed migraine therapies, 85% of them women. Patients paid about €6 million (61%) of the €9.9 million pharmacy bill, and atogepant, funded only at the end of 2024, already led spending. #SyenzaNews #Migraine #MarketAccess #Portugal
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