ArticleFrontiers in pharmacology2018
Managed Entry Agreements for Pharmaceuticals in the Context of Adaptive Pathways in Europe.
Article in Frontiers in pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
34 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Mapping the landscape of managed entry agreements: a systematic review of global frameworks, system-level components, and implementation challenges.Frontiers in pharmacology · 2026Pooled it
- HTA Barriers for Conditional Approval Drugs.PharmacoEconomics · 2023Pooled it
- Application of Managed Entry Agreements for Innovative Therapies in Different Settings and Combinations: A Feasibility Analysis.International journal of environmental research and public health · 2020Pooled it
- TRUST4RD: tool for reducing uncertainties in the evidence generation for specialised treatments for rare diseases.Orphanet journal of rare diseases · 2020Trial
- Implementing performance-based risk-sharing agreements in non-small cell lung cancer immunotherapy: a real-world data case study.Health economics review · 2025Article
- The value-for-money assessment and funding arrangements for high-priced drugs in an era of uncertainty: a comparative analysis of national health technology assessment agencies in South Korea, England, Australia, and Canada.BMC health services research · 2025Article
- Tearing down inequalities in the healthcare system across Europe: the BEACON project.Frontiers in public health · 2025Review
- A data-driven mathematical model for evaluating the societal and economic burden of delayed access to innovative medicines.AIMS public health · 2025Article
- A Formulary Management Group Consensus.Global journal on quality and safety in healthcare · 2024Article
- How Managed Entry Agreements Influence the Patients' Affordability to Biological Medicines-Bulgarian Example.Healthcare (Basel, Switzerland) · 2023Article
- An evaluation of managed access agreements in England based on stakeholder experience.International journal of technology assessment in health care · 2023Article
- Opportunities and Threats of the Legally Facilitated Performance-Based Managed Entry Agreements in Slovakia: The Early-Adoption Perspective.Healthcare (Basel, Switzerland) · 2023Article
- Time to reimbursement of novel anticancer drugs in Europe: a case study of seven European countries.ESMO open · 2023Article
- Introduction of managed entry agreements in Korea: Problem, policy, and politics.Frontiers in pharmacology · 2023Article
- The challenges of access to innovative medicines with limited evidence in the European Union.Frontiers in pharmacology · 2023Review
- Observational
- Stakeholder views of managed entry agreements: A literature review of national studies.Health policy OPEN · 2021Review
- How can we improve patients' access to new drugs under uncertainties? : South Korea's experience with risk sharing arrangements.BMC health services research · 2021Article
- Implementing Outcomes-Based Managed Entry Agreements for Rare Disease Treatments: Nusinersen and Tisagenlecleucel.PharmacoEconomics · 2021Article
- Common Problems, Common Data Model Solutions: Evidence Generation for Health Technology Assessment.PharmacoEconomics · 2021Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
As per the EMA definition, adaptive pathways is a scientific concept for the development of medicines which seeks to facilitate patient access to promising medicines addressing high unmet need through a prospectively planned approach in a sustainable way. This review reports the findings of activities undertaken by the ADAPT-SMART consortium to identify enablers and explore the suitability of managed entry agreements for adaptive pathways products in Europe. We found that during 2006-2016 outcomes-based managed entry agreements were not commonly used for products with a conditional marketing authorization or authorized under exceptional circumstances. The barriers and enablers to develop workable managed entry agreements models for adaptive pathways products were discussed through interviews and a multi-stakeholder workshop with a number of recommendations made in this paper.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.