ReviewFrontiers in pharmacology2017
Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation.
Review in Frontiers in pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
25 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Efficacy gap between phase II and subsequent phase III studies in oncology.British journal of clinical pharmacology · 2020Trial
- Metabolic reprogramming in sepsis-associated encephalopathy: emerging mechanisms, candidate biomarkers, and future therapeutic directions.Frontiers in medicine · 2026Review
- Managed Entry Agreements for Pharmaceutical Products in Three Maghreb Countries: Payer and Supplier Perspectives.Journal of market access & health policy · 2025Article
- Tearing down inequalities in the healthcare system across Europe: the BEACON project.Frontiers in public health · 2025Review
- The role of drug regulatory authorities and health technology assessment agencies in shaping incentives for antibiotic R&D: a qualitative study.Journal of pharmaceutical policy and practice · 2023Article
- Access to medicines for rare diseases: A European regulatory roadmap for academia.Frontiers in pharmacology · 2023Article
- Treatment patterns, adherence to international guidelines, and financial mechanisms of the market access of advanced breast cancer therapy in Bulgaria.Frontiers in public health · 2023Article
- The Role of Regulator-Imposed Post-Approval Studies in Health Technology Assessments for Conditionally Approved Drugs.International journal of health policy and management · 2022Article
- Social Media and COVID-19-Perceptions and Public Deceptions of Ivermectin, Colchicine and Hydroxychloroquine: Lessons for Future Pandemics.Antibiotics (Basel, Switzerland) · 2022Article
- The value of anticancer drugs - a regulatory view.Nature reviews. Clinical oncology · 2022Review
- Challenges and Opportunities With Routinely Collected Data on the Utilization of Cancer Medicines. Perspectives From Health Authority Personnel Across 18 European Countries.Frontiers in pharmacology · 2022Article
- Utilisation Trend of Long-Acting Insulin Analogues including Biosimilars across Europe: Findings and Implications.BioMed research international · 2021Article
- Integrative Review of Managed Entry Agreements: Chances and Limitations.PharmacoEconomics · 2020Review
- Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe.Clinical pharmacology and therapeutics · 2020Article
- Mapping of Current Obstacles for Rationalizing Use of Medicines (CORUM) in Europe: Current Situation and Potential Solutions.Frontiers in pharmacology · 2020Article
- The Expiry of HumiraFrontiers in pharmacology · 2020Article
- Pre-reimbursement: early assessment for coverage decisions.Wiener medizinische Wochenschrift (1946) · 2019Article
- Key enablers and barriers to implementing adaptive pathways in the European setting.British journal of clinical pharmacology · 2019Review
- Innovation in Regulatory Science Is Meeting Evolution of Clinical Evidence Generation.Clinical pharmacology and therapeutics · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
38 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Medicines receiving a conditional marketing authorization through Medicines Adaptive Pathways to Patients (MAPPs) will be a challenge for payers. The "introduction" of MAPPs is already seen by the European Medicines Agency (EMA) as a fait accompli, with payers not consulted or involved. However, once medicines are approved through MAPPs, they will be evaluated for funding by payers through different activities. These include Health Technology Assessment (HTA) with often immature clinical data and high uncertainty, financial considerations, and negotiations through different types of agreements, which can require monitoring post launch. Payers have experience with new medicines approved through conditional approval, and the fact that MAPPs present additional challenges is a concern from their perspective. There may be some activities where payers can collaborate. The final decisions on whether to reimburse a new medicine via MAPPs will have more variation than for medicines licensed via conventional processes. This is due not only to increasing uncertainty associated with medicines authorized through MAPPs but also differences in legal frameworks between member states. Moreover, if the financial and side-effect burden from the period of conditional approval until granting full marketing authorization is shifted to the post-authorization phase, payers may have to bear such burdens. Collection of robust data during routine clinical use is challenging along with high prices for new medicines during data collection. This paper presents the concept of MAPPs and possible challenges. Concerns and potential ways forward are discussed and a number of recommendations are presented from the perspective of payers.
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What Socratic holds
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 Socratic graph.