ReviewFrontiers in medical technology2021
Efficacy, Safety, and Economics of Innovative Medicines: The Role of Multi-Criteria Decision Analysis and Managed Entry Agreements in Practice and Policy.
Review in Frontiers in medical technology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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
4 citing papers in PubMed.
- Navigating market access after conditional reimbursement: a communication roadmap for disinvesting orphan drugs.International journal of technology assessment in health care · 2026Article
- A data-driven mathematical model for evaluating the societal and economic burden of delayed access to innovative medicines.AIMS public health · 2025Article
- Health technology assessment and innovation: here to help or hinder?International journal of technology assessment in health care · 2024Review
- The impact of level of documentation on the accessibility and affordability of new drugs in Norway.Frontiers in pharmacology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Through the years, solutions for accelerated access to innovative treatments are implemented in models of regulatory approvals, yet with limited data. Besides efficacy data, providing adequate safety data is key to transferring conditional marketing authorization to final marketing authorization. However, this remains a challenge because of the restricted availability and transferability of such data. Within this study, we set up a challenge to analyze the answers of two questions. First, from regulatory bodies' point of view, we bring the question of whether multi-criteria decision analysis (MCDA) is an adequate tool for further improvement of health technology assessment (HTA) of innovative medicines. Second, we ask if managed entry agreements (MEAs) pose solutions for facilitating the access to innovative medicines and further strengthening the evidence base concerning efficacy and effectiveness, as well as safety. Elaborating on such challenges brought us to conclude that increasing the attention to safety in MCDAs and MEAs will increase the trust of the authorities and improve the access for the manufacturers and the early availability of safe and effective medicines for the patients.
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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.