Barriers and opportunities for implementation of outcome-based spread payments for high-cost, one-shot curative therapies

S Michelsen, S Nachi, W Van Dyck… - Frontiers in …, 2020 - frontiersin.org
Background: The challenging market access of high-cost one-time curative therapies has
inspired the development of alternative reimbursement structures, such as outcome-based …

Challenges in the market access of regenerative medicines, and implications for manufacturers and decision-makers: a systematic review

T Qiu, M Pochopień, E Hanna, S Liang… - Regenerative …, 2022 - Taylor & Francis
Aim: Regenerative medicines (RMs) are expected to transform the treatment paradigm of
rare, life-threatening diseases, while substantial challenges impede its market access. This …

[HTML][HTML] Analytic considerations in applying a general economic evaluation reference case to gene therapy

MF Drummond, PJ Neumann, SD Sullivan, FU Fricke… - Value in Health, 2019 - Elsevier
The concept of a reference case, first proposed by the US Panel on Cost-Effectiveness in
Health and Medicine, has been used to specify the required methodological features of …

Recalibrating health technology assessment methods for cell and gene therapies

A Angelis, H Naci, A Hackshaw - Pharmacoeconomics, 2020 - Springer
Recently licensed cell and gene therapies have promising but highly uncertain clinical
benefits. They are entering the market at very high prices, with the latest entrants costing …

[图书][B] Pharmacoeconomics: from theory to practice

RJG Arnold - 2016 - taylorfrancis.com
The pharmaceutical industry is almost boundless in its ability to supply new drug therapies,
but how does one decide which are the best medicines to use within restricted budgets …

Application of managed entry agreements for innovative therapies in different settings and combinations: a feasibility analysis

RA Vreman, TF Broekhoff, H GM Leufkens… - International Journal of …, 2020 - mdpi.com
The reimbursement of expensive, innovative therapies poses a challenge to healthcare
systems. This study investigated the feasibility of managed entry agreements (MEAs) for …

Coverage with evidence development schemes for medical devices in Europe: characteristics and challenges

C Federici, V Reckers-Droog, O Ciani, F Dams… - The European Journal of …, 2021 - Springer
Objectives Medical devices are potentially good candidates for coverage with evidence
development (CED) schemes, as clinical data at market entry are often sparse and (cost-) …

[HTML][HTML] Uncertainty and cures: discontinuation, irreversibility, and outcomes-based payments: what is different about a one-off treatment?

A Towse, E Fenwick - Value in Health, 2019 - Elsevier
Payers are concerned that one-off “cures” bring great uncertainty with the consequential risk
of incorrect adoption decisions, and significant budget impact from large one-off payments …

Creeping through the backdoor: disruption in medicine and health

B Shaw, O Chisholm - Frontiers in Pharmacology, 2020 - frontiersin.org
Can disruption happen when no one notices? Disruptive technologies and processes are
fundamentally starting to up-end how medicines and health systems benefit patients but the …

[HTML][HTML] Are global health systems ready for transformative therapies?

E Faulkner, DS Spinner, M Ringo, M Carroll - Value in Health, 2019 - Elsevier
Background We have seen significant advancement in a range of health technologies, some
with transformative or curative potential. Nevertheless, it is often unclear how global health …