Perspectives, expectations, and concerns of European patient advocates on advanced therapy medicinal products

S Benvenuti, CM Wang, S Borroni - Frontiers in Medicine, 2021 - frontiersin.org
… on several different issues around Advanced Therapy Medicinal Products (ATMPs). …
Advanced therapy medicinal products and health technology assessment principles and practices

[HTML][HTML] Challenges for economic evaluations of advanced therapy medicinal products: a systematic review

AO de Labry-Lima, A Ponce-Polo, L García-Mochón… - Value in Health, 2023 - Elsevier
… Clinical studies need to be designed to align with health technology assessment requirements,
including generic quality of life, and payers should aim for clarity of criteria. Regulators …

Recent progress in European advanced therapy medicinal products and beyond

TTL Yu, P Gupta, V Ronfard, AA Vertès… - … in bioengineering and …, 2018 - frontiersin.org
… of medicine, pricing and reimbursement issues, technology adoption and permeation of
innovative advanced therapy medicinal products … & Regenerative Medicine International Society …

Introduction of health technology assessment for medicines in Slovakia

T Tesar, A Hloska, M Wawruch, L Lehocka… - … Assessment in Health …, 2017 - cambridge.org
… Pricing and Reimbursement of Medicinal Products In Slovakia, a single application is
filed for both the pricing and the reimbursement of medicinal products. However, in the following …

[HTML][HTML] Basics of advanced therapy medicinal product development in academic pharma and the role of a GMP simulation unit

I Johanna, A Daudeij, F Devina, C Nijenhuis… - … and Technology, 2023 - Elsevier
… , health technology assessment, market authorization, and reimbursement program, as
well as a patient outreach program to improve patient access. A next level of innovation and …

Recalibrating health technology assessment methods for cell and gene therapies

A Angelis, H Naci, A Hackshaw - Pharmacoeconomics, 2020 - Springer
therapies and cellular therapies, with the regulatory terminology for advanced therapy
medicinal products … , as for human cells and tissue products [9]. The FDA’s Office of Tissues and …

The underlying evidence for Advanced Therapy Medicinal Products

M Hoogendoorn - 2023 - studenttheses.uu.nl
Assessing these medicines has therefore posed challenges for both regulators and Health
Technology Assessment (HTA) decision makers. Despite having been mentioned in the …

Advanced therapy medicinal products for the eye: Definitions and regulatory framework

M López-Paniagua, A de la Mata, S Galindo… - Pharmaceutics, 2021 - mdpi.com
Advanced therapy medicinal products (ATMPs) are a group of … products for human use that
comprises somatic cell therapyAdvanced therapy medicinal products (ATMPs) are a large …

[HTML][HTML] Pharmacotherapeutic management of advanced therapy medicinal products

JL Poveda-Andrés, MJ Ruiz-Caldes… - Farmacia …, 2022 - Elsevier
… face when using advanced therapy medicinal products at the different … Advanced therapy
medicinal products: value judgement and ethica evaluation in health technology assessment

Advanced therapy medicinal products

A Lozano-Blázquez, D Makridaki… - European Journal of …, 2024 - ejhp.bmj.com
… expertise and their involvement in health technology assessments are even more crucial
for … Assessments of ATMPs should follow the same principles as those of the medication