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Article ; Online: Financing and Reimbursement of Approved Advanced Therapies in Several European Countries.

Iglesias-López, Carolina / Agustí, Antònia / Vallano, Antoni / Obach, Mercè

Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

2023 Volume 26, Issue 6, Page(s) 841–853

Abstract: Objectives: The uncertainty in the cost-benefit of advanced therapy medicinal products (ATMPs) is a current challenge for their reimbursement in health systems. This study aimed to provide a comparative analysis of the National Health Authorities (NHAs) ...

Abstract	Objectives: The uncertainty in the cost-benefit of advanced therapy medicinal products (ATMPs) is a current challenge for their reimbursement in health systems. This study aimed to provide a comparative analysis of the National Health Authorities (NHAs) reimbursement recommendations issued in different European countries. Methods: The NHA reimbursement recommendations for the approved ATMPs were compared among 8 European Union (EU) Countries (EU8: Ireland, England/Wales, Scotland, The Netherlands, France, Germany, Spain, and Italy). The search was carried out until December 31, 2021. Results: A total of 19 approved ATMPs and 76 appraisal reports were analyzed. The majority of the ATMPs were reimbursed, although with uncertainty in added therapeutic value. No relationship between the type of the European Medicines Agency approval and reimbursement was found. Managed entry agreements, such as payment by results, were necessary to ensure market access. The main issue during the evaluation was to base the cost-effectiveness analyses on assumptions because of the limited long-term data. The estimated incremental cost-effectiveness ratio among countries reveals high variability. Overall, the median time to NHA recommendation for the EU8 is in the range of 9 to 17 months. Conclusions: Transparent, harmonized, and systematic assessments across the EU NHAs in terms of cost-effectiveness, added therapeutic value, and grade of innovativeness are needed. This could lead to a more aligned access, increasing the EU market attractiveness and raising public fairness in terms of patient access and pricing.
MeSH term(s)	Humans ; Europe ; France ; Germany ; European Union ; Cost-Benefit Analysis
Language	English
Publishing date	2023-01-13
Publishing country	United States
Document type	Journal Article
ZDB-ID	1471745-1
ISSN	1524-4733 ; 1098-3015
ISSN (online)	1524-4733
ISSN	1098-3015
DOI	10.1016/j.jval.2022.12.014
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Article: The challenges of access to innovative medicines with limited evidence in the European Union.

Vallano, Antonio / Pontes, Caridad / Agustí, Antònia

Frontiers in pharmacology

2023 Volume 14, Page(s) 1215431

Abstract: The European Medicines Agency (EMA) fosters access to innovative medicines through accelerated procedures and flexibility in the authorization requirements for diseases with unmet medical needs, such as many rare diseases as well as oncological diseases. ...

Abstract	The European Medicines Agency (EMA) fosters access to innovative medicines through accelerated procedures and flexibility in the authorization requirements for diseases with unmet medical needs, such as many rare diseases as well as oncological diseases. However, the resulting increase of medicines being marketed with conditional authorizations and in exceptional circumstances has lead to higher clinical uncertainty about their efficacy and safety than when the standard authorizations are applied. This uncertainty has significant implications for clinical practice and the negotiation of pricing and reimbursement, particularly as high prices are based on assumptions of high value, supported by regulatory prioritization. The burden of clinical development is often shifted towards public healthcare systems, resulting in increased spending budgets and opportunity costs. Effective management of uncertainty, through appropriate testing and evaluation, and fair reflection of costs and risks in prices, is crucial. However, it is important not to sacrifice essential elements of evidence-based healthcare for the sake of access to new treatments. Balancing sensitive and rational access to new treatments, ensuring their safety, efficacy, and affordability to healthcare systems requires thoughtful decision-making. Ultimately, a responsible approach to timely access to innovative medicines that balances the needs of patients with healthcare systems' concerns is necessary. This approach emphasizes the importance of evidence-based decision-making and fair pricing and reimbursement.
Language	English
Publishing date	2023-08-31
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2587355-6
ISSN	1663-9812
ISSN	1663-9812
DOI	10.3389/fphar.2023.1215431
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Article ; Online: Clinical pharmacology facing the real-world setting: Pharmacovigilance, pharmacoepidemiology and the economic evaluation of drugs.

Agustí, Antonia / Cereza, Gloria / de Abajo, Francisco J / Maciá, Miguel A / Sacristán, José A

Pharmacological research

2023 Volume 197, Page(s) 106967

Abstract: Traditionally, clinical pharmacology has focused its activities on drug-organism interaction, from an individual or collective perspective. Drug efficacy assessment by performing randomized clinical trials and analysis of drug use in clinical practice by ...

Abstract	Traditionally, clinical pharmacology has focused its activities on drug-organism interaction, from an individual or collective perspective. Drug efficacy assessment by performing randomized clinical trials and analysis of drug use in clinical practice by carrying out drug utilization studies have also been other areas of interest. From now on, Clinical pharmacology should move from the analysis of the drug-individual interaction to the analysis of the drug-individual-society interaction. It should also analyze the clinical and economic consequences of the use of drugs in the conditions of normal clinical practice, beyond clinical trials. The current exponential technological development that facilitates the analysis of real-life data offers us a golden opportunity to move to all these other areas of interest. This review describes the role that clinical pharmacology has played at the beginning and during the evolution of pharmacovigilance, pharmacoepidemiology and economic drug evaluations in Spain. In addition, the challenges that clinical pharmacology is going to face in the following years in these three areas are going to be outlined too.
MeSH term(s)	Cost-Benefit Analysis ; Pharmacoepidemiology ; Pharmacology, Clinical ; Pharmacovigilance ; Drug Utilization
Language	English
Publishing date	2023-10-20
Publishing country	Netherlands
Document type	Review ; Journal Article
ZDB-ID	1003347-6
ISSN	1096-1186 ; 0031-6989 ; 1043-6618
ISSN (online)	1096-1186
ISSN	0031-6989 ; 1043-6618
DOI	10.1016/j.phrs.2023.106967
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Zs.A 721: Show issues

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Article: Adverse Drug Reactions in Pediatric Oncohematology: A Systematic Review.

Amaro-Hosey, Kristopher / Danés, Immaculada / Agustí, Antònia

Frontiers in pharmacology

2022 Volume 12, Page(s) 777498

Abstract: Introduction: ...

Abstract	Introduction:
Language	English
Publishing date	2022-02-03
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2587355-6
ISSN	1663-9812
ISSN	1663-9812
DOI	10.3389/fphar.2021.777498
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Article ; Online: The importance of reporting suspected adverse reactions caused by new drugs.

Agustí, Antònia

Multiple sclerosis (Houndmills, Basingstoke, England)

2015 Volume 21, Issue 11, Page(s) 1478–1479

MeSH term(s)	Cerebrovascular Disorders/chemically induced ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Humans ; Stevens-Johnson Syndrome/etiology ; Vasoconstriction/drug effects
Language	English
Publishing date	2015-10
Publishing country	England
Document type	Journal Article
ZDB-ID	1290669-4
ISSN	1477-0970 ; 1352-4585
ISSN (online)	1477-0970
ISSN	1352-4585
DOI	10.1177/1352458515600252
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Article ; Online: Predictors of Health Satisfaction in Spanish Physically Active Older Adults: A Cross-Sectional Observational Study.

Agustí, Ana Isabel / Guillem-Saiz, Javier / González-Moreno, Jesús / Cantero-García, María / Cigarroa, Igor / Parra-Rizo, María Antonia

Geriatrics (Basel, Switzerland)

2023 Volume 8, Issue 1

Abstract: Studies that analyze the predictors of satisfaction with the health of the elderly are scarce. That is the reason why the objective of this study is to analyze whether the physical-psychological state, sports practice, and the use of socio-health ... ...

Abstract	Studies that analyze the predictors of satisfaction with the health of the elderly are scarce. That is the reason why the objective of this study is to analyze whether the physical-psychological state, sports practice, and the use of socio-health resources are factors that predict satisfaction with health status in physically active elderly people. The Physical Activity and Quality of Life questionnaires were applied to a sample of 397 elderly people in this cross-sectional observational study. The data have been analyzed using Student's
Language	English
Publishing date	2023-02-18
Publishing country	Switzerland
Document type	Journal Article
ISSN	2308-3417
ISSN (online)	2308-3417
DOI	10.3390/geriatrics8010027
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Article ; Online: Reporting suspected adverse reactions to new commercialized medicines in real world.

Agustí Escasany, Antònia

Multiple sclerosis (Houndmills, Basingstoke, England)

2018 Volume 24, Issue 6, Page(s) 816–817

MeSH term(s)	Adverse Drug Reaction Reporting Systems ; Alemtuzumab ; Anemia, Hemolytic, Autoimmune ; Humans ; Multiple Sclerosis
Chemical Substances	Alemtuzumab (3A189DH42V)
Language	English
Publishing date	2018-01-23
Publishing country	England
Document type	Journal Article ; Comment
ZDB-ID	1290669-4
ISSN	1477-0970 ; 1352-4585
ISSN (online)	1477-0970
ISSN	1352-4585
DOI	10.1177/1352458518754999
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Article: Current landscape of clinical development and approval of advanced therapies.

Iglesias-Lopez, Carolina / Agustí, Antonia / Vallano, Antoni / Obach, Merce

Molecular therapy. Methods & clinical development

2021 Volume 23, Page(s) 606–618

Abstract: Advanced therapy medicinal products (ATMPs) are innovative therapies that mainly target orphan diseases and high unmet medical needs. The uncertainty about the product's benefit-risk balance at the time of approval, the limitations of nonclinical ... ...

Abstract	Advanced therapy medicinal products (ATMPs) are innovative therapies that mainly target orphan diseases and high unmet medical needs. The uncertainty about the product's benefit-risk balance at the time of approval, the limitations of nonclinical development, and the complex quality aspects of those highly individualized advanced therapies are playing a key role in the clinical development, approval, and post-marketing setting for these therapies. This article reviews the current landscape of clinical development of advanced therapies, its challenges, and some of the efforts several stakeholders are conducting to move forward within this field. Progressive iteration of the science, methodologically sound clinical developments, establishing new standards for ATMPs development with the aim to ensure consistency in clinical development, and the reproducibility of knowledge is required, not only to increase the evidence generation for approval but to set principles to achieve translational success in this field.
Language	English
Publishing date	2021-11-11
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2872938-9
ISSN	2329-0501 ; 2329-0501
ISSN (online)	2329-0501
ISSN	2329-0501
DOI	10.1016/j.omtm.2021.11.003
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Zs.A 7107: Show issues

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Article: Subzero Temperature Storage to Preserve the Quality Attributes of Veiled Virgin Olive Oil.

Díez-Betriu, Anna / Romero, Agustí / Ninot, Antonia / Tres, Alba / Vichi, Stefania / Guardiola, Francesc

Foods (Basel, Switzerland)

2023 Volume 12, Issue 6

Abstract: Unfiltered olive oils (UO) have gained popularity in the global market, but they lose their quality characteristics faster than filtered oils (FO). In this work, refrigeration and freezing temperatures were explored to maintain UO quality features during ...

Abstract	Unfiltered olive oils (UO) have gained popularity in the global market, but they lose their quality characteristics faster than filtered oils (FO). In this work, refrigeration and freezing temperatures were explored to maintain UO quality features during storage. A full factorial design was applied to an UO and to the same oil after filtration to evaluate the effect of storage temperature (room temperature, 4 °C and -20 °C) and freezing speed (slow-freezing, in the freezer at -20 °C and fast-freezing, in a bath of liquid nitrogen). Official quality parameters, polar and nonpolar phenolic compounds, oxidative stability index, volatile compounds and descriptive sensory profile were measured periodically over 24 months of storage in the dark. Storage temperature influenced the quality of both UO and FO, but in different ways. At non-freezing temperature, UO experienced a severe decrease in its sensory quality compared to FO, mainly due to the hydrolysis of secoiridoids and degradation of the volatile fraction, but storage at -20 °C allowed to effectively preserve UO quality traits, thus resulting as a suitable strategy to increase the shelf-life of UO to satisfy the demand of consumers for this particular product. The results showed that slow-freezing was the most appropriate method for freezing.
Language	English
Publishing date	2023-03-13
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2704223-6
ISSN	2304-8158
ISSN	2304-8158
DOI	10.3390/foods12061228
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Article ; Online: Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States.

Iglesias-Lopez, Carolina / Obach, Mercè / Vallano, Antonio / Agustí, Antonia

Cytotherapy

2021 Volume 23, Issue 3, Page(s) 261–274

Abstract: Background aims: Regulatory agencies in the European Union (EU) and in the United States of America (USA) have adapted and launched regulatory pathways to accelerate patient access to innovative therapies, such as advanced therapy medicinal products ( ... ...

Abstract	Background aims: Regulatory agencies in the European Union (EU) and in the United States of America (USA) have adapted and launched regulatory pathways to accelerate patient access to innovative therapies, such as advanced therapy medicinal products (ATMPs). The aim of this study is to analyze similarities and differences between regulatory pathways followed by the approved ATMPs in both regions. Methods: A retrospective analysis of the ATMPs approved by EU and US regulatory agencies was carried out until May 31, 2020. Data were collected on the features and timing of orphan drug designation (ODD), scientific advice (SA), expedited program designation (EP), marketing authorization application (MAA) and marketing authorization (MA) for both regions. Results: In the EU, a total of fifteen ATMPs were approved (eight gene therapies, three somatic cell therapies, three tissue-engineered products and one combined ATMP), whereas in the USA, a total of nine were approved (five gene therapies and four cell therapies); seven of these were authorized in both regions. No statistical differences were found in the mean time between having the ODD or EP granted and the start of the pivotal clinical trial or MAA in the EU and USA, although the USA required less time for MAA assessment than the EU (mean difference, 5.44, P = 0.012). The MAA assessment was shorter for those products with a PRIME or breakthrough designation.. No differences were found in the percentage of ATMPs with expedited MAA assessment between the EU and the USA (33.3% versus 55.5%, respectively, P = 0.285) or in the time required for the MAA expedited review (mean difference 4.41, P = 0.105). Approximately half of the products in both regions required an Advisory Committee during the MAA review, and 60% required an oral explanation in the EU. More than half of the approved ATMPs (67% and 55.55% in the EU and the USA, respectively) were granted an ODD, 70% by submitting preliminary clinical data in the EU. The mean number of SA and protocol assistance per product conducted by the European Medicines Agency was 1.71 and 3.75, respectively, and only 13% included parallel advice with health technology assessment bodies. A total of 53.33% of the products conducted the first SA after the pivotal clinical study had started, reporting more protocol amendments. Finally, of the seven ATMPs authorized in both regions, the type of MA differed for only two ATMPs (28.6%), and four out of eight products non-commercialized in the USA had a non-standard MA in the EU. Conclusions: The current approved ATMPs mainly target orphan diseases. Although EU and US regulatory procedures may differ, the main regulatory milestones reached by the approved ATMPs are similar in both regions, with the exception of the time for MAA evaluation, the number of authorized products in the regions and the type of authorization for some products. More global regulatory convergence might further simplify and expedite current ATMP development in these regions.
MeSH term(s)	Cell- and Tissue-Based Therapy ; Drug Approval ; European Union ; Genetic Therapy ; Humans ; Retrospective Studies ; Therapies, Investigational ; United States
Language	English
Publishing date	2021-01-19
Publishing country	England
Document type	Journal Article
ZDB-ID	2039821-9
ISSN	1477-2566 ; 1465-3249
ISSN (online)	1477-2566
ISSN	1465-3249
DOI	10.1016/j.jcyt.2020.11.008
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