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View article: Reporting reimbursement price decisions for onco-hematology drugs in Spain
Reporting reimbursement price decisions for onco-hematology drugs in Spain Open
Introduction Even using well-established technology assessment processes, the basis of the decisions on drug price and reimbursement are sometimes perceived as poorly informed and sometimes may be seen as disconnected from value. The liter…
View article: Financing and Reimbursement of Approved Advanced Therapies in Several European Countries
Financing and Reimbursement of Approved Advanced Therapies in Several European Countries Open
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 attr…
View article: Early Access to Medicines: Use of Multicriteria Decision Analysis (MCDA) as a Decision Tool in Catalonia (Spain)
Early Access to Medicines: Use of Multicriteria Decision Analysis (MCDA) as a Decision Tool in Catalonia (Spain) Open
Early access to medicines allows the prescription of a medicine before it is available in the public formulary to patients with severe or rare diseases with high unmet needs who have no authorised therapeutic alternatives available. In thi…
View article: Methodological Characteristics of Clinical Trials Supporting the Marketing Authorisation of Advanced Therapies in the European Union
Methodological Characteristics of Clinical Trials Supporting the Marketing Authorisation of Advanced Therapies in the European Union Open
Several advanced therapy medicinal products (ATMPs) have been approved in the European Union (EU). The aim of this study is to analyse the methodological features of the clinical trials (CT) that supported the marketing authorization (MA) …
View article: Description of the use of Multicriteria to Support Pricing and Reimbursement Decisions by European Health Technology Assessment Bodies.
Description of the use of Multicriteria to Support Pricing and Reimbursement Decisions by European Health Technology Assessment Bodies. Open
BackgroundHeterogeneity in drug access throughout Europe may be influenced by differences in drug-assessment strategies. The EUnetHTA’s assessment core model (EUnetHTA-core) and the EVIDEM’s multicriteria framework are reference methodolog…
View article: Potential approaches for the pricing of cancer medicines across Europe to enhance the sustainability of healthcare systems and the implications
Potential approaches for the pricing of cancer medicines across Europe to enhance the sustainability of healthcare systems and the implications Open
Introduction: There are growing concerns among European health authorities regarding increasing prices for new cancer medicines, prices not necessarily linked to health gain and the implications for the sustainability of their healthcare s…
View article: Additional file 1 of Description of the use of multicriteria to support pricing and reimbursement decisions by European health technology assessment bodies
Additional file 1 of Description of the use of multicriteria to support pricing and reimbursement decisions by European health technology assessment bodies Open
Additional file 1.
View article: Obesity causes irreversible mitochondria failure in visceral adipose tissue despite successful anti-obesogenic lifestyle-based interventions
Obesity causes irreversible mitochondria failure in visceral adipose tissue despite successful anti-obesogenic lifestyle-based interventions Open
Metabolic plasticity is the ability of a biological system to adapt its metabolic phenotype to different environmental stressors. We used a whole-body and tissue-specific phenotypic, functional, metabolomic and transcriptomic approach to s…
View article: Corrigendum: Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States
Corrigendum: Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States Open
[This corrects the article DOI: 10.3389/fphar.2019.00921.].
View article: Alpha1-antitrypsin ameliorates islet amyloid-induced glucose intolerance and β-cell dysfunction
Alpha1-antitrypsin ameliorates islet amyloid-induced glucose intolerance and β-cell dysfunction Open
These results demonstrate that treatment with AAT improves glucose homeostasis in mice overexpressing hIAPP and protects pancreatic β-cells from the cytotoxic actions of hIAPP mediated by macrophages. These results support the use of AAT-b…
View article: Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines
Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines Open
The understanding of the benefit risk profile, and relative effectiveness of a new medicinal product, are initially established in a circumscribed patient population through clinical trials. There may be uncertainties associated with the n…
View article: Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States
Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States Open
Advanced therapy medicinal products (ATMPs) are a fast-growing field of innovative therapies. The European Union (EU) and the United States (US) are fostering their development. For both regions, ATMPs fall under the regulatory framework o…
View article: Hurdles of environmental risk assessment procedures for advanced therapy medicinal products: comparison between the European Union and the United States
Hurdles of environmental risk assessment procedures for advanced therapy medicinal products: comparison between the European Union and the United States Open
An environmental risk assessment (ERA) consists of an analysis of the risks to human health and the environment that a medicinal product may cause due to its release during clinical development or after entering the market. Regulators in E…
View article: Implementing reflective multicriteria decision analysis (MCDA) to assess orphan drugs value in the Catalan Health Service (CatSalut)
Implementing reflective multicriteria decision analysis (MCDA) to assess orphan drugs value in the Catalan Health Service (CatSalut) Open
The study showed that reflective MCDA methodology could be implemented to complement the decision-making process in CatSalut, as an aid to determine the clinical added value for orphan medicines. MCDA provided transparency and a structured…
View article: The impact of parallel regulatory–health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations
The impact of parallel regulatory–health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations Open
Aims The parallel regulatory–health technology assessment scientific advice (PSA) procedure allows manufacturers to receive simultaneous feedback from both EU regulators and health technology assessment (HTA) bodies on development plans fo…
View article: Amyloid‐induced β‐cell dysfunction and islet inflammation are ameliorated by 4‐phenylbutyrate (PBA) treatment
Amyloid‐induced β‐cell dysfunction and islet inflammation are ameliorated by 4‐phenylbutyrate (PBA) treatment Open
Human islet amyloid polypeptide (hIAPP) aggregation is associated with β‐cell dysfunction and death in type 2 diabetes (T2D). we aimed to determine whether in vivo treatment with chemical chaperone 4‐phenylbutyrate (PBA) ameliorates hIAPP‐…
View article: How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory‐HTA parallel scientific advice
How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory‐HTA parallel scientific advice Open
Background In 2010, the European Medicines Agency (EMA) initiated a pilot project on parallel scientific advice with Health Technology Assessment bodies (HTABs) that allows manufacturers to receive simultaneous feedback from both the Europ…
View article: CCL22 Prevents Rejection of Mouse Islet Allografts and Induces Donor-Specific Tolerance
CCL22 Prevents Rejection of Mouse Islet Allografts and Induces Donor-Specific Tolerance Open
Manipulation of regulatory T cell (Treg) migration by islet expression of the chemokine CCL22 prevents diabetes in NOD mice and delays recurrent autoimmunity in syngeneic islet transplants. We sought to determine whether attracting Tregs w…