Informes de posicionamiento terapéutico: experiencia en España en el periodo 2013-2019

García, Verónica; Corbalán, Laura; Baquero, Sandra Victoria Gomez; García‐Esquinas, Esther; Sacristán, José Antonio

doi:10.1016/j.aprim.2020.02.012

Cited by 5 publications

(6 citation statements)

References 8 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The results of this study are consistent with those of clinical trials [8][9][10] , and support the idea that dupilumab presents clinical benefit in patients with moderate and severe AD, improving the signs and symptoms with acceptable safety, in comparison with the rest of therapeutic alternatives 2 .…”

Section: Discussionsupporting

confidence: 88%

“…The treatment of AD consists of topical and systemic corticosteroids and antihistamine, immunosuppressants such as cyclosporine or methotrexate, and even biological medicinal products (monoclonal antibodies, without indication described in label) or phototherapy 2 . Cyclosporine is considered the treatment of choice for moderate and severe forms of AD, being the only systemic immunosuppressant with demonstrated efficacy and authorized in Europe Union for this indication 3 .…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Real long-term data of dupilumab in atopic dermatitis

2020

View full text Add to dashboard Cite

SUMMARY Objectives: Dupilumab is the first biological drug indicated in atopic dermatitis (AD). The aim of this study is to assess effectiveness and safety of dupilumab in moderate-severe AD in clinical practice, and the quality of life of treated patients. Methods: Descriptive retrospective study was conducted. Effectiveness was measured by SCORingAtopic Dermatitis (SCORAD). Primary endpoint was SCORAD-75; secondary endpoints were SCORAD-90 and “total clearance”, at week 4, 12, 24 and 48. Safety was evaluated according to adverse events profile. Quality of life was assessed by Dermatology Life Quality Index (DLQI) at week 0 and 48. Results: At week 4, 2 patients presented SCORAD-75, none presented SCORAD-90 or clearance. At week 12, 2 patients showed SCORAD-75, 2 SCORAD-90 and one clearance. At weeks 24 and 48, 3 patients presented SCORAD-90 and 3 clearance. All patients presented mild-moderate adverse events. DLQI at week 48 was 0.7. Conclusions: Dupilumab presented adequate effectiveness and safety, improving quality of life of treated patients.

show abstract

Section: Discussionsupporting

confidence: 88%

Section: Introductionmentioning

confidence: 99%

Real long-term data of dupilumab in atopic dermatitis

2020

View full text Add to dashboard Cite

show abstract

“…Several studies have assessed the impact of the introduction and evolution of the IPTs in the pricing and reimbursement system in Spain and the efficiency of the process for their development (12;14;22;23). However, they have not conducted an in-depth assessment of the level of implementation of deliberative processes in HTA for medicines in Spain following a best practice framework.…”

Section: Discussionmentioning

confidence: 99%

Deliberative processes in health technology assessment of medicines: the case of Spain

Pinilla-Dominguez¹,

Domínguez²

2023

Int J Technol Assess Health Care

View full text Add to dashboard Cite

Objectives: Spain incorporated in 2020 changes in its health technology assessment (HTA), pricing, and reimbursement system for medicines including publishing reports, development of networks of experts, or consultation with stakeholders. Despite these changes, it is unclear how deliberative frameworks are applied and the process has been criticized for not being sufficiently transparent. This study analyses the level of implementation of deliberative processes in HTA for medicines in Spain. Methods: We review the grey literature and summarize the Spanish HTA, pricing, and reimbursement process of medicines. We apply the deliberative processes for HTA checklist, developed to assess the overall context of the deliberative process, and identify the stakeholders involved and type of involvement following the framework for evidence-informed deliberative processes, a framework for benefit package design that aims to optimize the legitimacy of decision making. Results: In the Spanish HTA, pricing, and reimbursement process deliberation takes place in order to exchange viewpoints and reach common ground, mainly during the prioritization, assessment, and appraisal steps. It is closed to the public, not clearly summarized in published documents and limited to the Ministry of Health, the regulatory agency, other Ministries, and experts with mostly clinical and/or pharmaceutical background. The views of stakeholders are only represented through consultation. Communication is the most commonly used form of stakeholder engagement. Conclusions: Despite improvements in transparency of the Spanish HTA process for evaluating medicines, aspects related to stakeholder involvement and implementation of deliberative frameworks need further attention in order to achieve further legitimacy of the process.

show abstract

“…Its bioavailability is 61–64% after subcutaneous administration, and the mean time to peak serum concentration is 3–7 days [ 87 ]. Subcutaneous administration is by pen or prefilled syringe.…”

Section: Biologicals Treatmentsmentioning

confidence: 99%

Severe Asthma and Biological Therapies: Now and the Future

Sardon-Prado,

Diaz-Garcia,

Corcuera-Elosegui

et al. 2023

JCM

View full text Add to dashboard Cite

Recognition of phenotypic variability in pediatric asthma allows for a more personalized therapeutic approach. Knowledge of the underlying pathophysiological and molecular mechanisms (endotypes) of corresponding biomarkers and new treatments enables this strategy to progress. Biologic therapies for children with severe asthma are becoming more relevant in this sense. The T2 phenotype is the most prevalent in childhood and adolescence, and non-T2 phenotypes are usually rare. This document aims to review the mechanism of action, efficacy, and potential predictive and monitoring biomarkers of biological drugs, focusing on the pediatric population. The drugs currently available are omalizumab, mepolizumab, benralizumab, dupilumab, and 1ezepelumab, with some differences in administrative approval prescription criteria between the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Previously, we described the characteristics of severe asthma in children and its diagnostic and therapeutic management.

show abstract

Informes de posicionamiento terapéutico: experiencia en España en el periodo 2013-2019

Cited by 5 publications

References 8 publications

Real long-term data of dupilumab in atopic dermatitis

Real long-term data of dupilumab in atopic dermatitis

Deliberative processes in health technology assessment of medicines: the case of Spain

Severe Asthma and Biological Therapies: Now and the Future

Contact Info

Product

Resources

About