Research Centre of Health Technology Assessment

Transcription

1 Research Centre of Health Technology Assessment Insitute of Hygiene, UCSC Rome Flavia Kheiraoui 16 Aprile 2012

2 Background - 1 Health Technology Assessment is a multidisciplinary approach that systematically analyses the epidemiological, clinical, economic, organizational, social and ethical implications of the application of a health technology usually drugs, medical devices or clinical/surgical practices.

3 The bridge between evidence and policy- making Knowledge Decisions Battista,1994 HTA is intended to provide a range of stakeholders with accessible, useable and evidence-based information that will guide decisions about technology and the efficient allocation of resources Battista RN, Hodge MJ. The evolving paradigm of health technology assessment: reflections for the millennium. CMAJ 1999; 160:

4 HTA TO EVALUATE MEDICINES KEY PRINCIPLES FROM GSK (Giugno 2005) 1. HTAs should be based on a clear, sophisticated and differentiated view of what constitutes value; 2. HTAs should be transparent and balanced; 3. HTAs should be based on early and inclusive dialogue, including with patients; 4. Evaluations should be flexible to allow new data to be considered; 5. Risk-sharing and flexibility is required in handling uncertainty;

5 HTA TO EVALUATE MEDICINES KEY PRINCIPLES FROM GSK (Giugno 2005) 6. Comprehensive understanding of the benefits of a drug in disease management is needed; 7. Payers should commit to rewarding added value; 8. Positive HTA outcomes should be implemented; 9. HTA should apply to all healthcare interventions.

6 Background - 2 The HTA Area of the Institute of Hygiene was established in 2008 by Professor Ricciardi with the aim to promote and carry out scientific research in the field of health technology assessment, support research and innovation and provide opportunities for the development of evidence-based knowledge. Our activities are research, training and publishing.

7 Human Resources Director: Prof. Walter Ricciardi Teamwork: Dr.ssa Flavia Kheiraoui Prof.ssa Maria Luisa di Pietro, Prof. Stefano Capri, Dr.ssa Chiara de Waure, Dr.ssa Maria Lucia Specchia, Dott. Silvio Capizzi, Dott.ssa Chiara Cadeddu, Dott. Francesco di Nardo, Dott.ssa Anna Maria Ferriero, Prof. Giuseppe La Torre

8 Objectives Identify strategies for technical assistance and support activities for companies and stakeholders; Evaluate new types of health technologies; Designing and implementing programs for Research and Education at the local, regional and national level; Improving new strategies for dissemination of HTA Reports to reach all stakeholders, including patients/citizens; Encourage new ways of cooperation with scientific organizations.

9 Methodology The methodology of HTA is widely reported in the literature, it requires the collection and systematic analysis of data and evidence relating to the use of technology and its impact. HTA has a multidisciplinary approach: the technology under investigation is evaluated from different perspectives; it differs from traditional methods of assessment for the role of different stakeholders in the evaluation. Our research methodology is reinforced by the validation with experts / representatives of outside interests.

10 Methodology

11 Methodology Each result, and in particular the final report of HTA, will be realized through the following phases: 1. definition of project objectives and methodology; 2. publication of the methodology and objectives of the project; 3. analysis and production of results as a final draft; 4. discussion in Advisory Board; 5. publication and dissemination of final report.

12 Results Since established were realized 11 HTA Reports, published on the IJPH: Report di Health Technology Assessment di denosumab (Prolia ) ) nel trattamento dell osteoporosi postmenopausale Vol. 8 Nr.2, Suppl. 2 Advate per il trattamento e la profilassi dell'emofilia A: una valutazione v di HTA Vol. 8 Nr.2, Suppl. 1 Uso di Mycamine (micafungin) nel trattamento della candidosi invasiva: report di HTA Vol. 7 Nr.4 Suppl. 2 Xelox nel trattamento del tumore del colon-retto Vol. 7 Nr.3, Suppl. 2 Utilizzo di Tocilizumab per il trattamento dell'artrite reumatoide in Italia: risultati di un progetto di Health Technology Assessment Vol. 7 Nr.2, Suppl. 2

13 Results Rapporto di Health Technology Assessment della vaccinazione anti-pneumococcica con Prevenar Vol. 7 Nr.2 Suppl. 1 Valutazione dell'impatto clinico, economico, organizzativo ed etico ico-sociale del vaccino Synflorix in Italia. Risultati del gruppo di lavoro HTA Vol. 6 Nr.4, Suppl. 5 Health Technology Assessment di Lucentis nel trattamento della degenerazione d maculare senile Vol. 6 Nr.2, Suppl. 3 Report HTA del vaccino quadrivalente anti-hpv Gardasil Vol. 6 Nr.2, Suppl. 2 La valutazione dell'impatto clinico, economico, organizzativo, etico e e sociale di lapatinib in Italia: risultati del gruppo di lavoro HTA Vol. 6 Nr.1, Suppl. 1 Health Technology Assessment della vaccinazione anti-hpv Vol. 4 Nr.2, Suppl. 1

14 Results 2 Teaching Books: 1. Comprendere l Health Technology Assessment IJPH 2009 (La Torre G, Kheiraoui F, Monteduro A); 2. Health Technology Assessment Principi, dimensioni e strumenti (Ricciardi w, La Torre G, De Waure C, Kheiraoui F, Gualano MR, Mannocci A, Nicolotti N, Specchia ML) SEED, in two editions: 2010, 2011 In 2011 the first White Paper on the HTA in Italy, aimed to reviewing the HTA methodology in the italian Regions and developing a training activity for HTA.

15 Health Technology Assessment on denosumab denosumab (IJPH Vol. 8 Nr.2, Suppl. 2, anno 2011) Objective: 1. To Realize a HTA report with the aim to evaluate the clinical and economic impact and the organizational and ethics implications of denosumab, from its introduction in the Italian healthcare setting. To realize: Working group with different skills (multidisciplinary approach): Epidemiologists, statisticians, clinicians, economists, experts in the organization of health services, ethics.

16 Health Technology Assessment on denosumab denosumab (IJPH Vol. 8 Nr.2, Suppl. 2, anno 2011) Contents of the Report: Chapter 1: Introduction and methodology A description of the objectives of the project and the methodology followed for the analysis and the evaluation of the results. Chapter 2: Epidemiologic setting Analysis of epidemiology of osteoporosis in Italy. Chapter 3: Description of the biotechnological features Description of the registration process and bio molecular features of denosumab. Chapter 4: Analysis of the effectiveness of denosumab and competitors Overview of the effectiveness and safety of denosumab versus the other drugs with a critical review of the available literature.

17 Health Technology Assessment on denosumab denosumab (IJPH Vol. 8 Nr.2, Suppl. 2, anno 2011) Chapter 5: Economic evaluation of denosumab in the Italian context A cost-effectiveness and a budget impact analysis of the introduction of denosumab in the National Health Service. Chapter 6: Evaluation of organizing aspects in the management of patient suffering from Diagnostic, therapeutic and healthcare management with a particular attention to the roles of GP to the optimization of health services provided. Chapter 7: Ethical evaluation of the introduction of denosumab Evaluating ethical implications, clinical benefits and patient needs. Charter 8: Key points for the decision maker A summary of the most relevant results of the HTA report.

18 Health Technology Assessment on denosumab denosumab (IJPH Vol. 8 Nr.2, Suppl. 2, anno 2011) Methods: A HTA report was realized considering epidemiological, organizational, and social aspects, through a scientific literature review to evaluate clinical context and risk factors for osteoporosis. For the economic evaluation were performed a cost-effectiveness and a budget impact analysis. To evaluate ethical implications were considered clinical benefits and patient needs.

19 Health Technology Assessment on denosumab denosumab (IJPH Vol. 8 Nr.2, Suppl. 2, anno 2011) Results: Denosumab is the first fully human monoclonal antibody inhibiting the activity and the development of osteoclasts in the treatment of postmenopausal osteoporosis. The economic evaluation has estimated a reduction in costs for the National Health Service with its introduction. Denosumab, for administering property and safety, is indicated in outpatients treatment, involving General Practitioners. The introduction of innovative drugs, such as denosumab, could allow more effective management of the disease in presence of equity of access to the drug throughout the whole country. HTA application for denosumab represents an important instrument in health care decision-making to produce a critical documentation about the real value of a product and its utilization in the Italian context.

20 Health Technology Assessment on denosumab denosumab (IJPH Vol. 8 Nr.2, Suppl. 2, anno 2011) Advisory Board: Participation of experts from various clinical aspects involved; Sharing content of the chapters of the Report; Comments, suggestions, revisions.

21 Health Technology Assessment on denosumab denosumab (IJPH Vol. 8 Nr.2, Suppl. 2, anno 2011)