Prof. Francesco Saverio Mennini

Transcription

1 Not reimburasable A STRUCTURED DEBATE REGARDING THE NATIONAL HEALTH ECONOMICS GUIDELINES IN SOUTHERN EUROPE Pharmaceutical Regulation and PhEconomics Guidelines in Italy Prof. Francesco Saverio Mennini Research Director, Economic Evaluation and HTA (EEHTA) CEIS Università degli studi di Roma «Tor Vergata» And Institute of Leadership and Management in Health, Kingston University, London,UK President, ISPOR Italy Rome Chapter 1 Regulatory processs and price definition (P&R) EMA European Medicines Agency Market authorization AIFA Italian Pharmaceutical Agency CTS Technical Scientific Commission 14 members: Director of AIFA and ISS 5 members nominated from MoH 5 by the regions 1 by Ministry of Finance and Economy 1 by Ministry of Economic Development CPR Pricing and Reimbursement Commission 19 members: 7 nominated by MoH 9 by the regions 1 by Ministry of Finance and Economy List C List A/H List C nn 2 1

2 Background Proper exploitation of innovation requires the assessment of: Effects on quality of care (mortality, morbidity, pain etc ) Effects on cost of care Effects on value of care (QALY) To date the majority of innovation has been assessed mainly in terms of quality of care, often the cost for achieving innovation is ignored, and so the ratio of decrease in other items, thus downgrading it real value. The new (future) approach New Dossier - Structured dossier - Must be attached: 1. Final HTA report based on Scientific Advice 2. BIM, in a simplified Excel format and editable in basic parameters. 3. Cost Effectiveness Model editable in basic parameters 4. Time to off-treatment curves 4 2

3 Criteria The innovation must demonstrate an improvement in terms of effectiveness and/or safety with respect to the standard of reference adopted in Italian welfare context. The innovation is evaluated through HTA studies in order to determine the ratio of incremental cost-effectiveness compared to the standard of reference Criteria Specific items 3

4 Indirect Cost (new AIFA GL) If it is adopted a societal perspective, must also include Indirect Costs related to Loss of Productivity, Informal Care and other Indirect Costs. Where possible, provide the cost grouped by type of event awaited in the natural history of the disease (e.g. costs for cardiovascular event, transplant, etc ). 7 Indirect Cost Which methodology? With regard to the Loss of Productivity: Friction cost methods Human Capital Approach? 8 4

5 Indirect Cost..it is Public Expenditure. Which kind of approach? Social Security System... stronger collaboration and connection between the different administrative database. so as to be able to understand the effects of a disease not only on the health system but also on the welfare system in general. 9 Procurement Joint Procurement? In general, EU level / cross-border JP of medicines seems unlikely in the near future. However, this will not prevent member states from engaging in smallscale JP. Even then, JP is not straightforward and may require adaptations of national legal frameworks related to price negotiations to be implemented. Cross border joint procurement: risks, advantages and previous experiences (pharma market) FS Mennini, N Dimitri, F Lichere, L Gitto, G Piga (in print, 2016) 10 5

6 Conclusion Great transparency in the information (methodology, price etc ). Attention to cost and not price. QoL Analysis of indirect costs. Connection with Tender ISPOR Italy Rome Chapter Scientific Commettee FS Mennini, A Cicchetti, A Migliore, PL Canonico, A Messori Thanks f.mennini@uniroma2.it Web: 6

7 Conclusion Potential impact of these molecules on health expenditure A cost-utility model (CUA) presented by the manufacturer based on its price proposal lacks certainty in several sub-populations Sound budget impact analysis (BIA) in the manufacturer submission file is needed Only an estimate of the NHS expenditure for the product to be purchased at proposed price is submitted, with under-estimation of other variables (e.g. comparators, duration of response etc.) Manufacturer s estimate to be reviewed and adjusted according to real-life epidemiological data 7