Dr Roberta Joppi

Agency:

IHSP

Organisation:

Italian Horizon Scanning Project

Tel:

0039 045 8076080

Fax:

0039 045 8076098

Email:

roberta.joppi@ulss20.verona.it

Website:

http://horizon.cineca.it/

Address:

Servizio Farmaceutico Territoriale, Azienda ULSS 20, Via Salvo D'Acquisto n.7, 37122 Verona, Italy

Agency Member Since:

01/11/2008

Additional Contacts:

Dr Chiara Poggiani, Dr Daniela Pase

EAAS Name:

Italian Horizon Scanning Project

EAAS Host Organisation:

Pharmaceutical Department of the Local Health Unit in Verona

Country and/or Region:

Veneto Region, Italy

Year EAAS formally established:

2006

EAAS Status:

Permanent

EAAS Main Output Language:

Italian and English

EAAS Description:

IHSP aims to collect, organize and evaluate information on emerging medicines and medical devices with medicated coating. IHSP is currently 100% publicly funded, and the main customers are the Italian Medicines Agency (AIFA) and the Veneto Region. The IHSP framework includes a Scientific Secretariat (three full-time and one part-time pharmacists, one administrative, three part-time IT people), and a Scientific Committee (IHSP-SC) of 14 members including 3 representatives of the AIFA, 2 representatives of Veneto Region, 2 representatives of the Verona’s Pharmaceutical Department, 7 experts in drug evaluation. A panel of 50 clinicians with expertise in different medical and surgical fields are involved in issuing a critical clinical assessment (New Product Information Report) for prioritized drugs. IHSP is supported by a technological infrastructure for data collection, check, monitoring and analysis. The database is available, by a restricted access (http://horizon.cineca.it/). Currently, 2,000 emerging drugs are in IHSP database. After drug identification (new chemical entities, new indications, new formulations, new dosages, new associations) lists of drugs for which a Marketing Authorization is expected in the next 36 months are prepared. Prioritization of drugs is performed by the IHSP-SC about 18 months before the hypothetic European Marketing Authorization on the basis of information collected in the “-18 Report”. A “New Product Information Report” (NPIR), including the critical clinical assessment, is issued for all prioritized drugs about 12 months before the European Marketing Authorization. Up to February 2009 IHSP has produced the following documents:  20 “-36 months Reports”  50 “-18 months Reports”  14 “New Product Information Report” Pharmacoeconomic modelling/evaluation are in development to quantify appropriate and sustainable costs for emerging pharmaceuticals. IHSP plans to collaborate with the International Society of Drug Bulletins (ISDB) and in general with Italian independent drug bulletins. IHSP plans to cooperate with international organizations involved in evaluation and appropriate use of drugs.

Main source of funding:

National health system - Department of Health or health services, Regional health system - Department of Health or health services

Purpose of EAAS:

• To inform decisions on coverage or reimbursement of health services
• To inform decisions on captical or recurrent spending
• To inform decisions on undertaking primary research
• To inform decisions on undertaking secondary research (health technology assessments, systematic reviews)

Types of technologies covered by EAAS:

• Pharmaceuticals (including vaccines)

Main customers of EAAS:

• National Government Health Departments & Ministers
• Regional, State or Provincial Government

Contents of Main Output from EAAS:

• Potential for significant health service impact
• Safety and efficacy
• Assessment of clinical effectiveness