THE ITALIAN REGIONAL ACCESS OF NEW CANCER DRUGS- AN EXAMPLE IN FOUR REGIONS

Author(s)

Visentin E, Heiman F, Ripellino C
IMS Health Information Solutions Medical Research S.r.l, Milan, Italy

OBJECTIVES: In Italy, federalism in health system leads to an increasingly fragmented and geographically differentiated Health, often even within the same region and also leads to a long and complex process for drugs market access and to get the access of patients. We conducted a survey in four regions in order to assess the inclusion of new cancer drugs within the regional formularies evaluating the time to access. METHODS: Once a drug is reimbursed by the national assessment body (AIFA), a further step consists in obtaining the authorization for reimbursement by the regional health systems (RHS), many of which have their own formulary of reimbursed pharmaceutical drugs. Currently, 16 Italian regions have adopted a regional formulary. The selected Regions for this analysis are Emilia Romagna, Piemonte, Lazio and Sardegna. We considered six new oncology drugs reimbursed by AIFA in 2014, excluding three oncology drugs that bypass the regional evaluation process since they respond to the requirement of therapeutic innovation. RESULTS: Nowadays, only the Regions of Piemonte and Emilia Romagna have evaluated all the 6 new oncology drugs reimbursed by AIFA in 2014 with average times from the national reimbursement decision to the regional one ranging from 3 months in Piemonte to 5 months in Emilia Romagna. The Lazio and Sardinia Regions have evaluated only 1 out of the 6 drugs with an access time of around 2.5 and 6 months, respectively.  CONCLUSIONS: In Italy, the average times from the national reimbursement decisions to the regional evaluations aiming to the formulary inclusion vary widely between Regions.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PCN277

Topic

Health Policy & Regulatory

Topic Subcategory

Approval & Labeling, Pricing Policy & Schemes, Reimbursement & Access Policy

Disease

Oncology

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