ITALIAN TIMINGS IN NEW DRUGS APPROVAL- AN UP-TO-DATE ANALYSIS

Author(s)

Lanati EP, Lidonnici D, Ronco V
MA Provider Srl, Milano, Italy

OBJECTIVES:  The present study analyses the timings of recently approved new drugs in Italy, pointing out the whole national process duration, from submission to price and reimbursement decision published on the Italian Official Journal. METHODS:  We screened all reports published on the Italian Medicines Agency website regarding the monthly decisional meetings of the two commissions in charge of discussing the pricing and reimbursement requests presented by pharma companies (Technical Scientific Committee and Price and Reimbursement Committee). The public reports have been analysed since January 2015 onward, focusing on new drugs approved by EMA with centralised procedure, and integrated with information taken from the Italian Official Journal. This was the basis for the creation of a database that will be monthly updated. For each drug analysed a number of standard checkpoint have been highlighted in order to measure the minimum, average and maximum timing for each approval phase. RESULTS:  The dataset collected up to June 2016 consisted of 94 drugs mentioned in AIFA report. They have been divided into four groups according to the available information: drugs still under assessment (8), drugs with no P&R request available (43), drugs with the information of the starting date of the procedure (reception of hard copy of the P&R dossier) (24), drugs which concluded the procedure since January 2015 (19). A complete analysis was focused on the last groups, pointing out a mean approval time of 115 days (min 36 max 246). Other checkpoints revealed the time between different phases: mean CTS-CPR 79 days (min 2 max 191); mean CPR-OJ publication 40 days (min 23 max 120). CONCLUSIONS:  Even if Italian pharma regulatory framework has also been indicated as one of the most up-to-date, Italy has always been pointed at as a slow country in terms of approval timings of new drugs. The analysis reveals a possible improving trend.

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

Value in Health, Vol. 19, No. 7 (November 2016)

Code

PHP49

Topic

Health Policy & Regulatory, Health Service Delivery & Process of Care

Topic Subcategory

Hospital and Clinical Practices, Pricing Policy & Schemes, Reimbursement & Access Policy

Disease

Multiple Diseases

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