PGI47 ISPOR 17th Annual European Congress ?· 4Universita’ di Napoli Federico II, Napoli, Italy, 5Papa…

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  • BACKGROUNDA report about the HCV patients in Italy published by Cittadinanza Attivia and EpaC (two of the main HCV patients associations) shows that Italian Regions are significantly different in terms of structures and treatments for these kind of patients. The introduction of new therapies increased these differences in terms of access to new drugs. The number of centers that can administer these new therapies is not equally distributed among the Italian Regions.In Italy only 15% of HCV patients are eligible for new treatments and among these patients, only one out of four is actually treated. Only 353 Italian centers can effectively administer the new therapies, often with an insufficient medical staff in terms of number1. Moreover, these centers are not equally distributed in the Italian Regions: the table 1 shows the number of centers in the main Italian Regions (in two Regions equivalent in terms of population like Lombardy and Sicily, for example, there is a substancial difference in terms of centers per million inhabitants: 3,50 centers per million inhabitants in Lombardy and 2,20 centers per million inhabitants in Sicily).

    COHORT OF HCV PATIENTS IN ITALY:SIZING AND TREATMENTS IN A SAMPLE

    OF ITALIAN HEPATOLOGY CENTERSAuthors: Lanati EP1, Lidonnici D1, Gasbarrini A2, Ruggeri M3, Sacchini D3, Caporaso N4, Fagiuoli S5

    1MA Provider, Milano, Italy, 2Policlinico Gemelli, Rome, Italy, 3Universit Cattolica del Sacro Cuore, Rome, Italy,4Universita di Napoli Federico II, Napoli, Italy, 5Papa Giovanni XXIII Hospital, Bergamo, Italy

    PGI47

    1). EpaC (http://www.epac.it/notizie/default.asp?id=890&id_n=11526)2). AIFA Data

    Table 1. Number of prescribing centers in the main Italian Regions

    via Marradi 3 - 20123 Milan - ITALYtel. +39 02 89096682 | fax +39 02 36631640

    e-mail info@maprovider.com | web www.maprovider.com

    OBjECTIVESThe aim of this study is to give an overview of the treatments available for the patients with Hepatitis C Virus (HCV) through the segmentation of HCV patients in Italy.

    METHODSThe study was carried out in 9 hepatology centers, treating HCV patients in 9 Italian Regions. The structures selected constitute a representative sample of the Italian scenario, being Centers of Excellence in HCV management in northern, southern, and center of Italy (representing about 24% of the 2.0002 patients treated with first generation Triple Therapy in Italy). The centers examined treat about 9.122 patients, 786 of whom transplanted (Table 2). In 2013 they treated about 851 patients, 378 with double therapy and 473 with triple therapy.

    Table 2. HCV Patients Classification

    Not classified

    F3-F4

    Trasplanted

    F2

    F0-F1

    Patients classification

    HCV Patients 2013Puglia

    131

    85

    261

    95

    136

    Bari

    Campania

    4

    5

    14

    2

    -

    Napoli

    Lombardia

    2.400

    1.000

    900

    -

    500

    Milano

    Piemonte

    452

    323

    833

    -

    -

    Torino

    FVG

    12

    34

    38

    -

    -

    Udine

    Sicilia

    46

    67

    99

    27

    4

    Palermo

    Lazio

    25

    32

    11

    -

    -

    Roma

    Liguria

    376

    270

    450

    -

    133

    Genova

    Marche

    405

    314

    378

    33

    13

    Ancona

    3.851

    2.130

    2.984

    157

    786

    Total

    Total patients 572 25 4.300 1.608 84 239 68 1.096 1.130 9.122

    The patients distribution has been investigated in terms of fibrosis stage (F0 to F4), therapy type (Triple, or Double therapy) and treatment status (naive or experienced patients).Some centers, like the one in Napoli and Udine, provided only information about patients treated in 2013 and not about the total number of HCV patients treated in the center.

    RESULTSData (collected from structures and Workshop of Pharmacoeconomics in Hepatology) show that HCV patients are more concentrated in the two fibrosis stage extremes: 43% in F0-F1 Range, 23% in F2, 32% in F3-F4 Range and 2% unclassified (Table 2 - Figure 1). In some Regions there were also patients not classified (e.g. in Puglia there were 95 patients out of 572 not classified).

    Figure 1. Fibrosis Stage Range

    The percentage of patients treated in 2013 is significantly variable among the Regions investigated: it goes from the 3% of the total number of HCV patients in the center in Milan to the 64% of patients treated in the center in Palermo.Data about drug administration (Table3 - Figure 2 a) demonstrate that, at national level, patients are equally distributed between therapy type (56% TT and 44% DT) and treatment status (49% naive and 51% experienced).

    ISPOR 17th Annual European CongressAmsterdam, November 8th | 12th 2014

    On the contrary, at Regional level many differences were found in all of the three parameters examined. In the structure investigated in Campania, for example, 72% of patients receive TT and 76% are experienced, while in Lazio 72% of patients receive DT and 72% are naive. Furthermore, considering the fibrosis stage, the 46% of patients treated in a center operating in Bari is in the range F3-F4, whilst in the center in Milan the 56% of the HCV patients treated is in range F0-F1 (Table 3 - Figure 2 b).

    Table 3. Drug administration and patients status

    With TT

    With DT

    Naive patients

    Patients treated 2013

    Total Patients

    Bari

    708

    47

    27

    20

    20

    Napoli

    25

    25

    7

    18

    6

    Milano

    4.300

    145

    58

    87

    85

    Torino

    1.608

    140

    50

    90

    60

    Udine

    84

    84

    24

    60

    25

    Palermo

    243

    154

    70

    84

    91

    Roma

    68

    36

    26

    10

    26

    Genova

    36

    81

    25

    56

    36

    Ancona

    1.143

    139

    91

    48

    72

    8.215

    851

    378

    473

    421

    Total

    Experienced patients 27 19 60 80 59 63 10 45 67 430

    % Experienced patients

    % Naive patients

    % TT

    % DT 57%

    43%

    43%

    57%

    28%

    72%

    24%

    76%

    40%

    60%

    59%

    41%

    36%

    64%

    43%

    57%

    29%

    71%

    30%

    70%

    45%

    55%

    59%

    41%

    72%

    28%

    72%

    28%

    31%

    69%

    44%

    56%

    65%

    35%

    52%

    48%

    44%

    56%

    49%

    51%

    Figure 2 a. Drug administration

    Figure 2 b. Patients status

    CONCLUSIONSThe study demonstrates that, concerning the treatment of HCV, there are significant differences among the hepatology centers, both in terms of patients health status and therapy pathways. Common guideline, at national level, about the therapies and patients management could help the Regions and the prescribing centers in dealing with this pathology and its problems.

    The quality management system operated by MA Provider S.r.l is in compliance withthe standard UNI EN ISO 9001: 2008 for planning and execution of consultancy

    services for the health care sector.

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