BACKGROUNDThe availability of new drugs for the treatment of Hepatitis C increased the complexity of HCV patient management. In Italy the introduction of the innovative drugs, in combination with interferon and ribavirin (triple therapy), occurred one year after the Ema approval. Despite the lack at national level of a uniform definition of criteria for access to treatment and disease management organization, different regional patterns of organization of care exist.

OBjeCtivesThe aim of this study is to describe the differences in Patients Diagnostic Therapeutic Pathways (PDTA) among Italian Regions, as the Italian scenario shows substantial differences in terms of Regional guidelines, organization and allocated budget.

MethODsThe Regional policies were examined analyzing the PDTAs of the most representative Regions that published and made available information about PDTAs and Guidelines. The analysis investigates the following Regional characteristics: establishment of a working group to define the PDTA, the gap of criteria for prescribing centers with the AISF guidelines, indication of therapeutic scheme for the different kind of patients, budget allocation, characteristics of the management model and existence of a follow up system.

ResUltsOnly 9 Regions published and made available the PDTA and guidelines (Table 1). The number of HCV patients was available only for some Regions, whilst only in two Regions has been possible to know the number of HCV patients Gen 1 (39.750 in Veneto and about 75.000 in Sicily) (Table 2).

PAtieNts DiAGNOstiC theRAPeUtiCPAthWAYs FOR hCv PAtieNts iN itAlY:

iMPACt OF ReGiONAliZAtiON iNtReAtMeNts AND GUiDeliNes

Authors: Lanati EP1, lidonnici D1, Gasbarrini A2, Ruggeri M3, sacchini D3, Caporaso N4, Fagiuoli s5

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

PGI55

1). Regional law and guidelines

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isPOR 17th Annual european CongressAmsterdam, November 8th | 12th 2014

Table 3. Criteria to define prescription centers

Liguria

Veneto

Emilia Romagna

Basilicata

Lombardia

SpecializedDepartment

N/A

P

P

Umbria

Marche

Lazio

P

Sicilia

Table 1.Regional Law

Liguria

Veneto

Emilia Romagna

Basilicata

Lombardia

REGION LAW

D. Reg. Lombardia del 18/01/2013

Delibera n.399 del 10/04/2013

Decreto n.261 del 27/12/2012

Delibera n. 46 del 25/01/2013

Linee Guida del 06/05/2013

HCV Patients

N/A

74.000

69.500

N/A

130.000

Gen 1 Patients

N/A

N/A

39.750

N/A

N/A

Umbria Delibera n.97 del 11/02/2013 N/A N/A

Marche

Lazio

Del. Reg. n.550 del 17/04/2013

Decreto n.U0038 del 07/08/2013

13.000

160.000

N/A

N/A

Sicilia D.A. Regione Sicilia n.0713/13 100.000 75.000

Table 2.Number of HCV Patients

The comparison of this data shows some common characteristics observed in all Regions: the presence of working group and criteria for the eligibility of patients and identification of prescribing centers. Since 2013 all Regions have identified a working group (except Liguria) and detailed the patient profile to prioritization (except Liguria and Sicily). Regarding identification of prescription center, as showed in Figure 1 and Table 3, the majority of Regions adapted the criteria based on the presence of specialized diagnostic labs and multidisciplinary team.

Figure 1. Criteria to define prescription centers

# HCV clinical records

N/A

P

P

P

P

P

At least 25patients in the

last 3 years

HCV RNAassay

N/A

within 3 days

less then1 week

P

within 3 days

within 72h

within 3 days

in 4-6 days

P

IL28Bgenotyping test

N/A

P

P

P

P

Liverbiopsy

N/A

P

P

P

P

P

P

Multidisciplinary team

N/A

P

P

P

P

P

P

P

Besides these characteristics, there is a substantial heterogeneity in Regional guidelines, especially regarding budget allocation, management model and follow up system. Indeed, if in some Regions like Basilicata and Veneto there is a specific budget allocation (respectively €1,2 ml and €12 ml in 2014), the management model is based on Hub and Spoke system and the follow up mechanism is clearly set up, in other Regions like Lombardy and Liguria the guidelines are more vague, detailing only few criteria. The budget allocated, where available, is showed in table 4, while the managing model for each Region investigated is illustrated in table 5.

Table 4. Regional Budget

Liguria

Veneto

Emilia Romagna

Basilicata

Lombardia

REGION PatientstreatedwithTT/Year(esteem)

N/A

60

500-700

500 (18/24m)

N/A

Umbria N/A

Marche

Lazio

N/A

1.232 (2013) and 1244 (2014)

Sicilia

Budget allocated

bottom-up

1,2 mln

12 mln

N/A

N/A

N/A

N/A

17,9 mln (2013) e 18,2 mln (2014)

Biannual report HUB

Table 5. Regional managing models

Liguria

Veneto

EmiliaRomagna

Basilicata

Lombardia

Working group

# expert

P

P

P

8

Umbria P

Marche

Lazio

14

P

Sicilia 12

PDTA

P

Background Analysis

P

P

P

P

P

P

P

Access pathways

P

P

CentersRequire-ments

P

P

P

P

P

P

P

Patients priority

P

P

P

P

P

P

Drugsdistribution

File F

Directdistribution

Directdistribution

Directdistribution

Directdistribution

Directdistribution

Directdistribution

Directdistribution

Directdistribution

HUB&Spoke

P (net)

P

P (net)

P

P

Follow up

P

P

P

Workinggroup

(HUB)

Workinggroup

HUB

These Regional differences are confirmed by other two data: the timespan between the market authorization (AIC) of the Triple Therapy (TT) for HCV patients and the integration in Regional guidelines (GL) and the number of prescribing centers per million inhabitants. The wide variety of results is presented in table 6 and table 7, with a range between 17 and 147 days (respectively in Veneto and in Emilia Romagna) for time to TT inclusion in Guidelines and with a range between 1,85 and 6,92 of prescribing centers per million inhabitants (respectively in Veneto and in Basilicata).

CONClUsiONsThe study demonstrate that, with a view to the future novel drugs, a common disease management model, including common guidelines and organizational model, is essential to avoid regional disparities in HCV therapies access.

LiguriaVeneto

Emilia Romagna

BasilicataLombardia

REGION #PrescriptionCenters

34499

13Umbria 5MarcheLazio

614

Sicilia 11TOTALE 105

# Centers per 1000 Km2

1,420,400,491,660,580,590,620,810,43

Media=0,78

# Centers per mlninhabitants

3,506,921,855,732,995,653,892,542,20

Media=3,92

Table 7. Number of prescribing centers per million inhabitants

AbruzzoLG Date

11/01/2013BasilicataCalabriaCampaniaEmilia RomagnaLazioLiguriaLombardiaMarchePugliaSardegnaSiciliaToscanaTrentino-Alto AdigeUmbriaValle d’AostaVenetoMEDIA

REGION

18/03/2013

06/05/2013

25/01/201318/01/201317/04/201301/02/201321/03/201311/04/201321/01/2013

11/02/2013

27/12/2012

Delta days from TT AICto LG inclusion

32

98

147

4639

12853

10112242

63

1774

Delta days from TT AIC toformulary inclusion

170

210213284

219

278219145194190

212,2

Table 6. Time to Triple Therapy AIC and Guideline inclusion

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