Biologics use in Crohn’s Disease in France

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vider in the past 6 months, respectively. Multivariable generalised linear models assessed HRQoL, activity impairment and HCRU by IBS-D severity, controlling for demographic and health characteristics.  Results: 1229 patients with IBS-D were included: mild (620; 50.4%), moderate (499; 40.6%) and severe (110; 9.0%). Patients with moderate IBS-D had worse HRQoL compared with those with mild IBS-D: MCS 40.32 vs. 43.15 (p< 0.001); PCS 47.97 vs. 49.53 (p= 0.003). Patients with severe IBS-D had worse HRQoL than patients with mild or moderate disease (MCS: 35.99; PCS: 44.16 [both p< 0.001]). Patients with moderate (36.0%; p< 0.001) or severe (47.4%; p< 0.001) IBS-D had significantly greater activity impairment, compared with patients with mild disease (29.3%), as well as more physician visits (moderate: 7.9 [p< 0.001] and severe: 9.2 [p= 0.001] vs. mild: 6.2) and gastroenterologist visits (moderate: 0.19 [p< 0.001] and severe: 0.29 [p< 0.001] vs. mild: 0.07). Similar results were observed for emergency room and hospital visits.  Conclusions: Patients with more severe IBS-D experience greater impairments in HRQoL and daily activities, and higher HCRU, representing a substantial burden of illness and highlighting the need for effective treatments to manage IBS-D symptoms.

GASTROINTESTINAL DISORDERS – Health Care Use & Policy Studies PGI32 Biologics use in Crohn’s Disease in France Gaudry J1, Morand F2, Willemin L3, Lee XY4, Lelli F5 1IMS Health, Boulogne-Billancourt, France, 2IMS Health, Paris La Défense, France, 3Janssen-Cilag, Issy-les-Moulineaux, France, 4Janssen-Cilag A/S, Birkerød, Denmark, 5Janssen-Cilag SpA, Cologno Monzese (MI), Italy

Objectives: Limited French real world data on Crohn’s disease (CD) patients treated with biologics is available. This study aims to describe the profile of French adult CD patients treated with biologics, treatment patterns, disease management, and biologic dosing patterns.  Methods: Two different sources of data reflecting clinical practice were used: a cross-sectional survey (Patient Database Survey-PDS) of 130 hospital-based hepato-gastroenterologists with data collected for CD patients treated by biologics between December 2015 and January 2016; an Electronic Medical Record(EMR) database with 100 office-based gastroenterologists and data collected over 12 months up to January 2016 for CD patients treated with adalimumab.  Results: 223 patients were identified in the EMR database: 45.3% were men, with a mean age of 40.1 years. 1,043 patients were identified through the PDS survey: 51.2% were men, with a mean age of 37.3 years, 20.2% were unemployed. 77.7% of PDS patients were on their first biologic (15.3% starting on biologic therapy), 22.3% in biologics failure (2nd line and above). 51.2% of patients suffered from severe CD before starting biologic therapy. 32.0% of PDS patients were severely impacted by CD in terms of quality of life(QoL), more so for biologic failure patients. Infliximab was the most commonly used biologic across treatment lines, followed by adalimumab and vedolizumab. Utilization rates of the higher recommended maintenance dose in PDS patients were 26.0% with infliximab, 21.6% with adalimumab, 41.5% with vedolizumab, and 15.7% with adalimumab for EMR patients. Average time to switching between different biologics is 50.0 months between 1st and 2nd biologic, 94.8 months between 1st and 3rd biologic.  Conclusions: CD is a burdensome disease for the patient, with a high percentage of patients having severely impaired QoL; utilization of the higher recommended maintenance dose indicates that currently available biologics may be insufficient for long term control of the disease. PGI33 HCV: Treat Ratio and Governance Footprints. Analysis of Regional Differences in Italy Lanati EP, Pizzi A, Marcelli A MA Provider Srl, Milano, Italy

Objectives: This analysis aimed to compare the regional healthcare governance systems in Italy with regard to Hepatitis C Virus (HCV) in order to assess regional differences in access pathways to treatment. Specifically, the main goal of the study was to quantitatively evaluate the ability of a Region to give access to treatment to HCV diagnosed patients.  Methods: The analysis introduces a “treat ratio” (TR) to compare the ratio between patients who received HCV treatment and total number of diagnosed patients across all Regions. The regional prevalence of diagnosed patients was derived from a research by the patients association EpaC. The regional prevalence of patients receiving HCV treatment was estimated by distributing the overall number of treatments administered in Italy (derived from AIFA registries) proportionally to the regional prevalence of Sovaldi payback, assumed as proxy for the overall distribution of HCV treatments. TR allows to compare the regional governance footprints in light of multiple governmental aspects, such as clinical pathways, local regulatory bodies, buying centralization, prescription monitoring, prescribing centres coordination.  Results: Sicily is the region with the highest TR (73%), as a result of wide treatment access combined with limited diagnosed prevalence. Conversely, Campania presents a more selective access system, where despite one of the highest diagnosis prevalence in Italy only one diagnosed patient out of four receives treatment (TR =  25%). Other big-spending regions such as Lombardy and Lazio are tied at a TR of ~15%, while Veneto is among the most restrictive regions for HCV treatment access (TR =  12%).  Conclusions: This quantitative-based/ qualitative-adjusted approach allows to understand how each regional regulatory context impacts access to treatment for HCV diagnosed patients, providing an objective assessment of a Region’s capacity to treat patients. As a general evidence, Regions where HCV clinical pathways have been implemented by local regulatory bodies result in a higher TR.

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PGI34 Market Access Challenges of Drugs for Chronic Hepatitis C: A Thematic Analysis of Health Technology Assessments Akesson C, Quinn C PRMA Consulting, Fleet, UK

Objectives: To capture emerging, recurring, and evolving factors in HTA of new direct-acting antivirals in chronic hepatitis C.  Methods: We reviewed and undertook a thematic analysis of HTAs of daclatasvir, sofosbuvir, ledipasvir/sofosbuvir, and simeprevir from seven HTA agencies in five countries, published between May 2014 and January 2016. These agencies represented three payer archetypes: cost-effectiveness (NICE, SMC [UK]; CADTH [Canada]); comparative clinical effectiveness (TC [France], G-BA [Germany]); and budget impact (CAMHDA, GENESISSEFH [Spain]). A coding framework for payer concerns was based on a network of themes: burden of disease and unmet need, comparators, clinical trial quality, clinical benefit, safety, subgroups, indirect treatment comparisons, PROs, utilities, cost-effectiveness, budget impact and access schemes.  Results: Fifteen HTAs were identified: NICE (4), SMC (2), TC (1), G-BA (2), CADTH (2), CAMHDA (3), GENESIS-SEFH (1). A number of themes were identified: 4 global themes (product and disease context, clinical benefit, cost-effectiveness, budget impact), 11 organising themes (description of disease, product characteristics, SOC and comparator, eligible patient population, trial design, clinical benefit, resource use, costs, costeffectiveness, budget impact, equity considerations), and 23 basic themes (unmet need, administration, innovation, mechanism of action, target patient population, place in treatment pathway, SOC and appropriate comparator, trial design, trial comparator, efficacy, safety, generalizability of clinical benefit, indirect treatment comparison, organizational impact, resource use, costs, cost-effectiveness model clinical inputs, cost-effectiveness analysis, model evaluation, utilities, uptake, budget impact, equity considerations). Basic themes in particular varied across payer archetypes, and over time.  Conclusions: Thematic analysis is a strong method for understanding payer concerns and areas of focus – for a specific indication, over time, and over jurisdictions. The observed themes are based on a review of HCV medications therefore not all will be generalizable to other diseases. Themes around trial endpoints and survival analysis did not arise, but may with other indications (e.g., oncology). PGI35 Assessment of Proton Pump Inhibitors Consumption in Ukraine in Comparison with other Countries of The World Iakovlieva L, Gerasymova O, Mishchenko O, Bezditko N, Tkachova O, Kyrychenko O, Matyashova N National University of Pharmacy, Kharkiv, Ukraine

Objectives: Proton pump inhibitors (PPIs) are the most effective antisecretory drugs in the treatment of acid-related diseases of digestive organs.  Methods: Assessment of PPI consumption was carried out by ATC/DDD-methodology. International Number of PPIs packaging, which were sold for a year in Ukraine, was taken from the information system “Drugs” of Company “Morion” (August, 2011-2015.). PPIs DDD are taken from the WHO website (http://www.whocc.no/ atc_ddd_index/). The data «Baltic Statistics on Medicines 2010-2012» was used to assess PPIs consumption in the Baltic countries (Lithuania, Latvia, Estonia), the data «Drug Consumption in Norway 2009-2013» - in Norway.  Results: Volumes of PPIs consumption in terms of DDDs/1000 inhabitants/day increased in 1,4 times in Ukraine during 2011-2015: from 5.99 in 2011 to 8.24 in 2015. From 2011 to 2015 in Ukraine the volumes of consumption increased for omeprazole (in 1.4 times), pantoprazole (in 2 times), ezomeprazole (in 5 times), decreased - for rabeprazole (in 3 times) and lansoprazole (in 2 times). According to the volume of PPIs consumption in 2011-2012 countries studied can be positioned the following order: Norway >  Estonia >  Latvia >  Lithuania > Ukraine. In Ukraine, the PPIs were consumed 3 times was less than in the Baltic countries, 6.5 times less - than in Norway. Drugs of omeprazole, pantoprazole, lansoprazole, esomeprazole were presented in Ukraine, in the Baltic countries and Norway, rabeprazole - only in Ukraine and Lithuania. Omeprazole - the leader by consumption volumes among PPIs in Ukraine and the Baltic countries, esomeprazole - in Norway.  Conclusions: Approximately from 0.59 to 0.82 % of the Ukraine population every day took 1 DDD of one of PPIs in 2011-2015. Level of PPIs consumption in terms of DDDs /1000 inhabitants/day in Ukraine was less than the level of PPIs consumption in the Baltic countries and Norway in 2011-2012. PGI36 Real World use of Biologics Therpies for Patients with Ulcerative Colitis in Japan Kuwabara H, Yamabe K Takeda Pharmaceutical Company Ltd., Tokyo, Japan

Objectives: Active ulcerative colitis (UC) causes a significant burden on patients’ quality of life. The recently approved biologics, anti-tumor necrosis factor (TNF) alpha agents, are effective but expensive. The introduction of cost-effectiveness assessments of health technologies is currently being discussed as a process of health care decision- making in Japan. The real world treatment pattern, especially for biologic use in UC, is described below to inform this discussion.  Methods: Data were obtained from a commercial claims database (Japan Medical Data Center, Tokyo, Japan) during the period between January 2005 and August 2015. To include incident cases, inclusion criteria were patients with 1) at least 2 diagnoses of UC (ICD-10 K51 or K593), 2) at least 1 prescription with 5-aminosalicylic acid (5-ASA) and 3) at least 6 months of continuous health plan enrollment before and after the first recorded diagnosis (Index). Additionally, patients having the first recorded prescription of 5-ASA on or within 6 months from the Index were included. Descriptive analyses of the treatment for UC were performed for all patients and patients experiencing the biologic therapies.  Results: A total of 2,391 patients were eligible for