How are Budget Impact Considerations Captured within Economic Evaluations? A Systematic Review of the Literature Focused on Rotavirus Vaccine

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leak testing, 42% patients’ anastomoses were over sewn, and over 2% were reinforced with a sealant. Following a positive test, about 90% of patients underwent over sewing of the staple line (median 4 suture strands used), sealant was applied in about 12% patients (median 2 sealant tubes used), a new anastomosis was created in about 6% patients (all with circular stapler), and about 7% had a colostomy. The average time required for these interventions was 19.4 ± 13.6 minutes. Despite addressing the intra-operative leak, a post-operative leak occurred in about 15% of patients.  Conclusions: Intraoperative anastomotic leaks are mostly managed by over sewing the staple line or by applying a surgical sealant, which can be time-, labor- and cost-intensive. Significant rates of post-operative leaks were observed despite addressing intra-operative leaks. Approaches towards standardizing anastomosis creation may help reduce the incidence of intraoperative leaks, the variability in management strategies, and the subsequent outcomes. PRM8 Empirical Calibration of Hepatitis C Virus (HCV) Natural History Model to the Chinese HCV-Infected Population

subtracted from the person’s follow-up time in the calculation of malaria disease incidence and the effectiveness of the interventions in terms of incidence rate ratio. We aimed to examine the implications of this common practice.  Methods: We examined the concepts of disease incidence and protective effect under different research purposes. We mathematically assess the relationship of the estimates of incidence rate and incidence rate ratio between assessments with and without the subtraction. We used published studies to illustrate.  Results: Conceptually, evaluation of disease prevention without the subtraction is analogous to intention-to-treat analysis in clinical trials, whereas the common practice of subtracting is analogous to per-protocol analysis. From a real world research point of view, the common practice leads to over-estimation of disease burden and intervention effectiveness. It does not indicate what will happen in real world when a preventive intervention is implemented. Case studies demonstrate that the over-estimation can be practically significant.  Conclusions: To subtract or not subtract a post-disease duration from follow-up time answer different practical questions, which need be clearly formulated. From a health policy and planning perspective, it is likely more appropriate not to subtract.

Lee K Goldhaber-Fiebert J,Stanford University, Stanford, CA, USA

Objectives: Hepatitis C Virus (HCV) infection represents a major public health challenge for China. About 10 million people in China are chronically HCV infected, accounting for 7% of the global burden. The current standard of HCV care in China relies on older, less-effective, interferon-based treatment regimens. There is, however, increasing demand for newer, highly effective but substantially more expensive treatments that include directly acting antivirals (DAAs). Model-based assessments of the comparative effectiveness and cost-effectiveness of alternative treatment strategies in China require representation of HCV’s natural history that faithfully reflects the epidemiology of HCV in China.  Methods: We construct a computerbased microsimulation model of the natural history of HCV infection to support future evaluations of alternative treatment strategies in China. The model includes risks of HCV infection, fibrosis progression, and transition to advanced liver disease states including decompensated cirrhosis and liver cancer. The model tracks whether each individual’s chronic HCV infection is currently detected or undetected, allowing for increased rates of detection through intervention. We reflect Chinese HCV epidemiology by calibrating our stratified infection and progression rates to multiple epidemiological targets that we identified through systematic review of China-specific studies.  Results: Empirical calibration identified model parameter values that are most consistent with observed data on HCV in China. The model output successfully produced fibrosis stage distribution close to the Chinese target data (f0-f4: 11,37,33,14,5%). We found that monthly risks of fibrosis progression among low risk groups were estimated close to the mean of prior distribution (0.01 and 0.008, respectively), whereas calibrated model had higher mortalities of advanced liver diseases than prior estimates.  Conclusions: We constructed and calibrated HCV natural history model that reflects the key features of HCV epidemiology in China. The model can be used to project the health and cost impact of future preventative and treatment intervention for HCV infection among the Chinese population. PRM9 Can Pharmaceutical Care Intervention Improve Lipid Profile in Type 2 Diabetes Patients; A Prospective Intervention Study in a Tertiary Hospital in Nigeria Ogbonna BO UNIVERSITY OF BENIN, BENIN CITY, EDO STATE, Nigeria

Objectives: Diabetes is the leading cause of emergency room visit and nontraumatic limb amputation globally, and many non-randomized studies indicated that pharmaceutical care (PC) is helpful at improving its management. This study analyzed the impact of pharmaceutical care on the lipid profiles of ambulatory type 2 diabetes patients to generate data and document information for effective management of the disease state.  Methods: The study was a single blinded randomized controlled prospective pre and post- test intervention study. The study at the medical outpatient unit lasted for 12 months; determine the effectiveness and net benefit of PC on lipid profile. The 124 eligible patients who gave their informed consent were randomly assigned into the intervention and control group. Patients in the intervention group received PC, which included point of care testing, medication reconciliation, drug therapy management, patient counseling on adherence and lifestyle modifications, and follow up, while those in the control group received the usual care. Data was analyzed for inferential statistics using students t-test at p< 0.05.  Results: the high-density lipoprotein (HDL) value dropped from a baseline of 0.6±0.79 mmol/l to 0.95±0.45 mmol/l (p= 0.0019). Very low-density lipoprotein (VLDL) dropped from 0.96±0.36 mmol/l to 0.60±0.35 mmol/l (p= 0.0053). The value of triglycerides (TG) changed 1.88±0.93 to 1.50±1.05 (p=  0.470) while that of total cholesterol (TC) dropped from 4.57±1.35 to 0.60± 2.23± 0.83 (p= 1.780) and low-density lipoproteins (LDL) from 1.88± 0.93 to 1.50± 57 (p= 5.760).  Conclusions: the study demonstrated that that PC intervention produced improvement on the lipid profile of type 2 diabetes patients. Study suggests that 12 months intervention can improve patients’ clinical outcome. The study implied that PC can lead to improved quality of life and reduction in emergency room visit since increase in HDL and reduction in VLDL, TG, TC, and LDL are positive indicators in diabetes management. PRM10 A Methodological Issue in Effectiveness Studies of Malaria Vaccines and Chemoprevention Cheung YB1, Xu Y1, Cairns M2, Milligan P2 1Duke-NUS Medical School, Singapore, Singapore, 2London School of Hygiene & Tropical Medicine, London, United Kingdom of Great Britain and Northern Ireland

Objectives: Studies of malaria vaccines and chemoprevention often classify a person who has suffered a malaria disease episode and received curative drug treatment as non-susceptible to new malaria infection for two to four weeks, depending on the pharmacokinetics of the curative drugs used. This duration is usually

RESEARCH ON METHODS – Cost Methods PRM11 A Systematic Review on Methodological Heterogeneity in Estimating Productivity Loss Associated with Colorectal Cancer Harsono K1, Soon S1, Chia JW2, Tan WS3, Chew MH3, Wee HL1 1National University of Singapore, Singapore, Singapore, 2National Cancer Centre Singapore, Singapore, Singapore, 3Singapore General Hospital, Singapore, Singapore

Objectives: Studies measuring productivity loss are inherently heterogeneous in their study designs and derivation methods. This systematic review aims to establish the extent of productivity loss in paid work associated with colorectal cancer (CRC) and examine the different measures of productivity loss by identifying sources of variation and drivers.  Methods: We searched PubMed and Web of Science for relevant studies published from January 2005 to August 2015 in the English language. Studies were included if they were (a) on economically-productive CRC patients and/ or caregivers, (b) reporting productivity loss of paid work associated with CRC, and (c) randomised controlled trials (RCTs), non-RCTs, cohort studies, case-control studies or cross-sectional studies. Information was abstracted by study design characteristics, patient/caregiver demographics, data sources, productivity loss components, calculation methods, and units of expression (in 2014 International dollars).  Results: 11 studies were included in this review (Europe (n= 5), the Americas (n= 3), Asia (n= 3)). All studies employed the human capital approach. At the national level (n= 2), productivity loss due to premature mortality ranged from $9.1mn–$1.27bn. Huge variations were found in estimates at the individual level (n= 9) depending on whether they were attributable to CRC, specific to defined interventions, or organised by phases of care or cancer spread. We identified five categories of sources of variation: study design, socio-demographics, clinical characteristics, care characteristics, and computation of productivity loss. Premature mortality or retirement was a key driver (43.6–66.5% of total productivity loss), with males affected more than females. Productivity loss was highest in the first year post-diagnosis for patients, and in the continuing phase for caregivers.  Conclusions: Clearly presenting information on clinico- and sociodemographics of study population, separate reporting of duration and derived productivity loss, units of expression, inclusion or exclusion of compensatory benefits, and applicable year and currency can facilitate appropriate use of productivity loss estimates. PRM12 How are Budget Impact Considerations Captured within Economic Evaluations? A Systematic Review of the Literature Focused on Rotavirus Vaccine Carvalho N University of Melbourne, Carlton, Australia

Background: In many low- and middle-income countries (LMICs), affordability is more important than cost-effectiveness as a gateway criterion for funding a new technology. Hence Budget Impact Analysis (BIA), in addition to cost-effectiveness analysis (CEA), is an essential decision-making component for policy-makers in the presence of limited resources. Despite this, BIAs remain less frequently conducted and less well researched than CEAs.  Objectives: To fill this gap by describing how budget impact considerations are captured within economic evaluations.  Methods: We develop and apply a quality assessment checklist based on the most recent recommendations from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Task Force to examine the extent to which existing economic evaluations provide sufficient evidence about budget impact to enable decision-making. We use rotavirus vaccination as a case study because it represents a major investment that has been recommended by the World Health Organization and there exist many economic studies of it, yet it has seen only partial uptake in LMICs. A systematic review of the literature was conducted to identify economic evaluations of rotavirus vaccine conducted in LMICs. We critically appraised the quality of BIAs and assessed the extension of CEAs to provide useful budget impact information.  Results: Six BIAs and 56 CEAs were identified. All BIAs adhered to the majority of ISPOR recommendations. A small number of recommendations were not adhered to by most articles, including model validation, justification of program time horizon, and providing undiscounted financial streams. Most CEAs could not be extended to provide useful budget impact information. CEAs rarely presented annual costs undiscounted, or estimated financial streams of costs during the first few years of program scale-up.  Conclusions: By highlighting current gaps in standard practices, we propose a comprehensive vaccine-specific strategy for conducting transparent and valuable BIAs alone or alongside CEAs.



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PRM13 Cost Assessment for Healthy Diet in the State of Penang, Malaysia Saleem F, Hassali MA Universiti Sains Malaysia, Penang, Malaysia

Objectives: Despite the critical peril of deteriorating wellbeing of the Malaysian population, there remains lack of information related to the cost assessment of eating a healthy diet. Within this context, the current study addresses the issue of affordability of healthy eating in Malaysia by calculating the direct cost of healthy eating options provided by the Malaysian Dietary Guidelines. Methods: The study was designed as a once-only, time-based walk-in survey. Three hypermarkets located in the centre of the Penang city were targeted for data collection. The examples provided by the Malaysian Dietary Guidelines for one-day menu for 1500, 2000 and 2500 kcal were used for cost calculation. Worksheets were used for data collection and the data was later transferred to SPSS v 18 for analysis. Based on the objectives of the study, the data was described descriptively and average spending for a month was calculated.  Results: Based on our study results, healthy eating was reported ‘unaffordable’ as on average, an individual following a 1500 kcal menu needed RM 845.50 (US $191.50) each month in order to stay healthy. Furthermore, those following 2000 and 2500 kcal menu plan had to spend RM 1062.30 (US $240.75) and RM 1437.60 (US $325.80) to consume healthy diet respectively.  Conclusions: Affordability shaped as a major barrier towards healthy eating in the state of Penang, Malaysia especially for households having low and middle income. The findings are of particular importance because the immediate and long-term consequences of unhealthy diet are comprehensive and can influence lifelong practices.

PRM14 A Review of Assessments of The Quality of Pharmacoeconomic Evaluations in China Zhou J1, Millier A2, Cheng X3, Aballea S2, Toumi M4 1Creativ-Ceutical, Beijing, China, 2Creativ-Ceutical, Paris, France, 3Creativ-Ceutical, Hong Kong, Hong Kong, 4Aix-Marseille University, Marseille, France

Objectives: Our objective was to explore potential challenges in conducting pharmacoeconomic evaluation (PE) analyses in China through a literature review on quality assessment of Chinese PE studies.  Methods: Literature reviews including a quality assessment of PE studies conducted in China were identified through PubMed, China National Knowledge Infrastructure (CNKI) databases and grey literature. Results of quality assessment and reported limitations of PE studies were collected and summarized.  Results: Fourteen reviews assessing the quality of PE studies were identified. Different quality assessment tools were used, with the Quality of Health Economic Studies (QHES) scale being the most common (n= 7). Other tools used included: CHEC-list, China PE guidelines, BMJ economic submission guidelines and ISPOR’s CHEERS checklist. References using QHES showed PE studies scored 64.5/100 on average (range 59-80/100). Twelve references considered only PEs reported in Chinese, one reference considered only studies in English and one considered both languages. When considering QHES, the quality of PE published in English was better than those published in Chinese (80/100 vs. 62/100). The main reported limitations of PE studies were: authors seldom stating perspective and funding source, inappropriate choices for comparators or analysis methods, seldom consideration of long-term effects, indirect costs, discounting and subgroup analyses, and lack of discussion about generalizability and extrapolation of results. Suggested reasons for low quality were: absence of Chinese guidelines until 2011, researchers’ lack of knowledge and experience in PE, unavailability of key data, guidelines hard to follow and lacking recognition, journals not requiring reporting standards for PE publication, and lack of attention to PE in China.  Conclusions: This synthesis of assessments of the quality of Chinese PEs performed in published literature reviews suggests that improvements are possible. Collaborative initiatives among researchers, guidelines developers, journals and policy makers may help raising the quality standards of future economic studies. PRM15 Systematic Literature Review and Assessment of the Reporting Quality of Economic Evaluation Studies in Non-Small Cell Lung Cancer in China Zhou J1, Ma F1, Cheng X2, Millier A3, Aballea S3, Toumi M4 1Creativ-Ceutical, Beijing, China, 2Creativ-Ceutical, Hong Kong, Hong Kong, 3Creativ-Ceutical, Paris, France, 4Aix-Marseille University, Marseille, France

Objectives: Recently, a number of pharmacoeconomic evaluations (PE) of nonsmall cell lung cancer (NSCLC) treatments were published in China. Our objective was to examine the compliance of these PE studies with the ISPOR’s Consolidated Health Economic Evaluation Reporting Standards (CHEERS).  Methods: The literature search was conducted using three Chinese databases (CNKI, Wanfang and CQvip). PE studies assessing treatments for NSCLC in China were included. The CHEERS checklist (24 items) was used to assess the reporting quality of those studies. Two reviewers performed the evaluation independently, with disagreement solved by discussion or by a third reviewer.  Results: There were 57 studies included between 2003 and 2015, of which, 33 were published in the Chinese core journals of science and technology. Further, 52 of the 57 cost-effectiveness/cost-minimisation analyses were either trial-based or observational study-based, while the remaining 5 were model-based analyses. On average, PE studies met 32% of CHEERS items, ranging from 17% to 79%. Almost 20% of CHEERS items were not applicable to the PE studies (4%-21%). When considering applicable items only, the PE studies met 40% of items (18% to 83%). Items related to “measurement of effectiveness”, “characterising uncertainty” and “conflict of interest” were not met by any PE study, whereas the item “choice of health outcomes” was met by almost all PE studies (95%). Items related to “characterising heterogeneity”, “measurement and valuation of preference based outcomes” and 5 items related to “analytical models” could not be applied by almost all PE studies (> 90%). When considering applicable items only,

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each item was met by 22% PE studies on average (0 to 100%).  Conclusions: The reporting quality of the Chinese-language PE publications in NSCLC was found to be low, which appears to reflect on the quality of analyses. This limits their usefulness for decision-making.

RESEARCH ON METHODS – Databases & Management Methods PRM16 Mapping of Existing Data Sources for the Conduct of Real-World Studies on Lung Cancer in China Yuen CY1, Bergamasco A2, Moride Y1 of Pharmacy, Université de Montréal, Montreal, QC, Canada, 2YolaRx Consultants, Paris, France

1Faculty

Objectives: Lung cancer represents a major burden worldwide and particularly in China. Real-world data (RWD) have become the cornerstone of evidence generation on the safety, effectiveness, and value of treatments in a clinical practice setting. Although several clinical databases are in existence in China, there is currently no repository of disease-specific databases for the conduct of RW studies in this country. This study aimed at identifying, characterizing, and assessing the usefulness of existing data sources on lung cancer patients in China.  Methods: A literature review was conducted using Medline and Embase (1 Jan. 2010-26 Jan. 2016). Clinical trials, case reports/series, literature reviews or opinions were excluded. Identified abstracts were screened for relevance. In addition, pragmatic web searches were conducted in English as well as simplified and traditional Chinese. For each retained data source, the following characteristics were extracted: type, setting, availability of patient- and disease-specific variables (e.g., clinical data, biomarkers, laboratory values, patient reported outcomes), linkage capabilities, and access policy.  Results: Literature search yielded 1,311 publications, of which 203 abstracts (15.5%) corresponding to 114 potential databases met the inclusion criteria. Pragmatic searches yielded 27 additional data sources. Following in-depth review of full-text articles, a total of 69 data sources were retained. In order of importance, these consisted of medical records (paper and electronic) (n= 35, 50.7%), cohorts with ad hoc data collection (n= 10, 14.5%), registries (n= 8, 11.6%), administrative claims (n= 6, 8.7%), mixed data sources (n= 5, 7.2%) and surveys (n= 3, 4.3%). Synthesis of the availability of lung-specific data elements and usefulness for real-world studies will be presented.  Conclusions: Several sources of RWD on lung cancer patients have been identified in China. Although most of them lack disease-specific data elements, electronic medical records and administrative claims databases contain valuable information and can potentially allow the conduct of real-world studies on lung cancer.

PRM17 Establishing an International Reference Pricing Database: an Innovative Tool to Support Drug Pricing Reform in China Zhou Y1, Gao Y1, Zhang L1, Xuan D2, Zhu S1, Yang F1, Xuan J3 Centennial Scientific Ltd, Shanghai, China, 2Vanderbilt University, Nashville, TN, USA, 3Sun Yat-Sen University, Guangzhou, China

1Shanghai

Objectives: International reference pricing (IRP) has increasingly been adapted by multiple countries over the past decades in Europe such as UK, France, Germany, and in Asia such as Taiwan, Korea, Japan, and Singapore. As China’s healthcare reform deepens, the China National Development and Reform Commission has eliminated the traditional cost-based pricing methodology and proposed new pricing strategies be based on market conditions, negotiations, and ability to pay. IRP has become an important component of the considerations. In response, we created an IRP database to facilitate the access of international pricing information.  Methods: A survey was conducted nationwide to determine referencing countries. A total of ten countries/regions including China, U.S., UK, Germany, France, Canada, Sweden, Japan, South Korean and Taiwan, were identified and included in the database. Based on Chinese commercial databases, top 200 drugs, in terms of selling volume, were identified to be covered. Pricing data for each country were sourced from the official websites released by local authorities. This database is expected to be updated every six months.  Results: An Excel-based database with userfriendly interface was constructed to allow users to accomplish price comparison among different countries/regions right on their desktop. Additionally, conversions between ex-factory price and public price were performed according to local currency and tax rate. Also, multiple search methodologies were instituted to allow users search via branded names, generic names, and ATC codes. Furthermore, a variety of brand names with the identical generic ingredients were identified in different countries/regions. The database also included drug formulation, strength, and pack size in each corresponding country/region. Finally, historical pricing data can be tracked in each country/region for reference and analysis since the launch of database.  Conclusions: The database is the very first database available in China that provides well-organized international pricing reference information based on Chinese market conditions. PRM18 Mapping of Existing Data Sources for the Conduct of Real-World Studies in Progressive Supranulcear Palsy (PSP) in North America, Europe and Japan Bergamasco A1, Yuen CY2, Kou T3, Moride Y2 Consultants, Paris, France, 2Faculty of Pharmacy, Université de Montréal, Montreal, QC, Canada, 3Bristol-Myers and Squibb, Hopewell, NJ, USA

1YolaRx

Objectives: Progressive supranuclear palsy (PSP) is an uncommon brain disorder affecting about 6/100,000 people worldwide. Currently, there is no effective treatment for this condition. Real-world data (RWD) are key to support future clinical