Value Added Medicines: The Need To Establish One Common Terminology For Repurposed Medicines

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in Nov-Dec 2013 using a U.S HCP panel. A geographically diverse sample of HCPs (Primary Care Physicians (PCPs), Pharmacists, Nurse Practitioners (NPs) and Physician Assistants (PAs)) spending > = 50% of time in direct ambulatory patient care (PCP/PA/NP) or working in a retail pharmacy (Pharmacists), with > = 2 yrs of practice experience and seeing/consulting > = 20 pts/wk were recruited. Survey collected beliefs about medication risks, information seeking behavior and communication on medication risk/safety.  Results: Eight hundred HCPs (200 each of PCPs/NPs/PAs/Pharmacists) participated. Approximately two-thirds reported using eHIS for > 50% of their patients in respective clinical practices/pharmacies. HCPs reported following computerized/eHIS capabilities in their settings: record patient history/demographic information (87%), record clinical notes (incl. patient’s medications/allergies) (86%), order medications (82%), view/order lab tests (75%), eHIS ability provide warnings of drug interaction/contraindications (to prescribers) (66%), share patient information electronically with other prescribers/providers (53%), provide patients with clinical summaries for each visit (52%), provide reminders for guideline-based interventions or screening tests (46%), provide patients with alerts if medications they take receives an FDA safety alert or recall (35%), allow patients to access their medical records or information on medications they are taking, incl. risk/safety information (34%), and exchange secure messages with patients (31%). These responses varied by HCP-type. Eighty-two percent of HCPs agreed their eHIS adds value to their practice by reducing medication risks/safety for patients.  Conclusions: eHIS was widely used and was reported to provide value in reducing medication risks/safety. However, eHIS use to provide medication alerts regarding medicine risk/safety or provide patients access to medical records or information on medication risks/safety was reported by only one-third of study participants. PHP135 Collecting Data To Enable Innovative Pricing Approaches Santos S1, Botrugno P2, Dion K2 1Roche, Amadora, Portugal, 2F. Hoffmann-La Roche Ltd, Basel, Switzerland

Objectives: IIncreasing pressure on healthcare budgets mean more flexible pricing approaches will be required to ensure patients can receive the latest medicines. In order to implement such solutions it is necessary to have automated drug utilisation data collection systems that show how medicines are being used. This analysis looks at what data needs to be collected to implement managed entry or risk-sharing agreements.  Methods: Various managed entry agreements (MEA) and risk sharing agreements (RSA) have been described previously. The data required to operationalise these agreements were identified. The data are commonly collected in hospital information systems.  Results: A total of 28 data fields were identified. These data fields are classified as Minimum Data Fields. These data exist at a source level, i.e. at hospitals and registries; companies would receive data in an anonymised and aggregated form. The source data fields need to cover four elements: administrative information, including patient ID, payer ID and hospital ID; information regarding the scope of the agreement, including details on the indication and line of treatment; information that allows the correct calculation of the money flow, e.g. number of cycles; data detailing appropriate usage of the medicine, e.g. mutation status.  Conclusions: By using hospital information systems to populate 30 data fields, it is possible to operationalise various MEAs or RSAs and support flexible pricing solutions. Information on how and where the drug is used will allow all parties to track it is being used appropriately, while comprehensive data sets will ensure money flows are correctly accounted for. The data will be collected by a third party and shared in accordance with locally applicable privacy and data protections laws. Pharmaceutical companies would only receive anonymised aggregated data, not patient level data.

PHP136 Big Data In Healthcare - Opportunities And Challenges Leppert F, Greiner W School of Public Health, Bielefeld University, Bielefeld, Germany

Objectives: Digital services provide a huge amount of different data and the discussion about the use of Big Data takes on greater significance. But Big Data subsumes a lot of different and heterogenic single applications. The aim of this study is to identify and categorize the fields of applications of Big Data in healthcare and its chances, risks and limitations.  Methods: A meta-review of reviews of big data studies was conducted for the years 2010-15. Excluded were studies with an exclusive methodical, statistical or technical focus.  Results: After reviewing 218 Abstracts 19 studies were included. Out of these six essential fields of application could be deduced: (1)On a population level prevalence studies analyze incidence, prevalence and development of diseases. Especially applications for the prediction of extremely prevalent, infectious and/or lethal diseases are on focus. (2)On an individual level Big Data applications help to analyze personalized factors of risk and identify the individual probability for the development of diseases. (3)A distinct focus of research is gene based analysis (omics). (4)While traditional clinical trials evaluate the efficacy of health technology, Big Data analyses provide real-worldevidence and information about the effectiveness. (5)In comparative studies regional and/or structural variations can be identified. (6)Within Clinical decision support systems patients’ specific characteristics can be compared with Big Data databases in real time and deliver therapy recommendations or probability of therapy’s success.  Conclusions: There are many opportunities for Big Data. Nevertheless, there are still limitations and unsolved challenges. For example, big data only show correlations and no casualization. In addition, there are high requirements regarding data safety and security, ethical discussions are necessary. A stronger and real time integration into eHealth solutions could achieve an expedient use of Big Data. Therefore, it is necessary to address the existing shortcomings and to integrate Big Data in existing solutions to foster its possibilities.

PHP137 Predicting Length Of Stay After Road Traffic Accident Accounting For Competing Endpoints With Time-Dependent Variables Van Belleghem G1, Devos S1, Lauwaert D2, Hubloue I2, Buyl R1, Pien K2, Putman K1 Universiteit Brussel, Jette, Belgium, 2University hospital Brussel, Jette, Belgium

1Vrije

Objectives: The doctor-patient relationship is shifting towards empowered patients who want to be informed about their hospitalisation. In this context, prediction models on health care utilisation can help support conveying information. As road traffic victims are often young and employed patients, who have a lot of questions about their health care use, we will focus our analysis on this subgroup. The aim of this study is to make personalized predictions of length of stay within acute hospitalisation for road traffic victims.  Methods: As there are multiple endpoints and time-dependent variables we chose to perform dynamic predictions by landmarking (LM) in competing risks. The competing risks were death and hospital discharge. Median length of stay LM were set every day, up until percentile 90. LM’s were marked every 3 days, leading to the following landmarks: day 0,1,2,3,6,9,12,15,18 and 21. Baseline-variables taken into account were sociodemographics, type of roadway-user, place and type of injury and comorbidities. Time-dependent-variables were surgeries, residence at intensive care and blood transfusion. Cox proportional hazards models are made for both outcomes at each landmark.  Results: Over the different LM-points the following trend is seen: in predicting time to death being male, being transferred to another hospital, acute circulatory diseases and blood-transfusions show a significantly higher probability of dying. In predicting time to hospital discharge having higher age and being male leads to a significantly higher probability of discharge while chronic diseases, blood transfusions and surgery are significant predictors with lower probabilities of discharge. Roadway user types had both an influence on deceased and being discharged.  Conclusions: Over the different landmarks for the same endpoint the predictors behave consistent. Significance and direction can differ between the endpoints. We are still working on the dynamic supermodel which averages the estimates over the different landmarks. PHP138 Assessment Of General Knowledge Concerning Health-Related Topics Zavras D, Kyriopoulos J National School of Public Health, Athens, Greece

Objectives: This study aims to investigate whether or not the frequency of internet use as well as the epidemiological and the demographic factors affect the assessment of general knowledge of health-related topics.  Methods: Data from the FLASH EUROBAROMETER 404 were used for the purpose of this study. The sample size was 1000 individuals aged 15 years or over (n= 1000). The dependent variable is the assessment of knowledge of health-related topics (four point scale, 1: very bad to 4: very good). Since the response variable is ordinal, Ordinal Logistic Regression was used during data analysis. Potential predictors in the model were the following: a) gender (1: male, 2: female); b) age; c) self-reported health status (1: very bad to 4: very good); d) existence of chronic health condition (0: no, 1: yes); e) frequency of internet use (1: never to 6: once a week or more often).  Results: The Ordinal Logistic Regression Model indicates that frequency of internet use, gender and selfreported health status are significant. More specifically, we found that women have higher probability than men to assess their knowledge of health-related topics as good (OR= 1.55; p= 0.015). The same holds for healthier individuals (OR= 1.42; p= 0.036). In addition, individuals using more frequently the internet to search for health-related information have a higher probability of assessing their knowledge concerning health-related topics as good (OR= 1.18; p= 0.001).  Conclusions: The assessment of knowledge concerning health-related topics depends on frequency of internet use, gender and self-reported health status. Women’s higher assessment of knowledge concerning health-related topics is attributed to the increased utilization of health services. Further research is required to explain the positive association between self-reported health status and assessment of knowledge of health-related topics. The association between frequency of internet use to search for health-related information and assessment of knowledge of health-related topics is obvious. PHP139 Value Added Medicines: The Need To Establish One Common Terminology For Repurposed Medicines Rémuzat C1, Toumi M2 1Creativ-Ceutical, Paris, France, 2Faculté

de Médecine, Laboratoire de Santé Publique, Aix-

Marseille Université, Marseille, France

Objectives: Even if the concept of value added medicines or repurposing of existing molecules has been known for many years, no common terminology has been agreed and their full potential value is not always rewarded, creating a disincentive for further development. Study objective was to propose a common framework/typology for value added medicines allowing for better assessment of their value.  Methods: A literature review was conducted in Medline, Embase, Cochrane databases, Generics and Biosimilars Initiative (GaBI), Google Scholar, European Medicines Agency, European Commission websites and available grey literature to identify the different nomenclatures describing the concept of value added medicines and to propose a common typology.  Results: Various nomenclatures were found for the concept of value added medicines, either broad or more restricted definitions based on outcomes and/or processes. Suggested typology we developed for value added medicines included two different algorithms. One algorithm related to the categories of value added medicines typology itself and one related to disease environment as the general context of disease and target population cannot be disconnected from the typology when assessing the whole product value. The first algorithm included 6 dimensions: 1) Repurposing model, i.e., drug repositioning (indication extension), drug reformulation, drug-drug combination;

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2) Regulatory status; 3) Targeted indication; 4) Combination to a device or service; 5) Patient benefit; 6) Impact on society. The second algorithm included 4 dimensions: 1) Population; 2) Disease burden; 3) Disease severity and chronicity; 4) Unmet needs.  Conclusions: This harmonised typology for value added medicines might allow better differentiating these products and enhancing their value assessment. Contrary to products like generic medicines, biosimilar medicines and hybrids, there is no regulatory definition for value added medicines. The recent European Commission STAMP initiative related to repurposing of established medicines raised this issue and will consider the opportunity to provide a definition. PHP140 Value Added Medicines: What Value Repurposed Medicines Might Bring To Society? Rémuzat C1, Toumi M2 1Creativ-Ceutical, Paris, France, 2Faculté

de Médecine, Laboratoire de Santé Publique, Aix-

between years 2013 to 2015. Average time to market access and time trends are calculated according to different therapeutic areas.  Results: In the studied time period, the Innovative pharmaceuticals recognized by AIFA can be clustered into three main therapeutic areas: Antivirals (n= 13), oncology /hematology (n= 7) and orphan disease drugs (n= 1). The average time for official reimbursability per therapeutic class is : 293 days ( 10 months ) for antiviral drugs , 467 days ( 15 months ) for oncology / hematology drugs and 285 days( 9 months) for orphan disease drug. We observe acceleration trend in the three years’ time span with an average decrease in time to reimbursability of 37% from the year 2013 to 2014 and 30% from years 2014 to 2015.   Conclusions: Assessment of innovative pharmaceuticals reimbursability is a complex and time consuming process despite recent policies aiming to speed market authorization procedures in Italy. Nevertheless, the effect of recent policies shows an improvement in overall time trends towards faster patient access to innovative drugs.The analysis suggests process optimization for innovative drug recognition to ensure early patient benefit.

Marseille Université, Marseille, France

Objectives: Value added medicines are defined as “medicines based on known molecules that address health care needs and deliver relevant improvements for patients, health care professionals and/or payers”. Study objective was to assess from health care providers’, patients’, regulators’ and payers’ perspective which value drug repurposing might bring to society.  Methods: Interviews were conducted with health care providers, patients and payers following presentation of key examples of value added medicines to assess how value added medicines might respond to their needs and society needs.  Results: Value added medicines may first represent an opportunity to address health care system inefficiencies such as irrational use of medicines (e.g. through new drug formulations or drug combinations improving adherence issues of already available therapies or through drug repositioning and drug reformulations for specific patient groups contributing to limit off-label use of medicines), inappropriate treatment options (e.g. by tailoring and expanding access of well-known therapies to particular patient subgroups’ needs), shortage of mature products by creating new market attractiveness of mature products, geographical inequity in drug access (e.g. new drug formulations for hospital-only medicines which could be used in out-patient settings, thus improving access in remote rural areas). Value added medicines may also represent an opportunity to better address health care provision and organisation and could contribute to reduction and re-allocation in health care use. Finally, in the current cost-constraint environment, value added medicines may represent an opportunity to create an intermediate step before switching to costly products and reduce budget impact.  Conclusions: Value added medicines represent an opportunity for society to address a number of drug related health care inefficiencies and also present an opportunity to deliver better health to patients, to enhance health care system efficiency and contribute to the sustainability of the health care systems. PHP141 Do First-In-Class Drugs Offer Larger Incremental Health Gains Than Next-In-Class Drugs? Chambers J, Thorat T, Wilkinson C, Neumann PJ Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies,Tufts Medical Center, Boston, MA, USA

Objectives: First-in-class drugs are those with novel mechanisms of action that offer a new therapeutic approach to treating a disease. In contrast, next-in-class drugs are those with a similar mechanism of action to existing drugs. The objective of this study was to compare the additional health gains associated with first-inclass and next-in-class drugs relative to the existing standard of care at the time of their approval.  Methods: We identified new molecular entities (NMEs) approved by the FDA from 1999-2012 (n= 392). We estimated health gains in terms of incremental quality-adjusted life-years (QALYs) gained for drugs approved for the first time from 1999 through 2012, relative to treatments available at the time of their approval. We identified incremental QALY gain estimates from published cost-utility analyses, and comparative effectiveness studies that estimated relative effectiveness using QALYs. We excluded studies that compared drugs to placebo or to no treatment when an alternative active treatment was available, and to be conservative we excluded estimates from studies supported by the pharmaceutical industry. We classified drugs as either first-in-class or next-in-class using the FDA’s categorization of NMEs. We compared estimated incremental QALY gains for drugs classified as firstin-class vs. next-in-class drugs using Mann Whitney U tests.  Results: We identified incremental QALY gain estimates for 118 drugs, representing approximately 30% of drugs approved from 1999 through 2012. We classified 47 drugs (40%) as first-in-class and 71 drugs (60%) as next-in-class. First-in-class drugs and next-in-class drugs were associated with mean QALY gains of 0.49 (standard deviation 1.17) and 0.09 (SD 0.92), respectively, and median QALY gains of 0.17 (interquartile range 0.40) and 0.013 (IQR 0.19), respectively (p= 0.018).  Conclusions: We found that for drugs in our sample, first-in-class drugs were associated with larger incremental health gains relative to standard of care at the time of their approval than next-in-class drugs.

PHP142 Time To Formal Reimbursability For Innovative Drugs In Italy Eid MA1, Giuliani G2 1University of Bologna, Bologna, Italy, 2Roche, Monza, Italy

Objectives: Recent legislation and policies in Italy aim to ensure patient access to innovative medicines .Pharmaceuticals recognized as innovative or potentially innovative are granted accelerated negotiation process to ensure rapid market access and formal reimbursability . This analysis aims to track retrospectively the real time required to formal reimbursability of pharmaceuticals recognized as innovative drugs by the Italian medicine agency ( AIFA)   Methods: Using a public list of innovative drugs, the research tracks the time span from the authorized approval of the committee for medicinal products for human use of European medicine agency until the market authorization dates published in official gazette of Italian republic

PHP143 A Study Evaluating Living Organ Donors In Kidney And Liver Transplantation Nair AG1, Noone JM2, Zacherle E1, Blanchette CM1 1University of North Carolina at Charlotte, Charlotte, NC, USA, 2Precision Health Economics, Davidson, NC, USA

Background: Few studies have evaluated patient characteristics and the hospital stay associated with living donor transplantations. Furthermore, little is known regarding living donor mortality, although previous reports have indicated that LDKTs have an estimated donor mortality of 0.03%, while the estimated mortality rate for LDLTs is 0.2-0.4%. Objectives: To provide insight on demographic characteristics, mortality, and hospital stay of living kidney and liver transplant patients.  Methods: The National Inpatient Sample (NIS) Core Dataset 2012 was used for the study. The measures evaluated in this study included gender, age, comorbidities, mortality rate, hospital charges, length of stay and hospital location. Kidney and liver donors were identified using ICD-9 diagnosis codes, V59.4 and V59.6 for kidney and liver donors, respectively.  Results: The proportion of LDKT and LDLT patients in the population were 0.014% and 0.0007%, respectively, of 7,296,968 discharges. Mortality rate for liver donors was 15.09%, while the mortality rate for kidney donors was 0.49%. COPD was found in 5.55% and 3.89% of kidney and liver donors, respectively, while mild liver disease, cerebrovascular disease and myocardial infarction was present in 0.19%, 0.00%, and 0.00% of liver donors, respectively (vs. 3.7%, 1.85%, and 1.85% of kidney donors). The average hospital charge for liver donors was $91,438 and 48,994 for kidney donors. Most donors (both liver and kidney) were found to be from large metropolitan cities.  Conclusions: Our study highlighted important characteristics of living donor liver and kidney transplant patients, including common comorbidities, mortality rates, length of stay and hospital charges associated with each living donor type. Of importance, is that the current study found a much higher rate of mortality for LDKTs than what previous reports have indicated. Future studies should elucidate on these findings and further determine differences between living donor patients. PHP144 Cost-Efficiency Of Medication Safety Program At Pediatrics, Obstetrics, And Gynecology Hospital, East Province, Saudi Arabia Alomi YA1, Alanazi AA2, Alsallouk SA3, Almaznai MM3, Abu-Alnaja NI4, Alduhilan M4, Alhojelan B4 1Ministry of Health, RIYADH, Saudi Arabia, 2Maternity Children Hospital Dammam, Dammam, Saudi Arabia, 3Health Affairs Eastern Province, MOH, RIYADH, Saudi Arabia, 4Maternity Children Hospital Dammam, RIYADH, Saudi Arabia

Objectives: Medication safety program started at East Province of Ministry of Health in 2013. The pharmacist prevents all drug related problems. The study objective to estimate cost-efficiency of Medication Safety program at the hospital in East province, Saudi Arabia by using American model of pharmacist intervention cost avoidance.  Methods: It is a 12-month 2015 of 500-bed Pediatrics, Obstetrics and Gynecology Hospital through preventing and documentation of medication errors in adults and pediatrics at Ministry of Health hospitals. The hospital had medication safety officer with medication safety committee. The program Led by trained pharmacist and delivered Basic medication safety education to all health professional. The estimated cost calculated Using International Study Model (Ling et al., Am J Health-Syst Pharm 2005), expressed in USD, the cost considered were the expected results of medication errors sequel if not stopped; starting from Physician visit, additional laboratory test, further treatment, hospital admission, Critical care admission to death stage.  Results: The total number of prevented medication errors were 1654 at 827 prescribed to 827 patients. The estimated cost avoidance of stopping medication was (115,591.12 USD) annually. The pharmacist avoided medication errors with estimated cost avoidance of drug-related problem (69.88 USD) per each prescription, and (139.76 USD) per patient. The highest drug of cost avoidance were Insulin injection (39,964.32 USD), iron tablet (11,526.9 USD) folic acid tablet (11,526.9 USD), and calcium tablet (11,526.9 USD), and Enoxaparin injection (9,637.02 USD). There was Three high-risk medication founded with errors Insulin, Enoxaparin, and Heparin with (43.12 %) of annual total cost avoidance.  Conclusions: In this medication safety program is a cost-efficiency simulation at Pediatrics and Obstetrics and Gynecology Hospital in Saudi Arabia, prevents medication misadventures, improve patient safety. Expanding drug safety program associated with preventing drugrelated problems, and cost avoidance simulation for Healthcare improvement and better care, and better patient outcomes. PHP145 Pharmacists Manpower Analysis In Years 2006-2014 At Minstery Of Health In Saudi Arabia