Analysis of the G-BA Decision-Making Criteria on the Benefit Assessment of Diabetes Treatments: Is Cost an Influencing Criterion?

VA L U E I N H E A LT H

based on DCCT data. The increased hypoglycemia (low HbA1c) scenario improved quality-adjusted life expectancy relative to the lower hypoglycemia rate scenario, yielding an improvement of 0.30 quality-adjusted life years, despite an increase in cumulative incidence of hypoglycemia-related mortality from 0.78% to 0.91%. Average complication costs decreased by GBP 928 from GBP 23,632 to GBP 22,703 with improved glycemic control.  Conclusions: The present analysis demonstrated the utility of computer simulation models such as the PRIME Diabetes Model in evaluating treatment guidelines. The analysis showed that the trade-offs of increased hypoglycemia and hypoglycemia-related mortality are more than offset by improvements in quality of life and reductions in cost at the population level. PDB72 The Impact of Biosimilar Launch on Molecule Price and Pharmaceutical Expense: The Case of the Insulin Glargine in Italy Tettamanti A, Cioni L, Tucci C QuintilesIMS, Milano, Italy

Objectives: Italian Medicines Agency (AIFA) sets the ex-factory price of hospital drug and negotiates discounts for the purchases to public institutions. Hospital and local health authority (ASL) are allowed to purchase drugs with a discount on the official selling price. Lower prices can be obtained through tenders, which are organized by groups of hospitals or at regional level. This research aims to analyze the impact on tender discounts and on the pharmaceutical expense of the therapeutic area following the biosimilar launch. Methods: An overview analysis of the insulin market was conducted, to individuate the market share (in terms of volume) covered by the originator insulin glargine from Jan 2016 to Mar 2017. An analysis of the monthly real purchase discount in tender was conducted to calculate the actual hospital expenditure and the changes in tender discount after the biosimilar introduction. The real tender price was statistically calculated starting from a QuintilesIMS database, which gathers sales data of hospital and local healthcare unit distribution.  Results: Since February 2016, the biosimilar introduction involved an increase of the originator tender discount from 11% to 20% compared to the ex-factory price. The biosimilar presented a price around 13% lower than the originator, remaining almost stable during the period of analysis. At regional level different prices were applied, resulting in a high variability of biosimilar adoption. Finally, tender price decreased among other long-acting basal insulins.  Conclusions: The biosimilars launch increases the level of competition of the market, pushing the originators to reduce their prices through tender discounts. This effect seems to involve not only the originator but also the other molecules within the therapeutic area, showing a common trend of price reduction. This entails an opportunity of saving for the healthcare system, especially for chronic and high spending therapeutic areas. PDB73 Health Economics Evidence in Peer-Reviewed Journals: Increase in Reporting of Real-World Data Over Time in Type 2 Diabetes Huang Y1, Hartog TE1, Vaghjiani R2, Patterson N2, Van Lier H1, van den Broek R1 1Excerpta Medica, Amsterdam, The Netherlands, 2Excerpta Medica, London, UK

Objectives: With the rising need to contain health care costs, health economic (HE) studies are of increasing interest to a variety of audiences. This study analyzed trends over time in HE information in type 2 diabetes (T2D) being published in peer-reviewed journals.  Methods: A literature search was performed using EMBASE to identify published original HE articles in T2D. The inclusion criteria of HE studies was based on definition by ISPOR and the search strategy was derived from previously published recommendations. Year 2008 was selected as the “baseline” year and compared to 2012 and 2016. Included studies were reviewed and categorized into research types (economic evaluation, cost analysis, clinical+cost study, other), data sources (trials, real-world, survey, literature, other), study perspective (payer, healthcare provide, patients, societal, other) and journal types (HE, general medicine, disease-specific, pharmacy, based on journal scope). Chi-square tests were used to compare the proportion of articles grouped by different categories during 2008-2016.  Results: The number of T2D HE studies increased from 63 in 2008 to 176 in 2012 and 199 in 2016. Most studies were economic evaluations (58.7%, 39.8% and 50.8% in 2008, 2012 and 2016, respectively). In 2008, studies mainly used data from trials (42.9%). This proportion decreased to 17.6% in 2012 and 24.1% in 2016. Meanwhile, real-world data became the main data source in HE studies (2008: 34.9%; 2012: 45.5%; 2016: 46.7%, p= 0.001). The perspective of the HE studies did not reveal significant changes during 2008-2016 (p= 0.180), with approximately 75% studies adopting a third-party payer’s perspective. HE studies more specifically targeted health economists/policy-maker journal audiences during 2008-2016 (2008: 19.0%; 2016: 41.7%, p= 0.003).  Conclusions: During the period 2008-2016, the number of HE publications increased in T2D with a shift from trial to real-world data sources. Our results suggest an increasing trend of publishing HE information targeting healthcare decision-makers. PDB74 Factors Affecting Polypharmacy in Elderly Patients with Diabetes in Greece Geitona M, Latsou D, Markou E, Michou I, Pitelis P, Papafili G, Toska A, Saridi M University of Peloponnese, Corinth, Greece

Objectives: To determine prevalence and factors affecting polypharmacy amongelderly diabetic patients in Greece.  Methods: A prospective multi-center crosssectional study was carried out in the regions of Attica and Western Greece. Data were collected via personal interviews at the outpatients’ and specialized diabetes units of the public, private and university hospitals. A random sample of 702 patients was selected out of 1.134 patients followed up from March to May 2016. A questionnaire was prepared based on the EU SIMPATHY experience including questions on patients’ characteristics, medication use and adherence, adverse drug reactions (ADRs) and self-assessment of health status. The criterion for polypharmacy was defined as the concomitant use of 5 or more medications.Descriptive and multiple regression analyses were performed to examine the impact of studied

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independent variables on polypharmacy. Data analysis was carried out using SPSS21.  Results: 644outpatients filled out the questionnaire (RR= 91.7%) witha mean age of 67.8 (SD 13) years and disease duration of11 (SD 8) years. The prevalence of polypharmacy among the sample is 22.5%. Mean number of medications used by each elder was 4.2 (SD 2.5). Approximately 6/10 patients received antidiabetic drug as monotherapy, and 4/10 receivedat least one more medication for other chronic diseases. The majority of the sample suffered from cardiovascular diseases. The findings showed that polypharmacy isaffected significantly by gender (P≤  0.01; β =  2,093), age (P =  0.005; β = 0,026), presence of ADRs (P =  0.085; β = 0,778), caregiver’ help in taking medicines (P =  0.025; β = -0.491), increased drug dosage in order to feel better (P =  0.028; β = 0.403) and self-assessment of health status (P ≤  0.01; β = -0.451).  Conclusions: Change management practices and integrated healthcare networks are needed to be introduced in Greece in order to support health providers to medication decision making as well as to educate elderly about the consequences of polypharmacy. PDB75 Analysis of the G-BA Decision-Making Criteria on the Benefit Assessment of Diabetes Treatments: Is Cost an Influencing Criterion? Vollmer A1, Leutloff J2, Pacheco L1 1GfK UK, London, UK, 2GfK, Nürnberg, Germany

Objectives: Since 2011, manufacturers have been required to submit a value dossier for clinical assessment to the Joint Federal Committee (G-BA). All new medical products, except hospital use only, orphan drugs and medicines with less than € 1 million annual sales are assessed. The objective of this research was to explore the reasons why treatments in diabetes have received a low G-BA assessment score (score below 5) and to assess whether the proposed cost of a treatment may be influencing factor in the G-BA assessment.  Methods: All completed G-BA assessments for diabetes indicated products between Jan-2011 to May-2017 were reviewed. For treatments scoring below 5 (no additional benefit proven), the key reasons behind the score were explored using the G-BA “Tragende Gründe zum Beschluss” documentation. Furthermore, the percentage difference in the annual average cost per patient of the new treatment versus the manufacturer selected comparator was assessed for the scope treatments using the G-BA “Beschlusstext”.  Results: The main reasons for treatments receiving a low benefit score were due to the study design and population, the comparator chosen by the manufacturer, a worse clinical outcome versus the selected comparator or no data to prove additional benefit. On average a ~300% i.e. ~700€  increase in the proposed annual cost per patient of the new therapy versus to the manufacturer selected comparator was observed.  Conclusions: No clinical data to prove additional benefit and the “inappropriate” study design for new treatments were the main reasons for the G-BA to assign a low benefit assessment score in indicated treatment populations. The differences in annual cost per patient between the new therapy and the comparator were found not to be significantly dissimilar for drugs/indications that received a positive benefit rating and those that received a negative rating. Therefore, cost does not seem to be an influencing factor in the benefit assessment. PDB76 Evaluating the Long-Term Impact of Improving Care for Patients with Type 2 Diabetes in China Wang LM1, Ye Q2, Kjerkegaard Nielsen O3, Gadegaard A3, Valentine WJ4, Hunt B5, Wang LH1 Center for Chronic and Non Communicable Diseases Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC), Beijing, China, 2Novo Nordisk A/S, Søborg, Denmark, 3Novo Nordisk A/S, Bagsværd, Denmark, 4Ossian Health Economics and Communications GmbH, Basel, Switzerland, 5Ossian Health Economics and Communications, Basel, Switzerland 1National

Objectives: The United Nations has set a number of Sustainable Development Goals (SDGs), including reducing premature mortality due to non-communicable diseases (NCDs) by one-third by 2030. Diabetes is associated with significant clinical and economic burden in China, and therefore the aim of the present analysis was to examine the health economic impact of improving care for patients with diabetes in China, and how this relates to meeting the SDG.  Methods: Long-term outcomes were projected for patients with type 2 diabetes meeting treatment targets recommended by the Chinese Diabetes Society versus remaining at the current standard of care. Baseline cohort characteristics were taken from patients with diabetes in the China NCD Surveillance study, supplemented with data from A1chieve and DiabCare. Costs of treating diabetes-related complications were taken from a study conducted in 20 Chinese hospitals and were inflated to 2015 values. Outcomes were discounted at 3% annually where appropriate.  Results: Bringing patients to treatment targets was associated with improved mean undiscounted life expectancy compared with current standard of care (18.50 versus 18.08 years). Nationally, discounted cost savings of up to CNY 540 billion could be generated as a result of reduced onset of diabetes-related complications if all patients with diabetes achieved treatment targets. Bringing patients to treatment targets reduced premature mortality due to diabetes by 6% compared with current standard of care. Therefore improving care is not sufficient to meet the SDG. In addition to improving care, a 29.1% of reduction in the prevalence of diabetes was required to meet the premature mortality target.  Conclusions: Long-term projections suggested that bringing diabetes patients to treatment targets resulted in improved life expectancy and significant cost-savings. Diabetes prevention should form one of the key aims in order to achieve the 2030 SDG premature mortality target in China. PDB77 Patient Characteristics of Premix Insulin Users in China: An Analysis of Electronic Medical Record Data Han S1, Wang K2, Hou J2, Wang J3, Wu EQ3 1Analysis Group, Inc., Beijing, China, 2Lilly Suzhou Pharmaceutical Company, Ltd., Shanghai, China, 3Analysis Group, Inc., Boston, MA, USA