- Email: [email protected]
Changing Of Prescriptions For Diabetes, Hyperlipidemia, And Hypertension, From Generic Drugs To Protected Brand Drugs : A Retrospective Cohort Study Using A National Inpatient Database In Japan
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in EU member states. Methods: To estimate the extent of the parallel export we used drug consumption data from the database Ex-PEND and IMS data. Since Ex-PEND considers the official health authority data based on health insurance companies reimbursement and IMS database considers the quantity of drugs that distributors supply to pharmacies, the difference between these two data can be roughly considered as a parallel export. Taking into account the structure of both databases, only prescription drugs could be evaluated. The difference in prices of most exported drugs we have obtained from the Ex-PRICE database, which collects drugs prices from officially published sources in EU member states. Results: In 2015, the estimated share of prescription drugs parallel export on total market volume was 8.8% and share on market value was 15.3%. We have found out that in 10 drugs which are exported in the highest volumes, the difference in price in Slovakia vs. EU countries fell into the range of 37% - 94% (per pack difference: € 257.09 - € 1877.89). Conclusions: We have found out that that there are significant price differences in drugs that are mostly exported from Slovakia compared with the member countries. These drugs are often not available to patients in Slovakia. Health system therefore should find mechanisms to ensure availability of medicines while maintaining basic European regulation on the free movement of goods within the EU. PHP72 Utilization And Cost Of Antimicrobials Used In Medicine And Surgery Departments Of A Tertiary Care Teaching Hospital Haligeri Veerana Goud B, Roy V Maulana Azad Medical College, University of Delhi, New Delhi, India
Objectives: Irrational use of antimicrobials has led to grave consequences of antimicrobial resistance and economic burden on the health care system. This study was conducted in find out the pattern and extent of antimicrobial usage in inpatients and outpatients of Medicine and Surgery department and also to determine the economic impact of antimicrobials against their usage. Methods: The study was conducted over a period of 14 months in both outpatients and inpatients departments of two units of Medicine and Surgery. Prescriptions of inpatients and outpatients were analyzed using International Classification Code of Diseases for diagnosis and Anatomical Therapeutic Chemical Classification (ATC) and Defined Daily Doses (DDDs) for the antimicrobials used. A total of 2128 outpatient prescriptions and 400 inpatients case sheets from Medicine and Surgery were included in the study. Results: In the outpatient department, the average number of medicines prescribed per patient was more in Medicine (3.0) than in Surgery (2.3). The most commonly used antimicrobial in both departments was amoxicillin+clavulanate. The use of antimicrobials in inpatient departments of both Medicine and Surgery was high, as 73.1% of the admitted patients were prescribed antimicrobials. The average antimicrobial prescribed per patient was 2.7. The most commonly used antimicrobials in the Medcine and Surgery inpatients were ceftriaxone, metronidazole and flouroquinolones. A total of 84 samples were sent for microbiological examination of which 39% were positive. Antimicrobial prescription for prophylactic conditions was greater in Surgery than in Medicine. The total DDDs/100 patient days in Medicine and Surgery were 3369 and 2247, respectively. Overall, the expenditure on the antimicrobials was 33% of the total cost of drug treatment. The average cost of antimicrobial per patient was INR 1501. Conclusions: We propose routine practice of batcerial culture and sensitivity testing, formulation of an antibiotic policy, and antimicrobial stewardship program to improve usage and clnical outcome. PHP73 Economic Resources Optimisation In The Hcv Setting: The Role Of The Daas Garagiola E1, Ferrario L1, Croce D1, Menzaghi B2, Quirino T2, Rizzardini G3, Foglia E1 1LIUC University, Castellanza, Italy, 2ASST Valle Olona, Busto Arsizio, Italy, 3ASST Fatebenefratelli Sacco, Milano, Italy
Objectives: Over the period 2014-2015, the advent of DAAs generated widespread concern, particularly within the Italian setting, characterised by continuous spending review actions. The study aimed at estimating the budget impact of the introduction of novel drugs approved in May 2015, compared with the historical situation based on the different treatment options available prior to May 2015, assuming the Lombardy Region Health Service (RHS) perspective. Methods: A budget impact analysis (BIA), representing Lombardy Region HCV healthcare expenditure evolution over three years, was developed, considering the overall HCV and HIV/HCV population. Patients’ previous medical history, degree of liver fibrosis, genotypes, achievement of sustained virological response (SVR) and direct healthcare total costs were the model input variables. Data were collected from scientific evidence, regional legislation and administrative information of two Lombardy Region Hospitals: Valle Olona and Fatebenefratelli Sacco. Results: Two different populations were hypothesised: i) the population related to the regional spending cap (N= 13,658), and ii) the population related to the organizational and productive cap (starting from the Regional Decree 7826, 2015, N= 31,722). At the 36 month-horizon of the base-case scenario for market penetration, the introduction of the novel therapies could lead to i) a substantial increase in HCV and HIV/HCV patients achieving a SVR (+20%) and ii) significant economic savings to the RHS (-6.64%/-7.15%), even considering the adverse events’ impacts. The initial investment in innovative therapies would be recovered within 24 months, generating outcomes improvement and economic benefits for the RHS, which could be consolidated in time. Conclusions: The results suggest the need of attentive healthcare planning that is able to 1) concentrate the therapeutic alternatives and 2) precisely forecast the HCV population, thus leading to: i) a reduction in health expenditure, ii) ensuring a better virological control, and iii) guaranteeing the best cost-effective result with a greater ledipasvir/ sofosbuvir consumption. PHP74 Market Uptake Models Of Biosimilars And Off-Patent Biological Medicines
Moorkens E1, Meuwissen N1, Huys I1, Vulto A2, Declerck P1, Simoens S1 Leuven, Leuven, Belgium, 2The Erasmus University Medical Center, Rotterdam, The Netherlands
1KU
Objectives: This study aims to identify different industrial players involved in reference biologic/biosimilar development, to investigate evolution in price, volume and market share of each class, and to identify market uptake models. Methods: A literature review was carried out using the databases PubMed and Embase. Studies could be published in English or in Dutch. Additionally, articles were identified by searching on the website of the Generics and Biosimilars Initiative (GaBI) journal, GaBI Online. The reference list of articles was reviewed as well for relevant studies. This literature was coupled with market data on prices, volumes and market shares of biosimilars. Furthermore, semi-structured interviews were conducted with companies developing biologicals/biosimilars. Results: Players on the biological market are the Big Pharma companies, biotechnological companies, generic companies, new entrants and companies from emerging countries. In Europe, an increase of volume of biosimilars is noticed. In the three best established markets with biosimilar competition (epoëtin, granulocyte-colony stimulating factor, and growth hormone), second-generation biologicals, or if not available non-referenced biologicals, compete with biosimilars. As a result, the market share of the reference product declined. Competition drives down prices in the epoëtin and granulocyte-colony stimulating factor markets where the number of biosimilars and price reductions are the largest. With respect to the global biological market, seven market uptake models were identified: no investment in biosimilars, investment in biotechnological companies, development of next-generation biologicals, development of biosimilars, investment in emerging countries, cooperation between companies, and revision of strategy for next-generation biologicals. Conclusions: Cooperation between companies has been a common strategy for marketing new products. The market share of a product differs between classes, between countries and between uptake models, and is influenced by local regulatory frameworks and policies. PHP75 Prescribing Behaviour And Drug Use In Pakistan Aziz MM1, Ji W1, Gillani AH1, Raza MA2, Fang Y1 1Xi’an Jiaotong University, Xi’an, Shaanxi, P. R. China, Xi’an, China, 2Bahauddin Zakariya University Multan, Multan, Pakistan
Objectives: Irrational drug use and prescribing behavior is a global challenge, predominantly affecting the poor countries. The aim of this study was to evaluate rationality and prescription behavior on the basis of single prescription. Methods: A total of 288 prescriptions were collected from the rural and urban areas of Multan division in 2015 and analyzed for prescribing behavior of health care professionals on the basis of average medicines per prescription. Among them 168 were collected from tertiary, secondary and primary care government hospitals. While 120 were collected from consultant physicians and general practicing doctors in private settings. SPSS version 18.0 was used for statistical analysis. Results: Total 288 prescriptions were evaluated during the study. Total 1368 medicines were prescribed. Total prescribed generic medicines were 807 and total prescribed research brands were 561. Total 274 antibiotics were prescribed. Total 1096 medicines were national essential drug list of Pakistan (EDL). Total 297 injectable were prescribed. Total mineral, Vitamins and nutrients were 191 Average medicines per prescription were 4.75. Average generic medicines per prescription were 2.8 and average research brands per prescription were 1.94. Average of medicines from EDL in a prescription was 3.8. Average (0.95) antibiotics were found in a prescription. Average (0.75) injectable presented in a prescription Average of minerals and vitamins and nutrients per prescription were 0.66. The average cost per prescription for one day was 126.43 PKR. Moreover it observed in the study, the prescribing behavior of the healthcare professional is variable with respect to locality, spatiality, patient’s economics and educational level of the prescriber Conclusions: The data reveals that there is an urgent need of educational intervention to change the behavior of health care professional. More managerial and regulatory efforts can rationalize the drug use in Pakistan
PHP76 Changing Of Prescriptions For Diabetes, Hyperlipidemia, And Hypertension, From Generic Drugs To Protected Brand Drugs : A Retrospective Cohort Study Using A National Inpatient Database In Japan Shimizu S Institute for Health Economics and Policy, minato-ku Tokyo, Japan
Objectives: Regulation of insurance reimbursement for drug prescriptions is less strict in Japan than in other OECD member countries, and physicians have greater discretion for prescriptions. In such a market, even if patients were being treated with generic drugs on a continuing basis, their prescriptions might be changed from generic drugs to protected brand drugs when they come on the market. This study aimed to clarify the switch from generic drugs to brand drugs in patients who had been treated with generic drugs, using nationwide administrative data. Methods: Pharmacy dispensing data from April 2011 to December 2014 was analyzed for each year. 1) We targeted patients who were treated with only generic drugs from April to September of each year and for whom dispensing records for periods of three months or more were available. 2) If there were prescriptions of a targeted brand drug for the patients described in 1) between October and March of each year, we defined it as a switch/add-on to the brand drug. Results: Of the diabetic patients (N= 181,378), hypertensive patients (N= 542,654), and hyperlipidemic patients (N= 343,188), brand drugs were prescribed for 81.6% of the diabetic patients, 79.3% of the hypertensive patients and 91.0% of the hyperlipidemic patients. Among the patients treated with only generic drugs, 7.4% of diabetic patients, 2.2% of hyperlipidemic patients, and 10.2% of diabetic patients were switched to brand drugs. Switches from generic drugs to protected brand drugs were more frequently observed in younger patients in their 40s and 50s than in the elderly patients (p< 0.05), and
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more frequently in male patients than in female patients (p< 0.05). Conclusions: In some cases, patients who were treated with generic drugs on a continuing basis were changed to the treatment with protected brand drugs.
HEALTH CARE USE & POLICY STUDIES – Equity and Access PHP77 Racial Disparities In Access To Pharmacy And Its Services In Pennsylvania Pednekar P1, Peterson AM2 1University of the Sciences, Philadelphia, PA, USA, 2University of the Sciences in Philadelphia, Philadelphia, PA, USA
Objectives: Persistent racial and ethnic disparities in the use of prescription medications often results into inequalities in health outcomes. Existing literature lacks evidence about how low access to pharmacy services may cause differences in the medication use among different race and ethnic groups. The goal of this study is to examine whether access to pharmacies varies across Pennsylvania counties based on their racial or ethnic composition. Methods: In this retrospective study, 10 counties in Pennsylvania, five with highest percentage of white population (White counties) and five with the highest black population (Black counties) were identified using the U.S. census data of 2010 and 2014. Pharmaceutical Assistance contract for the Elderly (PACE) dataset of 2015 was used to identify characteristics of pharmacies and their services for each county. Access to pharmacy and its services was identified using number and type of pharmacy as well as type of services. Chi-square test was used to compare differences in the distribution of pharmacies and types of services provided across the White and Black counties. Results: The five White counties were identified as Elk, Cameron, Jefferson, Warren, and Potter. The five Black counties were Delaware, Forest, Dauphin, Alleghany, and Monroe. The results showed only one pharmacy per square mile in Black counties (4,479 residents per pharmacy) in contrast to 24 pharmacies per square mile in White counties (4,330 residents per pharmacy). There were significantly more independent pharmacies (χ 2 = 59.43, p = < 0.0001) and delivery services (χ 2 = 21.553, p = < 0.0001) in the White counties compared to the Black counties. However, Black counties were found to have more chain pharmacies (χ 2= 57.97, p = < 0.0001) and 7-day services (χ 2 = 100.62, p = < 0.0001). Conclusions: There is not equal access to pharmacies or pharmacy services between the identified White and Black counties in Pennsylvania. PHP78 Review Of National Policies For Rare Diseases Across Eu Countries Hill CE, Garcia Sanchez JJ, Hill CA MAP BioPharma Limited, Cambridge, UK
Objectives: To review the success or failure in implementation of policies as a consequence of the 2009 European Commission (EC) recommendation on rare diseases. Methods: The policy context prior to publication of the 2009 EC recommendation on rare diseases was identified using data published through EUROPLAN. Levels of achievement in implementing national plans or strategies and key indicators by European Union (EU) Member States were ascertained from published data. Nine countries were excluded as plans were not available in English; these countries were Cyprus, Denmark, Greece, Latvia, Lithuania, Luxembourg, Norway, Portugal and Switzerland. Results: Prior to the EC recommendation, there were differences in policy regarding rare diseases throughout the EU. After its implementation, all seventeen countries included in this study created a national plan or strategy. Objectives were similar in each country and closely followed the EC recommendation. Sixteen countries achieved adequate definition, codification and inventorying rare diseases, as well as identifying ongoing national research projects, resources and priorities and provisions for cross-border collaboration. All seventeen countries also achieved: identifying appropriate national centres for participation in European Reference Networks, improved training and participation in European projects, patient organisation involvement in decision making and policy, and improved access to the social care system, for patients and their families. Fifteen countries also achieved provisions for pre and post graduate education of healthcare professionals. Sixteen countries achieved provision of national registries. Thirteen countries reported contributions to Orphanet. Conclusions: The EC recommendation provided a structure for countries when developing their rare disease plans and strategies, and has proved effective by the implementation of national plans. The needs of rare disease patients are now stated as a priority for EU countries, with most indicators assessed being achieved. However, adherence to indicators varied, so there is still irregularity in the rare disease landscape throughout the EU. PHP79 Comparison Of The Relationship Between Socio-Economic Status And Health-Related Quality Of Life Amongst Atopic Dermatitis Patients Across Different Healthcare Systems Papsch RB, Howe T, Vrabcheva T GfK UK, London, UK
Objectives: Healthcare systems globally aim to make services widely accessible to each of their citizens independent of their socio-economic status. This research compares several healthcare systems in terms of their ability to achieve this by analysing the relationship between patient income level and health-related quality of life using the example of atopic dermatitis patients. Methods: The GfK Disease Atlas cross-sectional observational study was conducted in China, India, Germany, South Korea and the USA between September 2014 and December 2014. The health-related quality of life (HRQoL: Dermatology Life Quality Index [DLQI]) for overall n= 275 patients diagnosed with atopic dermatitis was compared within each country for high versus low income patients, with distribution based on median household income. Results: Across all countries the lower income group had worse DLQI scores than the higher income group. While the differences in the DLQI scores between the high and the low income group were smallest in Germany
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(DLQI score 8.7 vs. 9.5) and South Korea (9.0 vs. 9.8), they were higher in the USA (7.2 vs. 8.6). In China (8.5 vs. 10.1) and India (9.4 vs. 10.8) these differences were also higher compared to Germany and South Korea, but were comparable to the USA. Conclusions: This research demonstrates that global healthcare systems differ in their ability to support the health-related quality of life of their citizens independent of their socio-economic status. Systems based on a comprehensive social insurance approach (Germany, South Korea) are more successful in this regard compared to systems where the concept of universal coverage is of lesser importance (USA). It also demonstrates that while certain emerging markets (China, India) are increasingly implementing mechanisms of universal coverage, they are not yet able to support the health-related QoL of patients of different socio-economic status equally well. PHP80 Trans-Pacific Partnership Agreement And Its Impact On Accessibility And Affordability Of Medicines: A Meta-Synthesis Yap YY1, Wong CP1, Khan TM1, Lee KS2, Ming LC3 1Monash University Malaysia, Sunway, Malaysia, 2Ministry of Health Malaysia, Selangor, Malaysia, 3University of Tasmania, Hobart, Australia
Objectives: To discuss the main consequences of the implementation of the TPP agreement (TTPA) in the pharmaceutical sector in regards to public health, focusing on the accessibility and affordability of medicines. This paper also looks at the likely impact of the TPP agreement on access to affordable medicines. Methods: Using a predetermined search strategy, we identified robust studies about the impact of the TPP on the pharmaceutical sector. Papers in the form of news, report, talks, factsheets and policy brief were excluded. Articles that discussed about the impact of TPP agreement towards public health but focusing on tobacco control were also excluded. Data was extracted, imported into Excel, and coded line-by-line. We used thematic analysis techniques to generate themes and a decision tree of the TTPA meta-synthesis. The identified themes were cross-checked against original articles to ensure consistency. We derived policy-relevant discourse from the findings. Results: A total of 85 full articles and reports were reviewed and finally 32 of these were used in the meta-synthesis. Two central themes to the TTPA emerged: intellectual property rights and transparency. Five subthemes were identified under intellectual property rights: patent subject matter (representing scope of patentability); patent term adjustment for patent office delays (representing patent term extension); protection of undisclosed test or other data (representing data exclusivity); protection of undisclosed test or other data (representing patent linkage); and compulsory licensing. Meanwhile, transparency and anti-corruption-procedural fairness, which presents restriction of coverage program and reimbursement, were identified as the subthemes of transparency. Conclusions: Findings indicate that the TPPA could potentially hinder the affordability and accessibility of medicine, which could increase risks to public health. Effective approaches in handling TPPA by countries that have signed and those yet to sign the agreement will benefit all parties: the government, the pharmaceutical industry and the general public. PHP81 Predicting Orphan Designation And Marketing Authorisation Based On A Review Of The European Medicines Agency Orphan Disease Register Garcia Sanchez JJ, Hill CA, Hill D MAP BioPharma Limited, Cambridge, UK
Objectives: To conduct a review of the orphan drug recommendations made by the European Medicines Agency (EMA) to date and to consider projections on potential future designations and likelihood of marketing authorisations. Methods: All orphan drug recommendations made by the EMA were analysed according to designation date, therapeutic area as categorised by the British National Formulary (BNF) and type of recommendation. Statistical analyses were undertaken in R and included projections up to 10 years, Spearman’s rank correlation coefficients such as type of recommendation and therapeutic area, and significance testing. Trends and likelihood of future marketing authorisation were extrapolated from the available data. Results: The first orphan drug designation was granted by the EMA in 2000. At the time of analysis (May 2016), a total of 1674 drugs had been assessed. 1344 drugs (80%) received a positive orphan drug designation, whereas only 21 (1%) received a negative recommendation, 295 (18%) were withdrawn and 14 (1%) applications expired. Overall, the number of orphan drug applications increased year-on-year, with applications reaching a peak of 150 in 2015. The most common therapeutic areas included malignant disease and immunosuppression, nutrition and blood and respiratory. A significant correlation was observed between a positive recommendation and drugs treating malignant disease and immunosuppression (Spearman’s rank correlation coefficient: 0.9382; p < 0.001). Projections on orphan drug designations, based on the current rate of positive recommendations, estimated that around 4,701 orphan drug designations could have been granted by 2026. Conclusions: The majority of applications for orphan designation are successful. Projections estimating increasing numbers of orphan drug designations and likelihood of marketing authorisation require consideration by reimbursement agencies across Europe. Ongoing work will explore the trends in withdrawal of orphan designation at the point of market authorisation. PHP82 Preliminary Evaluation Of “Introducing Immigrants To The Healthcare System In Chile” Pilot Programme Chepo M1, Cabieses B1, Bernales M1, MacIntyre AM1, Espinoza MA2 1Universidad del Desarrollo, Santiago, Chile, 2Pontificia Universidad Catolica de Chile, Santiago, Chile
Objectives: As part of the “universal health coverage for all” goal in Chile, a pilot intervention was created and piloted in the borough of Santiago, in the metropolitan region of Chile. The purpose of this study was to evaluate this pilot intervention after two months follow-up (May-July 2016). Methods: Based on previous research, we designed a healthcare intervention for immigrants in primary care. The intervention
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in EU member states. Methods: To estimate the extent of the parallel export we used drug consumption data from the database Ex-PEND and IMS data. Since Ex-PEND considers the official health authority data based on health insurance companies reimbursement and IMS database considers the quantity of drugs that distributors supply to pharmacies, the difference between these two data can be roughly considered as a parallel export. Taking into account the structure of both databases, only prescription drugs could be evaluated. The difference in prices of most exported drugs we have obtained from the Ex-PRICE database, which collects drugs prices from officially published sources in EU member states. Results: In 2015, the estimated share of prescription drugs parallel export on total market volume was 8.8% and share on market value was 15.3%. We have found out that in 10 drugs which are exported in the highest volumes, the difference in price in Slovakia vs. EU countries fell into the range of 37% - 94% (per pack difference: € 257.09 - € 1877.89). Conclusions: We have found out that that there are significant price differences in drugs that are mostly exported from Slovakia compared with the member countries. These drugs are often not available to patients in Slovakia. Health system therefore should find mechanisms to ensure availability of medicines while maintaining basic European regulation on the free movement of goods within the EU. PHP72 Utilization And Cost Of Antimicrobials Used In Medicine And Surgery Departments Of A Tertiary Care Teaching Hospital Haligeri Veerana Goud B, Roy V Maulana Azad Medical College, University of Delhi, New Delhi, India
Objectives: Irrational use of antimicrobials has led to grave consequences of antimicrobial resistance and economic burden on the health care system. This study was conducted in find out the pattern and extent of antimicrobial usage in inpatients and outpatients of Medicine and Surgery department and also to determine the economic impact of antimicrobials against their usage. Methods: The study was conducted over a period of 14 months in both outpatients and inpatients departments of two units of Medicine and Surgery. Prescriptions of inpatients and outpatients were analyzed using International Classification Code of Diseases for diagnosis and Anatomical Therapeutic Chemical Classification (ATC) and Defined Daily Doses (DDDs) for the antimicrobials used. A total of 2128 outpatient prescriptions and 400 inpatients case sheets from Medicine and Surgery were included in the study. Results: In the outpatient department, the average number of medicines prescribed per patient was more in Medicine (3.0) than in Surgery (2.3). The most commonly used antimicrobial in both departments was amoxicillin+clavulanate. The use of antimicrobials in inpatient departments of both Medicine and Surgery was high, as 73.1% of the admitted patients were prescribed antimicrobials. The average antimicrobial prescribed per patient was 2.7. The most commonly used antimicrobials in the Medcine and Surgery inpatients were ceftriaxone, metronidazole and flouroquinolones. A total of 84 samples were sent for microbiological examination of which 39% were positive. Antimicrobial prescription for prophylactic conditions was greater in Surgery than in Medicine. The total DDDs/100 patient days in Medicine and Surgery were 3369 and 2247, respectively. Overall, the expenditure on the antimicrobials was 33% of the total cost of drug treatment. The average cost of antimicrobial per patient was INR 1501. Conclusions: We propose routine practice of batcerial culture and sensitivity testing, formulation of an antibiotic policy, and antimicrobial stewardship program to improve usage and clnical outcome. PHP73 Economic Resources Optimisation In The Hcv Setting: The Role Of The Daas Garagiola E1, Ferrario L1, Croce D1, Menzaghi B2, Quirino T2, Rizzardini G3, Foglia E1 1LIUC University, Castellanza, Italy, 2ASST Valle Olona, Busto Arsizio, Italy, 3ASST Fatebenefratelli Sacco, Milano, Italy
Objectives: Over the period 2014-2015, the advent of DAAs generated widespread concern, particularly within the Italian setting, characterised by continuous spending review actions. The study aimed at estimating the budget impact of the introduction of novel drugs approved in May 2015, compared with the historical situation based on the different treatment options available prior to May 2015, assuming the Lombardy Region Health Service (RHS) perspective. Methods: A budget impact analysis (BIA), representing Lombardy Region HCV healthcare expenditure evolution over three years, was developed, considering the overall HCV and HIV/HCV population. Patients’ previous medical history, degree of liver fibrosis, genotypes, achievement of sustained virological response (SVR) and direct healthcare total costs were the model input variables. Data were collected from scientific evidence, regional legislation and administrative information of two Lombardy Region Hospitals: Valle Olona and Fatebenefratelli Sacco. Results: Two different populations were hypothesised: i) the population related to the regional spending cap (N= 13,658), and ii) the population related to the organizational and productive cap (starting from the Regional Decree 7826, 2015, N= 31,722). At the 36 month-horizon of the base-case scenario for market penetration, the introduction of the novel therapies could lead to i) a substantial increase in HCV and HIV/HCV patients achieving a SVR (+20%) and ii) significant economic savings to the RHS (-6.64%/-7.15%), even considering the adverse events’ impacts. The initial investment in innovative therapies would be recovered within 24 months, generating outcomes improvement and economic benefits for the RHS, which could be consolidated in time. Conclusions: The results suggest the need of attentive healthcare planning that is able to 1) concentrate the therapeutic alternatives and 2) precisely forecast the HCV population, thus leading to: i) a reduction in health expenditure, ii) ensuring a better virological control, and iii) guaranteeing the best cost-effective result with a greater ledipasvir/ sofosbuvir consumption. PHP74 Market Uptake Models Of Biosimilars And Off-Patent Biological Medicines
Moorkens E1, Meuwissen N1, Huys I1, Vulto A2, Declerck P1, Simoens S1 Leuven, Leuven, Belgium, 2The Erasmus University Medical Center, Rotterdam, The Netherlands
1KU
Objectives: This study aims to identify different industrial players involved in reference biologic/biosimilar development, to investigate evolution in price, volume and market share of each class, and to identify market uptake models. Methods: A literature review was carried out using the databases PubMed and Embase. Studies could be published in English or in Dutch. Additionally, articles were identified by searching on the website of the Generics and Biosimilars Initiative (GaBI) journal, GaBI Online. The reference list of articles was reviewed as well for relevant studies. This literature was coupled with market data on prices, volumes and market shares of biosimilars. Furthermore, semi-structured interviews were conducted with companies developing biologicals/biosimilars. Results: Players on the biological market are the Big Pharma companies, biotechnological companies, generic companies, new entrants and companies from emerging countries. In Europe, an increase of volume of biosimilars is noticed. In the three best established markets with biosimilar competition (epoëtin, granulocyte-colony stimulating factor, and growth hormone), second-generation biologicals, or if not available non-referenced biologicals, compete with biosimilars. As a result, the market share of the reference product declined. Competition drives down prices in the epoëtin and granulocyte-colony stimulating factor markets where the number of biosimilars and price reductions are the largest. With respect to the global biological market, seven market uptake models were identified: no investment in biosimilars, investment in biotechnological companies, development of next-generation biologicals, development of biosimilars, investment in emerging countries, cooperation between companies, and revision of strategy for next-generation biologicals. Conclusions: Cooperation between companies has been a common strategy for marketing new products. The market share of a product differs between classes, between countries and between uptake models, and is influenced by local regulatory frameworks and policies. PHP75 Prescribing Behaviour And Drug Use In Pakistan Aziz MM1, Ji W1, Gillani AH1, Raza MA2, Fang Y1 1Xi’an Jiaotong University, Xi’an, Shaanxi, P. R. China, Xi’an, China, 2Bahauddin Zakariya University Multan, Multan, Pakistan
Objectives: Irrational drug use and prescribing behavior is a global challenge, predominantly affecting the poor countries. The aim of this study was to evaluate rationality and prescription behavior on the basis of single prescription. Methods: A total of 288 prescriptions were collected from the rural and urban areas of Multan division in 2015 and analyzed for prescribing behavior of health care professionals on the basis of average medicines per prescription. Among them 168 were collected from tertiary, secondary and primary care government hospitals. While 120 were collected from consultant physicians and general practicing doctors in private settings. SPSS version 18.0 was used for statistical analysis. Results: Total 288 prescriptions were evaluated during the study. Total 1368 medicines were prescribed. Total prescribed generic medicines were 807 and total prescribed research brands were 561. Total 274 antibiotics were prescribed. Total 1096 medicines were national essential drug list of Pakistan (EDL). Total 297 injectable were prescribed. Total mineral, Vitamins and nutrients were 191 Average medicines per prescription were 4.75. Average generic medicines per prescription were 2.8 and average research brands per prescription were 1.94. Average of medicines from EDL in a prescription was 3.8. Average (0.95) antibiotics were found in a prescription. Average (0.75) injectable presented in a prescription Average of minerals and vitamins and nutrients per prescription were 0.66. The average cost per prescription for one day was 126.43 PKR. Moreover it observed in the study, the prescribing behavior of the healthcare professional is variable with respect to locality, spatiality, patient’s economics and educational level of the prescriber Conclusions: The data reveals that there is an urgent need of educational intervention to change the behavior of health care professional. More managerial and regulatory efforts can rationalize the drug use in Pakistan
PHP76 Changing Of Prescriptions For Diabetes, Hyperlipidemia, And Hypertension, From Generic Drugs To Protected Brand Drugs : A Retrospective Cohort Study Using A National Inpatient Database In Japan Shimizu S Institute for Health Economics and Policy, minato-ku Tokyo, Japan
Objectives: Regulation of insurance reimbursement for drug prescriptions is less strict in Japan than in other OECD member countries, and physicians have greater discretion for prescriptions. In such a market, even if patients were being treated with generic drugs on a continuing basis, their prescriptions might be changed from generic drugs to protected brand drugs when they come on the market. This study aimed to clarify the switch from generic drugs to brand drugs in patients who had been treated with generic drugs, using nationwide administrative data. Methods: Pharmacy dispensing data from April 2011 to December 2014 was analyzed for each year. 1) We targeted patients who were treated with only generic drugs from April to September of each year and for whom dispensing records for periods of three months or more were available. 2) If there were prescriptions of a targeted brand drug for the patients described in 1) between October and March of each year, we defined it as a switch/add-on to the brand drug. Results: Of the diabetic patients (N= 181,378), hypertensive patients (N= 542,654), and hyperlipidemic patients (N= 343,188), brand drugs were prescribed for 81.6% of the diabetic patients, 79.3% of the hypertensive patients and 91.0% of the hyperlipidemic patients. Among the patients treated with only generic drugs, 7.4% of diabetic patients, 2.2% of hyperlipidemic patients, and 10.2% of diabetic patients were switched to brand drugs. Switches from generic drugs to protected brand drugs were more frequently observed in younger patients in their 40s and 50s than in the elderly patients (p< 0.05), and
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more frequently in male patients than in female patients (p< 0.05). Conclusions: In some cases, patients who were treated with generic drugs on a continuing basis were changed to the treatment with protected brand drugs.
HEALTH CARE USE & POLICY STUDIES – Equity and Access PHP77 Racial Disparities In Access To Pharmacy And Its Services In Pennsylvania Pednekar P1, Peterson AM2 1University of the Sciences, Philadelphia, PA, USA, 2University of the Sciences in Philadelphia, Philadelphia, PA, USA
Objectives: Persistent racial and ethnic disparities in the use of prescription medications often results into inequalities in health outcomes. Existing literature lacks evidence about how low access to pharmacy services may cause differences in the medication use among different race and ethnic groups. The goal of this study is to examine whether access to pharmacies varies across Pennsylvania counties based on their racial or ethnic composition. Methods: In this retrospective study, 10 counties in Pennsylvania, five with highest percentage of white population (White counties) and five with the highest black population (Black counties) were identified using the U.S. census data of 2010 and 2014. Pharmaceutical Assistance contract for the Elderly (PACE) dataset of 2015 was used to identify characteristics of pharmacies and their services for each county. Access to pharmacy and its services was identified using number and type of pharmacy as well as type of services. Chi-square test was used to compare differences in the distribution of pharmacies and types of services provided across the White and Black counties. Results: The five White counties were identified as Elk, Cameron, Jefferson, Warren, and Potter. The five Black counties were Delaware, Forest, Dauphin, Alleghany, and Monroe. The results showed only one pharmacy per square mile in Black counties (4,479 residents per pharmacy) in contrast to 24 pharmacies per square mile in White counties (4,330 residents per pharmacy). There were significantly more independent pharmacies (χ 2 = 59.43, p = < 0.0001) and delivery services (χ 2 = 21.553, p = < 0.0001) in the White counties compared to the Black counties. However, Black counties were found to have more chain pharmacies (χ 2= 57.97, p = < 0.0001) and 7-day services (χ 2 = 100.62, p = < 0.0001). Conclusions: There is not equal access to pharmacies or pharmacy services between the identified White and Black counties in Pennsylvania. PHP78 Review Of National Policies For Rare Diseases Across Eu Countries Hill CE, Garcia Sanchez JJ, Hill CA MAP BioPharma Limited, Cambridge, UK
Objectives: To review the success or failure in implementation of policies as a consequence of the 2009 European Commission (EC) recommendation on rare diseases. Methods: The policy context prior to publication of the 2009 EC recommendation on rare diseases was identified using data published through EUROPLAN. Levels of achievement in implementing national plans or strategies and key indicators by European Union (EU) Member States were ascertained from published data. Nine countries were excluded as plans were not available in English; these countries were Cyprus, Denmark, Greece, Latvia, Lithuania, Luxembourg, Norway, Portugal and Switzerland. Results: Prior to the EC recommendation, there were differences in policy regarding rare diseases throughout the EU. After its implementation, all seventeen countries included in this study created a national plan or strategy. Objectives were similar in each country and closely followed the EC recommendation. Sixteen countries achieved adequate definition, codification and inventorying rare diseases, as well as identifying ongoing national research projects, resources and priorities and provisions for cross-border collaboration. All seventeen countries also achieved: identifying appropriate national centres for participation in European Reference Networks, improved training and participation in European projects, patient organisation involvement in decision making and policy, and improved access to the social care system, for patients and their families. Fifteen countries also achieved provisions for pre and post graduate education of healthcare professionals. Sixteen countries achieved provision of national registries. Thirteen countries reported contributions to Orphanet. Conclusions: The EC recommendation provided a structure for countries when developing their rare disease plans and strategies, and has proved effective by the implementation of national plans. The needs of rare disease patients are now stated as a priority for EU countries, with most indicators assessed being achieved. However, adherence to indicators varied, so there is still irregularity in the rare disease landscape throughout the EU. PHP79 Comparison Of The Relationship Between Socio-Economic Status And Health-Related Quality Of Life Amongst Atopic Dermatitis Patients Across Different Healthcare Systems Papsch RB, Howe T, Vrabcheva T GfK UK, London, UK
Objectives: Healthcare systems globally aim to make services widely accessible to each of their citizens independent of their socio-economic status. This research compares several healthcare systems in terms of their ability to achieve this by analysing the relationship between patient income level and health-related quality of life using the example of atopic dermatitis patients. Methods: The GfK Disease Atlas cross-sectional observational study was conducted in China, India, Germany, South Korea and the USA between September 2014 and December 2014. The health-related quality of life (HRQoL: Dermatology Life Quality Index [DLQI]) for overall n= 275 patients diagnosed with atopic dermatitis was compared within each country for high versus low income patients, with distribution based on median household income. Results: Across all countries the lower income group had worse DLQI scores than the higher income group. While the differences in the DLQI scores between the high and the low income group were smallest in Germany
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(DLQI score 8.7 vs. 9.5) and South Korea (9.0 vs. 9.8), they were higher in the USA (7.2 vs. 8.6). In China (8.5 vs. 10.1) and India (9.4 vs. 10.8) these differences were also higher compared to Germany and South Korea, but were comparable to the USA. Conclusions: This research demonstrates that global healthcare systems differ in their ability to support the health-related quality of life of their citizens independent of their socio-economic status. Systems based on a comprehensive social insurance approach (Germany, South Korea) are more successful in this regard compared to systems where the concept of universal coverage is of lesser importance (USA). It also demonstrates that while certain emerging markets (China, India) are increasingly implementing mechanisms of universal coverage, they are not yet able to support the health-related QoL of patients of different socio-economic status equally well. PHP80 Trans-Pacific Partnership Agreement And Its Impact On Accessibility And Affordability Of Medicines: A Meta-Synthesis Yap YY1, Wong CP1, Khan TM1, Lee KS2, Ming LC3 1Monash University Malaysia, Sunway, Malaysia, 2Ministry of Health Malaysia, Selangor, Malaysia, 3University of Tasmania, Hobart, Australia
Objectives: To discuss the main consequences of the implementation of the TPP agreement (TTPA) in the pharmaceutical sector in regards to public health, focusing on the accessibility and affordability of medicines. This paper also looks at the likely impact of the TPP agreement on access to affordable medicines. Methods: Using a predetermined search strategy, we identified robust studies about the impact of the TPP on the pharmaceutical sector. Papers in the form of news, report, talks, factsheets and policy brief were excluded. Articles that discussed about the impact of TPP agreement towards public health but focusing on tobacco control were also excluded. Data was extracted, imported into Excel, and coded line-by-line. We used thematic analysis techniques to generate themes and a decision tree of the TTPA meta-synthesis. The identified themes were cross-checked against original articles to ensure consistency. We derived policy-relevant discourse from the findings. Results: A total of 85 full articles and reports were reviewed and finally 32 of these were used in the meta-synthesis. Two central themes to the TTPA emerged: intellectual property rights and transparency. Five subthemes were identified under intellectual property rights: patent subject matter (representing scope of patentability); patent term adjustment for patent office delays (representing patent term extension); protection of undisclosed test or other data (representing data exclusivity); protection of undisclosed test or other data (representing patent linkage); and compulsory licensing. Meanwhile, transparency and anti-corruption-procedural fairness, which presents restriction of coverage program and reimbursement, were identified as the subthemes of transparency. Conclusions: Findings indicate that the TPPA could potentially hinder the affordability and accessibility of medicine, which could increase risks to public health. Effective approaches in handling TPPA by countries that have signed and those yet to sign the agreement will benefit all parties: the government, the pharmaceutical industry and the general public. PHP81 Predicting Orphan Designation And Marketing Authorisation Based On A Review Of The European Medicines Agency Orphan Disease Register Garcia Sanchez JJ, Hill CA, Hill D MAP BioPharma Limited, Cambridge, UK
Objectives: To conduct a review of the orphan drug recommendations made by the European Medicines Agency (EMA) to date and to consider projections on potential future designations and likelihood of marketing authorisations. Methods: All orphan drug recommendations made by the EMA were analysed according to designation date, therapeutic area as categorised by the British National Formulary (BNF) and type of recommendation. Statistical analyses were undertaken in R and included projections up to 10 years, Spearman’s rank correlation coefficients such as type of recommendation and therapeutic area, and significance testing. Trends and likelihood of future marketing authorisation were extrapolated from the available data. Results: The first orphan drug designation was granted by the EMA in 2000. At the time of analysis (May 2016), a total of 1674 drugs had been assessed. 1344 drugs (80%) received a positive orphan drug designation, whereas only 21 (1%) received a negative recommendation, 295 (18%) were withdrawn and 14 (1%) applications expired. Overall, the number of orphan drug applications increased year-on-year, with applications reaching a peak of 150 in 2015. The most common therapeutic areas included malignant disease and immunosuppression, nutrition and blood and respiratory. A significant correlation was observed between a positive recommendation and drugs treating malignant disease and immunosuppression (Spearman’s rank correlation coefficient: 0.9382; p < 0.001). Projections on orphan drug designations, based on the current rate of positive recommendations, estimated that around 4,701 orphan drug designations could have been granted by 2026. Conclusions: The majority of applications for orphan designation are successful. Projections estimating increasing numbers of orphan drug designations and likelihood of marketing authorisation require consideration by reimbursement agencies across Europe. Ongoing work will explore the trends in withdrawal of orphan designation at the point of market authorisation. PHP82 Preliminary Evaluation Of “Introducing Immigrants To The Healthcare System In Chile” Pilot Programme Chepo M1, Cabieses B1, Bernales M1, MacIntyre AM1, Espinoza MA2 1Universidad del Desarrollo, Santiago, Chile, 2Pontificia Universidad Catolica de Chile, Santiago, Chile
Objectives: As part of the “universal health coverage for all” goal in Chile, a pilot intervention was created and piloted in the borough of Santiago, in the metropolitan region of Chile. The purpose of this study was to evaluate this pilot intervention after two months follow-up (May-July 2016). Methods: Based on previous research, we designed a healthcare intervention for immigrants in primary care. The intervention