- Email: [email protected]
Recommendations In Clinical Guidelines, ‘No Benefit’ Ratings, And Opt-Out Decisions In Germany Since The Introduction Of The Amnog Law In 2011: How Do The Pieces Fit Together?
A466
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and patient condition improved 38 (23.17%). The most PharmacoEconomic impact was the patient length of hospital stay decreased 89 (54.27%), and reduction in the cost drug therapy monitoring 46 (28.05%). The estimated cost avoidance in the study period was (87,717.08 USD), and the total annual estimated cost avoidance (350,856.32 USD) Conclusions: Therapeutic Drug Monitoring pharmacist had the significant impact on patient condition and outcome, decrease a length of hospitalization, and avoid unnecessary an additional cost. The TDM program should apply in all clinical pharmacy services and at all hospitals in Saudi Arabia PHP151 Adherance To Medication Errors Repoting System At Public Hospital, Riyadh, Saudi Arabia Alomi YA1, Al-Shubbar NA2 of Health, RIYADH, Saudi Arabia, 2King Salman Hospital, RIYADH, Saudi Arabia
1Ministry
Objectives: Medication safety program started at Riyadh region of Ministry of Health in 2013. The pharmacist document all drug related problems. The goal of this study is to explore the pharmacist’s adherence to medication errors reporting system at the public hospital in Riyadh, Saudi Arabia. Methods: It is the retrospective analysis of a 12-month in the year of 2015; at 300-bed General Hospital through preventing and documentation of medication errors in adults and pediatrics. 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 medication error report consisted of patient demographic information, qualification of committing mistakes, time of errors occurs, type of medication errors, reasons for medication errors, medications stages involved, errors outcome, and action was taken Results: The total number of reports were 805. The pharmacist reported all reports (100%). The most information completed was causes of medication errors 775 (96.3%) and type of medication errors 770 (95.6%) followed by outcome of medication errors 764 (94.9%) and medication process stages involved 711 (88.3%). While the patient’s demographic information completed only (50%) in reports. The least completed item was the qualification of committing errors 3 (0.4%), and suggestion to prevent errors 2 (0.25%) followed by the time of mistakes and reporter information 0 (0%). Conclusions: Despite the medication error reporting is consider new at the public hospital the number of reporting was high. The system needs more effort to Adhere completeness medication errors reporting system; and that by development of an electronic reporting system, program awareness, and positive documentation system feedback changes in pharmacy practice PHP152 Workload Analysis And Staffing Requirement Of Clinical Pharmacy Services At Ministry Of Health In Saudi Arabia Alomi YA Ministry of Health, RIYADH, Saudi Arabia
Objectives: Clinical Pharmacy services at King Saud Medical City (KSMC) were the first founded by Ministry of Health. The aim of this study was to explore workload analysis of clinical pharmacy services at MOH hospital in Saudi Arabia Methods: Cross-sectional of a 6-month of providing clinical pharmacy services for adults at KSMC. Ten Clinical Pharmacist and expert trained pharmacist-provided clinical pharmacy services. It is including; drug information services, poisoning control services, therapeutic drug monitoring services, orthopedic services, oncology pharmacy services, pharmacoeconomic services, pain management services. All pharmacists should document the clinical pharmacy activities on a monthly basis; the clinical activities consisted of Central Clinical Pharmacy Activities domain, Patient-Specific Clinical Pharmacy Activities, Administration-Specific Clinical Pharmacy Activities domain, and some activities and time spent. Results: The Total full-time employee (FTE) for clinical pharmacy services was (15.752 FTE). The Central Clinical Pharmacy Activities was (4.72 FTE) pharmacist, Patient-Specific Clinical Pharmacy Activities was (4.292 FTE) pharmacist, and the Administration-Specific Clinical Pharmacy Activities was (6.68 FTE) pharmacist. The demand number of the full-time clinical pharmacist (5.75 FTE) pharmacist Of central clinical pharmacy activities, the highest number, was drug information services (1.43 FTE) pharmacist and in-services education (1.03 FTE) pharmacist. Of the patient specific clinical pharmacy activities; the highest number was medication monitoring (0.879 FTE) pharmacist and round medical participation (0.807 FTE) pharmacist. Of administration clinical pharmacy activities; the highest number was policies and procedures design (2.293 FTE) pharmacist and planning of clinical pharmacy services (1.56 FTE) pharmacsit. Conclusions: Workload analysis of clinical pharmacy services part of TQM indicators of clinical pharmacy system. Clinical pharmacy services overloaded with a high demand of clinical pharmacist. Administration clinical pharmacy should revise with changing emphasis to patient-specific clinical pharmacy activities. PHP153 Dimensionality Of Value: Are The Us And Europe Moving Towards Similar Or Different Definitions Of Pharmaceutical Value? Rowbottom R1, Capuano C2, Bower D2, Suponcic S3 Life Sciences, London, UK, 2Navigant Life Sciences, Boston, MA, USA, 3Navigant Life Sciences, Lawrenceville, NJ, USA
archetypes. Results: Emerging US value frameworks differ in dimensionality. However, a commonality across them is consideration of incremental improvement in efficacy, safety and/or tolerability vs. comparator. At its core this approach aligns closely with the comparative clinical effectiveness archetype central to many European HTA constructs. Select frameworks (especially ICER) layer on additional dimensions from other archetypes including health economic assessment. Interviewed European stakeholders acknowledge these similarities and are interested in better understanding differences in definition and dimensionality of pharmaceutical value as the US transitions to a value-based system and emerging frameworks build global awareness. Conclusions: Like European HTA constructs, US value frameworks aim to define the dimensions and scales of value that should be considered by stakeholders in making access decisions. This analysis illustrates key similarities between the dimensions of value considered in emerging US frameworks and those implicit to European HTAs. It concludes that the markets are converging in their definition of value, although this is driven primarily by changes ongoing in the US and spillover effects in Europe are yet to be determined. PHP154 The Ethical Issues Of Pharmacogenetic Tests Colak M, Tunceli HD, Pak MD baskent university, Ankara, Turkey
Objectives: It is possible to verify a genetic disorder of an individual and also to determine if the individual carries the sick gene to future generation in risky pregnancies or not with pharmacogenetic tests and also these tests enable us to do genetic mapping. Pharmacogenetic studies can be considered as “personalized medicine”. At this point ethical issues come up. In this study, the ethical issues of pharmacogenetic tests were evaluated according to medicine students. Methods: It is a descriptive cross-sectional study. The universe of the study consists of 456 medicine students and the sample consists of 280 randomly selected medicine students. Firstly definitive information about pharmacogenetic tests were given and then 11 ethical dimensions of pharmacogenetic tests were asked by face to face questionnaire design. Data were analyzed with SPSS 21.0 program. Descriptive statistics were used in the analysis. Results: 73,9% of the participants are concerned about unauthorized individuals may take the test results into their possession. 48,6% of the participants are worried about insurance companies may put pressure to their customers into taking pharmacogenetic tests. 70,4% of the participants are anxious about drawing biological map of nations having the threat of bioterrorism. Conclusions: The possibility of unauthorized individuals taking patients medical records into their possessions, genetic information being commercialized, insurance companies putting pressure on customers to take pharmacogenetics tests and employers putting pressure on employees to take this tests, securing medication safety with pharmaceuticals industry and possibility of the society’s genetic map being a potential for a biological attack (bioterrorism) as ethical issues were determined in the study PHP155 Stakeholders Views On The Role Of Hta And Rsas In Pharmaceutical Policy In Greece Tsakalogiannis C, Karampli E, Athanasakis K, Kyriopoulos J National School of Public Health, Athens, Greece
Objectives: The scope of this study was to record various stakeholders’ beliefs regarding the use of health technology assessment (HTA) in pharmaceutical policy in Greece and to investigate issues regarding the introduction of Risk Sharing Agreements (RSAs) in the reimbursement procedure. Methods: Fifteen semistructured interviews were conducted. Interviewees were recruited from Social Security organizations (public payers), policy makers, academia, pharmaceutical companies and patient associations. Participants were selected using purposive sampling, main inclusion criteria being their profession and knowledge of HTA methods. Twenty three individuals were contacted, from which eighteen agreed to participate. Saturation point was reached after fifteen interviews. Data were analyzed using framework content analysis. Results: According to stakeholders, there is an urging need for more extensive use of HTA methods. HTA is considered an appropriate tool for rationalizing pharmacy policy decisions. The establishment of an HTA organization is a demand of wide consensus, however opinions about its function and jurisdiction are diverse. Beyond concerns about technical and legal prerequisites, change in the current culture towards greater transparency were seen as prerequisites for the successful establishment of HTA. The latter refers also to the introduction of RSAs, which are considered a supplementary tool in reducing pharmaceutical expenditure. The extended use of e-prescription as a starting point for appropriate measurement of health outcomes and the experience of multinational companies and certain domestic organizations are marked as areas of opportunity. Stakeholders agreed that the introduction of HTA should be part of a pharmaceuticals’ pricing and reimbursement system reform, with the purpose to maximize health outcomes within closed budgets. Conclusions: The implementation of HTA in Greece has been delayed and abstract; however, currently there is consensus on its necessity. Greek health authorities are required to take major steps towards that direction. Engagement of all stakeholders is considered crucial for its success.
1Navigant
Objectives: There is a proliferation and evolution of new frameworks for assessing therapeutic value in the United States. These frameworks are garnering significant attention with regard to the dimensionality along which value is assessed and the stakeholder viewpoints considered. This research analyzes the dimensionality of US value frameworks and seeks to understand the extent to which they align with or diverge from payer (HTA) archetypes in Europe. Methods: Secondary research was conducted to characterize dimensionality of US value frameworks. Their temporal evolution was considered based on revisions and public comments. European archetypes were defined based on HTA guidelines and existing literature. Primary research was conducted with Payer, HTA and Policy decision-makers across several countries to compare and contrast US value frameworks with European
PHP156 Recommendations In Clinical Guidelines, ‘No Benefit’ Ratings, And Opt-Out Decisions In Germany Since The Introduction Of The Amnog Law In 2011: How Do The Pieces Fit Together? Staab TR1, Dintsios C2, Schulenburg J3, Ruof J1 1Roche Pharma, Grenzach-Wyhlen, Germany, 2Bayer Vital GmbH, Leverkusen, Germany, 3Leibniz University, Hanover, Germany
Objectives: Based on the pharmaceutical law (‘AMNOG’) that was introduced in Germany in 2011, the Federal Joint Committee (G-BA) is charged with the determination of the additional benefit of new medicines versus the available standard. This decision constitutes the basis for price negotiations between the statutory health insurance (GKV-SV) and the pharmaceutical companies. At any time the
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pharmaceutical companies may decide to withdraw their innovative drugs from the market. All withdrawals from the German market since 2011 were analysed with regards to the additional benefit granted by G-BA and recommendation status in clinical guidelines. Methods: Withdrawals from the German pharmaceutical market that completed a benefit assessment between January 2011 and June 2016 were identified and categorised into opt-out decisions (prior to completion of first price negotiation) and supply termination (during or after further price negotiations). Respective medicines were reviewed with regards to recommendation status in clinical guidelines and G-BA’s benefit decision. Results: Of 139 medications, 10 opt-outs and 12 supply terminations were identified. Twenty-one (95%) thereof received a ‘no benefit’ rating. Of the 12 terminations, 9 (75%) underwent the arbitration procedure. Most frequently (9 of 22), withdrawals concerned metabolic disorders. At the time of the benefit assessment, 19% of the withdrawn medicines were recommended specifically and 62% by therapeutic class in ≥ 1 relevant therapeutic guideline per indication. Conclusions: A ‘no benefit rating’ suggests that, based on available data, the new medicine does not provide additional benefit to patients. Yet, some of those medications are recommended in clinical guidelines. Our analysis indicates that new medicines with a ‘no benefit’ rating might still provide additional value to patients and health care systems which are not captured within the early benefit assessment. PHP157 General Practitioners Awareness On Medicines Cost And Financing In Bosnia And Herzegovina Catic T1, Martinovic I2, Avdagic L3 Economics and Outcomes Research, Sarajevo, Bosnia, 2Bosnalijek JSC, Sarajevo, Bosnia and Herzegovina, 3Faculty of Economics, Sarajevo, Bosnia and Herzegovina
1Health
Objectives: Public pharmaceutical spending in Bosnia and Herzegovina (BH) is constantly growing. Health Insurance Funds (HIF) are financing drugs prescribed in primary health care settings through reimbursement lists under the price that is set by governments. Reimbursed drugs are prescribed by general practitioners (GP) and often they are marked as “gate keepers” for rational drug utilization and drug budget control. Since there is no formal education in health economics and pharmacoeconomics in BH we have studied GPs awareness on cost of medicines and knowledge on reimbursement and pharmacoeconomics approaches in BH. Methods: We have developed and conducted survey consisted of sixteen questions/statements related to prices and cost of medicines, reimbursement system and pharmacoeconomics knowledge. Five-level Liker scale was used to measure respondents level of agreement/disagreement. Survey was distributed to 450 GPs in four major cities in BH. Descriptive statistics was used to evaluate responses. Results: Response rate was 99,0%. Majority of respondents were females (73,3%) and 47,3% are 30-40 years old. Majority of respondents are aware that generic drugs have lower prices and 56,5% discuss prices with patients prior to prescription. Even significant number of GPs agree that majority of patients need could be satisfied by drugs included into reimbursement lists, 39,1% disagree. Drugs wit price lower that 1,5EUR should not be reimbursed, and copayment should not exceed 2,5 EUR. GPs consider that members of Reimbursement board are not enough qualified. Even do majority of respondents show understanding of pharmacoeconomics concepts, 71,3% claim need for additional education in this field. Conclusions: Our study showed that GPs are regularly follow up reimbursement list updates being aware on drug prices. In order to improve rational drug prescribing they are interested in additional education in pharmacoeconomcis. PHP158 Access To New Drugs After The Introduction Of The 2011 Reimbursement Act In Poland Zaremba A, Iwanczuk T, Tatara T, Misiak J, Krakowian P, Wysoczanski W Agency for Health Technology Assessment and Tariff System in Poland (AOTMiT), Warsaw, Poland
Objectives: The new reimbursement law that came into force in Poland in 2012 listed amongst its goals better access to new, more effective treatments for Polish patients. The purpose of this study is to analyze the dynamics of including new drugs into the reimbursement lists (that are published every 2 months) since the introduction of the new law and to evaluate the impact of the Reimbursement Act on access to new drugs. Methods: All reimbursement lists (25) published since the introduction of the new reimbursement law and enumerating newly enlisted drugs were analyzed and active substances appearing on the list for the first time were extracted. Products containing the same active substance were calculated as one new active substance available (also in case of introducing an innovative pharmaceutical form). Drugs combinations were calculated as a new active substance even if one of the active ingredients had already been previously available. Foodstuffs intended for particular nutritional purposes and medical devices were excluded. Graphs illustrating new active substances inclusion into the particular reimbursement lists were generated. Results: Over the 4 and a half year of the new reimbursement law functioning over 250 new active substances have been introduced into public funding. There are no clear increasing or decreasing trends discernible. The number of new active substances introduced varies widely between lists. Relatively, the largest number of new active substances became available in 2014. Conclusions: The new reimbursement law led to inclusion into reimbursement lists of a significant number of new active substances. It constitutes an apparent change in comparison to the past, when few active substances had been introduced over decades. The new active substances are usually dedicated though to narrow subpopulations of particularly needy patients. PHP159 Implementation Of The Insurance Programs For Catastrophic Diseases In China: A Qualitative Study MAO W, Chen W Fudan University, Shanghai, China
A467
Objectives: To summarize the implementation progresses, challenges and trends of the Insurance Programs for Catastrophic Diseases (IPCD) in China. Methods: Policy document review and key informant interviews have been conducted in 8 Provinces. Results: IPCD was promoted by the State Council to cover Urban Resident Basic Medical Insurance (URBMI) and New Rural Cooperative Medical Scheme (NCMS) enrollees but Urban Employee Basic Medical Insurance(UEBMI) enrollees are also covered in some cities. Financial contribution rate, benefits package and operation of IPCDs vary among different cities and have close associations with local Basic Medical Insurance schemes (BMI). IPCD serves as an extension of BMI in two perspectives: the premium of IPCD is directly transferred from BMI fund and IPCD provides further reimbursement on the copayment after the reimbursement by BMI with a certain deductible, copayment rate and ceiling of payment. At least one city’s IPCD covers medications not included by provincial BMI reimbursable list. The majority of IPCD are operated by commercial insurance companies (CIC) under guidance of local BMI agency. Net loss, reputation and market share are the key indicators for the competitive bidding among CIC. In the early establishment of IPCD, BMI agencies share the responsibility with CIC if IPCD underwent deficit since the change of health services utilization is not predictable after introduction of IPCD due to lack of baseline observation. The partnership with CIC brings additional human resources to supervise health services provision, which benefits not only IPCD but also BMI. However, BMI agencies’ concern on the security of BMI enrollees’ information become major barrier for sharing information with CIC. Conclusions: IPCD relieves financial burden of patients by providing further reimbursement but its benefits package remains limited to BMI reimbursable list. CIC play an important role in supervising health services provision yet their specialties on actuarial services or risk control is under-developed. PHP160 Pharmaceutical Reimbursement Of Innovative Medicinal Products In Belgium Van Wilder P, Bormans V SMART&BI, Zaventem, Belgium
Objectives: The aim of this study was to investigate the reimbursement submissions of innovative medicines and analyze the consistency between the advice of the Commission for Reimbursement of Medicines (CRM) and the decision of the competent Minister. Methods: Data for submissions in the period 2010-2014 were extracted from the MORSE -report from the National Institute for Health and Disability Insurance (NIHDI)1. Products claiming added therapeutic value (class 1) or orphan medicinal products (OMP) were considered as innovative. The CRM’s advice was grouped into 3 categories: ‘positive’ (P), ‘negative’ (N) or ‘no proposition’ (NP, if no valid CRM proposition was voted). The Minister’s decision on reimbursement was coded as ‘positive’ (P) or ‘negative’ (N). Statistical analyses were executed in SPSS Statistics 22. [1] http://www.riziv.fgov.be/SiteCollectionDocuments/rapportmorse-2014.pdf Results: There were 72 class1 and 30 OMP – submissions: the median annual number was respectively 12 and 6.5. The percentages of CRM-advices being P, N or NP were respectively 29%, 42% and 29% for class1 and 57%, 27% and 17% for OMP (p < 0.05, chi-square = 6.88). There were 72 class1 and 32 OMP – decisions taken by the Minister. The percentage of decisions being P were 79% for class1 and 75% for OMP (NS, chi-square = 0.22). Agreement between the CRM’s proposition (P and N only) and the Minister’s decision was achieved in respectively 65% and 85% of class1 and OMP submissions. Disagreement occurred for 20 negative CRM propositions and 2 positive ones (p < 0.001, McNemar test). Conclusions: Overall the CRM advised positively for reimbursing innovation in < 40% of submissions with OMPs being advised positively about twice as much than class1 products. The Minister reimburses innovative products in > 75% of cases; disagreement with the CRM reflects mainly the decidision to reimburse products which were negatively advised by the CRM. PHP161 Linear, Flat And Mixed Pricing Structures As Negotiation Quantities Of New Medicinal Products In Context Of Amnog In Germany: A Comparison At Market Launch And Post Price Negotiations Bot D, Campion M, Ecker T Ecker + Ecker GmbH, Hamburg, Germany
Objectives: Within the framework of AMNOG price negotiations between pharmaceutical manufacturers and SHI (National Association of Statutory Health Insurance Funds), a relevant quantity for both parties is the pricing structure of the reimbursed price after negotiations. While the SHI generally favors a linear pricing structure (price increases with dose), the choice of pricing structure by manufacturers between flat pricing (identical price for different doses), linear pricing or a combination of the two (“mixed pricing”) depends on different parameters such as indication, expected physicians’ prescription behavior or conditions of parallel trade issues due to the European reference pricing. The objective of this study is to assess if manufacturers could maintain their favored pricing structure for new pharmaceuticals at market launch in Germany after price negotiations. Methods: Analysis is based on all price negotiations concluded until June 2016 in which manufacturers entered into either with a linear, a flat or a mixed pricing structure. Negotiations were excluded in this analysis if the respective drug was available only in one dose or if the drug has been withdrawn from the market before negotiation started. Afterwards, the selected negotiations were analyzed by comparing initial ex-factory prices of all packages for each drug at market launch and final prices after negotiations. Results: 47 relevant negotiations were identified. Manufacturers could maintain their favored pricing model in 38 negotiations (linear pricing= 17, flat pricing= 18, mixed pricing= 3) while pricing structures switched in 9 negotiations (linear to flat pricing= 1, linear to mixed pricing= 1, flat to linear pricing= 6, flat to mixed pricing= 1). Conclusions: In price
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and patient condition improved 38 (23.17%). The most PharmacoEconomic impact was the patient length of hospital stay decreased 89 (54.27%), and reduction in the cost drug therapy monitoring 46 (28.05%). The estimated cost avoidance in the study period was (87,717.08 USD), and the total annual estimated cost avoidance (350,856.32 USD) Conclusions: Therapeutic Drug Monitoring pharmacist had the significant impact on patient condition and outcome, decrease a length of hospitalization, and avoid unnecessary an additional cost. The TDM program should apply in all clinical pharmacy services and at all hospitals in Saudi Arabia PHP151 Adherance To Medication Errors Repoting System At Public Hospital, Riyadh, Saudi Arabia Alomi YA1, Al-Shubbar NA2 of Health, RIYADH, Saudi Arabia, 2King Salman Hospital, RIYADH, Saudi Arabia
1Ministry
Objectives: Medication safety program started at Riyadh region of Ministry of Health in 2013. The pharmacist document all drug related problems. The goal of this study is to explore the pharmacist’s adherence to medication errors reporting system at the public hospital in Riyadh, Saudi Arabia. Methods: It is the retrospective analysis of a 12-month in the year of 2015; at 300-bed General Hospital through preventing and documentation of medication errors in adults and pediatrics. 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 medication error report consisted of patient demographic information, qualification of committing mistakes, time of errors occurs, type of medication errors, reasons for medication errors, medications stages involved, errors outcome, and action was taken Results: The total number of reports were 805. The pharmacist reported all reports (100%). The most information completed was causes of medication errors 775 (96.3%) and type of medication errors 770 (95.6%) followed by outcome of medication errors 764 (94.9%) and medication process stages involved 711 (88.3%). While the patient’s demographic information completed only (50%) in reports. The least completed item was the qualification of committing errors 3 (0.4%), and suggestion to prevent errors 2 (0.25%) followed by the time of mistakes and reporter information 0 (0%). Conclusions: Despite the medication error reporting is consider new at the public hospital the number of reporting was high. The system needs more effort to Adhere completeness medication errors reporting system; and that by development of an electronic reporting system, program awareness, and positive documentation system feedback changes in pharmacy practice PHP152 Workload Analysis And Staffing Requirement Of Clinical Pharmacy Services At Ministry Of Health In Saudi Arabia Alomi YA Ministry of Health, RIYADH, Saudi Arabia
Objectives: Clinical Pharmacy services at King Saud Medical City (KSMC) were the first founded by Ministry of Health. The aim of this study was to explore workload analysis of clinical pharmacy services at MOH hospital in Saudi Arabia Methods: Cross-sectional of a 6-month of providing clinical pharmacy services for adults at KSMC. Ten Clinical Pharmacist and expert trained pharmacist-provided clinical pharmacy services. It is including; drug information services, poisoning control services, therapeutic drug monitoring services, orthopedic services, oncology pharmacy services, pharmacoeconomic services, pain management services. All pharmacists should document the clinical pharmacy activities on a monthly basis; the clinical activities consisted of Central Clinical Pharmacy Activities domain, Patient-Specific Clinical Pharmacy Activities, Administration-Specific Clinical Pharmacy Activities domain, and some activities and time spent. Results: The Total full-time employee (FTE) for clinical pharmacy services was (15.752 FTE). The Central Clinical Pharmacy Activities was (4.72 FTE) pharmacist, Patient-Specific Clinical Pharmacy Activities was (4.292 FTE) pharmacist, and the Administration-Specific Clinical Pharmacy Activities was (6.68 FTE) pharmacist. The demand number of the full-time clinical pharmacist (5.75 FTE) pharmacist Of central clinical pharmacy activities, the highest number, was drug information services (1.43 FTE) pharmacist and in-services education (1.03 FTE) pharmacist. Of the patient specific clinical pharmacy activities; the highest number was medication monitoring (0.879 FTE) pharmacist and round medical participation (0.807 FTE) pharmacist. Of administration clinical pharmacy activities; the highest number was policies and procedures design (2.293 FTE) pharmacist and planning of clinical pharmacy services (1.56 FTE) pharmacsit. Conclusions: Workload analysis of clinical pharmacy services part of TQM indicators of clinical pharmacy system. Clinical pharmacy services overloaded with a high demand of clinical pharmacist. Administration clinical pharmacy should revise with changing emphasis to patient-specific clinical pharmacy activities. PHP153 Dimensionality Of Value: Are The Us And Europe Moving Towards Similar Or Different Definitions Of Pharmaceutical Value? Rowbottom R1, Capuano C2, Bower D2, Suponcic S3 Life Sciences, London, UK, 2Navigant Life Sciences, Boston, MA, USA, 3Navigant Life Sciences, Lawrenceville, NJ, USA
archetypes. Results: Emerging US value frameworks differ in dimensionality. However, a commonality across them is consideration of incremental improvement in efficacy, safety and/or tolerability vs. comparator. At its core this approach aligns closely with the comparative clinical effectiveness archetype central to many European HTA constructs. Select frameworks (especially ICER) layer on additional dimensions from other archetypes including health economic assessment. Interviewed European stakeholders acknowledge these similarities and are interested in better understanding differences in definition and dimensionality of pharmaceutical value as the US transitions to a value-based system and emerging frameworks build global awareness. Conclusions: Like European HTA constructs, US value frameworks aim to define the dimensions and scales of value that should be considered by stakeholders in making access decisions. This analysis illustrates key similarities between the dimensions of value considered in emerging US frameworks and those implicit to European HTAs. It concludes that the markets are converging in their definition of value, although this is driven primarily by changes ongoing in the US and spillover effects in Europe are yet to be determined. PHP154 The Ethical Issues Of Pharmacogenetic Tests Colak M, Tunceli HD, Pak MD baskent university, Ankara, Turkey
Objectives: It is possible to verify a genetic disorder of an individual and also to determine if the individual carries the sick gene to future generation in risky pregnancies or not with pharmacogenetic tests and also these tests enable us to do genetic mapping. Pharmacogenetic studies can be considered as “personalized medicine”. At this point ethical issues come up. In this study, the ethical issues of pharmacogenetic tests were evaluated according to medicine students. Methods: It is a descriptive cross-sectional study. The universe of the study consists of 456 medicine students and the sample consists of 280 randomly selected medicine students. Firstly definitive information about pharmacogenetic tests were given and then 11 ethical dimensions of pharmacogenetic tests were asked by face to face questionnaire design. Data were analyzed with SPSS 21.0 program. Descriptive statistics were used in the analysis. Results: 73,9% of the participants are concerned about unauthorized individuals may take the test results into their possession. 48,6% of the participants are worried about insurance companies may put pressure to their customers into taking pharmacogenetic tests. 70,4% of the participants are anxious about drawing biological map of nations having the threat of bioterrorism. Conclusions: The possibility of unauthorized individuals taking patients medical records into their possessions, genetic information being commercialized, insurance companies putting pressure on customers to take pharmacogenetics tests and employers putting pressure on employees to take this tests, securing medication safety with pharmaceuticals industry and possibility of the society’s genetic map being a potential for a biological attack (bioterrorism) as ethical issues were determined in the study PHP155 Stakeholders Views On The Role Of Hta And Rsas In Pharmaceutical Policy In Greece Tsakalogiannis C, Karampli E, Athanasakis K, Kyriopoulos J National School of Public Health, Athens, Greece
Objectives: The scope of this study was to record various stakeholders’ beliefs regarding the use of health technology assessment (HTA) in pharmaceutical policy in Greece and to investigate issues regarding the introduction of Risk Sharing Agreements (RSAs) in the reimbursement procedure. Methods: Fifteen semistructured interviews were conducted. Interviewees were recruited from Social Security organizations (public payers), policy makers, academia, pharmaceutical companies and patient associations. Participants were selected using purposive sampling, main inclusion criteria being their profession and knowledge of HTA methods. Twenty three individuals were contacted, from which eighteen agreed to participate. Saturation point was reached after fifteen interviews. Data were analyzed using framework content analysis. Results: According to stakeholders, there is an urging need for more extensive use of HTA methods. HTA is considered an appropriate tool for rationalizing pharmacy policy decisions. The establishment of an HTA organization is a demand of wide consensus, however opinions about its function and jurisdiction are diverse. Beyond concerns about technical and legal prerequisites, change in the current culture towards greater transparency were seen as prerequisites for the successful establishment of HTA. The latter refers also to the introduction of RSAs, which are considered a supplementary tool in reducing pharmaceutical expenditure. The extended use of e-prescription as a starting point for appropriate measurement of health outcomes and the experience of multinational companies and certain domestic organizations are marked as areas of opportunity. Stakeholders agreed that the introduction of HTA should be part of a pharmaceuticals’ pricing and reimbursement system reform, with the purpose to maximize health outcomes within closed budgets. Conclusions: The implementation of HTA in Greece has been delayed and abstract; however, currently there is consensus on its necessity. Greek health authorities are required to take major steps towards that direction. Engagement of all stakeholders is considered crucial for its success.
1Navigant
Objectives: There is a proliferation and evolution of new frameworks for assessing therapeutic value in the United States. These frameworks are garnering significant attention with regard to the dimensionality along which value is assessed and the stakeholder viewpoints considered. This research analyzes the dimensionality of US value frameworks and seeks to understand the extent to which they align with or diverge from payer (HTA) archetypes in Europe. Methods: Secondary research was conducted to characterize dimensionality of US value frameworks. Their temporal evolution was considered based on revisions and public comments. European archetypes were defined based on HTA guidelines and existing literature. Primary research was conducted with Payer, HTA and Policy decision-makers across several countries to compare and contrast US value frameworks with European
PHP156 Recommendations In Clinical Guidelines, ‘No Benefit’ Ratings, And Opt-Out Decisions In Germany Since The Introduction Of The Amnog Law In 2011: How Do The Pieces Fit Together? Staab TR1, Dintsios C2, Schulenburg J3, Ruof J1 1Roche Pharma, Grenzach-Wyhlen, Germany, 2Bayer Vital GmbH, Leverkusen, Germany, 3Leibniz University, Hanover, Germany
Objectives: Based on the pharmaceutical law (‘AMNOG’) that was introduced in Germany in 2011, the Federal Joint Committee (G-BA) is charged with the determination of the additional benefit of new medicines versus the available standard. This decision constitutes the basis for price negotiations between the statutory health insurance (GKV-SV) and the pharmaceutical companies. At any time the
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pharmaceutical companies may decide to withdraw their innovative drugs from the market. All withdrawals from the German market since 2011 were analysed with regards to the additional benefit granted by G-BA and recommendation status in clinical guidelines. Methods: Withdrawals from the German pharmaceutical market that completed a benefit assessment between January 2011 and June 2016 were identified and categorised into opt-out decisions (prior to completion of first price negotiation) and supply termination (during or after further price negotiations). Respective medicines were reviewed with regards to recommendation status in clinical guidelines and G-BA’s benefit decision. Results: Of 139 medications, 10 opt-outs and 12 supply terminations were identified. Twenty-one (95%) thereof received a ‘no benefit’ rating. Of the 12 terminations, 9 (75%) underwent the arbitration procedure. Most frequently (9 of 22), withdrawals concerned metabolic disorders. At the time of the benefit assessment, 19% of the withdrawn medicines were recommended specifically and 62% by therapeutic class in ≥ 1 relevant therapeutic guideline per indication. Conclusions: A ‘no benefit rating’ suggests that, based on available data, the new medicine does not provide additional benefit to patients. Yet, some of those medications are recommended in clinical guidelines. Our analysis indicates that new medicines with a ‘no benefit’ rating might still provide additional value to patients and health care systems which are not captured within the early benefit assessment. PHP157 General Practitioners Awareness On Medicines Cost And Financing In Bosnia And Herzegovina Catic T1, Martinovic I2, Avdagic L3 Economics and Outcomes Research, Sarajevo, Bosnia, 2Bosnalijek JSC, Sarajevo, Bosnia and Herzegovina, 3Faculty of Economics, Sarajevo, Bosnia and Herzegovina
1Health
Objectives: Public pharmaceutical spending in Bosnia and Herzegovina (BH) is constantly growing. Health Insurance Funds (HIF) are financing drugs prescribed in primary health care settings through reimbursement lists under the price that is set by governments. Reimbursed drugs are prescribed by general practitioners (GP) and often they are marked as “gate keepers” for rational drug utilization and drug budget control. Since there is no formal education in health economics and pharmacoeconomics in BH we have studied GPs awareness on cost of medicines and knowledge on reimbursement and pharmacoeconomics approaches in BH. Methods: We have developed and conducted survey consisted of sixteen questions/statements related to prices and cost of medicines, reimbursement system and pharmacoeconomics knowledge. Five-level Liker scale was used to measure respondents level of agreement/disagreement. Survey was distributed to 450 GPs in four major cities in BH. Descriptive statistics was used to evaluate responses. Results: Response rate was 99,0%. Majority of respondents were females (73,3%) and 47,3% are 30-40 years old. Majority of respondents are aware that generic drugs have lower prices and 56,5% discuss prices with patients prior to prescription. Even significant number of GPs agree that majority of patients need could be satisfied by drugs included into reimbursement lists, 39,1% disagree. Drugs wit price lower that 1,5EUR should not be reimbursed, and copayment should not exceed 2,5 EUR. GPs consider that members of Reimbursement board are not enough qualified. Even do majority of respondents show understanding of pharmacoeconomics concepts, 71,3% claim need for additional education in this field. Conclusions: Our study showed that GPs are regularly follow up reimbursement list updates being aware on drug prices. In order to improve rational drug prescribing they are interested in additional education in pharmacoeconomcis. PHP158 Access To New Drugs After The Introduction Of The 2011 Reimbursement Act In Poland Zaremba A, Iwanczuk T, Tatara T, Misiak J, Krakowian P, Wysoczanski W Agency for Health Technology Assessment and Tariff System in Poland (AOTMiT), Warsaw, Poland
Objectives: The new reimbursement law that came into force in Poland in 2012 listed amongst its goals better access to new, more effective treatments for Polish patients. The purpose of this study is to analyze the dynamics of including new drugs into the reimbursement lists (that are published every 2 months) since the introduction of the new law and to evaluate the impact of the Reimbursement Act on access to new drugs. Methods: All reimbursement lists (25) published since the introduction of the new reimbursement law and enumerating newly enlisted drugs were analyzed and active substances appearing on the list for the first time were extracted. Products containing the same active substance were calculated as one new active substance available (also in case of introducing an innovative pharmaceutical form). Drugs combinations were calculated as a new active substance even if one of the active ingredients had already been previously available. Foodstuffs intended for particular nutritional purposes and medical devices were excluded. Graphs illustrating new active substances inclusion into the particular reimbursement lists were generated. Results: Over the 4 and a half year of the new reimbursement law functioning over 250 new active substances have been introduced into public funding. There are no clear increasing or decreasing trends discernible. The number of new active substances introduced varies widely between lists. Relatively, the largest number of new active substances became available in 2014. Conclusions: The new reimbursement law led to inclusion into reimbursement lists of a significant number of new active substances. It constitutes an apparent change in comparison to the past, when few active substances had been introduced over decades. The new active substances are usually dedicated though to narrow subpopulations of particularly needy patients. PHP159 Implementation Of The Insurance Programs For Catastrophic Diseases In China: A Qualitative Study MAO W, Chen W Fudan University, Shanghai, China
A467
Objectives: To summarize the implementation progresses, challenges and trends of the Insurance Programs for Catastrophic Diseases (IPCD) in China. Methods: Policy document review and key informant interviews have been conducted in 8 Provinces. Results: IPCD was promoted by the State Council to cover Urban Resident Basic Medical Insurance (URBMI) and New Rural Cooperative Medical Scheme (NCMS) enrollees but Urban Employee Basic Medical Insurance(UEBMI) enrollees are also covered in some cities. Financial contribution rate, benefits package and operation of IPCDs vary among different cities and have close associations with local Basic Medical Insurance schemes (BMI). IPCD serves as an extension of BMI in two perspectives: the premium of IPCD is directly transferred from BMI fund and IPCD provides further reimbursement on the copayment after the reimbursement by BMI with a certain deductible, copayment rate and ceiling of payment. At least one city’s IPCD covers medications not included by provincial BMI reimbursable list. The majority of IPCD are operated by commercial insurance companies (CIC) under guidance of local BMI agency. Net loss, reputation and market share are the key indicators for the competitive bidding among CIC. In the early establishment of IPCD, BMI agencies share the responsibility with CIC if IPCD underwent deficit since the change of health services utilization is not predictable after introduction of IPCD due to lack of baseline observation. The partnership with CIC brings additional human resources to supervise health services provision, which benefits not only IPCD but also BMI. However, BMI agencies’ concern on the security of BMI enrollees’ information become major barrier for sharing information with CIC. Conclusions: IPCD relieves financial burden of patients by providing further reimbursement but its benefits package remains limited to BMI reimbursable list. CIC play an important role in supervising health services provision yet their specialties on actuarial services or risk control is under-developed. PHP160 Pharmaceutical Reimbursement Of Innovative Medicinal Products In Belgium Van Wilder P, Bormans V SMART&BI, Zaventem, Belgium
Objectives: The aim of this study was to investigate the reimbursement submissions of innovative medicines and analyze the consistency between the advice of the Commission for Reimbursement of Medicines (CRM) and the decision of the competent Minister. Methods: Data for submissions in the period 2010-2014 were extracted from the MORSE -report from the National Institute for Health and Disability Insurance (NIHDI)1. Products claiming added therapeutic value (class 1) or orphan medicinal products (OMP) were considered as innovative. The CRM’s advice was grouped into 3 categories: ‘positive’ (P), ‘negative’ (N) or ‘no proposition’ (NP, if no valid CRM proposition was voted). The Minister’s decision on reimbursement was coded as ‘positive’ (P) or ‘negative’ (N). Statistical analyses were executed in SPSS Statistics 22. [1] http://www.riziv.fgov.be/SiteCollectionDocuments/rapportmorse-2014.pdf Results: There were 72 class1 and 30 OMP – submissions: the median annual number was respectively 12 and 6.5. The percentages of CRM-advices being P, N or NP were respectively 29%, 42% and 29% for class1 and 57%, 27% and 17% for OMP (p < 0.05, chi-square = 6.88). There were 72 class1 and 32 OMP – decisions taken by the Minister. The percentage of decisions being P were 79% for class1 and 75% for OMP (NS, chi-square = 0.22). Agreement between the CRM’s proposition (P and N only) and the Minister’s decision was achieved in respectively 65% and 85% of class1 and OMP submissions. Disagreement occurred for 20 negative CRM propositions and 2 positive ones (p < 0.001, McNemar test). Conclusions: Overall the CRM advised positively for reimbursing innovation in < 40% of submissions with OMPs being advised positively about twice as much than class1 products. The Minister reimburses innovative products in > 75% of cases; disagreement with the CRM reflects mainly the decidision to reimburse products which were negatively advised by the CRM. PHP161 Linear, Flat And Mixed Pricing Structures As Negotiation Quantities Of New Medicinal Products In Context Of Amnog In Germany: A Comparison At Market Launch And Post Price Negotiations Bot D, Campion M, Ecker T Ecker + Ecker GmbH, Hamburg, Germany
Objectives: Within the framework of AMNOG price negotiations between pharmaceutical manufacturers and SHI (National Association of Statutory Health Insurance Funds), a relevant quantity for both parties is the pricing structure of the reimbursed price after negotiations. While the SHI generally favors a linear pricing structure (price increases with dose), the choice of pricing structure by manufacturers between flat pricing (identical price for different doses), linear pricing or a combination of the two (“mixed pricing”) depends on different parameters such as indication, expected physicians’ prescription behavior or conditions of parallel trade issues due to the European reference pricing. The objective of this study is to assess if manufacturers could maintain their favored pricing structure for new pharmaceuticals at market launch in Germany after price negotiations. Methods: Analysis is based on all price negotiations concluded until June 2016 in which manufacturers entered into either with a linear, a flat or a mixed pricing structure. Negotiations were excluded in this analysis if the respective drug was available only in one dose or if the drug has been withdrawn from the market before negotiation started. Afterwards, the selected negotiations were analyzed by comparing initial ex-factory prices of all packages for each drug at market launch and final prices after negotiations. Results: 47 relevant negotiations were identified. Manufacturers could maintain their favored pricing model in 38 negotiations (linear pricing= 17, flat pricing= 18, mixed pricing= 3) while pricing structures switched in 9 negotiations (linear to flat pricing= 1, linear to mixed pricing= 1, flat to linear pricing= 6, flat to mixed pricing= 1). Conclusions: In price