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Differences And Decision Drivers In The Hta-Outcome Category Lower Benefit Between Iqwig And G-Ba Assment In The German Amnog Process
A664
VA L U E I N H E A LT H 2 0 ( 2 0 1 7 ) A 3 9 9 – A 8 1 1
were noticed. A rational antibiotic use policy should be framed. Longitudinal surveillance of ICU antibacterial used should be carried out. PHP69 Search Of High Active And Low Toxic Newly Synthesized Derivatives Of Piperidine For Regional Anesthesia Kadyrova D, Smagulova G, Kim I, Seitaliyeva A, Satbayeva E, Ananyeva L, Batagoeva Z Asfendiyarov Kazakh National Medical University, Almaty, Kazakhstan
Objectives: comparative assessment of local anesthetic activity of newly synthesized derivatives of piperidine for regional anesthesia, depending on their chemical structure. Methods: local anesthesia was determined by the method of “tail-flick” on white rats. Results: For research of activity of the compound at the particular type of anesthesia the great important index is duration of complete anesthesia. The duration of complete anaesthesia of LAS-174 was similar to trimecaine, slightly higher than that of novocaine and a little bit less than lidocaine (p> 0.05). Total duration of action of LAS-174 is higher than the novocaine and trimekain, and a few exceeding that of lidocaine (p> 0.05). LAS-175 index of full anesthesia was 2 times higher than trimekain, 2.5 times than novocaine and a few more than lidocaine (p> 0.05). By the total duration this compound exceeds the matched values of trimethoprim, lidocaine and novocaine in 3.4, 1.9 and 4.6 times, respectively. Replacement of the propyl radical to Amillic in the side chain at the 4-th carbon atom of the piperidine ring enhances local activity by the similar toxicity. In 1% solution duration of anesthesia of LAS-190 is similar to the trimecaine and slightly lower than the lidocaine. LAS-189 shows a weaker effect than trimekain and lidocaine (p> 0.05). LAS-189 and 190 by the duration of anesthesia was more effective than novocaine, but this difference is not statistically significant. Replacement of the propyl radical (LAS-189) to the phenyl (LAS-190) contributes to increase of local anesthetic activity, especially for the total duration. Acute toxicity of LAS-189 is 750±of 35.56, LAS-190 - 1284±43,87. Conclusions: the Introduction of a cyclopropane radical at the triple bind of the piperidine ring leads to increased local anesthetic effect, weighting of the radical at the 4th carbon atom contributes to the growth of activity and lower toxicity. PHP70 Forecasting Pharmaceutical Expenditure In Europe: Adjusting For The Impact Of Rebates And Discounts Espin J1, Schlander M2, Godman B3, Anderson P4, Mestre-Ferrandiz J5, Hutchings A6, Flostrand S7, Parnaby A7 1Andalusian School of Public Health, Granada, Spain, 2University of Heidelberg/German Cancer Research Center (DKFZ), Heidelberg, Germany, 3Karolinska Institutet, Stockholm, Sweden, 4Swansea University, Swansea, UK, 5Independent economics consultant, Madrid, Spain, 6Dolon Ltd, London, UK, 7Celgene International, Boudry, Switzerland
Objectives: European healthcare systems are under pressure to contain healthcare expenditure. Understanding future drug expenditure is an important consideration for payers when formulating policies. QuintilesIMS publishes European forecasts that are underpinned by its audited volume data and publicly available list prices. With increasing price pressures, list to net price divergence is growing, although some of this information is commercially sensitive and thus not publicly available. The objective of this study was to further develop an established forecast to account for this divergence and explore its impact. Methods: QuintilesIMS forecast of pharmaceutical expenditure in EU5 countries through 2021 is developed based on its capture of medicines pack data and using previously described methodologies (QuintilesIMS Market Prognosis publications). The top-line forecast was adjusted for each country to account for rebates and discounts that are not reflected within QuintilesIMS data, including industry-level rebates and product-level discounts to national, regional and hospital payers. Average rebate/discounts levels were estimated from aggregate data reported by national health system organisations, industry associations and interviews with country experts. Sensitivity analysis was undertaken to address uncertainty around estimates. Results: The QuintilesIMS forecast based on list prices predicts average compound annual growth rates (CAGR) of 3% across EU5. Using OECD data to account for rebates and discounts reduces the predicted expenditure growth rate by 1 to 2% points. Ongoing analyses are in development to explore extent and variation of this reduction across countries. Conclusions: The increasing frequency and magnitude of patient access schemes, rebates and discounts have led to a growing divergence between list and net prices for medicines in Europe. This is driven by policies such as external reference pricing, growth in risk sharing arrangements and a shift in pharmaceutical innovation from retail to hospital settings. Adjusting for these discounts is important to understand the future real pharmaceutical expenditure growth in Europe. PHP71 Persistence And Concentration Of Prescription Drug Expenditure Among Medicare Beneficiaries 2006-2013 Xu Y, Joyce G University of Southern California, Los Angeles, CA, USA
Objectives: The rapid growth of prescription drug spending is a major concern for U.S. policymakers. In 2016, prescription drugs accounted for over 16% of total health care spending and are projected to grow more rapidly in the next decade. Using longitudinal Part D claims from 2006-2013, we examined the persistence and concentration of prescription drug spending among Medicare beneficiaries. Methods: We followed beneficiaries’ claims histories for up to 9 years and defined the spending as the sum of out-of-pocket payment and Medicare plan payment. Results: Total spending on prescription drug increased by 61% between 2006-2013 in Part D plans, with average spending per beneficiary increasing from $2,326 to $2,943 over this period. An increasing larger fraction of total spending is attributable to the top-decile of the beneficiaries. In 2013, 2% of beneficiaries accounted for one third of total drug spending, and 5% accounted for over 40% of the total in Part D. The top 2% beneficiaries spent twice as much in 2013 as in 2006, while the lower spending group had marginal increases or even decreases. In contrast to medical
services, there was a high degree of persistence in drug spending. Beneficiaries in the top 2%/5%/10% of drug spending in year (t) were likely to remain in the top decile of spending in subsequent years. For example, 75%, 60% and 60% of the high spending beneficiaries in 2010 remained in the category for the subsequent 3 years, respectively. Subsidized beneficiaries (dual-eligibles for both Medicare and Medicaid, and Low-income-subsidy recipients) were disproportionately high users of prescription drugs, with 8 out of 10 beneficiaries in the top 5% of drug spending receiving subsidies for premiums and/or cost-sharing. Conclusions: Slowing the growth in drug spending will be challenging given the high degree of persistence and concentration in Part D expenditures, particularly for beneficiaries that face minimal cost-sharing. PHP72 Differences And Decision Drivers In The Hta-Outcome Category Lower Benefit Between Iqwig And G-Ba Assment In The German Amnog Process von Hein M, Jakovac M, Peters A, Eheberg D QuintilesIMS, Munich, Germany
Objectives: The outcome of the HTA-process (early benefit assessment) is crucial for the successful launch and commercialization of pharmaceuticals in Germany. The aim was to assess how often the evaluation “lower benefit” varies between IQWiG and G-BA. Additionally, we wanted to evaluate what triggered these decisions. Methods: IQWiG benefit assessments and G-BA decisions published on the G-BA website between 01.01.2011 and 15.05.2017 were screened using the QuintilesIMS HTA-database. Documents were screened for a “lower benefit” on a subpopulation-level and a descriptive analysis was performed to identify decision drivers. Results: The database search identified 12 dossiers where “lower benefit” was determined for at least one subpopulation. The IQWiG split patient populations into 48, the G-BA into 32 subpopulations. “Lower benefit” was determined for 15 subpopulations by the IQWiG and 2 by the G-BA. Lower benefit categorization by the IQWiG was triggered by negative effects related to endpoints in the categories safety (12), morbidity (5), mortality (4) and quality of life (3). The G-BA decisions were driven by negative effects in mortality (1) and morbidity (1). Conclusions: While the G-BA decision generally follows the IQWiG benefit assessment, IQWiG benefit assessment and G-BA decision differ significantly with regard to “lower benefit”. The G-BA determines a “lower benefit” in fewer cases and decisions are much less driven by safety outcomes. Furthermore, the G-BA does not split patient populations into that many subpopulations compared to the IQWiG which might also influence lower benefit assessment.
HEALTH CARE USE & POLICY STUDIES – Equity and Access PHP73 Influence of Peer Pressure Mechanism on Quality and Costs of Healthcare, on Examples of Israel, France and USA Rączka A, Hermanowski TR, Cegłowska U Medical University of Warsaw, Warsaw, Poland
Objectives: Quality management is an essential element of health care. In countries where health systems are characterized by high level of efficiency, quality programs are employed to ensure certain standards of medical services and patients’ safety. This paper aims to explore what methods of implementation and forms of peer pressure mechanism, as a part of quality improvement initiatives, are present in selected health systems and what is their impact on quality and costs of healthcare. Methods: A systematic review based on publications identified in PubMed database was conducted. A developed search strategy was used to select relevant papers published up to 30th May 2017. Results: Of the 471 references identified, data was collected from 17 studies (15 prospective and 2 retrospective). Publications covered many areas of healthcare including primary, specialized, ambulatory and hospital care. Evaluation of outcomes in 4 studies was based on data collected from questionnaires completed by members of medical stuff. In 15 studies healthcare providers and medical stuff received feedback concerning their performance of provided medical care. In majority of publications quality indicators were recognized as a useful tool for quality assessment. Researches selected for the systematic review confirmed presence of the peer pressure mechanism in examined health systems. Studied tool for quality improvement was implemented in different forms and with the reference to all identified publications, it applied to every level of healthcare. Its positive effect on quality and safety of medical services was demonstrated. Conclusions: The obtained results partly confirmed an initial hypothesis, in which positive impact of peer pressure mechanism on quality and costs of analysed health systems, was assumed. In order to fully confirm it, a further research, which would include publications referring to wider range of counties, is recommended. PHP74 The Effect of Policies for Improving the Access to New Medicines in South Korea: A Retrospective Analysis in 2007 - 2016 KIM E1, Lee E2 1UCB Korea, Seoul, Korea, Republic of (South), 2Sungkyunkwan University, Suwon-si, Gyeonggi-do, Korea, Republic of (South)
Objectives: The aim of this study is to analyze the status of national reimbursement decision depending on influential factors and the effect of policy change such as risk-sharing agreement, PE exemption and price negotiation exemption with NHIS compared pre with post-policy. Methods: A database was created based on publicly available information from 2007–2016 of the HIRA appraisals, certificates of regulatory approval, and MOHW listing announcement. For the categorical variable, Pearson’s Chi-squared test, or the two-side Fisher’s exact test is conducted and regarding continuous variables, Mann Whitney U test or Kruskcal-Wallis Test
VA L U E I N H E A LT H 2 0 ( 2 0 1 7 ) A 3 9 9 – A 8 1 1
were noticed. A rational antibiotic use policy should be framed. Longitudinal surveillance of ICU antibacterial used should be carried out. PHP69 Search Of High Active And Low Toxic Newly Synthesized Derivatives Of Piperidine For Regional Anesthesia Kadyrova D, Smagulova G, Kim I, Seitaliyeva A, Satbayeva E, Ananyeva L, Batagoeva Z Asfendiyarov Kazakh National Medical University, Almaty, Kazakhstan
Objectives: comparative assessment of local anesthetic activity of newly synthesized derivatives of piperidine for regional anesthesia, depending on their chemical structure. Methods: local anesthesia was determined by the method of “tail-flick” on white rats. Results: For research of activity of the compound at the particular type of anesthesia the great important index is duration of complete anesthesia. The duration of complete anaesthesia of LAS-174 was similar to trimecaine, slightly higher than that of novocaine and a little bit less than lidocaine (p> 0.05). Total duration of action of LAS-174 is higher than the novocaine and trimekain, and a few exceeding that of lidocaine (p> 0.05). LAS-175 index of full anesthesia was 2 times higher than trimekain, 2.5 times than novocaine and a few more than lidocaine (p> 0.05). By the total duration this compound exceeds the matched values of trimethoprim, lidocaine and novocaine in 3.4, 1.9 and 4.6 times, respectively. Replacement of the propyl radical to Amillic in the side chain at the 4-th carbon atom of the piperidine ring enhances local activity by the similar toxicity. In 1% solution duration of anesthesia of LAS-190 is similar to the trimecaine and slightly lower than the lidocaine. LAS-189 shows a weaker effect than trimekain and lidocaine (p> 0.05). LAS-189 and 190 by the duration of anesthesia was more effective than novocaine, but this difference is not statistically significant. Replacement of the propyl radical (LAS-189) to the phenyl (LAS-190) contributes to increase of local anesthetic activity, especially for the total duration. Acute toxicity of LAS-189 is 750±of 35.56, LAS-190 - 1284±43,87. Conclusions: the Introduction of a cyclopropane radical at the triple bind of the piperidine ring leads to increased local anesthetic effect, weighting of the radical at the 4th carbon atom contributes to the growth of activity and lower toxicity. PHP70 Forecasting Pharmaceutical Expenditure In Europe: Adjusting For The Impact Of Rebates And Discounts Espin J1, Schlander M2, Godman B3, Anderson P4, Mestre-Ferrandiz J5, Hutchings A6, Flostrand S7, Parnaby A7 1Andalusian School of Public Health, Granada, Spain, 2University of Heidelberg/German Cancer Research Center (DKFZ), Heidelberg, Germany, 3Karolinska Institutet, Stockholm, Sweden, 4Swansea University, Swansea, UK, 5Independent economics consultant, Madrid, Spain, 6Dolon Ltd, London, UK, 7Celgene International, Boudry, Switzerland
Objectives: European healthcare systems are under pressure to contain healthcare expenditure. Understanding future drug expenditure is an important consideration for payers when formulating policies. QuintilesIMS publishes European forecasts that are underpinned by its audited volume data and publicly available list prices. With increasing price pressures, list to net price divergence is growing, although some of this information is commercially sensitive and thus not publicly available. The objective of this study was to further develop an established forecast to account for this divergence and explore its impact. Methods: QuintilesIMS forecast of pharmaceutical expenditure in EU5 countries through 2021 is developed based on its capture of medicines pack data and using previously described methodologies (QuintilesIMS Market Prognosis publications). The top-line forecast was adjusted for each country to account for rebates and discounts that are not reflected within QuintilesIMS data, including industry-level rebates and product-level discounts to national, regional and hospital payers. Average rebate/discounts levels were estimated from aggregate data reported by national health system organisations, industry associations and interviews with country experts. Sensitivity analysis was undertaken to address uncertainty around estimates. Results: The QuintilesIMS forecast based on list prices predicts average compound annual growth rates (CAGR) of 3% across EU5. Using OECD data to account for rebates and discounts reduces the predicted expenditure growth rate by 1 to 2% points. Ongoing analyses are in development to explore extent and variation of this reduction across countries. Conclusions: The increasing frequency and magnitude of patient access schemes, rebates and discounts have led to a growing divergence between list and net prices for medicines in Europe. This is driven by policies such as external reference pricing, growth in risk sharing arrangements and a shift in pharmaceutical innovation from retail to hospital settings. Adjusting for these discounts is important to understand the future real pharmaceutical expenditure growth in Europe. PHP71 Persistence And Concentration Of Prescription Drug Expenditure Among Medicare Beneficiaries 2006-2013 Xu Y, Joyce G University of Southern California, Los Angeles, CA, USA
Objectives: The rapid growth of prescription drug spending is a major concern for U.S. policymakers. In 2016, prescription drugs accounted for over 16% of total health care spending and are projected to grow more rapidly in the next decade. Using longitudinal Part D claims from 2006-2013, we examined the persistence and concentration of prescription drug spending among Medicare beneficiaries. Methods: We followed beneficiaries’ claims histories for up to 9 years and defined the spending as the sum of out-of-pocket payment and Medicare plan payment. Results: Total spending on prescription drug increased by 61% between 2006-2013 in Part D plans, with average spending per beneficiary increasing from $2,326 to $2,943 over this period. An increasing larger fraction of total spending is attributable to the top-decile of the beneficiaries. In 2013, 2% of beneficiaries accounted for one third of total drug spending, and 5% accounted for over 40% of the total in Part D. The top 2% beneficiaries spent twice as much in 2013 as in 2006, while the lower spending group had marginal increases or even decreases. In contrast to medical
services, there was a high degree of persistence in drug spending. Beneficiaries in the top 2%/5%/10% of drug spending in year (t) were likely to remain in the top decile of spending in subsequent years. For example, 75%, 60% and 60% of the high spending beneficiaries in 2010 remained in the category for the subsequent 3 years, respectively. Subsidized beneficiaries (dual-eligibles for both Medicare and Medicaid, and Low-income-subsidy recipients) were disproportionately high users of prescription drugs, with 8 out of 10 beneficiaries in the top 5% of drug spending receiving subsidies for premiums and/or cost-sharing. Conclusions: Slowing the growth in drug spending will be challenging given the high degree of persistence and concentration in Part D expenditures, particularly for beneficiaries that face minimal cost-sharing. PHP72 Differences And Decision Drivers In The Hta-Outcome Category Lower Benefit Between Iqwig And G-Ba Assment In The German Amnog Process von Hein M, Jakovac M, Peters A, Eheberg D QuintilesIMS, Munich, Germany
Objectives: The outcome of the HTA-process (early benefit assessment) is crucial for the successful launch and commercialization of pharmaceuticals in Germany. The aim was to assess how often the evaluation “lower benefit” varies between IQWiG and G-BA. Additionally, we wanted to evaluate what triggered these decisions. Methods: IQWiG benefit assessments and G-BA decisions published on the G-BA website between 01.01.2011 and 15.05.2017 were screened using the QuintilesIMS HTA-database. Documents were screened for a “lower benefit” on a subpopulation-level and a descriptive analysis was performed to identify decision drivers. Results: The database search identified 12 dossiers where “lower benefit” was determined for at least one subpopulation. The IQWiG split patient populations into 48, the G-BA into 32 subpopulations. “Lower benefit” was determined for 15 subpopulations by the IQWiG and 2 by the G-BA. Lower benefit categorization by the IQWiG was triggered by negative effects related to endpoints in the categories safety (12), morbidity (5), mortality (4) and quality of life (3). The G-BA decisions were driven by negative effects in mortality (1) and morbidity (1). Conclusions: While the G-BA decision generally follows the IQWiG benefit assessment, IQWiG benefit assessment and G-BA decision differ significantly with regard to “lower benefit”. The G-BA determines a “lower benefit” in fewer cases and decisions are much less driven by safety outcomes. Furthermore, the G-BA does not split patient populations into that many subpopulations compared to the IQWiG which might also influence lower benefit assessment.
HEALTH CARE USE & POLICY STUDIES – Equity and Access PHP73 Influence of Peer Pressure Mechanism on Quality and Costs of Healthcare, on Examples of Israel, France and USA Rączka A, Hermanowski TR, Cegłowska U Medical University of Warsaw, Warsaw, Poland
Objectives: Quality management is an essential element of health care. In countries where health systems are characterized by high level of efficiency, quality programs are employed to ensure certain standards of medical services and patients’ safety. This paper aims to explore what methods of implementation and forms of peer pressure mechanism, as a part of quality improvement initiatives, are present in selected health systems and what is their impact on quality and costs of healthcare. Methods: A systematic review based on publications identified in PubMed database was conducted. A developed search strategy was used to select relevant papers published up to 30th May 2017. Results: Of the 471 references identified, data was collected from 17 studies (15 prospective and 2 retrospective). Publications covered many areas of healthcare including primary, specialized, ambulatory and hospital care. Evaluation of outcomes in 4 studies was based on data collected from questionnaires completed by members of medical stuff. In 15 studies healthcare providers and medical stuff received feedback concerning their performance of provided medical care. In majority of publications quality indicators were recognized as a useful tool for quality assessment. Researches selected for the systematic review confirmed presence of the peer pressure mechanism in examined health systems. Studied tool for quality improvement was implemented in different forms and with the reference to all identified publications, it applied to every level of healthcare. Its positive effect on quality and safety of medical services was demonstrated. Conclusions: The obtained results partly confirmed an initial hypothesis, in which positive impact of peer pressure mechanism on quality and costs of analysed health systems, was assumed. In order to fully confirm it, a further research, which would include publications referring to wider range of counties, is recommended. PHP74 The Effect of Policies for Improving the Access to New Medicines in South Korea: A Retrospective Analysis in 2007 - 2016 KIM E1, Lee E2 1UCB Korea, Seoul, Korea, Republic of (South), 2Sungkyunkwan University, Suwon-si, Gyeonggi-do, Korea, Republic of (South)
Objectives: The aim of this study is to analyze the status of national reimbursement decision depending on influential factors and the effect of policy change such as risk-sharing agreement, PE exemption and price negotiation exemption with NHIS compared pre with post-policy. Methods: A database was created based on publicly available information from 2007–2016 of the HIRA appraisals, certificates of regulatory approval, and MOHW listing announcement. For the categorical variable, Pearson’s Chi-squared test, or the two-side Fisher’s exact test is conducted and regarding continuous variables, Mann Whitney U test or Kruskcal-Wallis Test