- Email: [email protected]
Attitudes Towards Generic Substitution In Greece
A656
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
of the Ministry of Health, Labor and Welfare (MHLW). We investigated if new drugs listed from April 2014 to December 2016 had reference countries’ prices and Orphan Designation, and selected NHI prices of new drugs which have at least one or more reference countries’ prices, in addition to Orphan Designation. We compared the selected NHI prices with “Foreign Average Price (FAP)”, the average of all existing reference countries’ prices the “EU Average Price (EUP)”, the average of all existing prices of UK, Germany and France and the “US Price (USP).” Results: A total of 181 new drugs were listed on the NHI price list from April 2014 to December 2016. Out of 181 drugs, 120 drugs (66%) had at least one or more reference countries’ prices, of which 48 drugs (40%) received Orphan Designation. In addition, among the Orphan Designated drugs, 83%, 65% and 91% were priced lower than FAP, EUP and USP, respectively. For other drugs, 88%, 71% and 94% were priced lower than FAP, EUP and USP, respectively. Conclusions: In the past three years, NHI pricings for new drugs in Japan tended to be lower than Reference Countries’ prices, even of new drugs for unmet medical needs. Further guidance to value new drugs, especially Orphan Designated drugs, would be necessary for the pricing system in Japan. PHP24 Attitudes Towards Generic Substitution In Greece Kyriopoulos D1, Kyriopoulos I2, Athanasakis K1 School of Public Health, Athens, Greece, 2London School of Economics and Political Science, London, UK
1National
Objectives: Generic substitution is a popular measure for cost containment in pharmaceutical markets. During the last period, it was among the main priorities of the pharmaceutical policy agenda in Greece, and a key element of the economic adjustment programme in health sector. In this context, this study aims to examine the determinants of patients’ attitudes towards generic substitution in Greece. Methods: A cross-sectional survey was conducted on a representative national sample of 2012 adult individuals. The dependent variable is a binary variable regarding the extent to which respondents could accept generic substitution. The independent variables are: urbanity, social status, gender, age, marital status, education, source of information about pharmaceutical care, chronic conditions and knowledge about generics. The empirical analysis was conducted using a logistic regression model. Results: Our findings suggest that 39.2% of the respondents were willing to accept generic substitution in the pharmacy, as they considered generic medication as an equal therapeutic alternative to branded pharmaceuticals. Male, high educated and those living in urban areas are more likely to have a positive attitude towards generic substitution. Moreover, respondents who received information from their pharmacists are more likely to accept generic substitution, relative to those being informed by doctors. Chronic patients are less likely to accept generic substitution. In particular, the odds ratios are 0.79 and 0.70 for those having one and two or more conditions respectively. Social status, age, and marital status were not statistically significant determinants of the attitudes towards generic substitution. Conclusions: A significant share of the respondents is reluctant to accept generic substitution. In this context, some specific population groups may need further information about generic drugs and substitution, and the therapeutic equivalence between generics and branded drugs. The findings of this study are useful towards designing targeted interventions for specific population groups in Greece. PHP25 Evaluating Patients’, Physicians’ And Pharmacists’ Perception Regarding Generic Medicines In Ethiopia: Findings And Implications Erku DA1, Gebresillassie BM2, Tefera YG3, Belachew SA1, Abebe TB1, Haile KT1, Mekuria Ab1 of Gondar, Gondar, Ethiopia, 2university of gondar, gondar, Ethiopia, 3University of Gondar, City, Ethiopia
data” in 2015 public availability of such evidence has been highlighted. However, publication of clinical data is not a new issue and has been practiced before by HTA agencies like G-BA and IQWiG in Germany. The aim of this study is to determine the information provided in both, German dossiers/benefit assessments and the EMA database, comparing reporting quality. Methods: All documents were retrieved from the G-BA homepage and the EMA database until March 15th 2017. The following sources for extraction had to be available: Dossier module 4 and benefit assessment (G-BA), any clinical data available on the EMA database. Extraction included 16 study methods and 8 results items (method used by Koehler et al. BMJ 2015; 350: h796). Reporting quality was rated as “completely reported”, “partly reported” or “not reported”. Results: Overall only 2 drugs had both available, G-BA dossier/ assessment and EMA clinical data (Elotuzumab and Carfilzomib). For these 2 drugs 15 clinical studies were assessed. Both sources reached high grades of completeness. G-BA dossiers/assessments (2 studies) were 100% completely reported for methods (32 out of 32 items) and 87.5% completely reported for results (14 out of 16 items). For EMA clinical data (13 studies), the rate was 86.1% for methods (179 out of 208 items) and 97.1% for results (101 out of 104 items). Conclusions: Regarding reporting quality, no major differences between G-BA dossiers/assessments and EMA clinical data was observed. Both publicly available sources provide sufficient information on new drugs. Nevertheless, each datasource has advantages and deficits. AMNOG documents are available in German language only and the EMA database currently only contains a very limited number of newly approved drugs. PHP27 Medicine Prices Disparity Among Retail Pharmacies In Selangor, Malaysia Lim YW1, Neoh CF2, Lee KS1, Tan CS3, Khan TM4, Long CM5 1Pharmaceutical Services Division, Ministry of Health, Malaysia, Petaling Jaya, Malaysia, 2Universiti Teknology MARA, Malaysia, Shah Alam, Malaysia, 3KPJ International College, Bukit Mertajam, Malaysia, 4Monash University Malaysia, Subang Jaya, Malaysia, 5University of Tasmania, Hobart, Australia
Objectives: To date, there is no stipulated law to control medicine prices in Malaysia. This free pricing policy has led to disparity of prices between innovator and generic medicine among the private healthcare settings, namely general practitioner (GP) clinics (independent, chained) and retail pharmacies (RPs) (independent, chained). This study was carried out to evaluate the medicine (innovator, generic) prices variation among the RPs in Malaysia. Methods: Simulated client method was adopted in this study to obtain the actual selling medicine prices in the RPs in the state of Selangor, Malaysia. A total of 142 RPs were selected, using simple random sampling technique. Five data collectors were recruited and trained as simulated clients to elicit the actual selling price for the 10 selected medicines (both innovator and lowest price generic) which are highly used in Malaysia. Results: For innovator, only salbutamol 100 mcg inhaler (200 doses) (p= 0.043) and gliclazide 80 mg tablet (p= 0.043) were sold at a lower price at chain RPs when compared to independent RPs. As for lowest price generic products, only furosemide 40 mg tablet (p= 0.002) and metoprolol 100 mg tablet (p= 0.036) were found to be cheaper at the chained RPs than the independent RPs. Of note, simvastatin 20 mg tablet (Zocor®) was sold at a higher median (range) price at the chained RPs than the independent RPs [RM 2.63 (2.19-3.80) versus RM 2.32 (1.17-4.13), p= 0.009]. Conclusions: It was interesting to find that the perception of cheaper price of medicines in chained pharmacies as compared to independent pharmacies is fallacious. The findings of this study will facilitate policy makers in drawing conclusion about the differences of medicine prices and will be useful in devising appropriate policy for medicine price control in Malaysia.
1University
Objectives: Generic medicine prescribing has become a common practice in many countries. However, data regarding the perception of stakeholders (patients, prescribers and dispensers) regarding generic medicines in Ethiopia is scarce. The present survey aimed at investigating the perception of patients, physicians and community pharmacists regarding generic medicines in Ethiopia. Methods: A quantitative cross-sectional survey was conducted between January 1 and February 1, 2017. The questionnaire was administered to patients, physicians and community pharmacists. Frequencies, percentages, Mann Whitney and Kruskal Wallis tests were performed using Statistical Package for the Social Sciences (SPSS) software version 21.0 for Windows (SPSS Inc., Chicago, IL). Results: Majority of patients surveyed (83.1%) agreed that the costs of medicines in Ethiopia is too high and 61.4% of respondents believed that cost should be considered before a drug is prescribed. 75.2% of patients accept the pharmacist substituting their prescribed medications to a cheaper medicine. On the other hand, majority of physicians (70.6%) indicated a very low generic medicine prescription rate. About 91% of physicians and 87.2% of pharmacists agreed that they need a standard guideline to both prescribers and pharmacist on brand substitution process. Furthermore, 39.9% of the physicians and 87.2% of pharmacists agreed that drug advertisements by the manufacturers would influence their prescribing/dispensing practice. Conclusions: Our findings demonstrate that a significant proportion of patients, doctors and pharmacists hold negative perceptions of generic medicines. The insights obtained in the present study will be useful to healthcare organizations, policy makers and other stakeholders to design and implement a robust generic medicine policy and guideline, thereby promoting the rational and cost-effective use of medicine in the country. [BM1]Physicians. PHP26 Open To The Public? A Comparative Analysis Of Data Published Under The “Ema Policy On The Publication Of Clinical Data” And Dossiers For Early Benefit Assessments In Germany
PHP28 Pricing Pantoprazole In Greece: A Tale Of Distortion Ollandezos M, Papadopoulos K, Pentafragka E, Stefanidou Z Panhellenic Association of Pharmaceutical Industry, Athens, Greece
Objectives: Generics in Greece are priced at 65% of the price of the reference off-patent while off patents are priced at the minimum between a decrease of 50% of their latest on - patent price, and the average of the three lowest prices of the same product among the EU countries. The purpose of this study is to assess the price level of generics pantoprazole in Greece. Methods: Official pricing data were used to identify the three EU countries which set the outpatient market price for off-patent pantoprazole 40 mg in Greece in December 2016. The ex-factory prices for the originator and generics in each of the three EU countries were derived from the official price sources in each country. All prices were normalized to correspond to monthly treatment. Results: Originator pantoprazole price derived from the prices of the same product in Ireland, Poland and Austria. Average ex-factory price for generic pantoprazole 40mg in Greece (2.05€ ) were lower than the respective exfactory price in Ireland (3.08€ :- 33.31%), in Poland (2.61€ : -21.35%), and in Austria (2.76€ : -25.68%). Conclusions: Average ex-factory price for generic pantoprazole in Greece is up to 33.31% below the respective generic prices at the EU countries with the lowest price of the reference originator. With rebates and clawback considered, the average ex-factory price for generic pantoprazole in Greece is further reduced by 30% approximately in 2016. However, despite the excessively low net ex- factory price of generics (after rebates and clawback), current generic penetration (~25%) still remains far from the MoU target of 40% by volume for 2017. This suggests for the need of an effective and reasonable pricing regulation to ensure market viability for generics in parallel with demand side measures to foster generic use through appropriate incentives for physicians, pharmacists and patients.
El Ouardani W, Boehler Y TH Koeln, University of Applied Sciences, Leverkusen, Germany
PHP29 Demand And Supply Side Regulation Of Biosimilar Markets In Germany, France And England And Its Implications For Market Access Of Biosimilars
Objectives: Evidence on new drugs is key to various parties in health care for clinical and health policy decisions. With the “EMA policy on the publication of clinical
1University
Walendzik A1, Altin S2, Wasem J2 Duisburg-Essen, Essen, Germany, 2University of Duisburg-Essen, Essen, Germany
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
of the Ministry of Health, Labor and Welfare (MHLW). We investigated if new drugs listed from April 2014 to December 2016 had reference countries’ prices and Orphan Designation, and selected NHI prices of new drugs which have at least one or more reference countries’ prices, in addition to Orphan Designation. We compared the selected NHI prices with “Foreign Average Price (FAP)”, the average of all existing reference countries’ prices the “EU Average Price (EUP)”, the average of all existing prices of UK, Germany and France and the “US Price (USP).” Results: A total of 181 new drugs were listed on the NHI price list from April 2014 to December 2016. Out of 181 drugs, 120 drugs (66%) had at least one or more reference countries’ prices, of which 48 drugs (40%) received Orphan Designation. In addition, among the Orphan Designated drugs, 83%, 65% and 91% were priced lower than FAP, EUP and USP, respectively. For other drugs, 88%, 71% and 94% were priced lower than FAP, EUP and USP, respectively. Conclusions: In the past three years, NHI pricings for new drugs in Japan tended to be lower than Reference Countries’ prices, even of new drugs for unmet medical needs. Further guidance to value new drugs, especially Orphan Designated drugs, would be necessary for the pricing system in Japan. PHP24 Attitudes Towards Generic Substitution In Greece Kyriopoulos D1, Kyriopoulos I2, Athanasakis K1 School of Public Health, Athens, Greece, 2London School of Economics and Political Science, London, UK
1National
Objectives: Generic substitution is a popular measure for cost containment in pharmaceutical markets. During the last period, it was among the main priorities of the pharmaceutical policy agenda in Greece, and a key element of the economic adjustment programme in health sector. In this context, this study aims to examine the determinants of patients’ attitudes towards generic substitution in Greece. Methods: A cross-sectional survey was conducted on a representative national sample of 2012 adult individuals. The dependent variable is a binary variable regarding the extent to which respondents could accept generic substitution. The independent variables are: urbanity, social status, gender, age, marital status, education, source of information about pharmaceutical care, chronic conditions and knowledge about generics. The empirical analysis was conducted using a logistic regression model. Results: Our findings suggest that 39.2% of the respondents were willing to accept generic substitution in the pharmacy, as they considered generic medication as an equal therapeutic alternative to branded pharmaceuticals. Male, high educated and those living in urban areas are more likely to have a positive attitude towards generic substitution. Moreover, respondents who received information from their pharmacists are more likely to accept generic substitution, relative to those being informed by doctors. Chronic patients are less likely to accept generic substitution. In particular, the odds ratios are 0.79 and 0.70 for those having one and two or more conditions respectively. Social status, age, and marital status were not statistically significant determinants of the attitudes towards generic substitution. Conclusions: A significant share of the respondents is reluctant to accept generic substitution. In this context, some specific population groups may need further information about generic drugs and substitution, and the therapeutic equivalence between generics and branded drugs. The findings of this study are useful towards designing targeted interventions for specific population groups in Greece. PHP25 Evaluating Patients’, Physicians’ And Pharmacists’ Perception Regarding Generic Medicines In Ethiopia: Findings And Implications Erku DA1, Gebresillassie BM2, Tefera YG3, Belachew SA1, Abebe TB1, Haile KT1, Mekuria Ab1 of Gondar, Gondar, Ethiopia, 2university of gondar, gondar, Ethiopia, 3University of Gondar, City, Ethiopia
data” in 2015 public availability of such evidence has been highlighted. However, publication of clinical data is not a new issue and has been practiced before by HTA agencies like G-BA and IQWiG in Germany. The aim of this study is to determine the information provided in both, German dossiers/benefit assessments and the EMA database, comparing reporting quality. Methods: All documents were retrieved from the G-BA homepage and the EMA database until March 15th 2017. The following sources for extraction had to be available: Dossier module 4 and benefit assessment (G-BA), any clinical data available on the EMA database. Extraction included 16 study methods and 8 results items (method used by Koehler et al. BMJ 2015; 350: h796). Reporting quality was rated as “completely reported”, “partly reported” or “not reported”. Results: Overall only 2 drugs had both available, G-BA dossier/ assessment and EMA clinical data (Elotuzumab and Carfilzomib). For these 2 drugs 15 clinical studies were assessed. Both sources reached high grades of completeness. G-BA dossiers/assessments (2 studies) were 100% completely reported for methods (32 out of 32 items) and 87.5% completely reported for results (14 out of 16 items). For EMA clinical data (13 studies), the rate was 86.1% for methods (179 out of 208 items) and 97.1% for results (101 out of 104 items). Conclusions: Regarding reporting quality, no major differences between G-BA dossiers/assessments and EMA clinical data was observed. Both publicly available sources provide sufficient information on new drugs. Nevertheless, each datasource has advantages and deficits. AMNOG documents are available in German language only and the EMA database currently only contains a very limited number of newly approved drugs. PHP27 Medicine Prices Disparity Among Retail Pharmacies In Selangor, Malaysia Lim YW1, Neoh CF2, Lee KS1, Tan CS3, Khan TM4, Long CM5 1Pharmaceutical Services Division, Ministry of Health, Malaysia, Petaling Jaya, Malaysia, 2Universiti Teknology MARA, Malaysia, Shah Alam, Malaysia, 3KPJ International College, Bukit Mertajam, Malaysia, 4Monash University Malaysia, Subang Jaya, Malaysia, 5University of Tasmania, Hobart, Australia
Objectives: To date, there is no stipulated law to control medicine prices in Malaysia. This free pricing policy has led to disparity of prices between innovator and generic medicine among the private healthcare settings, namely general practitioner (GP) clinics (independent, chained) and retail pharmacies (RPs) (independent, chained). This study was carried out to evaluate the medicine (innovator, generic) prices variation among the RPs in Malaysia. Methods: Simulated client method was adopted in this study to obtain the actual selling medicine prices in the RPs in the state of Selangor, Malaysia. A total of 142 RPs were selected, using simple random sampling technique. Five data collectors were recruited and trained as simulated clients to elicit the actual selling price for the 10 selected medicines (both innovator and lowest price generic) which are highly used in Malaysia. Results: For innovator, only salbutamol 100 mcg inhaler (200 doses) (p= 0.043) and gliclazide 80 mg tablet (p= 0.043) were sold at a lower price at chain RPs when compared to independent RPs. As for lowest price generic products, only furosemide 40 mg tablet (p= 0.002) and metoprolol 100 mg tablet (p= 0.036) were found to be cheaper at the chained RPs than the independent RPs. Of note, simvastatin 20 mg tablet (Zocor®) was sold at a higher median (range) price at the chained RPs than the independent RPs [RM 2.63 (2.19-3.80) versus RM 2.32 (1.17-4.13), p= 0.009]. Conclusions: It was interesting to find that the perception of cheaper price of medicines in chained pharmacies as compared to independent pharmacies is fallacious. The findings of this study will facilitate policy makers in drawing conclusion about the differences of medicine prices and will be useful in devising appropriate policy for medicine price control in Malaysia.
1University
Objectives: Generic medicine prescribing has become a common practice in many countries. However, data regarding the perception of stakeholders (patients, prescribers and dispensers) regarding generic medicines in Ethiopia is scarce. The present survey aimed at investigating the perception of patients, physicians and community pharmacists regarding generic medicines in Ethiopia. Methods: A quantitative cross-sectional survey was conducted between January 1 and February 1, 2017. The questionnaire was administered to patients, physicians and community pharmacists. Frequencies, percentages, Mann Whitney and Kruskal Wallis tests were performed using Statistical Package for the Social Sciences (SPSS) software version 21.0 for Windows (SPSS Inc., Chicago, IL). Results: Majority of patients surveyed (83.1%) agreed that the costs of medicines in Ethiopia is too high and 61.4% of respondents believed that cost should be considered before a drug is prescribed. 75.2% of patients accept the pharmacist substituting their prescribed medications to a cheaper medicine. On the other hand, majority of physicians (70.6%) indicated a very low generic medicine prescription rate. About 91% of physicians and 87.2% of pharmacists agreed that they need a standard guideline to both prescribers and pharmacist on brand substitution process. Furthermore, 39.9% of the physicians and 87.2% of pharmacists agreed that drug advertisements by the manufacturers would influence their prescribing/dispensing practice. Conclusions: Our findings demonstrate that a significant proportion of patients, doctors and pharmacists hold negative perceptions of generic medicines. The insights obtained in the present study will be useful to healthcare organizations, policy makers and other stakeholders to design and implement a robust generic medicine policy and guideline, thereby promoting the rational and cost-effective use of medicine in the country. [BM1]Physicians. PHP26 Open To The Public? A Comparative Analysis Of Data Published Under The “Ema Policy On The Publication Of Clinical Data” And Dossiers For Early Benefit Assessments In Germany
PHP28 Pricing Pantoprazole In Greece: A Tale Of Distortion Ollandezos M, Papadopoulos K, Pentafragka E, Stefanidou Z Panhellenic Association of Pharmaceutical Industry, Athens, Greece
Objectives: Generics in Greece are priced at 65% of the price of the reference off-patent while off patents are priced at the minimum between a decrease of 50% of their latest on - patent price, and the average of the three lowest prices of the same product among the EU countries. The purpose of this study is to assess the price level of generics pantoprazole in Greece. Methods: Official pricing data were used to identify the three EU countries which set the outpatient market price for off-patent pantoprazole 40 mg in Greece in December 2016. The ex-factory prices for the originator and generics in each of the three EU countries were derived from the official price sources in each country. All prices were normalized to correspond to monthly treatment. Results: Originator pantoprazole price derived from the prices of the same product in Ireland, Poland and Austria. Average ex-factory price for generic pantoprazole 40mg in Greece (2.05€ ) were lower than the respective exfactory price in Ireland (3.08€ :- 33.31%), in Poland (2.61€ : -21.35%), and in Austria (2.76€ : -25.68%). Conclusions: Average ex-factory price for generic pantoprazole in Greece is up to 33.31% below the respective generic prices at the EU countries with the lowest price of the reference originator. With rebates and clawback considered, the average ex-factory price for generic pantoprazole in Greece is further reduced by 30% approximately in 2016. However, despite the excessively low net ex- factory price of generics (after rebates and clawback), current generic penetration (~25%) still remains far from the MoU target of 40% by volume for 2017. This suggests for the need of an effective and reasonable pricing regulation to ensure market viability for generics in parallel with demand side measures to foster generic use through appropriate incentives for physicians, pharmacists and patients.
El Ouardani W, Boehler Y TH Koeln, University of Applied Sciences, Leverkusen, Germany
PHP29 Demand And Supply Side Regulation Of Biosimilar Markets In Germany, France And England And Its Implications For Market Access Of Biosimilars
Objectives: Evidence on new drugs is key to various parties in health care for clinical and health policy decisions. With the “EMA policy on the publication of clinical
1University
Walendzik A1, Altin S2, Wasem J2 Duisburg-Essen, Essen, Germany, 2University of Duisburg-Essen, Essen, Germany