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Generic Competition and ITS Impact on Reference Pricing System and Medicnes Utilization in the Group of Sartans
A628
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
study; of them, 561(94%) met the study criteria. The mean age of the respondents was 55.96±14.6 years. Females constituted 58.2% of the study population. Approximately ffty percent of the prescriptions were monotherapies. Twice-daily dosing was associated with lower risk of uncontrolled hypertension (crude odds ratio [COR] = 0.51[0.15–0.73], adjusted odds ratio [AOR] = 0.69[0.163–0.91]). Monthly appointment was linked with a nearly 90% reduced incidence of uncontrolled BP (COR = 0.15[0.04–0.73], AOR = 0.093[0.024–0.359]). Conclusions: Monotherapies were the most frequently prescribed regimens. Twice-daily dosing and monthly appointments were associated with low incidence of uncontrolled BP. Clinicians should be vigilant in adjusting the frequency of dosing and should fx appointment date in consultation with their patients. PCV150 Potential Mortality Reduction with Optimal Usage of Sacubitril/ Valsartan Therapy for the Treatment of Heart Failure in Mexico Barbeau M1, Romo X2, Botello BS2, Haroun R3, MacPherson A4 Pharmaceuticals Canada Inc., Dorval, QC, Canada, 2Novartis Farmacéutica S.A. de C.V, Mexico City, Mexico, 3Novartis Pharma AG, Basel, Switzerland, 4Dalhousie University, Halifax, NS, Canada 1Novartis
Objectives: PARADIGM-HF, a phase III trial conducted in patients with heart failure (HF), showed that sacubitril/valsartan, a first-in-class angiotensin receptor neprilysin inhibitor for treatment of HF with reduced ejection fraction (HFrEF), provided incremental cardiovascular and overall survival benefit compared with enalapril. This analysis aims to quantify the number of all-cause deaths that could be avoided with optimal usage of sacubitril/valsartan in the treatment of HFrEF in Mexico. Methods: Data from INEGI Population 2010 Report and Projections was used to quantify the target population. A literature review was conducted to determine the prevalence of HF, and the proportion of HFrEF patients classified as NYHA Class II-IV, in Mexico. The number needed to treat (NNT) to avoid one death due to any cause, standardized to 12 months, was derived from the PARADIGM-HF trial. The potential number of deaths prevented or postponed with sacubitril/valsartan treatment was estimated along with multiple-way sensitivity analysis. The main outcome measure was all-cause mortality. Results: The 2017 population (≥ 18 years) in Mexico was estimated at 82,206,974 and the estimated prevalence of HF was 2.3%. Further, the percentage of HF registered episodes in the National Health System was 41.1%, yielding approximately 765,668 patients. Half of these patients had HFrEF; 85.0% of whom were NYHA Class II-IV. This equated to 326,986 patients with HFrEF NYHA II-IV. Finally, the absolute reduction in mortality in PARADIGM-HF was 2.8% over an average follow-up time of 27 months. This translates into a NNT, standardized to 12 months, of 80.3. Thus, optimal usage of sacubitril/valsartan therapy was estimated to potentially prevent 4,072 deaths each year. Conclusions: The findings from this analysis suggest that a substantial number of all-cause deaths could potentially be prevented with optimal implementation of sacubitril/valsartan therapy. Implementation of sacubitril/valsartan into routine clinical practice is important, and may substantially improve clinical outcomes among HFrEF patients in Mexico. PCV151 Generic Competition and ITS Impact on Reference Pricing System and Medicnes Utilization in the Group of Sartans Mitkova Z1, Manova M2, Savova A2, Stoimenova A3, Petrova G4 University-Sofia, Faculty of pharmacy, Sofia, Bulgaria, 2National Council on Prices and Reimbursement of Medicinal Products, Sofia, Bulgaria, 3The Bulgarian Drug Agency, Sofia, Bulgaria, 4Medical University of Sofia, Sofia, Bulgaria
We refer to the volume (in Standard Unit, SU), price per SU, and the market share of the generics vs, originator where patents had expired in 2012 in most countries (simvastatin, atorvastatin), and have partly expired (rosuvastatin pitavastin). Their market expansion was measured as CAGR (compound annual growth rate) and relative market share was illustrated. Results: 7 statins were observed, and 5 statins (atorvastatin, rosuvastatin, pravastatin, fluvastatin, simvastatin) were observed in all 10 countries. Generic market share was dominant in US, UK, and countries where reference pricing system has been implemented (Australia, France, Germany). The volume of statin was increased in all observed countries except US, yet the volume of atorvastatin and rosuvastatin increased in most countries whereas that of simvastatin decreased. For rosuvastatin, its patent expired in 4 countries (Korea, Taiwan, Australia, US) during the study period, and the generic replaced originator without market expansion in US and Australia, whereas market expanded dramatically without generic replacement in Korea and Taiwan. Recently launched statins (rosuvastatin & pitavastatin) are frequently priced highest, whereas mature statins (simvastatin) were tend to be priced lowest among statins. Conclusions: statin volume has expanded, yet its expansion differ dramatically based on the price, patent status, and the country characteristics. PCV153 Potential Mortality Reduction with Optimal Usage of Sacubitril/ Valsartan Therapy for the Treatment of Heart Failure in Chile Barbeau M1, Alvarez Fleitas M2, Tobar R2, Haroun R3, MacPherson A4 Pharmaceuticals Canada Inc., Dorval, QC, Canada, 2Novartis Chile S.A, Santiago de Chile, Chile, 3Novartis Pharma AG, Basel, Switzerland, 4Dalhousie University, Halifax, NS, Canada
1Novartis
Objectives: PARADIGM-HF, a phase III trial conducted in patients with heart failure (HF), showed that sacubitril/valsartan, a first-in-class angiotensin receptor neprilysin inhibitor for treatment of HF with reduced ejection fraction (HFrEF), provided incremental cardiovascular and overall survival benefit versus enalapril. This analysis aims to quantify the number of potential all-cause deaths that could be avoided with optimal usage of sacubitril/valsartan in the treatment of HFrEF in Chile. Methods: Data from the Instituto Nacional de Estadísticas was used to identify patients with heart failure for whom sacubitril/valsartan would be indicated, and a literature review was conducted to determine the prevalence of HF, the proportion of those NYHA Class II-IV and finally, the proportion of patients with HFrEF. The number needed to treat (NNT) to avoid one death, standardized to 12 months, was derived from the PARADIGM-HF trial. The potential number of deaths prevented or postponed as a result of sacubitril/valsartan treatment was estimated along with multi-way sensitivity analysis. The main outcome measure was all-cause mortality. Results: The 2017 population (≥ 20 years) in Chile was estimated at 13,413,474 and the estimated prevalence of HF was 2%. The percentage of patients diagnosed with HF in Chile was 80%. Of these, 75% were classified as NYHA Class II-IV, 48% of whom had HFrEF. This equated to 77,262 patients for whom sacubitril/ valsartan may be indicated. The absolute reduction in mortality in PARADIGM-HF was 2.8% over an average follow-up time of 27 months with a NNT standardized to 12 months of 80.3. Thus, optimal usage of sacubitril/valsartan therapy was estimated to prevent 962 deaths each year. Conclusions: The findings from this analysis suggest that a substantial number of deaths could potentially be prevented by optimal implementation of sacubitril/valsartan therapy. Thus, implementation of sacubitril/valsartan into routine clinical practice may substantially improve clinical outcomes in HFrEF patients in Chile.
1Medical
Objectives: Analysis of the impact of new medicines inclusion in the Positive Drug List (PDL) on medicines reference prices and utilization in the group of sartans Methods: Retrospective, observational and statistical analysis of the inclusion of new INNs-and generic products in the Bulgarian PDL during 2009-2015. The changes in reference prices that is the lowest price per DDD are calculated after every new products inclusion. Medicines utilization is measured through DDD/1000/ inh/day = ((Sales data in mg/ DDD)/(N inhabitans*365)). Statistical significance of corresponding changes is tested with t-test. Prices are collected from the official price register and sales data from drug agency. Results: Two new INN irbesartan and olmesartan were included in the PDL in 2011 and 2013 with following inclusion of 3 and 2 generic competitors. To already existing INNs 36 new generic products were added, and out of them 11 were with INN valsartan, 9 candesartan, 9 telmisartan, 2 losartan. The reference price decreases significantly for all INNs. The highest was the decrease in reference price for valsartan (from 0.4523 to 0.09464 BGN) and candesartan (from 0.6191 to 0.01567 BGN), where high number of new products was included. In contrast the utilization in DDD/1000inh/day increases significantly for candesartan (0.39 vs. 5.58) and telmisartan (1.81 vs. 8.18). For Losartan (7.23 vs. 4.23) and Valsartan (43.24 vs. 12.44) the utilization decreases significantly probably due to transfer to other INNs. Conclusions: Inclusion of new INNs and new generics impacted both prices and utilization of sartans. New products decrease the reference price but changes in utilization are not following the same logic. This pointed out that in general the generic and therapeutic competition improves a patients’ access to treatment. PCV152 Market Dynamics of Statin Medications Jung S1, Kim t1, Kwon H2, Bae S1 1Ewha Womans University, Seoul, Korea, Republic of (South), 2Mokwon University, Daejeon, Korea, Republic of (South)
Objectives: it is not clear whether the introduction of low-cost generics have actually reduced pharmaceutical spending, especially when the definition of target population is rather vague. We sought to describe market dynamics of statins, where in-patent and off-patent drugs are mixed and whose demand is relatively elastic. Methods: We utilized IMS Health Analytical Link databases from 2012 to 2016 in Italy, Japan, Germany, France, UK, US, Switzerland, Taiwan, Korea, and Australia.
PCV154 Antihypertensive Drug Treatment Prescribed for Essential Hypertension in a Private Hospital in South Sumatra, Indonesia Kristin E1, Yasmina A2 1Gadjah Mada University, Yogyakarta, Indonesia, 2Lambung Mangkurat University, Banjarmasin, Indonesia
Objectives: To assess antihypertensive drug treatment prescribed for essential hypertension in the Internal Medicine Polyclinic in a private hospital in South Sumatra, Indonesia. Methods: This cross-sectional study included outpatients diagnosed with essential hypertension in the Internal Medicine Polyclinic in a private hospital in South Sumatra, Indonesia during the period of July 2013 until December 2015. Patients’ characteristics and antihypertensive drug treatment data were collected from the polyclinic medical records and hospital pharmacy records. Antihypertensive drug treatment was assessed based on the number of antihypertensive drugs prescribed per prescription, generic classification, antihypertensive drug classes, antihypertensive drug combinations, and the agreement with the National Formulary. Results: A total of 345 patients with essential hypertension and 1126 prescriptions were included in this study. The average number of antihypertensive drug per prescription was 1.03±0.18. Most (67.9%) of the antihypertensive drugs were prescribed as generics. Calcium channel blockers (74.8%) and antihypertensive agents acting on the renin-angiotensin system (20.3%) were most commonly prescribed. Many patients received combination antihypertensive drugs, with hydrochlorothiazide and captopril as the most often combination (47.5%). Only 66.5% of the drugs in the prescriptions were in agreement with the list of drugs in the National Formulary. Conclusions: The treatment of essential hypertension in a private hospital in South Sumatra was improving. Attention needs to be directed to comply more with the National Formulary and generic prescribing. PCV155 Utilization Patterns of Lipid-Lowering Therapies in Patients at High Risk for or with Atherosclerotic Cardiovascular Disease: A Population-Based Study in South Korea Suh HS1, Kim S1, Kim H1, Kim E1, Han S1, Rane PP2, Fox KM3, Zhao Z4, Qian Y2 1Pusan National University, Busan, Korea, Republic of (South), 2Amgen, Thousand Oaks, CA, USA, 3Strategic Healthcare Solutions, Aiken, SC, USA, 4Amgen Inc., Thousand Oaks, CA, USA
Objectives: To explore the utilization patterns of lipid-lowering therapies in patients at high risk for or with atherosclerotic cardiovascular disease
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
study; of them, 561(94%) met the study criteria. The mean age of the respondents was 55.96±14.6 years. Females constituted 58.2% of the study population. Approximately ffty percent of the prescriptions were monotherapies. Twice-daily dosing was associated with lower risk of uncontrolled hypertension (crude odds ratio [COR] = 0.51[0.15–0.73], adjusted odds ratio [AOR] = 0.69[0.163–0.91]). Monthly appointment was linked with a nearly 90% reduced incidence of uncontrolled BP (COR = 0.15[0.04–0.73], AOR = 0.093[0.024–0.359]). Conclusions: Monotherapies were the most frequently prescribed regimens. Twice-daily dosing and monthly appointments were associated with low incidence of uncontrolled BP. Clinicians should be vigilant in adjusting the frequency of dosing and should fx appointment date in consultation with their patients. PCV150 Potential Mortality Reduction with Optimal Usage of Sacubitril/ Valsartan Therapy for the Treatment of Heart Failure in Mexico Barbeau M1, Romo X2, Botello BS2, Haroun R3, MacPherson A4 Pharmaceuticals Canada Inc., Dorval, QC, Canada, 2Novartis Farmacéutica S.A. de C.V, Mexico City, Mexico, 3Novartis Pharma AG, Basel, Switzerland, 4Dalhousie University, Halifax, NS, Canada 1Novartis
Objectives: PARADIGM-HF, a phase III trial conducted in patients with heart failure (HF), showed that sacubitril/valsartan, a first-in-class angiotensin receptor neprilysin inhibitor for treatment of HF with reduced ejection fraction (HFrEF), provided incremental cardiovascular and overall survival benefit compared with enalapril. This analysis aims to quantify the number of all-cause deaths that could be avoided with optimal usage of sacubitril/valsartan in the treatment of HFrEF in Mexico. Methods: Data from INEGI Population 2010 Report and Projections was used to quantify the target population. A literature review was conducted to determine the prevalence of HF, and the proportion of HFrEF patients classified as NYHA Class II-IV, in Mexico. The number needed to treat (NNT) to avoid one death due to any cause, standardized to 12 months, was derived from the PARADIGM-HF trial. The potential number of deaths prevented or postponed with sacubitril/valsartan treatment was estimated along with multiple-way sensitivity analysis. The main outcome measure was all-cause mortality. Results: The 2017 population (≥ 18 years) in Mexico was estimated at 82,206,974 and the estimated prevalence of HF was 2.3%. Further, the percentage of HF registered episodes in the National Health System was 41.1%, yielding approximately 765,668 patients. Half of these patients had HFrEF; 85.0% of whom were NYHA Class II-IV. This equated to 326,986 patients with HFrEF NYHA II-IV. Finally, the absolute reduction in mortality in PARADIGM-HF was 2.8% over an average follow-up time of 27 months. This translates into a NNT, standardized to 12 months, of 80.3. Thus, optimal usage of sacubitril/valsartan therapy was estimated to potentially prevent 4,072 deaths each year. Conclusions: The findings from this analysis suggest that a substantial number of all-cause deaths could potentially be prevented with optimal implementation of sacubitril/valsartan therapy. Implementation of sacubitril/valsartan into routine clinical practice is important, and may substantially improve clinical outcomes among HFrEF patients in Mexico. PCV151 Generic Competition and ITS Impact on Reference Pricing System and Medicnes Utilization in the Group of Sartans Mitkova Z1, Manova M2, Savova A2, Stoimenova A3, Petrova G4 University-Sofia, Faculty of pharmacy, Sofia, Bulgaria, 2National Council on Prices and Reimbursement of Medicinal Products, Sofia, Bulgaria, 3The Bulgarian Drug Agency, Sofia, Bulgaria, 4Medical University of Sofia, Sofia, Bulgaria
We refer to the volume (in Standard Unit, SU), price per SU, and the market share of the generics vs, originator where patents had expired in 2012 in most countries (simvastatin, atorvastatin), and have partly expired (rosuvastatin pitavastin). Their market expansion was measured as CAGR (compound annual growth rate) and relative market share was illustrated. Results: 7 statins were observed, and 5 statins (atorvastatin, rosuvastatin, pravastatin, fluvastatin, simvastatin) were observed in all 10 countries. Generic market share was dominant in US, UK, and countries where reference pricing system has been implemented (Australia, France, Germany). The volume of statin was increased in all observed countries except US, yet the volume of atorvastatin and rosuvastatin increased in most countries whereas that of simvastatin decreased. For rosuvastatin, its patent expired in 4 countries (Korea, Taiwan, Australia, US) during the study period, and the generic replaced originator without market expansion in US and Australia, whereas market expanded dramatically without generic replacement in Korea and Taiwan. Recently launched statins (rosuvastatin & pitavastatin) are frequently priced highest, whereas mature statins (simvastatin) were tend to be priced lowest among statins. Conclusions: statin volume has expanded, yet its expansion differ dramatically based on the price, patent status, and the country characteristics. PCV153 Potential Mortality Reduction with Optimal Usage of Sacubitril/ Valsartan Therapy for the Treatment of Heart Failure in Chile Barbeau M1, Alvarez Fleitas M2, Tobar R2, Haroun R3, MacPherson A4 Pharmaceuticals Canada Inc., Dorval, QC, Canada, 2Novartis Chile S.A, Santiago de Chile, Chile, 3Novartis Pharma AG, Basel, Switzerland, 4Dalhousie University, Halifax, NS, Canada
1Novartis
Objectives: PARADIGM-HF, a phase III trial conducted in patients with heart failure (HF), showed that sacubitril/valsartan, a first-in-class angiotensin receptor neprilysin inhibitor for treatment of HF with reduced ejection fraction (HFrEF), provided incremental cardiovascular and overall survival benefit versus enalapril. This analysis aims to quantify the number of potential all-cause deaths that could be avoided with optimal usage of sacubitril/valsartan in the treatment of HFrEF in Chile. Methods: Data from the Instituto Nacional de Estadísticas was used to identify patients with heart failure for whom sacubitril/valsartan would be indicated, and a literature review was conducted to determine the prevalence of HF, the proportion of those NYHA Class II-IV and finally, the proportion of patients with HFrEF. The number needed to treat (NNT) to avoid one death, standardized to 12 months, was derived from the PARADIGM-HF trial. The potential number of deaths prevented or postponed as a result of sacubitril/valsartan treatment was estimated along with multi-way sensitivity analysis. The main outcome measure was all-cause mortality. Results: The 2017 population (≥ 20 years) in Chile was estimated at 13,413,474 and the estimated prevalence of HF was 2%. The percentage of patients diagnosed with HF in Chile was 80%. Of these, 75% were classified as NYHA Class II-IV, 48% of whom had HFrEF. This equated to 77,262 patients for whom sacubitril/ valsartan may be indicated. The absolute reduction in mortality in PARADIGM-HF was 2.8% over an average follow-up time of 27 months with a NNT standardized to 12 months of 80.3. Thus, optimal usage of sacubitril/valsartan therapy was estimated to prevent 962 deaths each year. Conclusions: The findings from this analysis suggest that a substantial number of deaths could potentially be prevented by optimal implementation of sacubitril/valsartan therapy. Thus, implementation of sacubitril/valsartan into routine clinical practice may substantially improve clinical outcomes in HFrEF patients in Chile.
1Medical
Objectives: Analysis of the impact of new medicines inclusion in the Positive Drug List (PDL) on medicines reference prices and utilization in the group of sartans Methods: Retrospective, observational and statistical analysis of the inclusion of new INNs-and generic products in the Bulgarian PDL during 2009-2015. The changes in reference prices that is the lowest price per DDD are calculated after every new products inclusion. Medicines utilization is measured through DDD/1000/ inh/day = ((Sales data in mg/ DDD)/(N inhabitans*365)). Statistical significance of corresponding changes is tested with t-test. Prices are collected from the official price register and sales data from drug agency. Results: Two new INN irbesartan and olmesartan were included in the PDL in 2011 and 2013 with following inclusion of 3 and 2 generic competitors. To already existing INNs 36 new generic products were added, and out of them 11 were with INN valsartan, 9 candesartan, 9 telmisartan, 2 losartan. The reference price decreases significantly for all INNs. The highest was the decrease in reference price for valsartan (from 0.4523 to 0.09464 BGN) and candesartan (from 0.6191 to 0.01567 BGN), where high number of new products was included. In contrast the utilization in DDD/1000inh/day increases significantly for candesartan (0.39 vs. 5.58) and telmisartan (1.81 vs. 8.18). For Losartan (7.23 vs. 4.23) and Valsartan (43.24 vs. 12.44) the utilization decreases significantly probably due to transfer to other INNs. Conclusions: Inclusion of new INNs and new generics impacted both prices and utilization of sartans. New products decrease the reference price but changes in utilization are not following the same logic. This pointed out that in general the generic and therapeutic competition improves a patients’ access to treatment. PCV152 Market Dynamics of Statin Medications Jung S1, Kim t1, Kwon H2, Bae S1 1Ewha Womans University, Seoul, Korea, Republic of (South), 2Mokwon University, Daejeon, Korea, Republic of (South)
Objectives: it is not clear whether the introduction of low-cost generics have actually reduced pharmaceutical spending, especially when the definition of target population is rather vague. We sought to describe market dynamics of statins, where in-patent and off-patent drugs are mixed and whose demand is relatively elastic. Methods: We utilized IMS Health Analytical Link databases from 2012 to 2016 in Italy, Japan, Germany, France, UK, US, Switzerland, Taiwan, Korea, and Australia.
PCV154 Antihypertensive Drug Treatment Prescribed for Essential Hypertension in a Private Hospital in South Sumatra, Indonesia Kristin E1, Yasmina A2 1Gadjah Mada University, Yogyakarta, Indonesia, 2Lambung Mangkurat University, Banjarmasin, Indonesia
Objectives: To assess antihypertensive drug treatment prescribed for essential hypertension in the Internal Medicine Polyclinic in a private hospital in South Sumatra, Indonesia. Methods: This cross-sectional study included outpatients diagnosed with essential hypertension in the Internal Medicine Polyclinic in a private hospital in South Sumatra, Indonesia during the period of July 2013 until December 2015. Patients’ characteristics and antihypertensive drug treatment data were collected from the polyclinic medical records and hospital pharmacy records. Antihypertensive drug treatment was assessed based on the number of antihypertensive drugs prescribed per prescription, generic classification, antihypertensive drug classes, antihypertensive drug combinations, and the agreement with the National Formulary. Results: A total of 345 patients with essential hypertension and 1126 prescriptions were included in this study. The average number of antihypertensive drug per prescription was 1.03±0.18. Most (67.9%) of the antihypertensive drugs were prescribed as generics. Calcium channel blockers (74.8%) and antihypertensive agents acting on the renin-angiotensin system (20.3%) were most commonly prescribed. Many patients received combination antihypertensive drugs, with hydrochlorothiazide and captopril as the most often combination (47.5%). Only 66.5% of the drugs in the prescriptions were in agreement with the list of drugs in the National Formulary. Conclusions: The treatment of essential hypertension in a private hospital in South Sumatra was improving. Attention needs to be directed to comply more with the National Formulary and generic prescribing. PCV155 Utilization Patterns of Lipid-Lowering Therapies in Patients at High Risk for or with Atherosclerotic Cardiovascular Disease: A Population-Based Study in South Korea Suh HS1, Kim S1, Kim H1, Kim E1, Han S1, Rane PP2, Fox KM3, Zhao Z4, Qian Y2 1Pusan National University, Busan, Korea, Republic of (South), 2Amgen, Thousand Oaks, CA, USA, 3Strategic Healthcare Solutions, Aiken, SC, USA, 4Amgen Inc., Thousand Oaks, CA, USA
Objectives: To explore the utilization patterns of lipid-lowering therapies in patients at high risk for or with atherosclerotic cardiovascular disease