Anna Kemp-Casey - Academia.edu (original) (raw)

Papers by Anna Kemp-Casey

Drug Safety

Introduction Regulatory advisories on hydroxyzine and risk of QT prolongation and Torsade de poin... more Introduction Regulatory advisories on hydroxyzine and risk of QT prolongation and Torsade de pointes (TdP) were issued in the UK in April 2015 and Canada in June 2016. We hypothesized patients with risk factors for QT prolongation and TdP, compared with those without risk factors, would be less likely to initiate hydroxyzine in the UK and in British Columbia (BC), Canada, following advisories. Methods We conducted a longitudinal study with repeated measures, and evaluated hydroxyzine initiation in a UK cohort and a concurrent BC control cohort (April 2013-March 2016) as well as in a BC advisory cohort (June 2014-May 2017). Results This study included 247,665 patients in the UK cohort, 297,147 patients in the BC control cohort, and 303,653 patients in the BC advisory cohort. Over a 12-month post-advisory period, hydroxyzine initiation decreased by 21% in the UK (rate ratio 0.79, 95% confidence interval 0.66-0.96) relative to the expected level of initiation based on the pre-advisory trend. Hydroxyzine initiation did not change in the BC control cohort or following the Canadian advisory in the BC advisory cohort. The decrease in hydroxyzine initiation in the UK in the 12 months after the advisories was not significantly different for patients with risk factors compared with those without risk factors. Conclusion Hydroxyzine initiation decreased in the UK, but not in BC, in the 12 months following safety advisories. The decrease in hydroxyzine initiation in the UK was not significantly different for patients with versus without risk factors for QT prolongation and TdP.

BMJ Quality & Safety, 2022

Objective To evaluate the association between regulatory drug safety advisories and changes in dr... more Objective To evaluate the association between regulatory drug safety advisories and changes in drug utilisation. Design We conducted controlled, interrupted times series analyses with administrative prescription claims data to estimate changes in drug utilisation following advisories. We used random-effects meta-analysis with inverse-variance weighting to estimate the average postadvisory change in drug utilisation across advisories. Study population We included advisories issued in Canada, Denmark, the UK and the USA during 2009–2015, mainly concerning drugs in common use in primary care. We excluded advisories related to over-the-counter drugs, drug-drug interactions, vaccines, drugs used primarily in hospital and advisories with co-interventions within ±6 months. Main outcome measures Change in drug utilisation, defined as actual versus predicted percentage change in the number of prescriptions (for advisories without dose-related advice), or in the number of defined daily doses ...

Additional file 1: Description of study variables, missing data and exclusion.

Pharmacoepidemiology and Drug Safety, 2018

Public health research & practice, Jan 30, 2015

The Pharmaceutical Benefits Scheme (PBS) dataset provides detailed information about subsidised m... more The Pharmaceutical Benefits Scheme (PBS) dataset provides detailed information about subsidised medicines dispensed in Australia and is increasingly used for pharmacoepidemiological research. Use of the PBS dataset provides unique opportunities for such research, but comes with its own set of challenges that must be considered and addressed. This paper outlines some issues that commonly arise when using PBS data - relating to accurate identification of medicine dispensings and how to define medicine exposure - and suggests some possible approaches for dealing with them. The paper is intended as an introductory resource for researchers.

Public health research & practice, Jan 28, 2016

It is important for consumers, clinicians and health service planners to know the risk of recurre... more It is important for consumers, clinicians and health service planners to know the risk of recurrence of primary breast cancer after initial treatment. At present, none of Australia's state or territory cancer registries routinely report this information. We aimed to determine the incidence of recurrence in New South Wales (NSW) clinical practice for the period 18 months to 6 years after diagnosis of primary breast cancer. Retrospective cohort study using population-based linked health data. We identified 2416 women in the 45 and Up Study who were diagnosed with primary invasive breast cancer between 2003 and 2008 in NSW, and who had not had a recurrence 18 months after diagnosis. Unit-level hospital, pharmacy and outpatient medical claims were used to identify treatment for recurrence. Incidence of recurrence was calculated using individual person-time at risk (18 months to 6 years postdiagnosis), with follow-up censored for death or end of study period (median follow-up 3 years...

Public Health Research & Practice, 2015

Research in social & administrative pharmacy : RSAP, 2021

OBJECTIVES Patient contributions (co-payments) for one months' supply of a publicly-subsidise... more OBJECTIVES Patient contributions (co-payments) for one months' supply of a publicly-subsidised medicine in Australia were increased by 21% in January 2005 (US$2.73-$3.31 for social security recipients and 17.05−17.05-17.05−20.58 for others). This study investigates the relationship between patients' use of statin medication and hospitalisation for acute coronary syndrome and stroke, following this large increase in co-payments. METHODS We designed a retrospective cohort study of all patients in Western Australia who were dispensed statin medication between 2004 and 05. Data for the cohort was obtained from State and Federal linked databases. We divided the cohort into those who discontinued, reduced or continued statin therapy in the first six months after the co-payment increase. The primary outcome was two-year hospitalisation for acute coronary syndrome or stroke-related event. Analysis was conducted using Fine and Gray competing risk methods, with death as the competing risk. RESU...

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2021

INTRODUCTION In the general population, varenicline is consistently shown to be more efficacious ... more INTRODUCTION In the general population, varenicline is consistently shown to be more efficacious for smoking cessation than nicotine replacement therapy (NRT). Current clinical guidelines for the management of smoking during pregnancy recommend against the use of varenicline, whilst supporting the use of NRT. However, little is known about the comparative effectiveness of these smoking cessation therapies among pregnant women. AIMS AND METHODS Routinely-collected records of all births in two Australian States during 2011 and 2012 were used to create a population-based cohort of women who smoked during the first half of pregnancy. Pharmaceutical dispensing data were used to identify varenicline and nicotine patch dispensings in the first half of pregnancy. Propensity score matching was used to account for the potentially different distribution of confounding factors between the treatment groups. The outcome was defined as smoking abstinence during the second half of pregnancy. RESULT...

International Journal of Drug Policy

International Journal of Population Data Science

IntroductionIn January 2005, the Australian Government increased the consumer medication co-payme... more IntroductionIn January 2005, the Australian Government increased the consumer medication co-payment by 21%. Previous research found that this affected population-level utilisation of statins, which fell by 5% following the co-payment increase. The subsequent health impact on individuals reducing or ceasing use of statins is unknown. Objectives and ApproachTo explore the two-year risk of acute coronary syndrome (ACS) or stroke-related hospitalisation among individuals who discontinued, reduced or continued statin medicines after the 2005 PBS co-payments increase. This was achieved through a retrospective cohort study using linked administrative Commonwealth and State datasets for the Western Australian population. Outcomes were assessed using the Fine and Gray competing risks method, with death as the competing risk, adjusting for demographics, comorbidities and medication history. ResultsThere were 207,066 individuals identified as using statins before the co-payment increase. After...

Journal of Health Services Research & Policy

Objective This study examined the association between statin usage (discontinued, reduced or cont... more Objective This study examined the association between statin usage (discontinued, reduced or continued) and two-year death following a 21% increase in the Pharmaceutical Benefits Scheme (PBS) consumer co-payment in Western Australia. Methods A retrospective observational study in Western Australia using linked administrative Commonwealth PBS data and State hospital inpatient and death data (n = 207,066) was undertaken. We explored the two-year all-cause and ischemic heart disease(IHD)/stroke-specific-death in individuals who discontinued, reduced or continued statin medication following the January 2005 PBS co-payment increase, overall, by beneficiary status (general population vs. social security recipients) and by a history of admission for ischemic heart disease or stroke. Non-cardiovascular (CVD)-related death was also considered. Results In the first six months of 2005, 3.3% discontinued, 12.5% reduced and 84.2% continued statin therapy. We found those who discontinued statins ...

WHO South-East Asia Journal of Public Health

Background Little is known about how the different policies available to promote use of generic m... more Background Little is known about how the different policies available to promote use of generic medicines affect the price per unit supplied or sold. This study compares the influence of pricing policies for generic medicines on atorvastatin prices in Australia, New Zealand, the Republic of Korea and Singapore, after market entry of generic atorvastatin. Methods The annual price of atorvastatin per defined daily dose supplied (price/DDD) was examined for each country from 2006 to 2015 (≥2 years before and ≥4 years after generic market entry). Prices were converted to international dollars and cumulative percentage price reductions were calculated for the first 4 years following generic entry. Results Prior to market entry of generic atorvastatin, New Zealand had the lowest price ($0.10/DDD), and the Republic of Korea the highest ($2.89/DDD). The price/DDD fell immediately after generic entry in all countries except New Zealand, which already had low prices. The largest immediate decrease was observed in Singapore (46%, year 1). By the fourth year after generic entry, the price had fallen by 46–80% in all countries; however, large price differences between countries remained. Conclusion New Zealand’s tendering system and use of preferred medicines resulted in very low atorvastatin prices well before patent expiry. Pricing policies in the other three countries were effective in reducing atorvastatin prices, with reductions of between 46% and 80% within 4 years of generic entry. Where tendering and use of preferred medicines were the mechanisms for atorvastatin procurement (New Zealand), prices were lowest before and after generic entry. Mandatory price cuts, combined with price-disclosure policies (Australia), produced similar relative price reductions to tendering systems (New Zealand, Singapore) at 4 years. By comparison, mandatory price cuts upon generic entry as the sole measure, while initially effective, were associated with the smallest relative reduction in price after 4 years (Republic of Korea).

Australian Health Review

ObjectiveThis study assessed the effect of the frequency of general practitioner (GP) visitation ... more ObjectiveThis study assessed the effect of the frequency of general practitioner (GP) visitation in the 12 months before a 21% consumer copayment increase in the Pharmaceutical Benefits Scheme (PBS; January 2005) on the reduction or discontinuation of statin dispensing for tertiary prevention. MethodsThe study used routinely collected, whole-population linked PBS, Medicare, mortality and hospital data from Western Australia. From 2004 to 2005, individuals were classified as having discontinued, reduced or continued their use of statins in the first six months of 2005 following the 21% consumer copayment increase on 1 January 2005. The frequency of GP visits was calculated in 2004 from Medicare data. Multivariate logistic regression models were used to determine the association between GP visits and statin use following the copayment increase. ResultsIn December 2004, there were 22495 stable statin users for tertiary prevention of prior coronary heart disease, prior stroke or prior c...

BMC Medicine

Background Varenicline, bupropion and nicotine replacement therapy (NRT) are three effective phar... more Background Varenicline, bupropion and nicotine replacement therapy (NRT) are three effective pharmacotherapies for smoking cessation, but data about their safety in pregnancy are limited. We assessed the risk of adverse perinatal outcomes and major congenital anomalies associated with the use of these therapies in pregnancy in Australia. Methods Perinatal data for 1,017,731 deliveries (2004 to 2012) in New South Wales and Western Australia were linked to pharmaceutical dispensing, hospital admission and death records. We identified 97,875 women who smoked during pregnancy; of those, 233, 330 and 1057 were exposed to bupropion, NRT and varenicline in pregnancy, respectively. Propensity scores were used to match exposed women to those who were unexposed to any smoking therapy (1:10 ratio). Propensity scores and gestational age at exposure were used to match varenicline-exposed to NRT-exposed women (1:1 ratio). Time-dependent Cox proportional hazards models estimated hazard ratios (HR)...

WHO South-East Asia Journal of Public Health

Anna Kemp-Casey1, Joyce Ceria-Pereña2, Anna Melissa Guerrero2, Netnapis Suchonwanich3, Salbiah Mo... more Anna Kemp-Casey1, Joyce Ceria-Pereña2, Anna Melissa Guerrero2, Netnapis Suchonwanich3, Salbiah Mohd Salleh4, Elizabeth E Roughead1 1Sansom Institute for Health Research, University of South Australia, Adelaide, Australia, 2Pharmaceutical Division, Health Regulation Team, Department of Health, Manila, the Philippines, 3Health Intervention and Technology Assessment Program, Ministry of Public Health, Nonthaburi, Thailand, 4Pharmacy Practice and Development Division, Ministry of Health, Putrajaya, Malaysia Correspondence to: Dr Anna Kemp-Casey (anna.kemp-casey@unisa.edu.au)

Public Health Research & Practice

The proportion of individuals who reduced or ceased use of statin medications in 2005 increased b... more The proportion of individuals who reduced or ceased use of statin medications in 2005 increased by 2.1% compared with 2004, following an increase in the Pharmaceutical Benefits Scheme copayment for medications • Of those who ceased or reduced statin use, 8% and 10%, respectively, had prior heart disease, putting them at an increased risk of harms from suboptimal use of lipid-lowering therapy • General beneficiary status, and younger and healthier people were particularly at risk of ceasing or reducing statin medication • The findings provide policy makers and clinicians with new information about the impact of a large increase in the medication copayment on the use of medications by specific subgroups Research

Applied Health Economics and Health Policy

Objectives To describe how post-market utilisation analysis in Australia informs cost-effectivene... more Objectives To describe how post-market utilisation analysis in Australia informs cost-effectiveness assessment and pricing decisions, using aflibercept and ranibizumab as case studies. Methods Pharmaceutical claims were used to identify initiators of aflibercept and ranibizumab in the year after afliberceptlisting (December 2012), and ranibizumab initiators in the year before aflibercept listing. The dispensing rates for each cohort were calculated, and their demographic and clinical characteristics compared using Kruskal-Wallis tests. Results Aflibercept and ranibizumab each accounted for half the age-related macular degeneration market following aflibercept listing. Aflibercept initiators had similar dispensing rates to ranibizumab initiators in the pre-and post-aflibercept era (~ three scripts during the first 90 days, and eight to nine scripts during the following 12 months). All cohorts were similar in terms of their age, sex, residential aged-care status and geographic remoteness, and no differences were observed in their overall co-morbidity scores and history of thromboembolic events. Conclusions Contrary to clinical trial protocols, post-market utilisation research for ranibizumab and aflibercept demonstrates equivalent use in practice in terms of dose frequency, and the demographic and clinical characteristics of initiators. This supports Australia's decision to pay the same price for each rather than giving a premium to aflibercept. Many other countries are likely overpaying for aflibercept if their utilization patterns are similar to Australia's, and could benefit from incorporating routine utilisation assessment.

BMJ Open

aims to investigate the validity of the Rx-Risk comorbidity index using medicines mapped to the A... more aims to investigate the validity of the Rx-Risk comorbidity index using medicines mapped to the Anatomical Therapeutic Chemical (ATC) classification system. 1) The manuscript lacks clear presentation of motivation, possible novelty and/or contribution. 2) The study is based on a single year, which is not up-to-date. 3) Data section lacks clarity, which is valid for manuscript as a whole. Missing are basic descriptive statistics with better explanation of the variables used. 4) There are more limitations of this study than there are mentioned (only two), e.g. data from 2013-2014: how they are relevant in 2018? 5) Why logist model was selected, but it is only briefly reported? 6) What are implications? 7) Conclusion is very brief. 8) There is a limited liste of relevant references. 9) Big Table 1 is on more pages: what is its focus and novelty/contribution,? 10) How to explain in Table 2 the scalling system for weighted Rx-Ris score with "0,-1, 1, ..., 6)? 11) In Table 3 are not reported some basic statistics. It is also not clear where are presented results of logistic regressions? REVIEWER Kris Jamsen d3 Medicine, A Certara Company, Australia REVIEW RETURNED 16-Jan-2018 GENERAL COMMENTS The authors have performed a rigorous evaluation of the predictive properties of Rx-Risk with respect to mortality in older outpatient populations. The overall strategy for addressing the objective is clear, however, I have one major comment. It appears that the weighted Rx-Risk was calculated by entering the 43 comorbidity indicators (yes/no) to a logistic regression model with mortality as the outcome and age and gender as covariates. So, this implies that the resulting weights for the individual comorbidities account for age and gender. However, in the statistical analysis, it appears that models with weighted Rx-Risk were adjusted for age and gender. This seems redundant, since the weights already account for age and gender. As such, I think it would be useful to perform the analysis of the weighted Rx-Risk without age and gender adjustment. Or perhaps, do this as a sensitivity analysis. Also, I think that for the weighted Rx-Risk, validation should focus on the data that were not used to derive the weights (i.e., external validation). It seems that the key purpose of an internal validation of the weighted Rx-Risk, using the data the weights were derived from, would be to ensure accuracy in the weights. Once these issues are addressed, I'd be happy to reassess the manuscript. Also, if I have misunderstood anything, please advise.

Drug Safety

Introduction Regulatory advisories on hydroxyzine and risk of QT prolongation and Torsade de poin... more Introduction Regulatory advisories on hydroxyzine and risk of QT prolongation and Torsade de pointes (TdP) were issued in the UK in April 2015 and Canada in June 2016. We hypothesized patients with risk factors for QT prolongation and TdP, compared with those without risk factors, would be less likely to initiate hydroxyzine in the UK and in British Columbia (BC), Canada, following advisories. Methods We conducted a longitudinal study with repeated measures, and evaluated hydroxyzine initiation in a UK cohort and a concurrent BC control cohort (April 2013-March 2016) as well as in a BC advisory cohort (June 2014-May 2017). Results This study included 247,665 patients in the UK cohort, 297,147 patients in the BC control cohort, and 303,653 patients in the BC advisory cohort. Over a 12-month post-advisory period, hydroxyzine initiation decreased by 21% in the UK (rate ratio 0.79, 95% confidence interval 0.66-0.96) relative to the expected level of initiation based on the pre-advisory trend. Hydroxyzine initiation did not change in the BC control cohort or following the Canadian advisory in the BC advisory cohort. The decrease in hydroxyzine initiation in the UK in the 12 months after the advisories was not significantly different for patients with risk factors compared with those without risk factors. Conclusion Hydroxyzine initiation decreased in the UK, but not in BC, in the 12 months following safety advisories. The decrease in hydroxyzine initiation in the UK was not significantly different for patients with versus without risk factors for QT prolongation and TdP.

BMJ Quality & Safety, 2022

Objective To evaluate the association between regulatory drug safety advisories and changes in dr... more Objective To evaluate the association between regulatory drug safety advisories and changes in drug utilisation. Design We conducted controlled, interrupted times series analyses with administrative prescription claims data to estimate changes in drug utilisation following advisories. We used random-effects meta-analysis with inverse-variance weighting to estimate the average postadvisory change in drug utilisation across advisories. Study population We included advisories issued in Canada, Denmark, the UK and the USA during 2009–2015, mainly concerning drugs in common use in primary care. We excluded advisories related to over-the-counter drugs, drug-drug interactions, vaccines, drugs used primarily in hospital and advisories with co-interventions within ±6 months. Main outcome measures Change in drug utilisation, defined as actual versus predicted percentage change in the number of prescriptions (for advisories without dose-related advice), or in the number of defined daily doses ...

Additional file 1: Description of study variables, missing data and exclusion.

Pharmacoepidemiology and Drug Safety, 2018

Public health research & practice, Jan 30, 2015

The Pharmaceutical Benefits Scheme (PBS) dataset provides detailed information about subsidised m... more The Pharmaceutical Benefits Scheme (PBS) dataset provides detailed information about subsidised medicines dispensed in Australia and is increasingly used for pharmacoepidemiological research. Use of the PBS dataset provides unique opportunities for such research, but comes with its own set of challenges that must be considered and addressed. This paper outlines some issues that commonly arise when using PBS data - relating to accurate identification of medicine dispensings and how to define medicine exposure - and suggests some possible approaches for dealing with them. The paper is intended as an introductory resource for researchers.

Public health research & practice, Jan 28, 2016

It is important for consumers, clinicians and health service planners to know the risk of recurre... more It is important for consumers, clinicians and health service planners to know the risk of recurrence of primary breast cancer after initial treatment. At present, none of Australia's state or territory cancer registries routinely report this information. We aimed to determine the incidence of recurrence in New South Wales (NSW) clinical practice for the period 18 months to 6 years after diagnosis of primary breast cancer. Retrospective cohort study using population-based linked health data. We identified 2416 women in the 45 and Up Study who were diagnosed with primary invasive breast cancer between 2003 and 2008 in NSW, and who had not had a recurrence 18 months after diagnosis. Unit-level hospital, pharmacy and outpatient medical claims were used to identify treatment for recurrence. Incidence of recurrence was calculated using individual person-time at risk (18 months to 6 years postdiagnosis), with follow-up censored for death or end of study period (median follow-up 3 years...

Public Health Research & Practice, 2015

Research in social & administrative pharmacy : RSAP, 2021

OBJECTIVES Patient contributions (co-payments) for one months' supply of a publicly-subsidise... more OBJECTIVES Patient contributions (co-payments) for one months' supply of a publicly-subsidised medicine in Australia were increased by 21% in January 2005 (US$2.73-$3.31 for social security recipients and 17.05−17.05-17.05−20.58 for others). This study investigates the relationship between patients' use of statin medication and hospitalisation for acute coronary syndrome and stroke, following this large increase in co-payments. METHODS We designed a retrospective cohort study of all patients in Western Australia who were dispensed statin medication between 2004 and 05. Data for the cohort was obtained from State and Federal linked databases. We divided the cohort into those who discontinued, reduced or continued statin therapy in the first six months after the co-payment increase. The primary outcome was two-year hospitalisation for acute coronary syndrome or stroke-related event. Analysis was conducted using Fine and Gray competing risk methods, with death as the competing risk. RESU...

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2021

INTRODUCTION In the general population, varenicline is consistently shown to be more efficacious ... more INTRODUCTION In the general population, varenicline is consistently shown to be more efficacious for smoking cessation than nicotine replacement therapy (NRT). Current clinical guidelines for the management of smoking during pregnancy recommend against the use of varenicline, whilst supporting the use of NRT. However, little is known about the comparative effectiveness of these smoking cessation therapies among pregnant women. AIMS AND METHODS Routinely-collected records of all births in two Australian States during 2011 and 2012 were used to create a population-based cohort of women who smoked during the first half of pregnancy. Pharmaceutical dispensing data were used to identify varenicline and nicotine patch dispensings in the first half of pregnancy. Propensity score matching was used to account for the potentially different distribution of confounding factors between the treatment groups. The outcome was defined as smoking abstinence during the second half of pregnancy. RESULT...

International Journal of Drug Policy

International Journal of Population Data Science

IntroductionIn January 2005, the Australian Government increased the consumer medication co-payme... more IntroductionIn January 2005, the Australian Government increased the consumer medication co-payment by 21%. Previous research found that this affected population-level utilisation of statins, which fell by 5% following the co-payment increase. The subsequent health impact on individuals reducing or ceasing use of statins is unknown. Objectives and ApproachTo explore the two-year risk of acute coronary syndrome (ACS) or stroke-related hospitalisation among individuals who discontinued, reduced or continued statin medicines after the 2005 PBS co-payments increase. This was achieved through a retrospective cohort study using linked administrative Commonwealth and State datasets for the Western Australian population. Outcomes were assessed using the Fine and Gray competing risks method, with death as the competing risk, adjusting for demographics, comorbidities and medication history. ResultsThere were 207,066 individuals identified as using statins before the co-payment increase. After...

Journal of Health Services Research & Policy

Objective This study examined the association between statin usage (discontinued, reduced or cont... more Objective This study examined the association between statin usage (discontinued, reduced or continued) and two-year death following a 21% increase in the Pharmaceutical Benefits Scheme (PBS) consumer co-payment in Western Australia. Methods A retrospective observational study in Western Australia using linked administrative Commonwealth PBS data and State hospital inpatient and death data (n = 207,066) was undertaken. We explored the two-year all-cause and ischemic heart disease(IHD)/stroke-specific-death in individuals who discontinued, reduced or continued statin medication following the January 2005 PBS co-payment increase, overall, by beneficiary status (general population vs. social security recipients) and by a history of admission for ischemic heart disease or stroke. Non-cardiovascular (CVD)-related death was also considered. Results In the first six months of 2005, 3.3% discontinued, 12.5% reduced and 84.2% continued statin therapy. We found those who discontinued statins ...

WHO South-East Asia Journal of Public Health

Background Little is known about how the different policies available to promote use of generic m... more Background Little is known about how the different policies available to promote use of generic medicines affect the price per unit supplied or sold. This study compares the influence of pricing policies for generic medicines on atorvastatin prices in Australia, New Zealand, the Republic of Korea and Singapore, after market entry of generic atorvastatin. Methods The annual price of atorvastatin per defined daily dose supplied (price/DDD) was examined for each country from 2006 to 2015 (≥2 years before and ≥4 years after generic market entry). Prices were converted to international dollars and cumulative percentage price reductions were calculated for the first 4 years following generic entry. Results Prior to market entry of generic atorvastatin, New Zealand had the lowest price ($0.10/DDD), and the Republic of Korea the highest ($2.89/DDD). The price/DDD fell immediately after generic entry in all countries except New Zealand, which already had low prices. The largest immediate decrease was observed in Singapore (46%, year 1). By the fourth year after generic entry, the price had fallen by 46–80% in all countries; however, large price differences between countries remained. Conclusion New Zealand’s tendering system and use of preferred medicines resulted in very low atorvastatin prices well before patent expiry. Pricing policies in the other three countries were effective in reducing atorvastatin prices, with reductions of between 46% and 80% within 4 years of generic entry. Where tendering and use of preferred medicines were the mechanisms for atorvastatin procurement (New Zealand), prices were lowest before and after generic entry. Mandatory price cuts, combined with price-disclosure policies (Australia), produced similar relative price reductions to tendering systems (New Zealand, Singapore) at 4 years. By comparison, mandatory price cuts upon generic entry as the sole measure, while initially effective, were associated with the smallest relative reduction in price after 4 years (Republic of Korea).

Australian Health Review

ObjectiveThis study assessed the effect of the frequency of general practitioner (GP) visitation ... more ObjectiveThis study assessed the effect of the frequency of general practitioner (GP) visitation in the 12 months before a 21% consumer copayment increase in the Pharmaceutical Benefits Scheme (PBS; January 2005) on the reduction or discontinuation of statin dispensing for tertiary prevention. MethodsThe study used routinely collected, whole-population linked PBS, Medicare, mortality and hospital data from Western Australia. From 2004 to 2005, individuals were classified as having discontinued, reduced or continued their use of statins in the first six months of 2005 following the 21% consumer copayment increase on 1 January 2005. The frequency of GP visits was calculated in 2004 from Medicare data. Multivariate logistic regression models were used to determine the association between GP visits and statin use following the copayment increase. ResultsIn December 2004, there were 22495 stable statin users for tertiary prevention of prior coronary heart disease, prior stroke or prior c...

BMC Medicine

Background Varenicline, bupropion and nicotine replacement therapy (NRT) are three effective phar... more Background Varenicline, bupropion and nicotine replacement therapy (NRT) are three effective pharmacotherapies for smoking cessation, but data about their safety in pregnancy are limited. We assessed the risk of adverse perinatal outcomes and major congenital anomalies associated with the use of these therapies in pregnancy in Australia. Methods Perinatal data for 1,017,731 deliveries (2004 to 2012) in New South Wales and Western Australia were linked to pharmaceutical dispensing, hospital admission and death records. We identified 97,875 women who smoked during pregnancy; of those, 233, 330 and 1057 were exposed to bupropion, NRT and varenicline in pregnancy, respectively. Propensity scores were used to match exposed women to those who were unexposed to any smoking therapy (1:10 ratio). Propensity scores and gestational age at exposure were used to match varenicline-exposed to NRT-exposed women (1:1 ratio). Time-dependent Cox proportional hazards models estimated hazard ratios (HR)...

WHO South-East Asia Journal of Public Health

Anna Kemp-Casey1, Joyce Ceria-Pereña2, Anna Melissa Guerrero2, Netnapis Suchonwanich3, Salbiah Mo... more Anna Kemp-Casey1, Joyce Ceria-Pereña2, Anna Melissa Guerrero2, Netnapis Suchonwanich3, Salbiah Mohd Salleh4, Elizabeth E Roughead1 1Sansom Institute for Health Research, University of South Australia, Adelaide, Australia, 2Pharmaceutical Division, Health Regulation Team, Department of Health, Manila, the Philippines, 3Health Intervention and Technology Assessment Program, Ministry of Public Health, Nonthaburi, Thailand, 4Pharmacy Practice and Development Division, Ministry of Health, Putrajaya, Malaysia Correspondence to: Dr Anna Kemp-Casey (anna.kemp-casey@unisa.edu.au)

Public Health Research & Practice

The proportion of individuals who reduced or ceased use of statin medications in 2005 increased b... more The proportion of individuals who reduced or ceased use of statin medications in 2005 increased by 2.1% compared with 2004, following an increase in the Pharmaceutical Benefits Scheme copayment for medications • Of those who ceased or reduced statin use, 8% and 10%, respectively, had prior heart disease, putting them at an increased risk of harms from suboptimal use of lipid-lowering therapy • General beneficiary status, and younger and healthier people were particularly at risk of ceasing or reducing statin medication • The findings provide policy makers and clinicians with new information about the impact of a large increase in the medication copayment on the use of medications by specific subgroups Research

Applied Health Economics and Health Policy

Objectives To describe how post-market utilisation analysis in Australia informs cost-effectivene... more Objectives To describe how post-market utilisation analysis in Australia informs cost-effectiveness assessment and pricing decisions, using aflibercept and ranibizumab as case studies. Methods Pharmaceutical claims were used to identify initiators of aflibercept and ranibizumab in the year after afliberceptlisting (December 2012), and ranibizumab initiators in the year before aflibercept listing. The dispensing rates for each cohort were calculated, and their demographic and clinical characteristics compared using Kruskal-Wallis tests. Results Aflibercept and ranibizumab each accounted for half the age-related macular degeneration market following aflibercept listing. Aflibercept initiators had similar dispensing rates to ranibizumab initiators in the pre-and post-aflibercept era (~ three scripts during the first 90 days, and eight to nine scripts during the following 12 months). All cohorts were similar in terms of their age, sex, residential aged-care status and geographic remoteness, and no differences were observed in their overall co-morbidity scores and history of thromboembolic events. Conclusions Contrary to clinical trial protocols, post-market utilisation research for ranibizumab and aflibercept demonstrates equivalent use in practice in terms of dose frequency, and the demographic and clinical characteristics of initiators. This supports Australia's decision to pay the same price for each rather than giving a premium to aflibercept. Many other countries are likely overpaying for aflibercept if their utilization patterns are similar to Australia's, and could benefit from incorporating routine utilisation assessment.

BMJ Open

aims to investigate the validity of the Rx-Risk comorbidity index using medicines mapped to the A... more aims to investigate the validity of the Rx-Risk comorbidity index using medicines mapped to the Anatomical Therapeutic Chemical (ATC) classification system. 1) The manuscript lacks clear presentation of motivation, possible novelty and/or contribution. 2) The study is based on a single year, which is not up-to-date. 3) Data section lacks clarity, which is valid for manuscript as a whole. Missing are basic descriptive statistics with better explanation of the variables used. 4) There are more limitations of this study than there are mentioned (only two), e.g. data from 2013-2014: how they are relevant in 2018? 5) Why logist model was selected, but it is only briefly reported? 6) What are implications? 7) Conclusion is very brief. 8) There is a limited liste of relevant references. 9) Big Table 1 is on more pages: what is its focus and novelty/contribution,? 10) How to explain in Table 2 the scalling system for weighted Rx-Ris score with "0,-1, 1, ..., 6)? 11) In Table 3 are not reported some basic statistics. It is also not clear where are presented results of logistic regressions? REVIEWER Kris Jamsen d3 Medicine, A Certara Company, Australia REVIEW RETURNED 16-Jan-2018 GENERAL COMMENTS The authors have performed a rigorous evaluation of the predictive properties of Rx-Risk with respect to mortality in older outpatient populations. The overall strategy for addressing the objective is clear, however, I have one major comment. It appears that the weighted Rx-Risk was calculated by entering the 43 comorbidity indicators (yes/no) to a logistic regression model with mortality as the outcome and age and gender as covariates. So, this implies that the resulting weights for the individual comorbidities account for age and gender. However, in the statistical analysis, it appears that models with weighted Rx-Risk were adjusted for age and gender. This seems redundant, since the weights already account for age and gender. As such, I think it would be useful to perform the analysis of the weighted Rx-Risk without age and gender adjustment. Or perhaps, do this as a sensitivity analysis. Also, I think that for the weighted Rx-Risk, validation should focus on the data that were not used to derive the weights (i.e., external validation). It seems that the key purpose of an internal validation of the weighted Rx-Risk, using the data the weights were derived from, would be to ensure accuracy in the weights. Once these issues are addressed, I'd be happy to reassess the manuscript. Also, if I have misunderstood anything, please advise.