Exploring the association between stroke and acute myocardial infarction and statins adherence following a medicines co-payment increase.

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-$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. RESULTS: There were 207,066 patients using statins prior to the co-payment increase. Following the increase, 12.5% of patients reduced their use of statin medication, 3.3% of patients discontinued therapy, and 84.2% continued therapy. There were 4343 acute coronary syndrome and stroke-related hospitalisations in the two-year follow-up period. Multivariate analysis demonstrated that discontinuing statins increased the risk of hospitalisation for acute coronary syndrome or stroke-related events by 18% (95%CI = 0.1%-40%) compared to continuing therapy. Subgroup analysis showed that men aged <70 years were at increased risk of 54-63% after discontinuing statins compared to those continuing, but that women and older men were not. CONCLUSION: Discontinuing statin medication after a large increase patient cost contribution was associated with higher rates of acute coronary syndrome and stroke-related hospitalisation in men under 70 years. The findings highlight the importance of continued adherence to prescribed statin medication, and that discontinuing therapy for non-clinical reasons (such as cost) can possibly have negative consequences particularly for younger men.

Increased risk of 2-year death in patients who discontinued their use of statins.

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 were also likely to discontinue at least two other medicines compared to those who continued therapy. There were 4,607 all-cause deaths. For IHD/stroke-specific death, there were 1,317. For all non-CVD-related death, there were 2,808 deaths during the 2-year follow-up period. Cox regression models, adjusted for demographic and clinical characteristics, showed a 39%-61% increase in the risk of all-cause death for individuals who reduced or discontinued statin medication compared to those who continued their statin medication (Discontinued: Adj HR = 1.61, 95% CI 1.40-1.85; Reduced: Adj HR = 1.39, 95% CI 1.28-1.51). For IHD/stroke-specific death, there was an increased risk of death by 28-76% (Discontinued: Adj sHR = 1.76, 95% CI 1.37-2.27; Reduced: Adj sHR = 1.28, 95% CI 1.10-1.49), and for non-CVD-related death, there was an increased risk of death by 44-57% (Discontinued: Adj sHR = 1.57, 95% CI 1.31-1.88; Reduced: Adj sHR = 1.44, 95% CI 1.30-1.60), for individuals who discontinued or reduced their statin medication compared to those who continued. CONCLUSIONS: Patients who discontinued their statin therapy had a significantly increased risk of IHD and stroke death. Health professionals should be aware that large co-payment changes may be associated with patients discontinuing or reducing medicines to their health detriment. Factors that lead to such changes in patient medication-taking behaviour need to be considered and addressed at the clinical and policy levels.

Frequent general practitioner visits are protective against statin discontinuation after a Pharmaceutical Benefits Scheme copayment increase.

Objective This 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. Methods The 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. Results In December 2004, there were 22495 stable statin users for tertiary prevention of prior coronary heart disease, prior stroke or prior coronary artery revascularisation procedure. Following the copayment increase, patients either discontinued (3%), reduced (12%) or continued (85%) their statins. Individuals who visited a GP three or more times in 2004 were 47% less likely to discontinue their statins in 2005 than people attending only once. Subgroup analysis showed the effect was apparent in men, and long-term or new statin users. The frequency of GP visits did not affect the proportion of patients reducing their statin therapy. Conclusions Patients who visited their GP at least three times per year had a lower risk of ceasing their statins in the year following the copayment increase. GPs can help patients maintain treatment following rises in medicines costs. What is known about the topic? Following the 21% increase in medication copayment in 2005, individuals discontinued or reduced their statin usage, including for tertiary prevention. What does this paper add? Patients who visited their GP at least three times per year were less likely to discontinue their statin therapy for tertiary prevention following a large copayment increase. What are the implications for practitioners? This paper identifies the important role that GPs have in maintaining the continued use of important medications following rises in medicines costs.

Using Post-market Utilisation Analysis to Support Medicines Pricing Policy: An Australian Case Study of Aflibercept and Ranibizumab Use.

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 aflibercept-listing (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.

Pricing policies for generic medicines in Australia, New Zealand, the Republic of Korea and Singapore: patent expiry and influence on atorvastatin price.

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).

Impact of consumer copayments for subsidised medicines on health services use and outcomes: a protocol using linked administrative data from Western Australia.

INTRODUCTION: Across the world, health systems are adopting approaches to manage rising healthcare costs. One common strategy is a medication copayments scheme where consumers make a contribution (copayment) towards the cost of their dispensed medicines, with remaining costs subsidised by the health insurance service, which in Australia is the Federal Government.In Australia, copayments have tended to increase in proportion to inflation, but in January 2005, the copayment increased substantially more than inflation. Results from aggregated dispensing data showed that this increase led to a significant decrease in the use of several medicines. The aim of this study is to determine the demographic and clinical characteristics of individuals ceasing or reducing statin medication use following the January 2005 Pharmaceutical Benefit Scheme (PBS) copayment increase and the effects on their health outcomes. METHODS AND ANALYSIS: This whole-of-population study comprises a series of retrospective, observational investigations using linked administrative health data on a cohort of West Australians (WA) who had at least one statin dispensed between 1 May 2002 and 30 June 2010. Individual-level data on the use of pharmaceuticals, general practitioner (GP) visits, hospitalisations and death are used.This study will identify patients who were stable users of statin medication in 2004 with follow-up commencing from 2005 onwards. Subgroups determined by change in adherence levels of statin medication from 2004 to 2005 will be classified as continuation, reduction or cessation of statin therapy and explored for differences in health outcomes and health service utilisation after the 2005 copayment change. ETHICS AND DISSEMINATION: Ethics approvals have been obtained from the Western Australian Department of Health (#2007/33), University of Western Australia (RA/4/1/1775) and University of Notre Dame (0 14 167F). Outputs from the findings will be published in peer reviewed journals designed for a policy audience and presented at state, national and international conferences.

Declining rates of sterilization procedures in Western Australian women from 1990 to 2008: the relationship with age, hospital type, and government policy changes.

OBJECTIVE: To describe trends in age-specific incidence rates of female sterilization (FS) procedures in Western Australia and to evaluate the effects of the introduction of government-subsidized contraceptive methods and the implementation of the Australian government's baby bonus policy on FS rates. DESIGN: Population-based retrospective descriptive study. SETTING: Not applicable. PATIENT(S): All women ages 15-49 undergoing an FS procedure during the period January 1, 1990, to December 31, 2008 (n = 47,360 procedures). INTERVENTION(S): Records from statutory statewide data collections of hospitals separations and births were extracted and linked. MAIN OUTCOME MEASURE(S): Trends in FS procedures and the influence on these trends of the introduction of government policies: subsidization of long-acting reversible contraceptives (Implanon and Mirena) and the Australian baby bonus initiative. RESULT(S): The annual incidence rate of FS procedures declined from 756.9 per 100,000 women in 1990 to 155.2 per 100,000 women in 2008. Compared with the period 1990-1994, women ages 30-39 years were 47% less likely (rate ratio [RR] = 0.53; 95% confidence interval [CI], 0.39-0.72) to undergo sterilization during the period 2005-2008. Adjusting for overall trend, there were significant decreases in FS rates after government subsidization of Implanon (RR = 0.89; 95% CI, 0.82-0.97) and Mirena (RR = 0.81; 95% CI, 0.73-0.91) and the introduction of the baby bonus (RR = 0.70; 95% CI, 0.61-0.81). CONCLUSION(S): Rates of female sterilization procedures in Western Australia have declined substantially across all age groups in the last two decades. Women's decisions to undergo sterilization procedures may be influenced by government interventions that increase access to long-term reversible contraceptives or encourage childbirth.