CHARACTERISTICS OF MANAGED ENTRY AGREEMENTS IN AUSTRALIA.

OBJECTIVES: Australia relies on managed entry agreements (MEAs) for many medicines added to the national Pharmaceutical Benefits Scheme (PBS). Previous studies of Australian MEAs examined public domain documents and were not able to provide a comprehensive assessment of the types and operation of MEAs. This study used government documents approved for release to examine the implementation and administration of MEAs implemented January 2012 to May 2016. METHODS: We accessed documents for medicines with MEAs on the PBS between January 2012 and May 2016. Data were extracted on Anatomical Therapeutic Classification (ATC), type of MEA (financial, financial with outcomes, outcomes, and subcategories within each group), implementation and administration methods, source of MEA recommendation, and type of economic analysis. RESULTS: Of all medication indication pairs (MIPs) recommended for listing, one-third had MEAs implemented. Our study of eighty-seven MIPs had 170 MEAs in place. The Government's expert health technology assessment (HTA) committee recommended MEAs for 90 percent of the eighty-seven MIPs. A total of 81 percent of MEAs were simple financial agreements: the majority either discounts (32 percent) or reimbursement caps (43 percent). Outcome-based MEAs were least common (5 percent). Ninety-two percent of MEAs were implemented and operated through legal agreements. Approximately half of the MIPs were listed on the basis of accepted claims of cost-minimization. Forty-nine percent of medicines were in ATC L group. CONCLUSION: Advice from HTA evaluations strongly influences the implementation of ways to manage uncertainties while providing access to medicines. The government relied primarily on simple financial agreements for the managed entry of medicines for which there were perceived risks.

Patterns of antipsychotic medication use in Australia 2002-2007.

OBJECTIVE: Atypical antipsychotic medications that are primarily used to treat schizophrenia and bipolar disorder cost the Pharmaceutical Benefits Scheme (PBS) AUD$334.4m in 2007. There are indications that they have also been used outside the approved indications to treat behavioural disturbances in the elderly. The aim of the present study was therefore to examine (i) trends in prescribing of subsidized atypical antipsychotic drugs in the Australian population from 2002 to 2007; and (ii) gender and age differences in the utilization of these drugs. METHODS: Government (Medicare Australia) data on numbers of prescriptions, quantity and doses for atypical and typical antipsychotics from 2002 to 2007 were analysed. Defined daily dose per 1000 population per day were estimated for age and sex groups using Australian Bureau of Statistics population data. RESULTS: The proportion of prescribed antipsychotics that were atypical increased from 61% in 2002 to 77% in 2007. In male subjects, olanzapine was most often prescribed between the ages of 25 and 55 years. In female subjects, in contrast, the highest rates of prescribing were in those > or = 75 years. Lower doses of these drugs were prescribed in older adults. CONCLUSIONS: Atypical antipsychotic drugs were most commonly used to treat schizophrenia in younger men and behavioural disturbances in older women with dementia. They appear to have been used outside of the approved indication for schizophrenia and bipolar disorder with significant financial costs to the PBS. Research into the reasons for their extensive use in elderly women is needed to inform more rational prescribing of these medicines.

Changes in utilisation of hormone replacement therapy in Australia following publication of the findings of the Women's Health Initiative.

PURPOSE: To examine the impact of publication of the findings of the Women's Health Initiative (WHI) on the utilisation of hormone replacement therapy (HRT) in Australia with particular reference to the influence that media may have had on prescriber and consumer behaviour. METHODS: Retrospective data from the Australian Government Department of Health, Ageing DUSC Database and media hits from Factiva were reviewed to obtain prescription numbers, total cost and cost to the pharmaceutical benefits scheme and number of media hits from the year before publication of the combined HRT arm of the WHI. RESULTS: Prescribing of HRT products decreased significantly immediately following publication of the combined HRT arm of the WHI and continued to decline at a slower rate following publication of the memory and oestrogen only arms of the study. CONCLUSIONS: These results represent a more accurate national estimate of the change in HRT use in Australian women relative to previous findings from surveys carried out in Australia.

Smoking status of Australian general practice patients and their attempts to quit.

This paper seeks to report on smoking rates, quit attempt methods and success rates among adult patients attending Australian general practice. A cluster cross-sectional survey was used to survey adult patients (18+), who attended Australian GPs in during 2002 and 2003. Over a quarter of patients (27.3%; 95% CI: 26.0-28.7) were former smokers and one in five (21.5%; 95% CI: 20.1-22.9) were current smokers. Ninety-two percent of former and 80% of current smokers used only one method in their last quit attempt with cold turkey the most common method used by both former (88%) and current (62%) smokers. Overall, success rates varied from 77% for cold turkey to 23% for bupropion. Success rates were re-analysed to consider quit attempts post-bupropion listing, with success rate for cold turkey reduced to 40% while bupropion remained reasonably constant at 21%. By tailoring smoking cessation interventions to a smokers' preparedness to quit, scope exists to increase the pool of smokers offered strategies that are more effective in achieving abstinence and avoiding relapse rather than relying on less effective self-quitting behaviours such as cold turkey.

Use of Medicines with Anticholinergic and Sedative Effect Before and After Initiation of Anti-Dementia Medications.

BACKGROUND: People with dementia may be particularly sensitive to cognitive impairment induced by anticholinergic and sedative medicines. OBJECTIVE: This study aimed to examine if utilisation of medicines with anticholinergic and sedative effects changed before and after initiation of anti-dementia therapy. METHODS: A retrospective cohort study was conducted using Australian pharmacy claim data (Pharmaceutical Benefit Scheme). People with first (index) dispensing for a cholinesterase inhibitor or memantine between 1 January 2009 and 31 December 2010 who were aged 65 years or over at the time of initiation were included. The proportion who received sedatives or anticholinergics in the 6 months prior to and post initiation of anti-dementia therapy was determined. RESULTS: The cohort included 24,110 patients, with over half aged 75-84 years. Overall, 30 % received any class of anticholinergic or sedative medicine for at least 1 month in the 6 months prior to initiation of anti-dementia agents, and 36 % post initiation. Some patients (6 %) ceased anticholinergics or sedatives post initiation even though they had them in the months prior. However, 12 % commenced therapy with anticholinergics or sedatives post anti-dementia therapy initiation even though they were naïve to them in the 6 months prior to therapy. CONCLUSION: Medicines with anticholinergic or sedative effects were commonly dispensed in one-third of people with dementia. Prescribers need to consider a review of patients on anticholinergic therapy with cholinesterase inhibitors as the effectiveness of the cholinesterase therapy may be compromised.

A randomized double-blinded placebo-controlled crossover trial of nebulized taurolidine in adult cystic fibrosis patients infected with Burkholderia cepacia.

Burkholderia cepacia is an aggressive pathogen that colonizes cystic fibrosis (CF) patients, causing greatly increased morbidity and mortality. It is resistant to most antibiotics, but sensitive in vitro to a novel agent, taurolidine. This has not previously been used against B. cepacia, nor given in nebulized form. We assessed the effect of nebulized taurolidine on United Kingdom epidemic (ET12) B. cepacia infection in 20 adult CF patients attending our regional adult cystic fibrosis outpatient clinic using a prospective, randomized, double-blinded placebo-controlled crossover trial. Nebulized taurolidine (4 mL 2% solution) or saline (4 mL 0.9% solution) was given twice daily. Each arm lasted 4 weeks, with a 2-week intervening washout period. Sputum B. cepacia colony counts (primary outcome measure), spirometry, and symptoms (secondary outcome measures) were assessed. Eighteen patients completed the study. There was no change in B. cepacia colony counts or spirometry, nor symptom scores. We conclude that, although taurolidine is well tolerated in nebulized form, in this study it had no in vivo anti-B. cepacia activity.

Uptake of methylnaltrexone in Australian patients with opioid-induced constipation: a review of the number of prescriptions presented in the first 12 months of subsidisation.

BACKGROUND: Disturbed bowel habits are very common in palliative care patients, most commonly thought to be due to opioid use. The peripheral opioid-antagonist methylnaltrexone has been subsidised in Australia to ensure that palliative care patients have timely and equitable access to this medication. The aim of this paper is to describe the use of methylnaltrexone in the first year after it was subsidised for palliative care, in particular focusing on the actual use of this medication compared with predicted need. METHODS: The predicted need for methylnaltrexone was calculated using an epidemiological approach based on data collected by the Australian Institute of Health and Welfare to determine the number of Australian deaths annually. A single source of data was used to determine the number of patients who die while under the care of palliative services in Australia (National Census of Palliative Care Services, 1999). These figures allowed the number of people likely to be receiving opioids to be estimated and therefore the number who could potentially benefit from methylnaltrexone. RESULTS: The number of patients who might benefit was calculated to be 5000, which contrasts with the 261 actual prescriptions written for methylnaltrexone. Even more striking was the disparity between initial prescriptions and the 93 requests for ongoing use. CONCLUSIONS: These data highlight much lower use of methylnaltrexone than predicted and raise a number of questions including the fact that the palliative care literature emphasises opioids as the dominant cause of constipation in palliative care patients given little ongoing use of methylnaltrexone.

Adherence, persistence and continuation with cholinesterase inhibitors in Alzheimer's disease.

AIM: To determine adherence, persistence and continuation beyond 6 months with cholinesterase inhibitors in Australians with Alzheimer's disease. METHODS: Adherence and persistence with cholinesterase inhibitors were assessed by data linkage using the Pharmaceutical Benefits Scheme (PBS) Authority database and other health databases. RESULTS: Over 18 000 people commenced cholinesterase inhibitors during 2004. Adherence was 79.4% while the medication possession ratio was 0.88. Some 70.3% of people filled all six scripts for the initial trial period of therapy. Some 57.3% of evaluable patients accessed funding beyond six prescriptions, indicating that their clinicians had declared that there was a two-point or more greater improvement in the Mini-Mental State Examination. Despite the high rate of continuation beyond 6 months, the rates of institutionalisation and death were no different to those reported in clinical trials. CONCLUSIONS: Persistence and adherence with cholinesterase inhibitors was reasonable once treatment was established. There was an unexpectedly high continuation rate beyond six prescriptions.

The effects of the market withdrawal of temazepam gel capsules on benzodiazepine injecting in Sydney, Australia.

INTRODUCTION AND AIMS: This study assessed the impact on benzodiazepine injection among IDU in Sydney of removing temazepam gel capsule preparations from the Australian market. DESIGN AND METHODS: Several data sources were used: (1) data from the NSW Illicit Drug Reporting System (IDRS) (an annual, cross-sectional survey of regular IDU in Sydney) for the period 1996 - 2005; (2) data from inner Sydney outreach services and the Sydney Medically Supervised Injecting Centre (MSIC) on last drug injected; and (3) national benzodiazepine prescription data, by formulation, from the Drug Utilisation Sub-Committee for the period 2001 - 06. RESULTS: Removal of temazepam gel capsule formulations from the Australian market in 2004 resulted in increased prescribing of tablet formulations but overall benzodiazepine prescription numbers remained stable. Injection of benzodiazepines ceased as a mode of administration of benzodiazepines among IDU in inner Sydney, but very frequent oral use of benzodiazepines remained highly prevalent. DISCUSSION AND CONCLUSIONS: Removal of an easily injectable form of benzodiazepines appeared to halt injection of benzodiazepines among disadvantaged IDU. However, IDU continue to use the drug heavily and interventions to assist IDU with reducing dependent benzodiazepine use are warranted. There is a need for continued vigilance to emergent injecting drug use risks to implement timely harm reduction strategies.