Sole supply of influenza vaccine: economic common sense or a disaster waiting to happen?

The interruption to the New Zealand influenza vaccine supply in 2005 (caused by a manufacturing error) greatly disrupted the annual influenza vaccination programme. The sole-tendering process used by PHARMAC was blamed by some for the crisis, which may have been alleviated by having more than one supplier. In this article, the author discusses the issues resulting from having limited options of vaccine supply. Supply problems are not limited to influenza vaccine but the tight timelines required for vaccine delivery may make it wise to secure two suppliers in future. Like all health insurance, the cost of supply redundancy will be appreciable.     

Hospital drug and therapeutics committees in Australia: is there a role for economic evaluation at the institutional level?

Decisions about spending on medicines occur at different levels in the Australian health care system. This commentary describes the role of economic evaluation at the institutional (public hospital) level. In contrast to the decisions taken at the level of Federal subsidy (listing on the Pharmaceutical Benefits Scheme) formal pharmacoeonomic data analyses are usually not available, and arguably often not relevant to decision making within the public hospital setting. Future research is needed to develop and explore models of best practice and how to incorporate pharmacoeconomic evidence into local decisions.     

Assessing the economic impact of psychiatric disorders: where to begin?

Over the past decade, psychiatric disorders have increasingly been regarded as serious public health concerns, with debilitating symptoms as well as high social and economic costs to patients, caregivers, third party payers and society. In this article, we review findings from recent research on psychiatric disorders, while providing a framework for assessing their pharmacoeconomic impact. In particular, we consider the prevalence of psychiatric disorders, their far-reaching impacts, and their associated treatment patterns. These categories present a starting point for analysing the pharmacoeconomic consequences of psychiatric disorders and underlie an expert opinion in this context     

What's in a cost? Comparing economic and public health measures of alcohol's social costs

Studies based on a cost of illness method frequently assert large social costs from a variety of risky activities, the harms from which most typically fall upon the risk-taker himself. Many of these costs are inadmissible in a standard economic framework; consequently, figures derived by the cost of illness method are not comparable with other economic notions of cost and are of very limited policy use.     

Cost-effectiveness of continuous combined hormone replacement therapy in long-term use: economic evaluation based on a 9‑year study in Finland

ABSTRACT

Objectives: To investigate the cost-effectiveness of continuous combined hormone replacement therapy (ccHRT) (Indivina) in postmenopausal women in Finland treated for up to nine consecutive years in the course of a randomised controlled trial.

Methods: In-study event data were accrued for cardiac and vascular events, cancers and fractures. These event incidence data were applied to first-year direct medical costs for these events, derived from published sources. Reference event incidence data were derived from hospital discharge records and relevant national registries for age-matched women (aged 50–70 years) in Finland with an assumed HRT usage rate of 40%. Cost-effectiveness was expressed as additional cost per quality-adjusted life year (QALY) gained for women on ccHRT compared with the general population. All input data were discounted at 3% per annum.

Results: The additional cost per QALY gained for ccHRT was less than €5000 throughout the nine calendar years examined and remained well below the threshold of acceptability of €50?000 in a range of sensitivity analyses. The lowest dose-combination of ccHRT examined improved quality of life at no greater cost than no treatment.

Conclusions: This appraisal, based on event data from a uniquely long study of ccHRT, indicates that this intervention is cost-effective for the relief of symptoms of menopause.     

Clinical,economic, and organizational impact of pharmacists’ interventions in a cognitive-behavioral unit in France

International Journal of Clinical Pharmacy - Objective Evaluate the clinical, economic, and organizational impact of pharmaceutical interventions performed during medication review in a...     

Clinical and economic impact of a pharmacist‐intervention to promote sequential intravenous to oral clindamycin conversion

A multicentre, prospective, controlled study compared the clinical efficacy, safety and economic impact of a pharmacist intervention to promote sequential intravenous to oral clindamycin conversion. A total of 473 patients receiving intravenous clindamycin for at least 72 hours were included in the study. Two groups were established: an intervention group (204 patients) in which an informative sheet recommending the sequential treatment was provided, and a control group (269 patients). Clindamycin was prescribed for respiratory infections in 38.9% and for prophylaxis in surgery in 25.4% of the patients (71% were contaminated surgery). No difference between groups regarding sex, infection severity, health status or clinical progress was observed. Both the stepdown treatments after 72 hours of intravenous clindamycin and the change to the oral route later on, were significantly increased with the intervention (p<0.001, p<0.001 respectively). No significant differences between both groups were found in the number of patients with adverse effects associated with the IV therapy, although the incidence tended to be lower in the intervention group (49/204 intervention versus 85/269 control, p=0.07). Compliance with the recommended clindamycin dosing regimen was significantly higher in the intervention group, in which 1.3 days reduction of intravenous therapy provided an average cost savings of PTA5246 (95%CI 25567935) per treatment. A higher reduction of 1.7 days was achieved in those patients candidates for switch therapy on the third day of intravenous clindamycin. A sequential program with clindamycin may provide a costeffective alternative to conventional therapy and the introduction of an information sheet is a costeffective strategy to promote it.     

National Institute for Clinical Excellence (NICE): Is economic appraisal working?

This paper analyses the 32 technology appraisals completed by the National Institute for Clinical Excellence (NICE) in the UK from its establishment to the end of January 2002. It looks at why technologies have been rejected, what has happened to products reviewed at launch, evidence of rationing on cost-effectiveness grounds, and the issues raised for manufacturers and for NICE in the collection and analysis of economic data. It finds that around two-thirds of NICE appraisals have been of pharmaceuticals. Only two 'first in class' products have been reviewed at launch, with quite different results. There is clear evidence of the use of cost-effectiveness criteria to restrict or reject technologies, although these are not the only criteria used in decision making. While a number of concerns with the appraisal process raised by manufacturers have been addressed by NICE, and while the Department of Health is currently consulting on changes to the referral system whereby products are selected for review by NICE, manufacturers remain concerned about the timing of referrals in the product life cycle and about the quality and consistency of the reviews of evidence undertaken by academic groups for NICE. Concerns in the National Health Service centre on whether the right technologies are being referred to NICE and also on the opportunity cost of positive NICE recommendations. Given global budget constraints and the difficulty of withdrawing services, the NICE recommendations tend to preempt growth money that could be used for more cost-effective purposes. NICE should be asked to look at established technologies that may not be cost effective and whose discontinuance could therefore release resources for other more cost-effective treatments.     

Challenges in health state valuation in paediatric economic evaluation: are QALYs contraindicated?

With the growth in the use of health economic evaluation to inform healthcare resource allocation decisions, the challenges in applying standard methods to child health have become apparent. A unique limitation is the paucity of child-specific preference-based measures. A single, valid, preference-based measure of utility that can be used in children of all ages does not exist. Thus, the ability to derive a QALY for use in cost-utility analysis (CUA) is compromised. This paper presents and discusses existing and novel options for deriving utilities for paediatric health states for use in CUAs. While a direct elicitation may be preferred, a child's ability to complete a standard gamble or time trade-off task is hampered by cognitive and age limitations. The abstract notions contained in indirect instruments such as the EQ-5D and Health Utilities Index may also pose challenges for young children. Novel approaches to overcome these challenges include the development of age-appropriate instruments such as the EQ-5D-Y, the development of new child-specific utility instruments such as the Child Health Utility-9D and the re-calibration of existing adult instruments to derive preference weights for health states from children themselves. For children aged <6 years, researchers have little choice but to use a proxy reporter such as parents. While parents may be reliable reporters for physical activity limitations and externally manifest symptoms, their ability to accurately report on subjective outcomes such as emotion is questionable. Catalogues of utility weights for a range of conditions are increasingly becoming available but retain many of the same limitations as valuing health states from children or from proxies. Given the dynamic relationship in quality of life (QOL) between family members when a child is ill, it seems appropriate to consider a 'family perspective' rather than an individual perspective in child health state valuation. In a collective approach, health state utilities derived from multiple family members may be combined mathematically. Alternatively, in a unitary approach, a single utility estimate may be determined to represent the family's perspective. This may include deriving utilities through parent-child dyad estimation or by using a household model that combines the utility weights of the patient and family members, incorporating reciprocal QOL effects. While these various approaches to child health state valuation represent novel research developments, the measurement challenges and threats to validity persist. Given the importance of non-health benefits to child health, especially in the domains of education and public policy, it may be worthwhile to consider an approach that allows incorporation of externalities to produce a cost-benefit analysis. The use of discrete-choice methods to assess willingness to pay for novel child health interventions holds promise as a means to produce meaningful economic evidence. Regardless of the approach taken, the highest degree of methodological rigour is essential. The increasing attention being paid by health economic researchers to the measurement challenges of paediatric health state valuation can only increase the value of child health economic evidence for decision making.     

How does youth cigarette use respond to weak economic periods? Implications for the current economic crisis

This paper examines whether youth cigarette use increases during weak economic periods (as do youth alcohol and drug use). The data come from the 1997 National Longitudinal Survey of Youth. With repeated measures over the 1997-2006 period, for almost 9,000 individuals, the samples include 30,000+ teenagers (15-19 years) and 30,000+ young adults (20-24 years). Logit models with state and year controls are estimated. The results indicate that teenagers and young adults increase cigarette use when the economy is weaker, implying that the current financial crisis has likely increased youth cigarette use relative to what it would have otherwise been.     

Statin therapy in the elderly: does it make good clinical and economic sense?

HMG-CoA reductase inhibitors (statins) have been established as the dominant treatment for coronary heart disease (CHD). This dominance is based on an impressive body of clinical trial evidence showing significant benefits in primary prevention of cardiovascular events in individuals at risk for CHD and in secondary prevention of such events in patients with CHD and high or normal plasma cholesterol levels. There is, however, significant room for improvement in the treatment of CHD with respect both to drug efficacy and to the disparity between evidence-based medicine and actual clinical practice particularly in relation to treatment strategies for the elderly. Current statins fall short of requirements for 'ideal' lipid-lowering treatment in several respects; 'super' statins and other agents currently in development may satisfy more of these requirements. Moreover, available therapies are not applied optimally, because of physician nonacceptance and/or patient noncompliance; thus, the majority of patients with CHD or its risk factors still have cholesterol levels that exceed guideline targets. There is also evidence that older patients with CHD, or at high risk of CHD, are undertreated - possibly because of concerns regarding the increased likelihood of adverse events or drug interactions or doubts regarding the cost effectiveness of statin therapy in this population. This group is of particular clinical relevance, since it is showing a proportionate rapid expansion in most national populations. To address their potential healthcare needs, the ongoing Pravastatin in the Elderly at Risk (PROSPER) study is assessing the effects of pravastatin in elderly patients (5804 men and women aged 70-82 years) who either have pre-existing vascular disease or are at significant risk for developing it, with the central hypothesis that statin therapy (pravastatin 40 mg/day) will diminish the risk of subsequent major vascular events compared with placebo. After a 3.2-year treatment period, a primary assessment will be made of the influence of statin treatment on major cardiovascular events (a combination of CHD death, nonfatal myocardial infarction, and fatal or nonfatal stroke). Optimal deployment of the currently available agents and of newer agents (no matter how well they satisfy requirements for ideal treatment) ultimately depends on the establishment of an evidence base and may require far-reaching educational programmes that change the way risk factor management is viewed by caregivers and patients alike.     

Substance use and recessions: what can be learned from economic analyses of alcohol?

In this paper, I conduct a review of the economics literature examining the relationship between alcohol use and the macro economy comparing methods, measures and findings. Like illicit drug consumption, the relationship between alcohol use and economic conditions is not entirely straightforward since there are various theoretical explanations for why they might be positively or negatively related. Empirical findings suggest that the relationship between drinking and the economy depends on the type of user and whether use is examined in developing or developed countries. In developed countries, heavy drinkers consume less in a downturn, while light drinkers consume more. This pro-cyclical relationship found for heavy drinking does not hold for developed countries where disposable income is low. The implications for researchers interested in understanding how illicit drug consumption varies with the business cycle are that they must be careful to consider differential responses across user types as well as expensive and inexpensive drugs.     

Acrylamide: a cooking carcinogen?

Exposure to acrylamide (AA) has been monitored by mass spectrometric detection of the adduct, N-(2-carbamoylethyl)valine (CEV), to the N-termini of hemoglobin (Hb), according to the N-alkyl Edman method. In these studies, a conspicuous background level, about 40 pmol/g of globin, of apparently the same adduct was regularly observed in Hb from persons without known exposure to AA. For testing of the hypothesis that this adduct originates from AA formed in cooking, rats were fed fried animal standard diet for 1 or 2 months. These animals exhibited a strong increase of the level of the studied Hb adduct, compared to control rats fed unfried diet. By gas chromatography/tandem mass spectrometry, the identity with CEV was confirmed by the concordance of the product ion spectrum of the studied adduct with that of a verified standard and by interpretation of the fragment ions. Further support of the chemical structure, at the same time pinpointing AA as the causative reactive factor, was obtained through the demonstration that AA is formed in the heating of the feed and that the level of AA in the fried feed is compatible with the measured levels of the CEV adduct. The raised CEV adduct levels observed in experimental animals are of a magnitude that is similar to the background level in nonsmoking humans. These data render it likely that cooking of food is a major source of the background dose of AA also in humans. An evaluation of cancer tests of AA and available data for its metabolism leads to the estimation that the background dose of AA is associated with a considerable cancer risk.     

Niacin: a lipid polypill?

Niacin is one of the oldest yet also most diverse lipid lowering agents. As it not only lowers low-density-lipoprotein (LDL) cholesterol, triglycerides (TG) and lipoprotein(a) [Lp(a)] but also increases high-density-lipoprotein (HDL) cholesterol, it is useful for treating a wide variety of lipid disorders including mixed hyperlipidaemia, hypertriglyceridaemia and isolated low HDL cholesterol, as well as elevated Lp(a). Niacin, which exists in several different formulations, such as immediate release (IR), extended release (ER) and slow release (SR) niacin, has several modes of action: it modulates liver TG synthesis, which leads to increased intracellular apolipoprotein (apo) B degradation and increases TG lipolysis in adipose tissue. Recently, a specific niacin receptor has also been discovered. Several clinical outcome trials have demonstrated that niacin reduces coronary artery disease risk in combination with statins and two large mortality trials are currently underway looking at hard end-point reduction with niacin and statin compared to statin alone. Niacin's major adverse event (AE) is flushing, and this prevents many patients from either taking it or reaching target doses of this drug. Flushing incidence and intensity is reduced with ER-niacin and by co-administration of aspirin and a selective or non-selective prostaglandin inhibitor.     

Eudragit®: a technology evaluation

Introduction: Eudragit is the brand name for a diverse range of polymethacrylate-based copolymers. It includes anionic, cationic, and neutral copolymers based on methacrylic acid and methacrylic/acrylic esters or their derivatives.

Areas covered: In this review, the physicochemical characteristics and applications of different grades of Eudragit in colon-specific/enteric-coated/sustained release drug delivery and taste masking have been addressed.

Expert opinion: Eudragits are amorphous polymers having glass transition temperatures between 9 to > 150^oC. Eudragits are non-biodegradable, nonabsorbable, and nontoxic. Anionic Eudragit L dissolves at pH > 6 and is used for enteric coating, while Eudragit S, soluble at pH > 7 is used for colon targeting. Studies in human volunteers have confirmed that pH drops from 7.0 at terminal ileum to 6.0 at ascending colon, and Eudragit S based systems sometimes fail to release the drug. To overcome the shortcoming, combination of Eudragit S and Eudragit L which ensures drug release at pH < 7 has been advocated. Eudragit RL and RS, having quaternary ammonium groups, are water insoluble, but swellable/permeable polymers which are suitable for the sustained release film coating applications. Cationic Eudragit E, insoluble at pH ≥ 5, can prevent drug release in saliva and finds application in taste masking.     

Niacin: a lipid polypill?

Niacin is one of the oldest yet also most diverse lipid lowering agents. As it not only lowers low-density-lipoprotein (LDL) cholesterol, triglycerides (TG) and lipoprotein(a) [Lp(a)] but also increases high-density-lipoprotein (HDL) cholesterol, it is useful for treating a wide variety of lipid disorders including mixed hyperlipidaemia, hypertriglyceridaemia and isolated low HDL cholesterol, as well as elevated Lp(a). Niacin, which exists in several different formulations, such as immediate release (IR), extended release (ER) and slow release (SR) niacin, has several modes of action: it modulates liver TG synthesis, which leads to increased intracellular apolipoprotein (apo) B degradation and increases TG lipolysis in adipose tissue. Recently, a specific niacin receptor has also been discovered. Several clinical outcome trials have demonstrated that niacin reduces coronary artery disease risk in combination with statins and two large mortality trials are currently underway looking at hard end-point reduction with niacin and statin compared to statin alone. Niacin's major adverse event (AE) is flushing, and this prevents many patients from either taking it or reaching target doses of this drug. Flushing incidence and intensity is reduced with ER-niacin and by co-administration of aspirin and a selective or non-selective prostaglandin inhibitor.     

The economic impact of neuropsychiatric symptoms in Alzheimer's disease: can drugs ease the burden?

The majority of patients with Alzheimer's disease (AD) will have clinically significant neuropsychiatric symptoms during the course of their disease. There is growing evidence that neuropsychiatric symptoms increase direct costs of care in patients with AD, especially the costs associated with formal long-term care and unpaid caregiving. For example, we have estimated that a 1-point worsening of the neuropsychiatric inventory score is associated with an incremental increase of between USD 247 and USD 409 per year in total direct costs of care based upon year 2001 US dollars, depending on the value of unpaid caregiving. Although data are still limited, there have been a series of well designed, controlled clinical trials that have established the efficacy of several drugs used in the treatment of neuropsychiatric symptoms in patients with AD. The economic impact of using efficacious drugs to treat neuropsychiatric symptoms in patients with AD has not been evaluated formally. To successfully complete formal economic evaluations of these drugs there is a need for more research to refine methods for determining the economic value of unpaid caregiving and to collect more data concerning the incremental effects of neuropsychiatric symptoms on QOL, costs of care and survival. The current ongoing treatment trials that are collecting economic and QOL data as a part of the trial will be able to perform cost-effectiveness and cost-utility analyses of these new efficacious drugs. These economic evaluations will provide important information for decision makers who are formulating healthcare policy for the treatment of patients with AD.