PubMed Health⌕ Search

Biomedical subjects

P Trueman

Publications and source records attributed to P Trueman.

13 recordsLinked to original sources

Assessing the cost-effectiveness of HAART for adults with HIV in England.

OBJECTIVE: To assess the cost-effectiveness of highly active antiretroviral therapy (HAART) compared with two nucleoside reverse transcriptase inhibitors (NRTIs) for HIV infected individuals. DESIGN: Different data sources on the clinical effects and costs of treatments were combined using a Markov model. SETTING: English HIV treatment centres. Perspective UK public finance. INTERVENTIONS: HAART - dual NRTI therapy plus a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor - vs. dual NRTI therapy. PARTICIPANTS: Hypothetical cohorts of 1000 individuals infected with HIV. Outcome measures Projected life expectancy, cost-effectiveness in UK pound per life-year saved and per quality-adjusted life-years (QALYs) saved. RESULTS: Assuming a 2-year additional treatment effect of therapy with HAART produced incremental cost-effectiveness ratios of pound14 602 per life-year saved and pound17 698 per QALY saved. CONCLUSIONS: The results were sensitive to a number of assumptions including the cost of HAART and the discount rate, but they suggest that the use of HAART in England is at least moderately cost-effective compared with treatment with two NRTIs alone.

Adult↗

Developing guidance for budget impact analysis.

The role of economic evaluation in the efficient allocation of healthcare resources has been widely debated. Whilst economic evidence is undoubtedly useful to purchasers, it does not address the issue of affordability which is an increasing concern. Healthcare purchasers are concerned not just with maximising efficiency but also with the more simplistic goal of remaining within their annual budgets. These two objectives are not necessarily consistent. This paper examines the issue of affordability, the relationship between affordability and efficiency and builds the case for why there is a growing need for budget impact models to complement economic evaluation. Guidance currently available for such models is also examined and it is concluded that this guidance is currently insufficient. Some of these insufficiencies are addressed and some thoughts on what constitutes best practice in budget impact modelling are suggested. These suggestions include consideration of transparency, clarity of perspective, reliability of data sources, the relationship between intermediate and final end-points and rates of adoption of new therapies. They also include the impact of intervention by population subgroups or indications, reporting of results, probability of re-deploying resources, the time horizon, exploring uncertainty and sensitivity analysis, and decision-maker access to the model. Due to the nature of budget impact models, the paper does not deliver stringent methodological guidance on modelling. The intention was to provide some suggestions of best practice in addition to some foundations upon which future research can build.

Budgets↗

Can economic evaluation guidelines improve efficiency in resource allocation? The cases of Portugal, The Netherlands, Finland, and the United Kingdom.

The use of economic evaluation in decision making appears to have increased over the past few years and economic evaluation is looked upon as another measure to help contain costs and improve efficiency in an evidence-based decision-making environment. Following the examples of Australia and the Canadian Province of Ontario, four European Union (EU) countries (Finland, the Netherlands, Portugal, and the United Kingdom) have recently introduced economic evaluation guidelines. In addition to the Australian and Canadian guidelines, which constitute a hurdle to reimbursement, the paradigm that seems to be evolving in the four EU countries follows a similar route. Finland and the Netherlands seem to be moving toward the notion of a fourth hurdle to reimbursement, whereas the National Institute for Clinical Excellence in England and Wales was in principle meant to influence practice, although in reality this essentially acts as a hurdle to reimbursement, requiring a different data set to that used by regulatory authorities. Whereas the Portuguese guidelines were developed to assist in preparing economic submissions to support reimbursement decisions, they are unclear about when such evidence will be required and also discuss the dissemination of economic evidence to broader audiences. The introduction of these guidelines poses a number of challenges to policy makers, the implications of which are analyzed in the paper: a) to ensure that economic evaluations are carried out scientifically without industrial or political bias; b) to define an acceptable methodology that would increase their credibility; and c) to address certain practical issues ranging from deciding how to use economic evaluations in policy making to setting up new institutions or improving the coordination and dissemination of evidence. The variation in the use of economic evaluation guidelines in the four EU countries highlights the differences in national pharmaceutical policies and is in line with policy makers' continuous attempts to contain costs. While the paper critically discusses the guidelines, it also points out that a series of methodologic issues need to be addressed if economic criteria are to be introduced in policy making with the aim to improve resource allocation. The paper concludes that economic evaluation as a discipline is beginning to impact on policy, whereas the consistent use of economic evaluation results is, in principle, being adopted by policy makers but needs to go a step further to reach practitioners.

Drug Therapy↗

Health economics. Perfect combination.

The assumption by some HAs that a shift from mono to combination drug therapies for HIV results in a proportional increase in drug expenditure, regardless of health gains, is misguided. Methods of calculating anti-HIV drug expenditure have failed to keep up with changing treatment regimes. There is an urgent need to change the way data on antiretroviral use is collected and presented to establish the true cost-effectiveness of new drug regimes.

Anti-HIV Agents↗

Research into the use of health economics in decision making in the United Kingdom--Phase II. Is health economics 'for good or evil'?

The purpose of this phased research project is to better understand the role of health economic arguments in the decision making process of healthcare providers and purchasers in the United Kingdom. Phase I of the research was directed at General Practitioners (GPs); in phase II we broadened the scope of the research to include different agents who influence resource allocation and the wider health care environment. The objective of phase II was to determine the relevance and appeal of diverse health economic measures to different decision makers. This phase of qualitative research involved 34 decision makers in 17 duo interviews. The study has provided a rich source of qualitative evidence on the role of health economics in decision making. The main conclusions to emerge are; different individuals seek different outcomes; health economic studies should report actionable conclusions; and any cost savings must be applicable. To succeed, economists need to demonstrate a better understanding of the contracting and budgetary processes of the National Health Service. Opinions of the value of health economic evaluations varied widely, however most respondents believed it would become increasingly influential in the prioritisation process in the National Health Service of the future.

Contract Services↗

Prevalence of lower urinary tract symptoms and self-reported diagnosed 'benign prostatic hyperplasia', and their effect on quality of life in a community-based survey of men in the UK.

OBJECTIVES: To assess the prevalence of lower urinary tract symptoms (LUTS) in a community-based population in the UK, to measure the impact of these symptoms on quality of life and health status in men with self-reported 'benign prostatic hyperplasia' ('BPH'), and to evaluate health-seeking behaviour in this population. SUBJECTS AND METHODS: A postal survey was distributed to an age-stratified random sample of 1500 men aged 50 years or older from throughout England, Scotland and Wales. The self-administered survey included: demographic questions; the EuroQoL (EQ-5D) instrument, consisting of a health-status index questionnaire and a visual analogue scale (VAS) on which participants rated their current health status; the International Prostate Symptom Score (IPSS) questionnaire; and a questionnaire assessing the participants' health-seeking behaviour and awareness of BPH. RESULTS: Responses to the survey were received from 1115 (74%) of the 1500 men. Overall, 41% (450/ 088) had an IPSS of > or =8, indicating moderate-to-severe LUTS, yet only 196 men (18%) reported that they had been diagnosed with 'BPH'. Both quality of life (as measured by the EQ-5D) and general health status (as measured by the VAS) decreased as urinary symptom severity increased, and the greater the severity, the more men who reported a problem with mobility, self-care, usual activity, pain/discomfort, and anxiety/depression (the five domains of the EQ-5D). The possibility of symptoms worsening appeared to be the key determinant in the respondents' decisions to consult a medical professional for their LUTS. Less than 11% of the respondents were aware of the availability of specific prescription drug therapies or surgical options for the treatment of 'BPH'. The most common first treatment strategy for those consulting for symptoms was watchful waiting (34%), followed by surgery (30%) and prescription drugs (21%). CONCLUSIONS: Moderate-to-severe LUTS were relatively common in this UK population of men over the age of 50, yet relatively few had been diagnosed with 'BPH'. As LUTS adversely affect quality of life, improved treatment options and increased public awareness of BPH and LUTS are needed to combat a problem facing the growing number of elderly men in the population.

Aged↗

Health economics in HIV disease. A review of the European literature.

The costs of providing healthcare resources for patients with HIV disease have continued to rise during the last 2 decades since the first outbreak of AIDS. Although new and effective therapies have become available during this time, and are increasingly being used, outcome measures for, and the economic consequences of, differing models of care are poorly documented or understood. Most available economic and clinical data, especially data documenting post-therapy outcomes, are from small, short term studies. This has led to the use of modelling to estimate which determinants can improve the quality and cost effectiveness of HIV care in the future. Although the attempt to provide what is currently perceived to be the standard of care is stretching many healthcare budgets, it is an anachronism that there are few studies of health economics in HIV disease. Most published data relate only to North America, and there remains a paucity of European studies. This paper provides a review of the available data from Europe and attempts to highlight the trends that have taken place to date.

Cost of Illness↗

A prospective evaluation of the cost effectiveness of adding lamivudine to zidovudine-containing antiretroviral treatment regimens in HIV infection. European perspective.

BACKGROUND: A prospective cost-effectiveness analysis undertaken as part of the CAESAR (Canada, Australia, Europe, South Africa) placebo-controlled clinical trial showed that adding lamivudine to zidovudine-containing regimens for 1 year reduced progression to AIDS or death and, in addition, significantly reduced the number of hospitalisations, unscheduled outpatient visits and the requirement for medications for HIV-related illness. Data from all 1840 patients included in the intent-to-treat population of the CAESAR trial were used in the analysis reported in this paper. Because a third-party payer perspective was adopted, possible savings associated with increased productivity (indirect costs) were not taken into account. All costs were adjusted to 1997 prices. RESULTS: The savings associated with reduced healthcare resource use in the CAESAR study were estimated to be 3045 Deutschmarks (DM) [German analysis] or 432 pounds sterling (Pound) [UK analysis] per patient for the 1-year time period. These savings partly offset the cost of lamivudine in the 2 countries. The German analysis showed that the addition of lamivudine to zidovudine-containing regimens resulted in an incremental cost-effectiveness ratio of DM22,405 [95% confidence interval (CI): -DM2199 to DM59,154] for progression to AIDS/death avoided and of DM8869 (95% CI: -DM1047 to DM23,365) for HIV-related illness avoided. The corresponding ratios for the UK analysis were 12,030 Pounds (95% CI: 6752 Pounds to 21,888 Pounds) for progressions avoided and 4762 Pounds (95% CI: 2796 Pounds to 9484 Pounds) for new and recurrent HIV-related illness avoided. CONCLUSIONS: Our findings indicate that treatments that slow the progression of HIV infection to AIDS or death have the potential to facilitate healthcare savings during the period that the treatment is effective. The results also demonstrate that it is possible to undertake economic evaluations in parallel with a major clinical end-point study.

Adult↗

DNA sequence analysis of methylene chloride-induced HPRT mutations in Chinese hamster ovary cells: comparison with the mutation spectrum obtained for 1,2-dibromoethane and formaldehyde.

Glutathione-S-transferase-mediated metabolism of methylene chloride (MC) generates S-chloromethylglutathione, which has the potential to react with DNA, and formaldehyde, which is a known mutagen. MC-induced mutations in the HPRT gene of Chinese hamster ovary cells have been sequenced and compared with the mutations induced by 1, 2-dibromoethane (1,2-DEB), which is known to act through a glutathione conjugate, and formaldehyde. All three compounds induced primarily point mutations, with a small number of insertion and deletion events. The most common point mutations induced by MC were GC-->AT transitions (4/8), with two GC-->CG transversions and two AT-->TA transversions. This pattern of mutations showed greater similarity with 1,2-DBE, where the dominant point mutations were GC-->AT transitions (7/9), than formaldehyde, where all mutations were single base transversions and 5/6 occurred from AT base pairs. The mutation sequence results for MC suggest that S-chloromethylglutathione plays a major role in MC mutagenesis, with only a limited contribution from formaldehyde. The involvement of a glutathione (GSH) conjugate in MC mutagenicity would be analogous to the well-characterized pathway of activation of 1,2-DBE.

Animals↗

Functionally important conserved amino-acids in interferon-alpha 2 identified with analogues produced from synthetic genes.

A gene was chemically synthesised and expressed in Escherichia coli to produce [Ala30,32,33]IFN-alpha 2, an analogue of human alpha 2-interferon (IFN-alpha 2) which is devoid of activity on human cells. Eight additional analogues provided single changes in IFN-alpha 2 at each of these three conserved positions. No one residue is essential for activity, but both antiviral and anti-proliferative activity are particularly sensitive to changes in the side-chain of Arg33.

Amino Acids↗

Chemical synthesis of a human interferon-alpha 2 gene and its expression in Escherichia coli.

A 511-base pair DNA fragment encoding human interferon-alpha 2 has been chemically synthesised and expressed from a lac UV5 and a synthetic trp promoter in Escherichia coli. The synthesis involved preparation of 68 oligodeoxyribonucleotides and their enzymic ligation. The product expressed from the trp promoter system had high antiviral activity and displayed biological effects similar to those of Namalwa interferon on natural killer cell activity and in a Daudi cell growth inhibition assay. E.coli minicells containing plasmid DNA with the synthetic IFN-alpha 2 gene under trp promoter control produce a protein with the same electrophoretic mobility as a sample of authentic IFN-alpha 2. The protein from E.coli cross-reacts with the monoclonal antibody NK-2 and was readily purified, close to homogeneity, by immunoadsorption chromatography on NK-2 sepharose.

Amino Acid Sequence↗

'Fourth hurdle reviews', NICE, and database applications.

The 'fourth hurdle' is commonly described as what has to be done to gain market access and reimbursement for a pharmaceutical, medical technology, or biotech product. Demonstrating to regulatory agencies just a product's safety, efficacy, and quality (the first three hurdles) is no longer sufficient. Manufacturers must often now demonstrate both clinical effectiveness (Is the new product better than currently available alternatives, including no treatment?) as well as cost-effectiveness (Is the product good value for money?) in order to assure success in the marketplace. In the last few years there have been a number of governmental and non-governmental agencies constituted for fourth hurdle reviews and recommendations to governments and other funding and reimbursement agencies. The National Institute for Clinical Effectiveness (NICE) in the UK, although not the first such group, is arguably the most visible and influential. This paper describes the NICE review process in detail, as well as the expected substantial impact of fourth hurdle reviews on drug development and clinical trials. Potential uses of databases and modelling in fourth hurdle reviews are also explored.

Cost-Benefit Analysis↗

The cost-effectiveness of triple nucleoside analogue therapy antiretroviral regimens in the treatment of HIV in the United Kingdom.

PURPOSE: Treatment of HIV infection has improved markedly in recent years due to the use of combination antiretroviral therapies. However, the cost of these treatments remains a concern for those who fund health services. This article reports the results of an economic evaluation to determine the incremental cost-effectiveness of triple combination nucleoside analogue (NA) therapy compared with dual NA therapy. METHOD: A Markov model was developed to assess the incremental cost effectiveness of triple therapy treatment versus dual therapy treatment. Clinical data was derived from published clinical trials and large observational cohorts whilst cost data was derived from a prospective database that monitors health care resource use in the UK HIV population. RESULTS: The model predicted that triple NA combination treatment extended life expectancy by an additional 1.2 years compared with dual therapy NA treatment with an incremental cost-effectiveness ratio of 8,419 pounds per life-year saved. The incremental cost per quality-adjusted life-year (QALY) was estimated to be between 10,072-16,168 pounds per QALY gained depending on the assumptions. CONCLUSION: The results show triple nucleoside analogue therapy to be a cost effective means of delaying HIV progression and extending life expectancy. However, further research into this issue is warranted.

Anti-HIV Agents↗