The cost effectiveness of chlorofluorocarbon-free beclomethasone dipropionate in the treatment of chronic asthma: a cost model based on a 1-year pragmatic,randomised clinical study

OBJECTIVE: To compare the cost effectiveness of hydrofluoroalkane 134a-beclomethasone dipropionate (HFA-BDP; Qvar) [corrected] with chlorofluorocarbon-beclomethasone dipropionate (CFC-BDP) in patients with chronic stable asthma previously receiving CFC-BDP, from the perspective of a healthcare provider. DESIGN: Cost-effectiveness analysis based on a 12-month pragmatic, randomised, parallel group, open-label clinical trial assessing safety and efficacy of HFA-BDP at approximately half the dose of CFC-BDP in patients with stable asthma. SETTING: International, multicentre study at 57 study sites in the US, UK, The Netherlands, and Belgium. Healthcare costs were calculated for UK-based healthcare [in 1999 as pounds (pounds sterling)]. PATIENTS AND PARTICIPANTS: Patients (n = 473) > or =12 years of age with currently stable asthma that had been stable (i.e. no exacerbations requiring oral corticosteroid use in the last 4 weeks) for at least the preceding month. MAIN OUTCOME MEASURES: Average and incremental cost-effectiveness ratios based upon symptom-free days, improvement in health-related quality of life, and total and drug-only direct healthcare costs. RESULTS: Patients in the HFA-BDP group experienced a significantly higher percentage of symptom-free days than patients in the CFC-BDP group by the end of the study period (42.4 vs 20.0%; p = 0.006). A greater percentage of patients in the HFA-BDP group had a clinically significant improvement in health-related quality of life than in the CFC-BDP group [35.3 (n = 116/329) vs 16.1% (n = 18/112)]. Total per patient healthcare costs were similar between the two groups. The average cost per symptom-free day per patient was 1.36 pounds sterling for HFA-BDP and 1.81 pounds sterling for CFC-BDP based on total healthcare costs. The incremental cost per symptom-free day for using HFA-BDP instead of CFC-BDP was negative, indicating that HFA-BDP is a dominant strategy and may be a cost-saving intervention compared with CFC-BDP. A sensitivity analysis varying both cost and outcome parameters further supported this finding for most scenarios tested. The cost to achieve a clinically significant improvement in health-related quality of life over the study period was 13.24 pounds sterling per improved patient per week for HFA-BDP and 29.38 pounds sterling per patient per week for CFC-BDP. CONCLUSIONS: These findings indicate that HFA-BDP is a cost-effective intervention when compared with CFC-BDP in this group of patients with stable asthma. In the majority of scenarios HFA-BDP provides more effective asthma control at a similar cost to CFC-BDP.     

Cost effectiveness of palivizumab for respiratory syncytial virus prophylaxis in high-risk children: a UK analysis

OBJECTIVE: To assess the cost effectiveness of palivizumab (a preventative treatment against severe respiratory syncytial virus [RSV] infection) in children at high risk of hospitalisation, i.e. preterm infants < or = 35 weeks gestation, children with bronchopulmonary dysplasia (BPD) and children with congenital heart disease (CHD). METHODS: A decision tree model was developed employing data sources from the published literature, palivizumab clinical trials, official UK price/tariff lists and national population statistics. The comparator was no prophylaxis. The primary perspective of the study was that of the UK NHS. In a societal perspective scenario analysis, the future lost productivity of a child resulting from RSV-related mortality (indirect costs) was also included. The cost of administration of palivizumab, hospital care for RSV infections and the cost of asthma treatment were included. The analysis was based on a lifetime follow-up period in order to capture the impact of palivizumab on long-term morbidity and mortality resulting from an RSV infection. The primary efficacy outcome in the palivizumab clinical trials was the number of RSV hospitalisations avoided, which was extrapolated to effectiveness outcomes, i.e. number of life-years gained and number of QALYs. Costs and effects were discounted by 3.5%. RESULTS: In preterm infants and children with BPD, prophylaxis with palivizumab compared with no prophylaxis had an incremental cost-effectiveness ratio (ICER) of 7042 pounds/QALY without discounting outcomes, increasing to 16,720 pounds/QALY after discounting. In babies with CHD, the use of palivizumab resulted in an ICER of 2427 pounds/QALY without discounting outcomes and 6664 pounds/QALY after discounting. One-way sensitivity analyses and probabilistic sensitivity analyses confirmed the robustness of the model. A scenario analysis showed that the inclusion of indirect costs leads to further improvement in the cost-effectiveness outcomes for palivizumab. CONCLUSION: This study suggests that palivizumab prophylaxis against severe RSV infection in children at high risk may be cost effective from the NHS perspective (vs no prophylaxis), and that the positive clinical and economic benefits may persist beyond one RSV season.     

Cost-effectiveness of levodopa/carbidopa/entacapone (Stalevo) compared to standard care in UK Parkinson's disease patients with wearing-off

BACKGROUND AND METHODS: A Markov model was developed to evaluate the cost-effectiveness of levodopa/carbidopa/entacapone (LCE;Stalevo), in the treatment of patients with Parkinson's disease (PD) and end-of-dose motor fluctuations (wearing-off). LCE, with or without other antiparkinsonian medications, was compared to UK standard care, comprising traditional levodopa/ dopa-decarboxylase inhibitor (DDCI) with other antiparkinsonian medications (e.g. selegiline or dopamine agonists) added as needed. The costs and outcomes of both treatments were projected over a period of 10 years from the perspective (a) of society as a whole and (b) of the UK National Health Service (NHS). Sensitivity analyses, including second-order Monte Carlo simulations, were performed to assess the confidence level of the primary results. RESULTS: Treatment with LCE produced an average gain of +1.04 quality-adjusted life-years (QALYs) per patient (2.57 vs. 1.53) in the base-case analysis (discount rate 3.5%). This gain was accompanied by a reduction in the total 10-year direct cost of care to society of 10198 pounds per patient ( approximately E14800). From the societal perspective, therefore, LCE was dominant, producing better clinical outcomes with lower costs. This dominance was reiterated in all sensitivity analyses of society-focused analysis, including a shortening of the time-frame to 5 years.Although treatment with LCE resulted in an increase in direct costs per patient of 3239 pounds (25756 pounds versus 22517 pounds) to the NHS over the 10-year period analysed, the incremental cost-effectiveness ratio (ICER) of LCE was only 3105 pounds per QALY gained (approximately E4500). All ICERs to the NHS remained below 3800 pounds per QALY gained in univariate sensitivity analyses applying different discount rates. When a shorter, 5-year, time-horizon was analysed, the NHS-related ICER for LCE was 6526 pounds per QALY gained. All these ICERs are within the range usually considered to indicate acceptable or highly acceptable cost effectiveness (defined as < 30000 pounds per QALY gained).The results of the Monte Carlo simulations indicated that the likelihood of LCE being either 'dominant' or more effective at an 'acceptable cost' from either the societal or the NHS perspective was high, exceeding 96% in the base-case sensitivity analysis, and was 93% even when all the uncertainties associated with the model were taken into consideration simultaneously. In particular, compared to standard care, the probability that LCE would provide better outcomes at a lower cost to society as a whole was 77% in the base-case sensitivity analysis and 72% in the scenario involving the highest degree of uncertainty. CONCLUSIONS: In the UK the use of LCE to treat PD patients with wearing-off is beneficial to individual patients and likely to offer money savings to society as a whole, compared with UK standard therapy. The added cost of the medication itself is exceeded by the savings made in other direct costs of PD, mainly those relating to social care or PD-related private expenditures.     

Modelling the cost effectiveness of cholinesterase inhibitors in the management of mild to moderately severe Alzheimer's disease

OBJECTIVE: To estimate the cost effectiveness (from the UK NHS and personal social services perspective) of the cholinesterase inhibitors donepezil, rivastigmine and galantamine compared with usual care in the treatment of mild to moderately severe Alzheimer's disease. Patients had a mean age of 74 years, a mean disease duration of 1 year and a mean Alzheimer's disease assessment scale-cognitive subscale score of 24. METHODS: A pharmacoeconomic model was used to predict long-term outcomes over a 5-year time horizon and to estimate the cost effectiveness of cholinesterase inhibitors for the management of Alzheimer's disease. The model structure is informed by a systematic review of the literature on the clinical and cost effectiveness of cholinesterase inhibitors and a review of the literature on the costs and outcomes associated with treatment for Alzheimer's disease. The main outcome measure used was the cost per quality-adjusted life-year (QALY) gained. All healthcare costs (excluding cholinesterase inhibitor costs) were indexed to pounds sterling (2003 values). Drug costs are 2005 values. Multivariate probabilistic sensitivity analysis and scenario analysis were undertaken to assess uncertainty in the results. RESULTS: The clinical benefits on cognition from treatment with cholinesterase inhibitors resulted in an incremental cost per QALY gained ranging from 53,780 pounds sterling to 74,735 pounds sterling, over 5 years (vs usual care). Uncertainty analysis suggests that the probability of any of these treatments having an incremental cost per QALY of < 30,000 pounds sterling is < 21%. The key determinants of cost effectiveness were the effectiveness of treatment, the mean treatment cost and the cost savings associated with an expected delay in disease progression. CONCLUSIONS: Results presented in this paper suggest that the use of cholinesterase inhibitors may not be a cost-effective use of NHS resources. Guidance from the National Institute for Health and Clinical Effectiveness (NICE) in the UK on their judgements surrounding the acceptability of technologies as an effective use of resources, indicates there would need to be special reasons for accepting cholinesterase inhibitors as a cost-effective use of NHS resources.     

Modelling the long term cost effectiveness of clopidogrel for the secondary prevention of occlusive vascular events in the UK

OBJECTIVE: To assess the long term cost effectiveness of clopidogrel monotherapy compared with acetylsalicylic acid (aspirin; ASA) monotherapy in patients at risk of secondary occlusive vascular events (OVEs) in the UK. DESIGN: Cost utility analysis based on clinical data from CAPRIE (a multicentre randomised controlled trial, involving 19185 patients); long-term effects were extrapolated beyond the trial period using a Markov model populated with data from UK observational studies. Health economic evaluation carried out from the perspective of the UK National Health Service. PARTICIPANTS: A representative cohort of 1000 UK patients aged 60 years (approximate mean age of the CAPRIE population), with the qualifying diagnoses of myocardial infarction, ischaemic stroke and peripheral arterial disease, who are at risk of secondary OVEs (non-fatal myocardial infarction, non-fatal stroke or vascular death). INTERVENTIONS: Patients were assumed to receive treatment with either clopidogrel (75 mg/day) for 2 years followed by ASA (325 mg/day, average) for their remaining lifetime, or ASA alone (325 mg/day, average) for life. MAIN OUTCOME MEASURES: Incremental cost per life year gained and incremental cost per quality-adjusted life year (QALY) gained. RESULTS: In the base case, the incremental cost effectiveness of clopidogrel versus ASA in this population is estimated at 18888 pounds per life year gained and 21 489 pounds per QALY gained. Multiple deterministic and probabilistic sensitivity analyses suggest the model is robust to variations in a wide range of input parameters. CONCLUSION: Two years of treatment with clopidogrel can be considered a cost effective intervention in patients at risk of secondary OVEs in the UK.     

Cost effectiveness of human immunodeficiency virus postexposure prophylaxis for healthcare workers

OBJECTIVE: The United States Public Health Service (USPHS) published recommendations for human immunodeficiency virus (HIV) postexposure prophylaxis (PEP) of healthcare workers in May 1998. The aim of this study was to analyse the cost effectiveness of the USPHS PEP guidelines. DESIGN AND SETTING: This was a modelling study in the setting of the US healthcare system in 1989. The analysis was performed from the societal perspective; however, only HIV healthcare costs were considered and health-related losses of productivity were not included. METHODS: A decision tree incorporating a Markov model was created for 4 PEP strategies: the current USPHS recommendations, triple drug therapy, zidovudine monotherapy or no prophylaxis. A probabilistic sensitivity analysis using a Monte Carlo simulation was performed. Confidence intervals (CIs) around cost-effectiveness estimates were estimated by a bootstrapping method. RESULTS: The costs (in 1997 US dollars) per quality-adjusted life-year (QALY) save by each strategy were as follows: monotherapy $US688 (95% CI: $US624 to $US750); USPHS recommendations $US5211 (95% CI: $US5126 to $US5293); and triple drug therapy $US8827 (95% CI: $US8715 to $US8940). The marginal cost per year of life saved was: USPHS recommendations $US81 987 (95% CI: $US80 437 to $US83 689); triple drug therapy $US970 451 (95% CI: $US924 786 to $US 1 014 429). Sensitivity testing showed that estimates of the probability of seroconversion for each category of exposure were most influential, but did not change the order of strategies in the baseline analysis. With the prolonged HIV stage durations and increased costs associated with recent innovations in HIV therapy, the marginal cost effectiveness of the USPHS PEP strategy was decreased to $US62 497/QALY saved. All 3 intervention strategies were cost effective compared with no postexposure prophylaxis. CONCLUSIONS: Current USPHS PEP recommendations are marginally cost effective compared with monotherapy, but the additional efficacy of triple drug therapy for all risk categories is rewarded by only a small reduction in HIV infections at great expense. For the foreseeable future, assuming innovations in therapy that employ expensive drug combinations earlier in the HIV disease course to extend life expectancy and the increasing prevalence of HIV drug resistance, our model supports the use of the USPHS PEP guidelines.     

Cost-utility analysis of survival with epoetin-alfa versus placebo in stage IV breast cancer

BACKGROUND: In a multinational trial of anaemic patients with cancer receiving nonplatinum-containing chemotherapy, epoetin-alfa effectively increased haemoglobin levels, reduced red blood cell transfusion requirements, and improved QOL. Although the study was not designed or powered to evaluate survival, a survival trend was noted favouring epoetin-alfa compared with placebo (median survival 17 vs 11 months [p = 0.126]). OBJECTIVES: To determine the incremental cost utility of epoetin-alfa versus placebo in anaemic patients with stage IV breast cancer from a UK National Health Service perspective. METHODS: Patient data regarding transfusions, epoetin-alfa usage, chemotherapy treatment cycles, and adverse events were recorded, with survival follow-up for 12-36 months post-study. Stage IV breast cancer therapy costs were collected by surveying UK oncologists, and utilities for associated health states were from published sources. Costs were in British pounds and year 2000 values. Costs and benefits were jointly determined for the stage IV breast cancer subgroup (n = 55). Incremental cost-utility ratios (ICURs) were calculated assuming a 6% annual discount rate for costs and a 1.5% annual discount rate for benefits. Bootstrap simulations (10,000 iterations) were conducted to account for uncertainty, and sensitivity analyses were conducted to establish robustness. RESULTS: The ICUR for epoetin-alfa treatment was pounds 8,851 per QALY, with a 99% probability of a positive net benefit in QALYs (net benefit = 0.4805 years of perfect life) and a 94% probability of being acceptable using a threshold ICUR of pounds 30,000/QALY. The main cost drivers distinguishing epoetin-alfa from placebo were the costs of drug and patient care due to increased survival. CONCLUSIONS: The available data suggest a high probability of favourable cost-utility outcomes with epoetin-alfa treatment for anaemia in patients with stage IV breast cancer receiving nonplatinum-containing chemotherapy. Additional studies are warranted.     

The cost effectiveness of stratified care in the management of migraine

OBJECTIVE: To examine the cost effectivess of a stratified-care regimen for patients with migraine--in which patients are stratified by severity of illness, and then prescribed differing treatments according to level of severity--compared with a conventional stepped-care approach. DESIGN AND METHODS: A decision analytic model was constructed to simulate a controlled clinical trial in which patients with migraine receiving primary medical care were randomly assigned to treatment under a stepped-care or a stratified-care regimen. A health service payer perspective was adopted and the time horizon was 1 year. Data inputs were: (i) the frequency and disability of migraine, derived from population-based studies; (ii) disability level-specific treatment response rates for over-the-counter analgesics,aspirin/metoclopramide and zolmitriptan as the representative of high-end therapy obtained from an international consensus opinion enquiry; and (iii) unit costs of healthcare obtained from UK health service sources. MAIN OUTCOME MEASURES AND RESULTS: The estimated 1-year direct healthcare costs per primary care patient with migraine were pound sterling 156.82 for stepped care and sterling pound 151.57 for stratified care. Estimates of treatment response rates were 40 and 71% for stepped and stratified care, respectively. The cost per successfully treated attack was sterling pound 23.43 for stepped care and sterling pound 12.60 for stratified care. Stratified care remained cost effective when tested in a wide range of one-way sensitivity analyses, and probabilistic sensitivity analysis showed the cost effectiveness of stratified care to be significant at the 3% level. Conditional confidence analysis showed that the level of confidence in the cost effectiveness of stratified care varied positively with the case mix, i.e. in populations where the proportion of moderate and severely disabled patients with migraine was greater than 25%, the cost effectiveness of stratified care remained statistically significant. CONCLUSION: A stratified-care treatment strategy (including zolmitriptan as the representative of high-end therapy) is a highly cost-effective method of managing migraine in the primary care setting compared with stepped care, delivering improved clinical outcomes at no additional cost.     

Cost-utility analysis of primary prophylaxis versus treatment on-demand for individuals with severe haemophilia

OBJECTIVE: To assess the cost effectiveness of primary prophylaxis with clotting factor instead of treatment following a bleed (on-demand) for individuals with severe haemophilia. DESIGN: Different data sources on the clinical effects and costs of treatments were combined using a Markov model. SETTING: English treatment centres. PERSPECTIVE: UK societal. PARTICIPANTS: Hypothetical cohorts of 100 individuals with severe haemophilia A or B or severe von Willebrands disease. INTERVENTIONS: Primary prophylaxis treatment on-demand with clotting factor. OUTCOME MEASURES: Costs, quality-adjusted life-years (QALYs) and incremental cost per QALY in UK pounds ( pound, 1999/2000 values). RESULTS: The baseline results showed that treating individuals with severe haemophilia A/severe von Willebrands disease or severe haemophilia B with primary prophylaxis instead of treatment on-demand cost an additional pound 46500 and pound 8600 per QALY gained, respectively. However, the results were extremely sensitive to a number of factors including the clotting factor unit cost, the time between prophylactic doses and the discount rate. CONCLUSIONS: Despite the high costs of treatment, primary prophylaxis was cost effective compared with treatment on-demand in some scenarios. Primary prophylaxis is more likely to be cost effective for individuals with severe haemophilia B compared with individuals with severe haemophilia A/severe von Willebrands disease. Further research is required to assess the relationship between methods of clotting factor infusion and health-related quality-of-life.     

Modelling the cost implications of using carboxymethylcellulose dressing compared with gauze in the management of surgical wounds healing by secondary intention in the US and UK

OBJECTIVE: To estimate the costs of using carboxymethyl cellulose dressing (CMCD; Aquacel* Hydrofiber) compared to gauze in managing surgical wounds healing by secondary intention in the US and UK. STUDY DESIGN: This was a modelling study performed from the perspective of payers (i.e. the hospital and community sector in the US and the National Health Service (NHS) in the UK). METHODS: Clinical outcomes attributable to managing surgical wounds healing by secondary intention with gauze were obtained from the published literature in the English language. There were no published studies on wounds healing by secondary intention with CMCD. Hence, the analysis conservatively assumed that wound healing rates associated with gauze would be the same for CMCD. These data were combined with resource utilisation estimates derived from a panel of clinicians enabling us to perform decision modelling. The models were used to determine the expected direct healthcare costs eight weeks after the surgical wounds were dressed by CMCD or gauze and left to heal by secondary intention in the US and UK. RESULTS: All wounds are expected to heal within eight weeks, irrespective of dressing. Managing abscesses and other surgical wounds with CMCD instead of gauze in the US is expected to reduce costs by 4% in both wound types (i.e. $247 and $507 respectively) per patient over eight weeks. In the UK, managing abscesses and other surgical wounds with CMCD instead of gauze is expected to reduce costs by 30% (574 pounds) and 12% (581 pounds) respectively per patient over eight weeks. The lower cost of managing CMCD-treated patients is due to decreased nursing costs associated with a lower frequency of CMCD changes compared to gauze dressing changes. CONCLUSION: Dressing surgical wounds healing by secondary intention with CMCD instead of gauze is expected to lead to a reduction in healthcare costs in both the US and UK. Hence, the purchase price of a dressing is not indicative of the cost effectiveness of a given method of surgical wound care.     

Oseltamivir: a review of its use in influenza

Oseltamivir is a prodrug of oseltamivir carboxylate (Ro 64-0802, GS4071), a potent and selective inhibitor of the neuraminidase glycoprotein essential for replication of influenza A and B viruses. Studies in volunteers with experimental human influenza A or B showed that administration of oral oseltamivir 20 to 200 mg twice daily for 5 days reduced both the quantity and duration of viral shedding compared with placebo. Subsequent assessment of the drug at a dosage of 75 mg twice daily for 5 days in otherwise healthy adults with naturally acquired febrile influenza showed that oseltamivir reduced the duration of the disease by up to 1.5 days and the severity of illness by up to 38% compared with placebo when initiated within 36 hours of symptom onset (earlier initiation of therapy was associated with faster resolution). The incidence of secondary complications and the use of antibacterials were also reduced significantly in oseltamivir recipients. A liquid formulation of oseltamivir (2 mg/kg twice daily for 5 days) has been shown to be effective in the treatment of children with influenza, and data presented in abstracts suggest that the drug may also be of use in high-risk populations such as the elderly or those with chronic cardiac or respiratory disease. In addition to treatment efficacy, the drug has demonstrated efficacy when used for seasonal or household prophylaxis. Oral oseltamivir (75 mg once or twice daily for 6 weeks) during a period of local influenza activity significantly prevented the development of naturally acquired influenza by >70% compared with placebo in unvaccinated otherwise healthy adults. The drug also demonstrated efficacy when used adjunctively in previously vaccinated high-risk elderly patients (92% protective efficacy). Short term administration of oseltamivir (75 mg once daily for 7 days) may significantly reduce the risk of illness in household contacts of infected persons when administered within 48 hours of symptom onset in the infected person. Oseltamivir 75 mg twice daily for 5 days was well tolerated in clinical trials in healthy adults and high-risk patients, with nausea and vomiting being the most commonly reported events. Gastrointestinal events were mild and transient and both nausea and vomiting were less likely when oseltamivir was taken with food. Conclusions: Oseltamivir is a well tolerated orally active neuraminidase inhibitor which significantly reduces the duration of symptomatic illness and hastens the return to normal levels of activity when initiated promptly in patients with naturally acquired influenza. It therefore represents a useful therapeutic alternative to zanamivir (especially in patients who prefer oral administration or who have an underlying respiratory disorder) and the M2 inhibitors amantadine and rimantadine (because of its broader spectrum of anti-influenza activity and lower likelihood of resistance) in patients with influenza. In addition, although annual vaccination remains the best means of influenza prevention, there may be a place for oseltamivir in providing household prophylaxis or adjunctive prophylaxis in high-risk vaccinated patients during an outbreak of the disease or for use in patients in whom vaccination is unsuitable or ineffective.     

Oseltamivir: new preparation. An antiviral agent with little impact on influenza

(1) Oseltamivir, an oral antiviral agent, has been marketed in the European Union for the prevention and treatment of suspected influenza during epidemics. (2) Three prevention trials done in the general population showed moderate effects, with a 3.5-4% reduction (in absolute values) in serologically confirmed episodes of 'flu. According to one trial, oseltamivir was moderately effective as a prophylactic for close contacts of 'flu cases (6.6% in absolute values). (3) There are three placebo-controlled double-blind trials evaluating oseltamivir as a treatment for 'flu, two in adults and one in children. (4) At a dose of 75 mg twice a day, oseltamivir shortened symptoms by about 24 hours. There was no evidence that oseltamivir prevented complications that need antibiotic therapy. Influenza virus isolates from adult patients belonged to type A in more than 90% of cases. There is no sound evidence that oseltamivir is effective against type B influenza virus. (5) There was no reduction in the frequency of complications in a trial in at-risk adults with chronic respiratory or cardiovascular disorders, or in a trial in asthmatic children. (6) Patients receiving oseltamivir in clinical trials were more likely to suffer nausea and vomiting than patients given placebo. (7) Oseltamivir has not been compared with oral amantadine or inhaled zanamivir. (8) It is best to use amantadine when prophylaxis is needed during epidemics. In the curative setting, the poor risk-benefit ratio of oseltamivir, zanamivir, and amantadine, argues against the use of these drugs.     

Potential costs and effects of the National Service Framework for Coronary Heart Disease in the UK

OBJECTIVE: To estimate the costs and effect of implementing the National Service Framework for Coronary Heart Disease (CHD) in the UK. DESIGN: Decision trees were built on the results from randomised controlled trials on improving coronary revascularisation. All costs were presented in UK pounds (1997 values). PATIENTS: Each year 6600 new patients with CHD are expected to require revascularisation in the UK. INTERVENTIONS: The new patients would be equally divided into those undergoing coronary artery bypass grafting (CABG) and those undergoing a percutaneous coronary intervention (PCI) i.e., percutaneous transluminal angioplasty (PCTA). PTCA could be administered with or without abciximab (a glycoprotein IIb/IIIa receptor antagonist), stent, or stent plus abciximab (stent+). RESULTS: CABG/stent alone has an incremental cost of more than 115,489 pounds per additional quality-adjusted life-year (QALY) gained compared with CABG/ PTCA+. This high incremental cost is not attractive because if CABG/ stent would be added to abciximab (CABG/stent+) its incremental cost-effectiveness ratio would be 2529 pounds per extra QALY compared with CABG/stent. Therefore, the debate should not be limited to the issue of stents but it should focus on the need for administering abciximab in addition to stent. The 5-year direct costs of implementing such a strategy in the UK is expected to be 50.6 million pounds (1997 values). CONCLUSIONS: Abciximab and probably any glycoprotein IIb/IIIa receptor antagonists should be added to any PCI, especially if stents are used.     

The cost effectiveness of infliximab for severe treatment-resistant rheumatoid arthritis in the UK

OBJECTIVE: To estimate the cost effectiveness (from the UK NHS and personal social service perspectives) of infliximab plus methotrexate (MTX) compared with MTX alone, in the treatment of patients with severe rheumatoid arthritis (RA) who were not adequately controlled on disease-modifying antirheumatic drugs and who were resistant to MTX. METHOD: Clinical data for the first year of therapy were taken from the ATTRACT (Anti-Tumour Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy) and a Markov model developed to assess costs and consequences in the longer term. Transition probabilities and health state valuations for the model were estimated based on the ARAMIS (Arthritis, Rheumatism, and Aging Medical Information System) cohort, and resource use and costs ( 2,000 pounds values) obtained from various sources in the UK. Univariate sensitivity analyses were conducted to test the robustness of the results. RESULTS: The primary analysis suggested that infliximab plus MTX had an ICER of 33,618 pounds per QALY gained. Alternative modelling assumptions and various other sensitivity analyses were applied, but the ICER always remained within the range for interventions typically funded by the NHS. CONCLUSION: This model suggests, with its underlying assumptions and data, that the combination of infliximab and MTX may be a cost-effective treatment (from the UK NHS and personal social service perspectives) for patients experiencing RA that cannot be maintained on MTX alone.     

Neuraminidase inhibitors in pediatric patients: potential place in influenza therapy

Influenza is responsible for annual epidemics, and is associated with significant morbidity and mortality. The development and use of antiviral agents is one of the recent strategies used to control influenza. Zanamivir and oseltamivir are members of a new class of antiviral agents, the neuraminidase inhibitors, that are effective in the treatment of influenza. These drugs have been evaluated in double-blind, placebo-controlled trials in children. Efficacy was shown by shortened duration of influenza-related symptoms in children treated with neuraminidase inhibitors. Seasonal prophylaxis in adults, and administration to household contacts of influenza-infected persons has decreased the incidence of influenza infection and illness. Adverse effects of zanamivir are minimal, while oseltamivir is associated with gastrointestinal upset, which does not usually require the medication to be ceased. No serious adverse events have been reported in children receiving these medications. Caution should be exercised in the use of zanamivir in children with asthma due to the potential development of bronchospasm and respiratory distress. Development of resistance to these medications is reported to occur less frequently than with amantadine. Resistance to zanamivir has been rarely detected during clinical trials, while up to 5.5% of influenza strains isolated from children after treatment were reported to be resistant to oseltamivir. Due to the role children play in the spread of influenza within the community, use of these medications may help control influenza epidemics.     

Health-related quality of life and cost impact of irritable bowel syndrome in a UK primary care setting

OBJECTIVES: To identify the impact of irritable bowel syndrome (IBS) on health-related quality of life (HR-QOL), time off work and the utilisation and cost of health services. DESIGN: A case-control study was undertaken matching patients with IBS and controls. Quality-of-life information was collected using the Medical Outcomes Study 36-item Short Form (SF-36) health survey, EuroQOL instrument (EQ-5D) and IBS Quality-of-Life (IBS-QOL) instruments. Data on time off work was also collected. National Health Service (NHS) resource use in primary and secondary care was estimated by review of general practitioner (GP) and hospital records over a 12-month period. SETTING: Recruitment was from six GPs' surgeries in the Trent Region of the United Kingdom. PARTICIPANTS: 161 patients with IBS, as defined by the Rome Criteria I were recruited. These were compared with 213 controls matched for age, sex and social characteristics. MAIN OUTCOME MEASURES: SF-36 and EQ-5D scores; mean number of days off work; mean NHS costs per person during the 12-month study period. RESULTS: Patients with IBS had considerably lower HR-QOL than controls. They scored worse in all dimensions of the SF-36 and the EQ-5D and they had more time off work. On average patients with IBS cost the NHS 123 UK pounds (95% confidence interval: 35 UK pounds to 221 UK pounds, 1999 values) more per year than individuals in the control group (p = 0.04). CONCLUSIONS: IBS affects patients through reduced quality of life, more time off work and greater healthcare utilisation than a control group of patients without IBS. The difference in quality of life was pronounced and unusual in that it was influential in every dimension of both the SF-36 and the EQ-5D.     

Pharmacoeconomic assessment of oseltamivir in treating influenza – the case of otherwise healthy Danish adolescents and adults

Objective: To assess the pharmacoeconomics of treating influenza with oseltamivir in healthy Danish adolescents and adults.Method: Cost-effectiveness and cost-utility analyses were used to compare oseltamivir to usual care (symptomatic treatment with over the counter (OTC) medicine), considering both the societal and health care payers perspectives. The population group studied was otherwise healthy adolescents and adults, aged 13 to 64. Danish data were collected to simulate results that are specific to Denmark. The economic model included first- and second-order Monte Carlo simulations. Sensitivity analyses were conducted to test the robustness of the analyses.Main outcome measure: The cost-effectiveness study was expressed as gain in cost per day to return to normal activity, and the cost-utility study as cost per QALY (quality adjusted life years) gained.Results: From a societal perspective, oseltamivir was a dominant treatment compared to usual care. From a health care payers perspective, the cost-effectiveness ratio was |CE 12.3 per gain in day to return to normal activity and |CE 5,063 /QALY gained. A sensitivity analysis leaving out hospitalisation, complications, and mortality showed increased cost-effectiveness and cost-utility ratios. However, treatment with oseltamivir remained cost-effective, assuming a willingness to pay for health benefits at |CE 26,174/QALY.Conclusion: Pharmacoeconomic analyses of influenza treatment with oseltamivir in an otherwise healthy Danish adolescent/adult population show that this treatment saves money for society and is associated with a relatively low cost from a health care payers perspective. Treatment of influenza with oseltamivir would be cost-effective for healthy adolescents/adults in Denmark.