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David Price,
Stanley D Musgrave,
Lee Shepstone,
Elizabeth V Hillyer,
Erika J Sims,
Richard F T Gilbert,
Elizabeth F Juniper,
Jon G Ayres,
Linda Kemp,
Annie Blyth, Edward C F Wilson,
Stephanie Wolfe,
Daryl Freeman,
H Miranda Mugford,
Jamie Murdoch,
Ian Harvey
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ABSTRACT: Most randomized trials of treatment for asthma study highly selected patients under idealized conditions.
We conducted two parallel, multicenter, pragmatic trials to evaluate the real-world effectiveness of a leukotriene-receptor antagonist (LTRA) as compared with either an inhaled glucocorticoid for first-line asthma-controller therapy or a long-acting beta(2)-agonist (LABA) as add-on therapy in patients already receiving inhaled glucocorticoid therapy. Eligible primary care patients 12 to 80 years of age had impaired asthma-related quality of life (Mini Asthma Quality of Life Questionnaire [MiniAQLQ] score ≤6) or inadequate asthma control (Asthma Control Questionnaire [ACQ] score ≥1). We randomly assigned patients to 2 years of open-label therapy, under the care of their usual physician, with LTRA (148 patients) or an inhaled glucocorticoid (158 patients) in the first-line controller therapy trial and LTRA (170 patients) or LABA (182 patients) added to an inhaled glucocorticoid in the add-on therapy trial.
Mean MiniAQLQ scores increased by 0.8 to 1.0 point over a period of 2 years in both trials. At 2 months, differences in the MiniAQLQ scores between the two treatment groups met our definition of equivalence (95% confidence interval [CI] for an adjusted mean difference, -0.3 to 0.3). At 2 years, mean MiniAQLQ scores approached equivalence, with an adjusted mean difference between treatment groups of -0.11 (95% CI, -0.35 to 0.13) in the first-line controller therapy trial and of -0.11 (95% CI, -0.32 to 0.11) in the add-on therapy trial. Exacerbation rates and ACQ scores did not differ significantly between the two groups.
Study results at 2 months suggest that LTRA was equivalent to an inhaled glucocorticoid as first-line controller therapy and to LABA as add-on therapy for diverse primary care patients. Equivalence was not proved at 2 years. The interpretation of results of pragmatic research may be limited by the crossover between treatment groups and lack of a placebo group. (Funded by the National Coordinating Centre for Health Technology Assessment U.K. and others; Controlled Clinical Trials number, ISRCTN99132811.).
New England Journal of Medicine 05/2011; 364(18):1695-707. · 53.30 Impact Factor
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Edward C F Wilson
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ABSTRACT: Actinic keratosis (AK) is caused by chronic exposure to UV radiation (sunlight). First-line treatments are cryosurgery, topical 5-fluorouracil (5-FU) and topical diclofenac. Where these are contraindicated or less appropriate, alternatives are imiquimod and photodynamic therapy (PDT).
To compare the cost effectiveness of imiquimod and methyl aminolevulinate-based PDT (MAL-PDT) from the perspective of the UK NHS.
A decision tree model was populated with data from a literature review and used to estimate costs and QALYs gained and incremental cost effectiveness over 1 year. The model simulated patients who were in secondary care, who had four to nine AK lesions, and for whom cryosurgery, 5-FU and diclofenac were contraindicated or considered less appropriate.
Over 1 year, imiquimod cost £174 less than MAL-PDT (year 2006 values) but resulted in 0.005 fewer QALYs gained. The incremental cost-effectiveness ratio (ICER) of MAL-PDT over imiquimod was £34,576. In the probabilistic sensitivity analysis, there was a 75% probability that imiquimod was cost effective compared with MAL-PDT at a threshold of £20,000 per QALY gained, falling to 73% at £30,000.
Imiquimod may be the more cost-effective treatment at conventional cost-effectiveness thresholds. A direct head-to-head study of MAL-PDT versus imiquimod is required to reduce uncertainty.
PharmacoEconomics 11/2010; 28(11):1055-64. · 2.66 Impact Factor
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Edward C F Wilson,
David Price,
Stanley D Musgrave,
Erika J Sims,
Lee Shepstone,
Jamie Murdoch,
H Miranda Mugford,
Annie Blyth,
Elizabeth F Juniper,
Jon G Ayres,
Stephanie Wolfe,
Daryl Freeman,
Richard F T Gilbert,
Elizabeth V Hillyer,
Ian Harvey
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ABSTRACT: Information is lacking on the relative effectiveness and cost effectiveness--in a real-life primary-care setting--of leukotriene receptor antagonists (LTRAs) and long-acting beta2 adrenergic receptor agonists (beta2 agonists) as add-on therapy for patients whose asthma symptoms are not controlled on low-dose inhaled corticosteroids (ICS).
To estimate the cost effectiveness of LTRAs compared with long-acting beta2 agonists as add-on therapy for patients whose asthma symptoms are not controlled on low-dose ICS.
An economic evaluation was conducted alongside a 2-year, pragmatic, randomized controlled trial set in 53 primary-care practices in the UK. Patients aged 12-80 years with asthma insufficiently controlled with ICS (n = 361) were randomly assigned to add-on LTRAs (n = 176) or long-acting beta2 agonists (n = 185). The main outcome measures were the incremental cost per point improvement in the Mini Asthma Quality of Life Questionnaire (MiniAQLQ), per point improvement in the Asthma Control Questionnaire (ACQ) and per QALY gained from perspectives of the UK NHS and society.
Over 2 years, the societal cost per patient receiving LTRAs was pounds sterling 1157 versus pounds sterling 952 for long-acting beta2 agonists, a (significant, adjusted) increase of pounds sterling 214 (95% CI 2, 411) [year 2005 values]. Patients receiving LTRAs experienced a non-significant incremental gain of 0.009 QALYs (95% CI -0.077, 0.103). The incremental cost per QALY gained from the societal (NHS) perspective was pounds sterling 22,589 (pounds sterling 11,919). Uncertainty around this point estimate suggested that, given a maximum willingness to pay of pounds sterling 30,000 per QALY gained, the probability that LTRAs are a cost-effective alternative to long-acting beta2 agonists as add-on therapy was approximately 52% from both societal and NHS perspectives.
On balance, these results marginally favour the repositioning of LTRAs as a cost-effective alternative to long-acting beta2 agonists as add-on therapy to ICS for asthma. However, there is much uncertainty surrounding the incremental cost effectiveness because of similarity of clinical benefit and broad confidence intervals for differences in healthcare costs.
UK National Research Register N0547145240; Controlled Clinical Trials ISRCTN99132811.
PharmacoEconomics 07/2010; 28(7):597-608. · 2.66 Impact Factor
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Edward C F Wilson,
Erika J Sims,
Stanley D Musgrave,
Lee Shepstone,
Annie Blyth,
Jamie Murdoch,
H Miranda Mugford,
Elizabeth F Juniper,
Jon G Ayres,
Stephanie Wolfe,
Daryl Freeman,
Richard F T Gilbert,
Ian Harvey,
Elizabeth V Hillyer,
David Price
[show abstract]
[hide abstract]
ABSTRACT: Information is lacking on the relative effectiveness and cost effectiveness--in a primary-care setting--of leukotriene receptor antagonists (LTRAs) as an alternative to inhaled corticosteroids (ICS) for initial asthma controller therapy.
To compare the cost effectiveness of LTRAs versus ICS for patients initiating asthma controller therapy.
An economic evaluation was conducted alongside a 2-year, pragmatic, randomized controlled trial set in 53 primary-care practices in the UK. Patients aged 12-80 years with asthma and symptoms requiring regular anti-inflammatory therapy (n = 326) were randomly assigned to LTRAs (n = 162) or ICS (n = 164). The main outcome measures were the incremental costs per point improvement in the Mini Asthma Quality of Life Questionnaire, per point improvement in the Asthma Control Questionnaire and per QALY gained from the UK NHS and societal perspectives.
Over 2 years, resource use was similar between the two treatment groups, but the cost to society per patient was significantly higher for the LTRA group, at pounds sterling 711 versus pounds sterling 433 for the ICS group (adjusted difference pounds sterling 204; 95% CI 74, 308) [year 2005 values]. Cost differences were driven primarily by differences in prescription drug costs, particularly study drug costs. There was a nonsignificant (imputed, adjusted) difference between treatment groups, favouring ICS, in QALYs gained at 2 years of -0.073 (95% CI -0.143, 0.010). Therapy with LTRAs was, on average, a dominated strategy, and, at a threshold for willingness to pay of pounds sterling 30,000 per QALY gained, the probability of LTRAs being cost effective compared with ICS was approximately 3% from both societal and NHS perspectives.
There is a very low probability of LTRAs being cost effective in the UK, at 2005 values, compared with ICS for initial asthma controller therapy.
UK National Research Register N0547145240; Controlled Clinical Trials ISRCTN99132811.
PharmacoEconomics 01/2010; 28(7):585-95. · 2.66 Impact Factor
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ABSTRACT: Prioritizing candidates for health-care expenditure using cost per Quality-Adjusted Life Year (QALY) is a helpful but insufficient means of ranking alternative uses for scarce health-care funds at the local level. This is because QALYs do not by themselves capture all criteria decision makers need to take into account. Other criteria such as reducing inequalities, meeting national and local priorities and public acceptability also feature in the decision maker's utility function. Programme budgeting and marginal analysis (PBMA) is an established framework for systematic priority setting in which a 'weighted benefit score' for each option is calculated based on all relevant decision-making criteria. Ranking options as a ratio of cost to benefit is desirable and necessary to ensure efficiency. In this paper we review a number of approaches to scoring costs and benefits of options in a PBMA context. Several approaches rank by benefit score alone, rather than efficiency (cost per unit of benefit). Of those that do rank by efficiency, we discuss the benefits and drawbacks. The optimal approach is far from clear, with each technique having its own strengths and weaknesses. A deliberative approach using summaries of costs and benefits of options as a basis for discussion may be preferable.
Health Economics 06/2008; 18(4):467-78. · 2.12 Impact Factor
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ABSTRACT: Medication review by pharmacists is increasingly being implemented in the primary care setting and has been incorporated into the new pharmacy contract in the UK. This study aims to determine the cost effectiveness of home-based medication review in older people.
This economic evaluation was based on a randomised controlled trial (the HOMER [HOME-based medication Review] trial). Patients aged >80 years (n = 872) were recruited if admitted as an emergency to an acute or community hospital in Norfolk or Suffolk (any cause), returning to their own home or warden-controlled accommodation, and taking two or more drugs daily on discharge. Patients randomised to the intervention group received two home visits by a pharmacist within 2 and 8 weeks of discharge to educate patients and carers about their drugs, remove out-of-date drugs, inform GPs of drug reactions or interactions and inform the local pharmacist if an adherence aid was needed. The control arm received usual care. Economic evaluation was performed from the UK NHS perspective, with follow-up for 6 months and cost data from 2000. Resource use data were collected from hospital episode statistics and from a sample of GP records of trial participants. Intervention, hospital, ambulance and general practice costs were considered to determine average costs and incremental cost-effectiveness ratios. Use of the EQ-5D questionnaire permitted outcomes to be expressed as QALYs. Probabilistic sensitivity analysis was employed to calculate cost-effectiveness acceptability curves.
Mortality and admission data were available for 829 of 855 patients included in the study (415 intervention and 414 control patients). Of those patients randomised to the intervention group, 358 had a medication review at a total intervention cost of 51,622 pound (or 124 pound per randomised patient). The intervention did not reduce hospital admissions. The average cost per intervention group patient was 1695 pound compared with 1424 pound for control patients. The incremental cost per life year gained through the intervention was 33,541 pound. The incremental cost per QALY gained in the intervention was 54,454 pound. Sensitivity analysis suggested a 25% probability that home-based medication review is cost effective using a threshold of 30,000 pound per QALY.
The current policy imperative for implementing medicines review needs to be reconsidered in the light of the findings of this study: a small, non significant gain in quality of life, no reduction in hospital admissions and a low probability of cost effectiveness.
PharmacoEconomics 01/2007; 25(2):171-80. · 2.66 Impact Factor
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ABSTRACT: In the English NHS, Primary Care Trusts (PCTs) are required to commission health services, to maximise the well-being of the population, subject to the available budget. There are numerous techniques employed to make decisions, some more rational and transparent than others. A weighted benefit score can be used to rank options but this does not take into account value for money from investments.
We developed a weighted benefit score framework for use in an English PCT which ranked options in order of 'cost-value' or 'cost per point of benefit'. Our method differs from existing techniques by explicitly combining cost and a composite weighted benefit score into the cost-value ratio.
The technique proved readily workable, and was able to accommodate a wide variety of data and competing criteria. Participants felt able to assign scores to proposed services, and generate a ranked list, which provides a solid starting point for the PCT Board to discuss and make funding decisions. Limitations included potential for criteria to be neither exhaustive nor mutually exclusive and the lack of an interval property in the benefit score limiting the usefulness of a cost-value ratio.
A technical approach to decision making is insufficient for making prioritisation decisions, however our technique provides a very valuable, structured and informed starting point for PCT decision making.
Cost Effectiveness and Resource Allocation 02/2006; 4:3. · 0.87 Impact Factor
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ABSTRACT: To estimate the annual direct cost of managing erectile dysfunction (ED) to the UK National Health Service (NHS) and to examine the impact of the introduction of sildenafil in 1998 and Schedule 11 restrictions in 1999.
A prevalence-based cost-of-illness approach was used. The period 1997 to 2000 was covered. The numbers of ED prescriptions, prosthesis implantations and general practitioner (GP) consultations were retrieved retrospectively from UK resource utilisation databases. The number of specialist consultations and psychosexual therapy sessions were estimated from NHS clinic data. National resource unit costs were applied.
Between 1997 and 2000 the number of men presenting with ED increased from 79,800 to 257,984. The cost to the NHS increased from pounds sterling 29.4 million to pounds sterling 73.8 million (2000 estimates). The cost per patient fell from pounds sterling 368 to pounds sterling 286. In 1997, most NHS costs came from psychosexual therapy (30.7%), specialist consultations (20.2%) and intracavernosal injections (26.6%). By 2000, NHS costs came primarily from specialist consultations (32.0%), sildenafil prescriptions (26.2%), psychosexual therapy (13.6%) and GP consultations (12.0%). The annual cost was most sensitive to the number of drug prescriptions and specialist consultations.
The increased NHS cost of managing ED was due mainly to a three-fold increase in the number of men presenting to GPs, substantial numbers of whom were then referred for specialist consultations under Schedule 11 restrictions. This naturally resulted in the increased use of all resources including sildenafil. The cost effectiveness of transferring prescribing responsibility in cases of severe distress from specialists to GPs in primary care remains to be determined.
PharmacoEconomics 02/2002; 20(13):879-89. · 2.66 Impact Factor
