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Donepezil, rivastigmine, galantamine and memantine for ...

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patients are seen to discontinue <strong>galantamine</strong><br />

treatment (e.g. owing to non-compliance), they are<br />

assumed to have changes in cognition <strong>and</strong><br />

psychotic symptoms equivalent to those who had<br />

never received <strong>galantamine</strong> treatment. Ward <strong>and</strong><br />

colleagues report analyses <strong>for</strong> mild-to-moderate<br />

AD, <strong>and</strong> two subgroups of patients: those with<br />

moderate disease only (baseline MMSE < 18), <strong>and</strong><br />

those responding to treatment (maintained or<br />

improved ADAS-cog over 6 months).<br />

Ward <strong>and</strong> colleagues report that treatment with<br />

<strong>galantamine</strong> at a 16-mg dose resulted in an<br />

estimated 12% reduction in the time patients<br />

required FTC, delaying the need <strong>for</strong> FTC by<br />

2.5 months. At the 24-mg dose the estimated<br />

reduction in time patients required FTC was 15%,<br />

with a delay in the need <strong>for</strong> FTC of 3.02 months.<br />

The Ward <strong>and</strong> colleagues model assumes no<br />

survival advantage from <strong>galantamine</strong>, but<br />

considers health-related QoL. Using health state<br />

utility data from Neumann <strong>and</strong> colleagues, 110 the<br />

authors apply utilities of 0.60 <strong>and</strong> 0.34,<br />

respectively, <strong>for</strong> the health states defined as pre-<br />

FTC <strong>and</strong> FTC [see discussion of Neumann <strong>and</strong><br />

colleagues in the section ‘Health state<br />

utilities/values <strong>for</strong> AD’ (p. 115)]. Over 10 years the<br />

authors estimate a mean gain of 0.06 QALY (this<br />

finding is not presented by treatment regimen, i.e.<br />

16 or 24 mg). See the discussion of the study by<br />

Neumann <strong>and</strong> colleagues in the section referred to<br />

above.<br />

Studies by Getsios <strong>and</strong> colleagues, 95 Garfield <strong>and</strong><br />

colleagues, 96 <strong>and</strong> Caro <strong>and</strong> colleagues 97 define<br />

their baseline cohort according to trial<br />

participants in trials reported by Raskind <strong>and</strong><br />

colleagues 61 <strong>and</strong> Wilcock <strong>and</strong> colleagues. 64<br />

Migliaccio-Walle <strong>and</strong> colleagues 98 define their<br />

patient cohort using combined trial data from<br />

Raskind <strong>and</strong> colleagues <strong>and</strong> Tariot <strong>and</strong><br />

colleagues. 63 Study methods are reported in<br />

Appendix 13 <strong>and</strong> findings <strong>for</strong> these non-UK<br />

studies, with further detail in Appendix 14.<br />

Estimation of costs within economic<br />

evaluations (<strong>galantamine</strong>)<br />

In line with the AHEAD model <strong>for</strong>mat, costeffectiveness<br />

studies assign costs to the health<br />

states <strong>for</strong> pre-FTC <strong>and</strong> FTC. Studies estimate the<br />

monthly cost associated with pre-FTC <strong>and</strong> with<br />

FTC by location, that is, community or<br />

institutional setting. As the AHEAD model<br />

simulates disease progression over time, patients<br />

move from the pre-FTC health state, which is<br />

relatively inexpensive, to the more resourceintensive<br />

health state of FTC. The cost associated<br />

© Queen’s Printer <strong>and</strong> Controller of HMSO 2006. All rights reserved.<br />

Health Technology Assessment 2006; Vol. 10: No. 1<br />

with FTC is calculated as a composite cost, with<br />

proportions assigned according to the location of<br />

care (e.g. community or institution). In the<br />

estimation of health state costs, studies use various<br />

country-specific data sources <strong>for</strong> resource use <strong>and</strong><br />

unit costs.<br />

Ward <strong>and</strong> colleagues 99 in their UK CEA use data<br />

from two UK national surveys (conducted by<br />

OPCS during 1985 <strong>and</strong> 1986), 134 to estimate the<br />

resource used by cognitively impaired patients<br />

residing in the community or an institutional<br />

setting. Detail on the specific resources used <strong>and</strong><br />

subsequent cost analysis is not provided (other<br />

than in one illustrative figure <strong>for</strong> community care<br />

costs). The authors estimate the cost of providing<br />

FTC to patients in the community at £433 per<br />

month <strong>and</strong> in an institutional setting £1878 per<br />

month. The estimated monthly costs at lower<br />

levels of dependency (pre-FTC) are £238 per<br />

patient.<br />

From the two UK national surveys Ward <strong>and</strong><br />

colleagues assume that 48% of cognitively<br />

impaired patients requiring FTC are living in an<br />

institutional care setting. Although the authors<br />

recognise that the composition of institutional care<br />

has changed considerably since the mid-1980s,<br />

they believe that the proportion of persons in<br />

institutional care as a whole had remained<br />

constant at 48% (no justification provided). For<br />

those persons assumed to be in residential care,<br />

42% were assumed to be in private nursing homes,<br />

37% in private residential care <strong>for</strong> the elderly, 11%<br />

in local authority care, 8% in voluntary residential<br />

care <strong>and</strong> 2% in hospital. These estimates were<br />

based on data taken from published sources on<br />

persons with dementia.<br />

Ward <strong>and</strong> colleagues report the expected 10-year<br />

cumulative costs per patient were £28,134 <strong>for</strong> the<br />

non-<strong>galantamine</strong> treatment cohort, £28,615 <strong>for</strong><br />

the <strong>galantamine</strong> 16 mg/day cohort (increase of<br />

1.7% over no treatment) <strong>and</strong> £28,806 <strong>for</strong> the<br />

<strong>galantamine</strong> 24 mg/day cohort (increase of 2.4%<br />

over no treatment). Treatment with <strong>galantamine</strong><br />

increased annual costs <strong>for</strong> the first 3 years, with<br />

costs in subsequent years partially offset by<br />

delaying the need <strong>for</strong> FTC <strong>and</strong> with 80% of the<br />

treatment cost (<strong>galantamine</strong> cost) expected to be<br />

offset over 10 years.<br />

For subgroup analyses, Ward <strong>and</strong> colleagues<br />

predict small cost savings over time of £228 in<br />

moderate AD (16 mg/day <strong>galantamine</strong>) <strong>and</strong> more<br />

substantial savings at £1372 (16 mg/day<br />

<strong>galantamine</strong>) in the subset of patients who<br />

99

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