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Galantamine

A Pharmacoeconomic Review of its Use in Alzheimer’s Disease

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Abstract

Abstract

Galantamine is one of several orally administered cholinesterase inhibitors that improve cognition in patients with mild to moderate Alzheimer’s disease. Compared with placebo, galantamine 16 or 24 mg/day improved cognition and activities of daily living, delayed emergence of behavioural symptoms and reduced caregiver burden in three pivotal randomised studies of 5 or 6 months’ duration.

Galantamine may reduce the considerable economic burden of Alzheimer’s disease by delaying the need for full-time care (FTC) in patients with mild to moderate Alzheimer’s disease. In pharmacoeconomic analyses with a time horizon of 10 years conducted in Canada, Sweden, The Netherlands and the US, data from the pivotal trials were incorporated into a model to examine economic implications associated with galantamine treatment. FTC was defined in the model as the consistent requirement for caregiving and supervision for the greater part of each day regardless of the location of care and the identity of caregiver. When the effect of galantamine 16 or 24 mg/day was analysed from the perspective of a comprehensive healthcare payer, treatment was associated with cost savings (inclusive of drug costs) relative to no treatment, regardless of country for which the model was customised. Cost savings resulted from the delay in the time until FTC was required in patients with mild to moderate disease. In sensitivity analyses, cost savings were most sensitive to the cost of institutional care.

In the analyses that considered the effect of galantamine 24 mg/day solely on cognition, galantamine was predicted to reduce the time FTC was required by ≈10% in patients with mild to moderate Alzheimer’s disease compared with no pharmacological treatment. Greater reductions in the time that FTC was required were predicted when the effects of galantamine 16 or 24 mg/day on behavioural symptoms in addition to cognition were considered in the US analysis or in sensitivity analyses in studies in other countries.

In conclusion, pharmacoeconomic analyses, which were based on modelling of data from pivotal clinical trials with galantamine and included drug costs, indicate that galantamine treatment may result in cost savings from a healthcare payer perspective. The effects of galantamine on cognition and behavioural symptoms in patients with mild to moderate Alzheimer’s disease are predicted to delay the need for FTC, which may result in cost savings. From a societal perspective, the caregiver burden of caring for a patient with Alzheimer’s disease in the community may be decreased and the time that patients have without severe disease may be prolonged.

Alzheimer’s Disease

Alzheimer’s disease, which is characterised by progressive loss of cognition, a decline in the ability to perform activities of daily living and the development of behavioural symptoms, is the most common form of irreversible dementia. The average prevalence is ≈5% in those aged 65 years and older. Although there are other possible risk factors for Alzheimer’s disease (e.g. family history of dementia, presence of Down’s syndrome), age is the most relevant risk factor.

Alzheimer’s disease is associated with a considerable cost burden, regardless of whether costs of formal, informal or formal plus informal care are included. In the US, Alzheimer’s disease is considered to be the third most costly disease and is estimated to cost approximately $US80 to $US100 billion per year. Although public and private healthcare insurers carry many of the direct costs of Alzheimer’s disease, patients and their families bear many other expenses. In the early stages of the disease, patients often live at home; as the disease progresses and patients become increasingly dependent on the care of others, they are placed in institutions. Because the estimated costs of caring for a patient with Alzheimer’s disease are lower when care is given in the community than when given in institutional facilities, a substantial increase in costs is associated with the decision to move a patient from the community to institutionalised care. Due to the increased need for care and supervision, the costs of Alzheimer’s disease generally increase as the severity of disease increases.

The current focus of symptomatic treatment of patients with Alzheimer’s disease is augmentation of cholinergic neurotransmission to delay further deterioration in cognitive abilities and behaviour and to increase functional performance. Several orally administered cholinesterase inhibitors (galantamine, donepezil, rivastigmine and tacrine) are now available and all achieve improvements in cognition in patients with mild to moderate Alzheimer’s disease. Unlike the other cholinesterase inhibitors, galantamine also allosterically modulates nicotinic acetylcholine receptors. The choice of therapy in the individual patient may be influenced by differences in improvement of symptoms other than cognition, and by the pharmacological, tolerability and administration profiles of these agents.

Therapeutic Use of Galantamine

Compared with placebo, galantamine 16 or 24 mg/day improved cognition and activities of daily living, delayed the emergence of behavioural symptoms and reduced caregiver burden in three pivotal randomised studies of 5 or 6 months’ duration.

In these trials, galantamine significantly improved cognition compared with placebo (differences in favour of galantamine were 3.1 points for the galantamine 16 mg/day group and 2.9 to 3.9 points for the galantamine 24 mg/day groups) as measured by the 11-item cognitive subscale of the Alzheimer’s disease Assessment Scale (ADAS-cog). Moreover, improvements of >-4 points in ADAS-cog were shown by a significantly greater proportion of galantamine 16 or 24 mg/day recipients than placebo recipients. Galantamine was also superior to placebo on the Clinician’s Interview-Based Impression of Change plus Caregiver Input scale, which measures global functioning.

Treatment with galantamine may have beneficial effects on some aspects of instrumental and basic activities of daily living as measured in the pivotal trials. One of these trials also included measurement of behavioural symptoms and showed that galantamine significantly delayed the development of behavioural symptoms in patients with Alzheimer’s disease compared with placebo.

The cognitive and functional benefits of galantamine result in a reduction in caregiver burden. Preliminary results from one study showed that no additional caregiver supervision and less time with assistance with activities of daily living was required by galantamine 24 mg/day recipients after 6 months’ treatment compared with baseline.

The adverse events most commonly associated with galantamine, as with other cholinesterase inhibitors, are cholinergic in nature. These include nausea, vomiting, diarrhoea, weight loss and anorexia, and were reported by 6 to 17% of galantamine 16 or 24 mg/day recipients and 1 to 6% of placebo recipients in the 5-month pivotal trial, which used the recommended 4-week dose escalation regimen. Most events were transient and of mild to moderate severity. Treatment was discontinued due to adverse events in 7 and 10% of galantamine 16 and 24 mg/day recipients and 7% of placebo recipients. No clinically relevant changes in laboratory values (including hepatic enzymes) or vital signs were observed in the pivotal trials.

Pharmacoeconomic Analyses of Galantamine

Potential cost savings may occur if patients with mild to moderate Alzheimer’s disease receive a drug, such as galantamine, that slows the decline in cognition and the development of behavioural symptoms, and thereby delays the need for full-time care (FTC) in an institution or at home. FTC is defined as the consistent requirement for caregiving and supervision for the greater part of each day regardless of the location of care or identity of the caregiver. The Assessment of Health Economics in Alzheimer’s Disease (AHEAD) model uses algorithms to predict the time until FTC is required or death occurs in patients with mild to moderate Alzheimer’s disease. Index scores for five characteristics shown to be predictors of the need for FTC in patients with Alzheimer’s disease, and four characteristics predictive of death are incorporated in the model.

By incorporating key clinical data from pivotal clinical trials of galantamine, the AHEAD model has been customised to estimate the long-term health and cost implications of galantamine 16 or 24 mg/day treatment compared with no pharmacological treatment in patients with Alzheimer’s disease in Canada, Sweden, The Netherlands and the US. Each analysis had a time horizon of 10 years and was conducted from the perspective of a comprehensive healthcare payer. Costs of formal care (e.g. medical and home help costs) and the proportions of patients requiring FTC that would receive FTC in institutions were derived from recent data corresponding to the locality of the analysis.

Relative to no treatment, cost savings (inclusive of drug-related costs) with galantamine were predicted regardless of the country for which the model was customised, and resulted from the reduction in the time patients required FTC. Most base analyses considered the effect of galantamine 24 mg/day solely on cognition; galantamine reduced the time FTC was required by ≈10% in patients with mild to moderate Alzheimer’s disease, and by ≈11% in the subgroup of patients with moderate Alzheimer’s disease. It was predicted that 5.6 patients with mild to moderate Alzheimer’s disease or 3.9 patients with moderate Alzheimer’s disease need to start treatment with galantamine 24 mg/day to prevent 1 year of FTC.

The US analysis, which included the effect of galantamine 16 or 24 mg/day on both cognition and behavioural symptoms, predicted that cost savings and increased time until FTC was required would result with galantamine.

Because patients with moderate disease need FTC sooner than those with mild disease, cost savings were calculated to be greater in the subgroup of patients with moderate disease than in patients with mild to moderate Alzheimer’s disease.

In the sensitivity analyses, cost savings varied depending on the input of reasonable changes in key parameters. Results were most sensitive to the cost of institutional care; the proportion of patients requiring FTC in an institution and the acquisition cost of galantamine were other important variables. Total cost savings in the Dutch or Canadian analyses were predicted to increase by ≈60 or 100%, respectively, when the effects of galantamine 24 mg/day on behavioural symptoms in addition to the effect on cognitive symptoms were considered in sensitivity analyses (using data from the pivotal galantamine trial that addressed behavioural symptoms).

Using the same economic model, preliminary results of a Canadian analysis favoured galantamine 16 or 24 mg/day over donepezil 5 or 10 mg/day or low- or high-dose rivastigmine in the treatment of mild to moderate Alzheimer’s disease in a comparison of predicted costs and time patients required FTC. This analysis, which had a 10-year time horizon, incorporated data from Cochrane meta-analyses of pivotal trials of the three cholinesterase inhibitors into the model.

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Lyseng-Williamson, K.A., Plosker, G.L. Galantamine. Pharmacoeconomics 20, 919–942 (2002). https://doi.org/10.2165/00019053-200220130-00005

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