One-year within-trial and lifetime-horizon modeled health economic evaluation of the risk-stratified Prediabetes Lifestyle Intervention Study (PLIS) for prediabetes remission in Germany
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Background
Lifestyle interventions can increase the probability of remission of prediabetes to normal glucose tolerance, but their economic value remains unclear. We assessed the within-trial and lifetime-horizon modeled cost-effectiveness of intensive and conventional lifestyle interventions in risk-stratified participants with prediabetes.
Methods
A health economic evaluation was conducted alongside the 12-month multicenter PLIS trial (n=1,105). High-risk participants were randomized to intensive (HR-INT) or conventional (HR-CONV); low-risk participants to conventional lifestyle intervention (LR-CONV) or control (only short single consultation; LR-CTRL) with risk stratification based on insulin secretion, insulin sensitivity, and liver fat content. Within-trial analyses estimated incremental costs per additional remission to normoglycemia and per quality-adjusted life year (QALY). Lifetime cost-effectiveness was modelled using a four-state Markov Model.
Findings
At 12 months, HR-INT and LR-CONV increased remission compared with their respective comparators. The incremental cost per additional remission was €7,081 (95% CI: dominated-47,277) for HR-INT and €4,278 (1,312–11,793) for LR-CONV from a health insurance perspective. A willingness-to-pay of €22,000 (HR-INT) and €7,500 (LR-CONV) per additional remission corresponded to 90% probability of cost-effectiveness. Neither intervention was cost-effective in terms of QALYs gained within the 12-months period. Lifetime modelling suggested that both HR-INT and LR-CONV are not only cost-effective, but also cost-saving, relative to HR-CONV and LR-CTRL, respectively. Also in the probabilistic sensitivity analysis, most simulations indicated dominance (71.7% for HR and 88% for LR).
Interpretation
Based on short-term economic evaluation, the interventions assessed were cost-effective regarding additional participants with remission, not for incremental QALYs gained. Lifetime modelling suggests cost savings for both risk groups. Targeting populations with lifestyle interventions to achieve prediabetes remission seems to generate good value for money in the long term.
Trial registration number: NCT01947595
Research in context
What is already known about this subject?
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Lifestyle modification is pivotal for type 2 diabetes prevention in individuals with prediabetes; improvements are needed to overcome nonresponse to preventive interventions.
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The 12-month Prediabetes Lifestyle Intervention Study (PLIS) was the first multicenter study, which involved eight study sites in university hospitals in Germany, where investigators prospectively tested different intensities of lifestyle intervention in a risk-stratified manner.
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PLIS achieved higher remission rates of prediabetes with an intensive lifestyle intervention (16 counseling sessions) in high-risk participants and a conventional lifestyle intervention (8 counselling sessions) in low-risk participants, relative to a conventional (8 counselling sessions) and control lifestyle intervention (single short counselling session), respectively.
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As risk-stratified diabetes prevention has not been implemented so far and more intense lifestyle interventions are usually associated with higher healthcare utilization, it remains unclear whether these interventions are cost-effective.
What is the key question?
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Are intensive and conventional lifestyle interventions of the Prediabetes Lifestyle Intervention Study cost-effective after 12 months and over the lifetime horizon?
What are the new findings?
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Intensive lifestyle intervention in high-risk participants and the conventional lifestyle intervention in low-risk participants are both likely to be cost-effective at a willingness-to-pay threshold between €10,000 and €20,000 per additional person with prediabetes remission.
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Neither intensive lifestyle intervention nor conventional lifestyle intervention are cost-effective in terms of quality adjusted life years gained in the 12-month trial period; however, this was not unexpected, given the limited scope for short-term improvement in health-related quality of life in a largely asymptomatic population with high baseline utility values.
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Simulation modeling with a lifetime horizon thereby shows that intensive lifestyle intervention in high-risk participants and conventional lifestyle intervention in low-risk participants may be not only cost-effective but also cost-saving.
How might this impact on clinical practice in the foreseeable future?
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Individualized, risk phenotype-based lifestyle intervention in prediabetes may be cost-effective regarding remission to normal glucose regulation in the short- and regarding quality-adjusted life years gained the long-term.
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When evaluating lifestyle-based type 2 diabetes prevention, a long-term perspective is essential, as the intervention may translate into clinically meaningful and economically relevant benefits only over time through delayed diabetes onset, fewer diabetes-related complications, and reduced healthcare utilization.
