Long-Term Health Economic Evaluation of Intermittently Scanned Glucose Monitoring Compared with Self-Monitoring Blood Glucose in a Real-World Setting in Finnish Adult Individuals with Type 1 Diabetes.

Background and Aims: There has been an evolving trend in the use of intermittently scanned continuous glucose monitoring (isCGM) among individuals with type 1 diabetes. Although isCGM is proven to be beneficial in the treatment of individuals with type 1 diabetes, its use leads to increasing device costs. This study aimed to investigate the long-term cost-effectiveness of isCGM. Methods: Long-term clinical outcomes and costs were projected using the IQVIA Core Diabetes Model (v10.0) based on the observed real-world outcomes of isCGM. The clinical input data for the analysis were sourced from a real-world patient cohort from Eastern Finland, including 877 adult individuals with type 1 diabetes with isCGM (i.e., Freestyle Libre 1 and 2). At the baseline, the patients' mean age was 48 years, and the mean duration of diabetes was 25.8 years. The mean baseline HbA1c was 8.6%, and the mean 12-month change from baseline in HbA1c was -0.37% after the initiation of isCGM. The cost-effectiveness analysis was performed over a lifetime time horizon. A discount rate of 3% was used for the future costs and health outcomes. Results: The projected use of isCGM was associated with improved quality-adjusted life year (QALY) expectancy of 0.84 QALYs after the start of isCGM. The direct lifetime costs were 7861 EUR higher with the use of isCGM, which resulted in an incremental cost-effectiveness ratio of 9396 EUR per QALY gained. Conclusions: According to the present analysis, the use of isCGM is considered cost-effective in adult individuals with type 1 diabetes in a real-world setting in Finland.

A study on the quantity, type, economic value and reasons for pharmaceutical waste returned to pharmacies in Finland.

INTRODUCTION: Some medicines purchased are not used, resulting in pharmaceutical waste. Finland, among many other countries, is seeking to reduce the amount of pharmaceutical waste, but little information on this is currently available. This study aimed to evaluate the quantity, type, economic value, and reasons for returning pharmaceutical waste from households to community pharmacies in Finland. METHODS: Community pharmacies (n = 82) quantified and qualified the amount of pharmaceutical waste returned to them over three days in May 2022. The data was collected using an electronic form. The reasons for returning medicines were asked from customers who returned medicines using a paper questionnaire. The data was analyzed for frequencies and percentages. To estimate the economic value, we used the Finnish medicines prices at the end of June 2022. The annual economic value was calculated by means of a pharmacy size-weighted average. The confidence intervals were estimated using the non-parametric bootstrap method. Sensitivity analyses were conducted to examine the reliability of the results. RESULTS: In total, 5173 medicines were returned to pharmacies, of which 66 % were prescription medicines. The most common medicines group returned were medicines for nervous system (18 %), respiratory system (16 %), and alimentary tract and metabolism (12 %). The estimated annual economic value of the medicines returned was 81 million euros (CI 95 % M€61-M€103), of which the cost to society was 43 million euros (CI 95 % M€30-M€60). 799 customers responded to the questionnaire (Response rate 81.9 %). The limited shelf life of the medicine after opening (36 %), improvement of the medical condition or symptom (25 %), and the unnecessarily large pack size (22 %) were common reasons for returning. CONCLUSION: A considerable amount of pharmaceutical waste is returned to pharmacies, causing unnecessary costs to both individuals and society, indicating the need to reduce waste. The limited shelf life and large pack sizes of medicines account for a large proportion of causes for household pharmaceutical waste. Reducing pharmaceutical waste requires action from all actors in the pharmaceutical chain.

Modelling health and economic impact of nutrition interventions: a systematic review.

Diet related non-communicable diseases (NCDs), as well as micronutrient deficiencies, are of widespread and growing importance to public health. Authorities are developing programs to improve nutrient intakes via foods. To estimate the potential health and economic impact of these programs there is a wide variety of models. The aim of this review is to evaluate existing models to estimate the health and/or economic impact of nutrition interventions with a focus on reducing salt and sugar intake and increasing vitamin D, iron, and folate/folic acid intake. The protocol of this systematic review has been registered with the International Prospective Register of Systematic Reviews (PROSPERO: CRD42016050873). The final search was conducted on PubMed and Scopus electronic databases and search strings were developed for salt/sodium, sugar, vitamin D, iron, and folic acid intake. Predefined criteria related to scientific quality, applicability, and funding/interest were used to evaluate the publications. In total 122 publications were included for a critical appraisal: 45 for salt/sodium, 61 for sugar, 4 for vitamin D, 9 for folic acid, and 3 for iron. The complexity of modelling the health and economic impact of nutrition interventions is dependent on the purpose and data availability. Although most of the models have the potential to provide projections of future impact, the methodological challenges are considerable. There is a substantial need for more guidance and standardization for future modelling, to compare results of different studies and draw conclusions about the health and economic impact of nutrition interventions.

Economic evaluation of infliximab, synthetic triple therapy and methotrexate in the treatment of newly diagnosed juvenile idiopathic arthritis.

BACKGROUND: Evaluation of costs and short-term cost-effectiveness of infliximab plus methotrexate (IFX + MTX); triple therapy of hydroxychloquine, sulphasalazine, and methotrexate (TRIPLE); or methotrexate monotherapy (MTX) in patients with new-onset polyarticular juvenile idiopathic arthritis (JIA). METHODS: In a prospective multicenter study (ACUTE-JIA), costs and health outcomes of 60 randomized patients with new-onset disease-modifying anti-rheumatic drug (DMARD)-naïve polyarticular JIA were analyzed during the first year. A mapping algorithm was used to obtain utility values from Child Health Assessment Questionnaire (CHAQ). Wallace criteriae were used to assess clinically inactive disease (CID). Linear regression with non-parametric bootstrapping was used to adjust imbalances at baseline. RESULTS: Using prices for IFX biosimilar, adjusted annual mean (SD) costs of treatment (€) were 21,164 (4158), 12,136 (5286), and 18,300 (8635) on IFX + MTX, TRIPLE, and MTX, respectively. Incremental cost-effectiveness ratio (ICER) for IFX + MTX as compared with TRIPLE or MTX were 3442 € or 678 € per additional month spent in CID. Mean (SD) quality-adjusted life years (QALYs) for IFX + MTX, TRIPLE and MTX were 0.755 (0.065), 0.725 (0.062), and 0.686 (0.124). ICER for IFX + MTX vs TRIPLE was 294,433 €, and for IFX + MTX vs MTX 31,435 € per QALY gained. CONCLUSIONS: In short-term, biosimilar IFX + MTX can be considered cost-effective when compared with MTX alone. TRIPLE was cost-effective when compared with MTX and showed cost advantage when compared with IFX + MTX. Cost per time spent in CID showed similar results than ICER evaluations. TRIAL REGISTRATION: This trial was primarily registered with the Ethical Board of Helsinki District University Hospital ( https://www.hus.fi ), clinical trial number 211864, and later with ClinicalTrials.gov, number NCT01015547.

Economic evaluation of using polygenic risk score to guide risk screening and interventions for the prevention of type 2 diabetes in individuals with high overall baseline risk.

Type 2 diabetes (T2D) with increasing prevalence is a significant global public health challenge. Obesity, unhealthy diet, and low physical activity are one of the major determinants of the rise in T2D prevalence. In addition, family history and genetic risk of diabetes also play a role in the process of developing T2D. Therefore, solutions for the early identification of individuals at high risk for T2D for early targeted detection of T2D, prevention, and intervention are highly preferred. Recently, novel genomic-based polygenic risk scores (PRSs) have been suggested to improve the accuracy of risk prediction supporting the targeting of preventive interventions to those at highest risk for T2D. Therefore, the aim of the present study was to assess the cost-utility of an additional PRS testing information (as a part of overall risk assessment) followed by a lifestyle intervention and an additional medical therapy when estimated 10-year overall risk for T2D exceeded 20% among Finnish individuals screened as at the high-risk category (i.e., 10%-20% 10-year overall risk of T2D) based on traditional risk factors only. For a cost-utility analysis, an individual-level state-transition model with probabilistic sensitivity analysis was constructed. A 1-year cycle length and a lifetime time horizon were applied in the base-case. A 3% discount rate was used for costs and QALYs. Cost-effectiveness acceptability curve (CEAC) and estimates for the expected value of perfect information (EVPI) were calculated to assist decision makers. The use of the targeted PRS strategy reclassified 12.4 percentage points of individuals to be very high-risk individuals who would have been originally classified as high risk using the usual strategy only. Over a lifetime horizon, the targeted PRS was a dominant strategy (i.e., less costly, more effective). One-way and scenario sensitivity analyses showed that results remained dominant in almost all simulations. However, there is uncertainty, since the probability (EVPI) of cost-effectiveness at a WTP of 0€/QALY was 63.0% (243€) indicating the probability that the PRS strategy is a dominant option. In conclusion, the results demonstrated that the PRS provides moderate additional value in Finnish population in risk screening leading to potential cost savings and better quality of life when compared with the current screening methods for T2D risk.

Data-driven long-term glycaemic control trajectories and their associated health and economic outcomes in Finnish patients with incident type 2 diabetes.

BACKGROUND: Treatments should be customized to patients to improve patients' health outcomes and maximize the treatment benefits. We aimed to identify meaningful data-driven trajectories of incident type 2 diabetes patients with similarities in glycated haemoglobin (HbA1c) patterns since diagnosis and to examine their clinical and economic relevance. MATERIALS AND METHODS: A cohort of 1540 patients diagnosed in 2011-2012 was retrieved from electronic health records covering primary and specialized healthcare in the North Karelia region, Finland. EHRs data were compiled with medication purchase data. Average HbA1c levels, use of medications, and incidence of micro- and macrovascular complications and deaths were measured annually for seven years since T2D diagnosis. Trajectories were identified applying latent class growth models. Differences in 4-year cumulative healthcare costs with 95% confidence intervals (CIs) were estimated with non-parametric bootstrapping. RESULTS: Four distinct trajectories of HbA1c development during 7 years after T2D diagnosis were extracted: patients with "Stable, adequate" (66.1%), "Slowly deteriorating" (24.3%), and "Rapidly deteriorating" glycaemic control (6.2%) as well as "Late diagnosed" patients (3.4%). During the same period, 2.2 (95% CI 1.9-2.6) deaths per 100 person-years occurred in the "Stable, adequate" trajectory increasing to 3.2 (2.4-4.0) in the "Slowly deteriorating", 4.7 (3.1-6.9) in the "Rapidly deteriorating" and 5.2 (2.9-8.7) in the "Late diagnosed" trajectory. Similarly, 3.5 (95% CI 3.0-4.0) micro- and macrovascular complications per 100 person-years occurred in the "Stable, adequate" trajectory increasing to 5.1 (4.1-6.2) in the "Slowly deteriorating", 5.5 (3.6-8.1) in the "Rapidly deteriorating" and 7.3 (4.3-11.8) in the "Late diagnosed" trajectory. Patients in the "Stable, adequate" trajectory had lower accumulated 4-year medication costs than other patients. CONCLUSIONS: Data-driven patient trajectories have clinical and economic relevance and could be utilized as a step towards personalized medicine instead of the common "one-fits-for-all" treatment practices.

Hospital treatment costs associated with incident complications in patients with type 2 diabetes-real-world study based on electronic patient information systems.

BACKGROUND: Type 2 diabetes (T2D) and its complications cause a significant public health and economic challenge. To enable the optimal resource allocation across different prevention and treatment policies for the management of T2D-related complications, detailed cost estimates related to the complications of T2D are needed. Therefore, the objective of the study was to provide reliable and sufficiently detailed real-world estimates of costs associated with different T2D complications in a Finnish university hospital setting. METHODS: A cohort of T2D patients living in the catchment area of a university hospital during 2012 and 2016 was identified from the comprehensive national FinDM diabetes database for longitudinal assessment of T2D associated complication treatment costs. Data on patient-level events were extracted from the FinDM data and complemented with all accountable services and related detailed costing data gathered from the university hospital's electronic patient information systems by using unique personal identity codes. Patients were screened for their first diagnoses of complications using the same national quality registry definitions as in the FinDM database. Multivariable gamma regression model with a log link function was applied to study the association between baseline factors and complication costs. In addition, an interactive online tool was developed to create predicted costs for complication costs with selected baseline factors. RESULTS: A total of 27 255 prevalent and incident patients with T2D were identified from the national FinDM register. Finally, a total of 16 148 complication episodes for 7 895 patients were included in the cost analyses. The mean estimated one-year hospital treatment costs of T2D-related complication varied from 6 184 to 24 507 euros per complication. Regression analyses showed that coexisting conditions are significantly associated with initial and recurrent complication costs. CONCLUSIONS: The study shows updated Finnish cost estimates and their main cost drivers for T2D-related complications treated in the university hospital setting. The results of our study highlight the significance of guideline implementation, effective preventive treatments for T2D, as well as the importance of treatment adherence to avoid these costly complications.

Type 2 Diabetes-Related Health Economic Impact Associated with Increased Whole Grains Consumption among Adults in Finland.

The prevalence of type 2 diabetes (T2D) is increasing rapidly worldwide. A healthy diet supporting the control of energy intake and body weight has major importance in the prevention of T2D. For example, a high intake of whole grain foods (WGF) has been shown to be inversely associated with risk for T2D. The objective of the study was to estimate the expected health economic impacts of increased WGF consumption to decrease the incidence of T2D in the Finnish adult population. A health economic model utilizing data from multiple national databases and published scientific literature was constructed to estimate these population-level health economic consequences. Among the adult Finnish population, increased WGF consumption could reduce T2D-related costs between 286€ and 989€ million during the next 10-year time horizon depending on the applied scenario (i.e., a 10%-unit increase in a proportion of daily WGF users, an increased number (i.e., two or more) of WGF servings a day, or alternatively a combination of these scenarios). Over the next 20-30 years, a population-wide increase in WGF consumption could lead to much higher benefits. Furthermore, depending on the applied scenario, between 1323 and 154,094 quality-adjusted life years (QALYs) could be gained at the population level due to decreased T2D-related morbidity and mortality during the next 10 to 30 years. The results indicate that even when the current level of daily WGF consumption is already at a relatively high-level in a global context, increased WGF consumption could lead to important health gains and savings in the Finnish adult population.

Pharmacy-based screening to detect persons at elevated risk of type 2 diabetes: a cost-utility analysis.

BACKGROUND: Early identification of people at elevated risk of type 2 diabetes (T2D) is an important step in preventing or delaying its onset. Pharmacies can serve as a significant channel to reach these people. This study aimed to assess the potential health economic impact of screening and recruitment services in pharmacies in referring people to preventive interventions. METHODS: A decision analytic model was constructed to perform a cost-utility analysis of the expected national health economic consequences (in terms of costs and quality-adjusted life years, QALYs) of a hypothetical pharmacy-based service where people screened and recruited through pharmacies would participate in a digital lifestyle program. Cost-effectiveness was considered in terms of net monetary benefit (NMB). In addition, social return on investment (SROI) was calculated as the ratio of the intervention and recruitment costs and the net present value of expected savings. Payback time was the time taken to reach the break-even point in savings. In the base scenario, a 20-year time horizon was applied. Probabilistic and deterministic sensitivity analyses were applied to study robustness of the results. RESULTS: In the base scenario, the expected savings from the pharmacy-based screening and recruitment among the reached target cohort were 255.3 m€ (95% CI - 185.2 m€ to 717.2 m€) in pharmacy visiting population meaning 1412€ (95% CI - 1024€ to 3967€) expected savings per person. Additionally, 7032 QALYs (95% CI - 1344 to 16,143) were gained on the population level. The intervention had an NMB of 3358€ (95% CI - 1397€ to 8431€) using a cost-effectiveness threshold of 50,000 €/QALY. The initial costs were 122.2 m€ with an SROI of 2.09€ (95% CI - 1.52€ to 5.88€). The expected payback time was 10 and 8 years for women and men, respectively. Results were most sensitive for changes in effectiveness of the intervention and selected discount rate. CONCLUSIONS: T2D screening and recruitment to prevention programs conducted via pharmacies was a dominant option providing both cost savings and QALY gains. The highest savings can be potentially reached by targeting recruitment at men at elevated risk of T2D.

Cost-effectiveness of physical activity intervention in children - results based on the Physical Activity and Nutrition in Children (PANIC) study.

BACKGROUND: We assessed the cost-effectiveness of a 2-year physical activity (PA) intervention combining family-based PA counselling and after-school exercise clubs in primary-school children compared to no intervention from an extended service payer's perspective. METHODS: The participants included 506 children (245 girls, 261 boys) allocated to an intervention group (306 children, 60 %) and a control group (200 children, 40 %). The children and their parents in the intervention group had six PA counselling visits, and the children also had the opportunity to participate in after-school exercise clubs. The control group received verbal and written advice on health-improving PA at baseline. A change in total PA over two years was used as the outcome measure. Intervention costs included those related to the family-based PA counselling, the after-school exercise clubs, and the parents' taking time off to travel to and participate in the counselling. The cost-effectiveness analyses were performed using the intention-to-treat principle. The costs per increased PA hour (incremental cost-effectiveness ratio, ICER) were based on net monetary benefit (NMB) regression adjusted for baseline PA and background variables. The results are presented with NMB and cost-effectiveness acceptability curves. RESULTS: Over two years, total PA increased on average by 108 h in the intervention group (95 % confidence interval [CI] from 95 to 121, p < 0.001) and decreased by 65.5 h (95 % CI from 81.7 to 48.3, p < 0.001) in the control group, the difference being 173.7 h. the incremental effectiveness was 87 (173/2) hours. For two years, the intervention costs were €619 without parents' time use costs and €860 with these costs. The costs per increased PA hour were €6.21 without and €8.62 with these costs. The willingness to pay required for 95 % probability of cost-effectiveness was €14 and €19 with these costs. The sensitivity analyses revealed that the ICER without assuming this linear change in PA were €3.10 and €4.31. CONCLUSIONS: The PA intervention would be cost-effective compared to no intervention among children if the service payer's willingness-to-pay for a 1-hour increase in PA is €8.62 with parents' time costs. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01803776. Registered 4 March 2013 - Retrospectively registered, https://clinicaltrials.gov/ct2/results?cond=&term=01803776&cntry=&state=&city=&dist= .

Total cost of care increases significantly from early to mild Alzheimer's disease: 5-year ALSOVA follow-up.

INTRODUCTION: We studied the costs of formal and informal care in relation to Alzheimer's disease (AD) progression. METHODS: 231 persons with AD with a family caregiver were followed up for 5 years. The Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) was used to measure AD progression. Health and social care unit costs were used for formal care costs. An opportunity cost method for lost leisure time was applied to analyse the cost of informal care. RESULTS: Total cost of care in early stage AD (CDR-SB ≤ 4) was 16,448€ (95% CI 13,722-19,716) annually. In mild (CDR-SB 4.5-9), moderate (CDR-SB 9.5-15.5) and severe (CDR-SB ≥ 16) AD, the total costs were 2.3, 3.4 and 4.4 times higher, respectively. A one-unit increase in CDR-SB increased the total, formal and informal costs by 15, 11 and 18%, respectively. CONCLUSIONS: Compared to early AD, the costs of total, formal and informal care are remarkably higher already in mild AD. This finding emphasises early diagnosis, interventions and family support for persons with AD and their caregivers.

Impact of co-payment level increase of antidiabetic medications on glycaemic control: an interrupted time-series study among Finnish patients with type 2 diabetes.

BACKGROUND: A new special reimbursement scheme (SRS) for non-insulin medications used for treatment of hyperglycaemia in type 2 diabetes (T2D) was implemented in Finland on January 1, 2017. The new SRS affected all community-dwelling Finnish T2D patients as all community-dwelling residents are eligible for reimbursement for prescription medications. The aim of the study was to evaluate the impact of this co-payment increase on glycaemic control among Finnish T2D patients. METHODS: Data on glycaemic control were collected with HbA1c measures from electronic health records from primary health care and specialized care in the North Karelia region, Finland, from patients with a confirmed T2D diagnosis in 2012 who were alive on January 1, 2017 (n = 8436). Average HbA1c levels were measured monthly 36 months before and 33 months after the policy change. Consumption of diabetes medications was measured with defined daily doses (DDDs) based on reimbursed medication purchases. Interrupted time series design analysed with segmented regression model was applied to examine the effect of the policy change on average HbA1c levels. RESULTS: Eight thousand one hundred forty-three T2D patients had at least one HbA1c measurement within 01/2014-9/2019. Mean age of the patients was 68.1 (SD 11.3) years and 53.0% were women. Average time since T2D diagnosis was 11.5 (SD 6.1) years. An estimated increase of 0.81 (95% confidence interval, CI, 0.04-1.58) mmol/mol in average HbA1c levels was detected at the time of the policy change. In subgroup analyses, strongest effects were detected among patients who used only other diabetes medications than insulin or metformin in 2016 (3.56 mmol/mol, 95% CI 2.50-4.62). Meanwhile, yearly consumption of diabetes medications decreased slightly from 618.9 (SD 487.8) DDDs/patient in 2016 to 602.9 (SD 475.6) DDDs/patient in 2017 (p = 0.048). CONCLUSIONS: Simultaneously with the increase of the co-payment level, the average HbA1c level increased among T2D patients from the North Karelia region, Finland. This may be explained by the decreased consumption of diabetes medications between 2016 and 2017. Special attention should be allocated to glycaemic control of patients utilizing only other antidiabetic medications than metformin or insulin.

The effects of reimbursement reform of antidiabetic medicines from the patients' perspective - a survey among patients with type 2 diabetes in Finland.

BACKGROUND: In Finland, the reimbursement rate for antidiabetic medicines other than insulins was lowered from 100 to 65% at the beginning of 2017. The objective of this study was to examine the effects of this reform experienced by patients with type 2 diabetes. The objective was also to explore if socio-economic status affects this experience. METHODS: The data were collected by conducting a survey among Finnish adults with type 2 diabetes (n = 603). The baseline survey was conducted in November-December 2016. A second follow-up survey was conducted at the end of 2017 where the participants' experience of the reimbursement reform was surveyed with an open-ended question. Free-form inductive content analysis was used to categorize the answers. The association between the participants' characteristics and reporting an effect caused by the reimbursement reform was studied with binomial logistic regression. RESULTS: 285 (47.3%) participants reported an effect of some kind caused by the reimbursement reform. The most common reported effects were economic effects (32.7%) and annoyance (12.4%). Having financial difficulties in purchasing antidiabetic medicines (odds ratio (OR) 5.20, 95% confidence interval (Cl) 2.99-9.06) or not having annual deductible exceeded (OR 2.17, 95% CI 1.19-3.95), and use of certain antidiabetic medication groups at baseline were associated with reporting an effect. Socio-economic status was not associated with the likelihood of reporting an effect. CONCLUSIONS: Almost half of the participants with type 2 diabetes reported an effect, most commonly economic effects, such as increased expenditure or difficulty in purchasing medicines, after the reimbursement reform. It is important to study the effects of reimbursement reforms also from the patients' perspective.

Cost-effectiveness of secukinumab compared to other biologics in the treatment of ankylosing spondylitis in Finland.

AIM: This study assesses the cost-effectiveness of secukinumab vs currently licensed biologics for the treatment of ankylosing spondylitis (AS) from the Finnish health care system perspective. METHODS: A semi-Markov model compared secukinumab with adalimumab, adalimumab biosimilar, certolizumab pegol, etanercept, etanercept biosimilar, golimumab, and infliximab in a biologic-naïve population over a lifetime horizon. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was used to assess the treatment response. Efficacy inputs were obtained from the network meta-analysis, and other model inputs were obtained from the published literature and Finnish sources. Main study outcomes included quality-adjusted life years (QALYs) gained and incremental cost-effectiveness ratio in terms of cost per QALY gained. Robustness of results was confirmed by sensitivity analyses and alternative scenario analyses. RESULTS: Secukinumab achieved highest QALYs (13.1) at lowest expected lifetime cost (€279,872) vs other comparators in biologic-naïve AS patients in the base case analysis, thus it dominated other biologics. Golimumab had a second highest QALYs (12.9) at the total cost of €309,551. Results were sensitive to variation in BASDAI 50 response for secukinumab, baseline Bath Ankylosing Spondylitis Functional Index (BASFI) score across all drugs, change in BASDAI and BASFI scores, and discount rates as observed in the one-way sensitivity analyses. Secukinumab was either dominant or cost-effective treatment in different alternative scenarios. CONCLUSION: Secukinumab presented itself to be the dominant (ie, less costly and more effective) treatment vs other comparators for the biologic-naïve patients with AS in Finland.

Digitally supported program for type 2 diabetes risk identification and risk reduction in real-world setting: protocol for the StopDia model and randomized controlled trial.

BACKGROUND: The StopDia study is based on the convincing scientific evidence that type 2 diabetes (T2D) and its comorbidities can be prevented by a healthy lifestyle. The need for additional research is based on the fact that the attempts to translate scientific evidence into actions in the real-world health care have not led to permanent and cost-effective models to prevent T2D. The specific aims of the StopDia study following the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework are to 1) improve the Reach of individuals at increased risk, 2) evaluate the Effectiveness and cost-effectiveness of the digital lifestyle intervention and the digital and face-to-face group lifestyle intervention in comparison to routine care in a randomized controlled trial (RCT), and 3) evaluate the Adoption and Implementation of the StopDia model by the participants and the health care organizations at society level. Finally, we will address the Maintenance of the lifestyle changes at participant level and that of the program at organisatory level after the RCT. METHODS: The StopDia study is carried out in the primary health care system as part of the routine actions of three provinces in Finland, including Northern Savo, Southern Carelia, and Päijät-Häme. We estimate that one fifth of adults aged 18-70 years living in these areas are at increased risk of T2D. We recruit the participants using the StopDia Digital Screening Tool, including questions from the Finnish Diabetes Risk Score (FINDRISC). About 3000 individuals at increased risk of T2D (FINDRISC ≥12 or a history of gestational diabetes, impaired fasting glucose, or impaired glucose tolerance) participate in the one-year randomized controlled trial. We monitor lifestyle factors using the StopDia Digital Questionnaire and metabolism using laboratory tests performed as part of routine actions in the health care system. DISCUSSION: Sustainable and scalable models are needed to reach and identify individuals at increased risk of T2D and to deliver personalized and effective lifestyle interventions. With the StopDia study we aim to answer these challenges in a scientific project that is fully digitally integrated into the routine health care. TRIAL REGISTRATION: ClinicalTials.gov . Identifier: NCT03156478 . Date of registration 17.5.2017.

Costs of administration, travelling, and productivity losses associated with hospital administration of multiple myeloma drugs in Finland.

AIM: To estimate the drug administration, travelling, and productivity costs associated with infusion or subcutaneous proteasome inhibitor (PI) treatments (specifically carfilzomib and bortezomib) for multiple myeloma (MM) patients in Finland. MATERIALS AND METHODS: Price tariffs of Finnish hospital districts are used as the basis of invoicing sent to healthcare service payers. A review of these price tariff lists was conducted and obtained data analysed to estimate the mean unit cost of PI administration visit. Travelling costs stratified by areas with different population densities were assessed, based on the national travelling reimbursement register data maintained by the Social Insurance Institution of Finland. Productivity costs due to time spent on administration visits and travelling were estimated based on an expert interview and a spatial healthcare accessibility analysis. RESULTS: Nineteen (95%) of the Finnish hospital districts were included in the review. Relevant unit cost information was found for 15 (75%) of the districts. The mean PI administration cost alone was 270€ (95% CI = 189€-351€) per administration and increased to 371€ when travelling costs were included. Productivity costs added, the mean PI administration costs totalled 405€ for bortezomib and 437€ for carfilzomib. LIMITATIONS: The costing rationale of price tariffs may vary between hospital districts. Productivity costs were estimated conservatively, due to lack of data. CONCLUSIONS: The administration of intravenous or subcutaneous PIs to treat MM in healthcare facilities causes significant and potentially avoidable healthcare, travelling, and indirect costs, and they should be included in all health economic evaluations (HEEs). As the cost estimates utilized in this study represent most of central hospitals in the country, they provide useful information for future HEEs. A broader conclusion is that novel oral medications, such as the first oral PI, have a significant potential for reducing administration-related costs of subcutaneous or intravenous PIs.

Long-term medical costs of Alzheimer's disease: matched cohort analysis.

OBJECTIVES: Medical costs associated with Alzheimer's disease (AD) are characterised by uncertainty and are often presented in a format unsuitable for decision modelling. We set out to estimate long-term medical costs attributable to AD compared to the general population for use in decision modelling. METHODS: We used multiple logistic regressions to generate propensity scores to match 26,951 incident cases of AD with 26,951 people without AD, identified from Danish hospital and medication registries. Costs were available for up to 11 years for each individual, representing costs for 10 years before and 5 years after diagnosis. Generalised estimating equations were employed to investigate the effect of having AD on primary care, medication, hospital and total costs in the matched cohort. We also explored the impact of other socio-economic and demographic factors on healthcare costs. RESULTS: We report costs by year to diagnosis, from 10 years before to 5 after. AD was associated with significantly higher costs, driven by medication and hospital costs, especially around the time of diagnosis. Mean total medical cost was €4996 higher for AD than for the control group in year of diagnosis, after which primary and hospital costs decreased to pre-diagnostic levels. AD had higher attributable primary care costs in years preceding diagnosis. CONCLUSIONS: Reporting AD-attributable costs by year to diagnosis can be useful for use in decision modelling. Medical costs attributed to AD are driven by diagnostic procedures and medication, and the impact of AD on medical costs may not be as high or prolonged as previously suggested.

Cost-effectiveness analysis of secukinumab versus other biologics and apremilast in the treatment of active Psoriatic arthritis: a Finnish perspective.

OBJECTIVE: To study cost-effectiveness of an interleukin (IL)-17A inhibitor secukinumab, with other biologics and apremilast in patients with Psoriatic arthritis (PsA) from payer perspective in Finland. METHODS: In this semi-Markov model, subcutaneous (SC) secukinumab was compared with SC treatments etanercept and its biosimilar, certolizumab pegol, adalimumab and its biosimilar, golimumab, ustekinumab, intravenous (IV) treatment infliximab, as well as oral non-biologic apremilast. Patients without prior exposure (naïve) to biologics and without moderate to severe psoriasis were considered for secukinumab 150 mg group. Secukinumab 300 mg group included naïve patients with moderate to severe psoriasis and all patients with prior biologic exposure. The PsA Response Criteria (PsARC) at 12-week was primary criteria for treatment response. Other clinical as well as cost related model inputs were derived from relevant clinical trials as well as Finnish publications. The key model outcomes were quality-adjusted life years and incremental cost-effectiveness ratio. An annual 3% discount rate was applied to all future costs and benefits. Model input variations were assessed through sensitivity analyses and alternative scenario analyses. RESULTS: For a lifetime horizon (60 years), secukinumab 150 mg dominated all branded SC biologics and apremilast with highest QALY of 8.01 and lowest lifetime cost of €187,776, while it was cost-effective against IV infliximab among biologic-naïve patients without moderate to severe psoriasis. Secukinumab 300 mg was cost-effective against all branded SC biologics and apremilast and dominated IV infliximab among biologic-naïve patients with moderate to severe psoriasis, while it was cost-effective in biologic experienced patients. With the one-way sensitivity analysis, PsARC response, drug acquisition cost, and health assessment questionnaire score were the most important parameters affecting the outcomes. Across all treatment groups, patients on secukinumab were most likely to achieve highest net monetary benefit than other competitors in probabilistic sensitivity analysis. With alternative scenario analysis, results largely remained unchanged. CONCLUSIONS: Secukinumab is a cost-effective treatment for PsA patients from a Finnish payer's perspective.

Does routinely collected patient-reported outcome data represent the actual case-mix of elective coronary revascularization patients?

Aims: Patient-reported outcomes (PROs) are valuable for effectiveness evaluation, but it is unknown whether the patient views obtained represent the actual case mix. We studied the representativeness of the responses obtained to a routinely administered health-related quality of life (HRQoL) questionnaire in a cardiology unit. Methods and results: Elective coronary artery bypass grafting (CABG; n = 404) and percutaneous coronary intervention (PCI; n = 738) patients operated during June 2012 to August 2014 in the Heart Center, Kuopio University Hospital. The characteristics of the patients with a baseline (n = 260 and 290 for CABG and PCI, respectively) or both baseline and follow-up HRQoL measurements (n = 203 and 189 for CABG and PCI, respectively) were compared with those who did not respond (n = 144 and 448 for CABG and PCI). Baseline questionnaires were less likely obtained from older CABG patients (odds ratio 0.51, 95% confidence interval 0.28-0.91) and those with more severe disease (0.20, 0.05-0.79). Among PCI patients, women (0.64, 0.45-0.91), smokers (0.74, 0.53-1.04), and those with more severe disease (0.26, 0.13-0.52) or more hospital days were underrepresented. Conclusion: Routinely collected PROs in cardiac patients may be biased towards younger and healthier patients. This needs to be recognized when evaluating the representativeness of such data. The routine collection of these data should be adequately resourced.

Budget impact of intravenous iron therapy with ferric carboxymaltose in patients with chronic heart failure and iron deficiency in Germany.

AIMS: Treatment of iron deficiency (ID) in patients with heart failure (HF) with intravenous iron substitution [ferric carboxymaltose (FCM)] has previously shown significant improvements in exercise capacity, New York Heart Association (NYHA) functional class, quality of life, and reduction of hospitalization. The aim of this study was to estimate the budget impact of FCM treatment for patients with HF and ID. METHODS AND RESULTS: Individual patient data from four double-blind randomized controlled trials were pooled for this analysis. Expected outcomes were modelled for a treatment period of 1 year, using multivariate statistical methods. Associated unit costs were derived from claims data. Budget impact was calculated from the perspective of the Statutory Health Insurance. Multiple deterministic sensitivity analyses were performed. The annual budget impact for therapy with FCM vs. no-iron therapy was €2 735 505 and €2 695 474 for 1000 patients, respectively, resulting in additional annual costs of €40.03 for each treated patient. Main costs drivers are the FCM treatment cost and cost of hospitalizations due to HF worsening. FCM therapy compared with no-iron therapy resulted in reduced cost per 1000 patients: for reduced hospitalization due to HF worsening (52 vs. 129 hospitalizations amounting to €230 591 vs. €597 078), for reduced other medication (€1 611 007 vs. €1 679 908), fewer outpatient visits (€332 523 vs. €378 019), and home visits (€29 627 vs. €40 469). Sensitivity analyses showed robustness of the results. CONCLUSIONS: Therapy with FCM has a minimal budget impact of €40 031 per 1000 patients per year. This budget impact translates into reduced and shorter hospitalizations and improved symptomatic status of the patients.