Erenumab Decreases Headache-Related Sick Leave Days and Health Care Visits: A Retrospective Real-World Study in Working Patients with Migraine.

INTRODUCTION: The prevalence of migraine is highest among working age individuals, and this disease is associated with an increased number of sick leaves and health care visits, as well as lost productivity. Erenumab, the first monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) pathway, is effective in decreasing the monthly number of migraine days, but evidence of its impact on the number of sick leave days and health care visits in patients with migraine is limited. METHODS: This retrospective registry study focused on occupationally active patients with migraine treated with erenumab at a Finnish private health care provider, Terveystalo. Erenumab responders, defined as patients who had at least two unique prescriptions of erenumab and no prescription of other CGRP inhibitor (CGRPi), were followed for 12 months prior to and after erenumab treatment initiation (index), and the change in the number of headache-related and all-cause sick leave days, health care visits and prescriptions for other medications during this period were assessed from the registry data. The same outcomes were assessed in an age- and sex-matched control group of migraine patients not receiving CGRPi to control for potential changes in patient behavior and health care practices during the COVID-19 pandemic. RESULTS: Altogether, 162 patients who were entitled to employer-sponsored health care received erenumab and met the 12-month follow-up requirements. In the responder group (n = 82; 50.1%) headache-related sick leave days were reduced by 73.9% (p = 0.035) and health care visits by 44.6% (p < 0.001) in the 12 months following treatment initiation compared to the period of 12 months prior to treatment. All-cause sick leave days were reduced by 19.4% and all-cause health care visits by 13.5%, but these changes were not statistically significant. Triptan prescriptions decreased by 30.4% (p = 0.012) and other prophylactic treatments by 31.5% (p = 0.004). No significant changes were observed in the corresponding outcomes in the migraine control group during the same period. CONCLUSIONS: The results of this registry study suggest that in addition to the effect on the monthly number of migraine days documented in clinical trials, erenumab can significantly reduce the number of headache-related sick leave days and health care visits in employed patients with migraine managed in routine clinical practice.

Real-world clinical diagnostics of heart failure patients with reduced or preserved ejection fraction.

AIMS: The study aimed at investigating the use of guideline-recommended diagnostic tools and medication in patients with heart failure (HF) in specialty care in Southwest Finland. We also compared the characteristics of the diagnosed and undiagnosed patients as well as laboratory tests, procedures, and treatments in everyday clinical practice. METHODS AND RESULTS: Patients diagnosed with HF, cardiomyopathy, or hypertension-induced heart disease (n = 20 878, primary cohort) or not diagnosed with HF but having a record of elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) (>125 ng/L, n = 24 321, secondary cohort) were included in the study from the specialty care patient register of the Hospital District of Southwest Finland during the years 2005-2017. Among patients with an International Classification of Diseases, Tenth Revision (ICD-10) code for HF, only 50% had ejection fraction (EF) data to be found by data mining from the electronic health records. Of these patients, 39% (n = 4042) had EF ≤ 40% [HF with reduced EF (HFrEF)] and 61% (n = 6347) had EF > 40%. Elevated NT-proBNP together with EF > 40% narrowed down the number to 4590 patients, a population defined as HF with preserved EF (HFpEF) patients. HFpEF patients were further stratified into HF with mildly reduced EF (HFmrEF; EF 41-50%, n = 1468) and EF > 50% patients (n = 3122) to compare clinical characteristics. NT-proBNP was higher within the HFrEF patients vs. HFpEF {4580 [inter-quartile range (IQR): 2065-9765] vs. 2900 [2065-9765] ng/L, P < 0.001}. Baseline co-morbidities differed between HFpEF and HFrEF groups. Further, HFpEF patients had more procedures and lab tests taken prior to diagnosis than had HFrEF patients. HFmrEF patients were found to resemble more HFrEF than EF > 50% patients. In 70% (n = 17 156) of patients in the secondary cohort, the NT-proBNP concentrations were >300 ng/L, median was 1090 (IQR 551-2558) ng/L and EF 58.4 ± 12.1% (n with EF available = 6845). Reduced EF was present in 6.8% of patients lacking HF diagnosis. CONCLUSIONS: Half of the patients with ICD-10 code for HF did not have EF data available after a visit at specialty care. In particular, the diagnosis of HFpEF seems challenging, reflected as an increase in procedures and laboratory test preceding diagnosis compared with those in HFrEF patients. Also, a large proportion of patients did not have HF diagnosis, yet they presented elevated NT-proBNP concentrations and clinical characteristics resembling those of HFpEF patients.

Burden of migraine in Finland: multimorbidity and phenotypic disease networks in occupational healthcare.

BACKGROUND: Migraine is a complex neurological disorder with high co-existing morbidity burden. The aim of our study was to examine the overall morbidity and phenotypic diseasome for migraine among people of working age using real world data collected as a part of routine clinical practice. METHODS: Electronic medical records (EMR) of patients with migraine (n = 17,623) and age- and gender matched controls (n = 17,623) were included in this retrospective analysis. EMRs were assessed for the prevalence of ICD-10 codes, those with at least two significant phi correlations, and a prevalence >2.5% in migraine patients were included to phenotypic disease networks (PDN) for further analysis. An automatic subnetwork detection algorithm was applied in order to cluster the diagnoses within the PDNs. The diagnosis-wise connectivity based on the PDNs was compared between migraine patients and controls to assess differences in morbidity patterns. RESULTS: The mean number of diagnoses per patient was increased 1.7-fold in migraine compared to controls. Altogether 1337 different ICD-10 codes were detected in EMRs of migraine patients. Monodiagnosis was present in 1% and 13%, and the median number of diagnoses was 12 and 6 in migraine patients and controls. The number of significant phi-correlations was 2.3-fold increased, and cluster analysis showed more clusters in those with migraine vs. controls (9 vs. 6). For migraine, the PDN was larger and denser and exhibited one large cluster containing fatigue, respiratory, sympathetic nervous system, gastrointestinal, infection, mental and mood disorder diagnoses. Migraine patients were more likely affected by multiple conditions compared to controls, even if no notable differences in morbidity patterns were identified through connectivity measures. Frequencies of ICD-10 codes on a three character and block level were increased across the whole diagnostic spectrum in migraine. CONCLUSIONS: Migraine was associated with an increased multimorbidity, evidenced by multiple different approaches in the study. A systematic increase in the morbidity across the whole spectrum of ICD-10 coded diagnoses, and when interpreting PDNs, were detected in migraine patients. However, no specific diagnoses explained the morbidity. The results reflect clinical praxis, but also undoubtedly, the pathophysiological phenotypes related to migraine, and emphasize the importance of better understanding migraine-related morbidity.

Impact of multiple sclerosis phenotypes on burden of disease in Finland.

Aims: The aim of this study was to quantify how multiple sclerosis (MS) phenotypes differ from each other in respect of costs and quality-of-life.Materials and methods: The study is based on survey data from Finnish patients with MS (n = 553). The information contained disease type, disease severity according to self-reported Expanded Disease Severity Scale (EDSS), healthcare resource use, and medication use. In addition, information related to employment and early retirement was collected. EQ-5D-VAS and Multiple Sclerosis Impact Scale-29 (MSIS-29) instruments were used to collect quality-of-life data, and Fatigue Severity Scale (FSS) instrument for evaluating fatigue. Patients were stratified based on their disease type (relapsing-remitting MS (RRMS), secondary progressive MS (SPMS), primary progressive MS (PPMS)) and disease severity. The data were primarily analyzed using summary statistics.Results: SPMS had the highest annual total cost (71,177€) followed by PPMS (51,082€) and RRMS (36,492€). Early retirement covered the greatest share of costs in RRMS (39%) and SPMS (43%). In PPMS, early retirement and professional care were the two most equally important cost drivers, contributing together 56% of the total costs. Direct healthcare costs were responsible for 33%, 19%, and 18% of total costs in RRMS, SPMS, and PPMS. The mean EDSS in RRMS, SPMS, and PPMS were 2.5, 5.5, and 5.9, respectively. Differences in the quality-of-life were observed with both disease specific (MSIS-29) and generic (EQ-5D-VAS) instruments. The mean utility value from EQ-5D among patients with RRMS, SPMS, and PPMS was 0.76, 0.52, and 0.49, respectively. In addition, patients with SPMS and PPMS were more likely to report fatigue than patients with RRMS.Conclusions: MS phenotype has an impact on costs and quality-of-life of the patients. Early retirement seems to be one of the most important contributors to MS-related costs.

Sunitinib First-line Treatment in Metastatic Renal Cell Carcinoma: Costs and Effects.

BACKGROUND/AIM: Tyrosine kinase inhibitors are important in the treatment of metastatic renal cell cancer (mRCC). The aim of the study was to evaluate the costs and effects of sunitinib in mRCC. PATIENTS AND METHODS: A total of 81 mRCC patients who received first-line sunitinib therapy between 2010 and 2014 were recruited. Drug doses, laboratory and imaging studies, outpatient visits and inpatient stays were recorded. Health-related quality of life (HRQoL) was measured (15D- and EQ-5D - 3L questionnaires). RESULTS: The cost of sunitinib (mean 22,268 €/patient range 274 € to 105,121 €) covered 73% of the total costs during the treatment period. The total treatment cost was 30,530 €/patient (range=1,661-111,516 €). The median overall survival was 17.9 months. HRQoL decreased during treatment. CONCLUSION: The main cost during sunitinib treatment of mRCC was the drug itself (73% of the total costs). Drug costs and HRQoL should be considered when choosing treatment for mRCC.

Heart failure in Finland: clinical characteristics, mortality, and healthcare resource use.

AIMS: The aims of this study were to describe patient characteristics of the adult chronic heart failure (HF) population and to estimate the prevalence, incidence, healthcare resource utilization (HCRU), and mortality associated with HF in Southwest Finland. METHODS AND RESULTS: This was a retrospective biobank and clinical registry study. Adult patients with an HF diagnosis (International Statistical Classification of Diseases and Related Health Problems (ICD) code I50) during 2004-2013 in secondary care were included in the study and compared with age-matched and gender-matched control patients without an I50 diagnosis. HF patients were stratified in groups by left ventricular ejection fraction (LVEF) as follows: LVEF < 40% [HF with reduced ejection fraction (HFrEF)]; LVEF ≥ 40% [HF with preserved ejection fraction (HFpEF)]; or unknown (LVEF unknown). HCRU was stratified by inpatient, outpatient, and emergency room visits. In 2013, the incidence of HF was 3.2/1000, and the prevalence was 13.9/1000 inhabitants (n = 15 594). In the stratified analysis of HF patients (n = 8833, average ± SD age 77.1 ± 11.2), 1115 (12.6%) patients had HFrEF (female 31.3%), 1449 (16.4%) had HFpEF (female 50.9%), and 6269 (71%) had unknown LVEF (female 52.1%). The most common co-morbidities were essential hypertension (58%), chronic elevated serum creatinine (57.3%), atrial fibrillation and flutter (55.1%), and chronic ischaemic heart disease (46.4%). Patients with HF diagnosis had higher HCRU compared with that of age-matched and gender-matched controls (3.7 more days per year at the hospital for HF patients compared with the controls). The total 5 year mortality was 62.6% for HF patients and 28.3% for controls, with higher age being the strongest predictor of mortality. Moreover, multivariable Cox regression analysis showed that patients with HFrEF had a 13% (95% confidence interval 2.7-25%) increased risk of mortality compared with HFpEF patients. CONCLUSIONS: The high mortality rate and HCRU among the studied HF patients highlight the severity of the disease and the economic and social burden on both patients and society. This calls for improved methods of care for this large patient population.

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.

Burden of migraine in Finland: health care resource use, sick-leaves and comorbidities in occupational health care.

BACKGROUND: The highest prevalence of migraine is detected among people who are of working age. The aim of this study was to assess the burden of migraine in an occupational health care setting using real world data collected as a part of routine clinical practice. METHODS: This retrospective register study included migraineurs using occupational health care at the private health care provider Terveystalo. An age and gender matched control population was established for comparison. Electronic medical records were assessed for overall and migraine related health care visits, sick-leaves and comorbidities. Stratification to acute and prophylactic treatment groups along with prophylactic treatment lines was based on prescriptions. RESULTS: Among the 369,383 individuals in the study cohort, 7.4% women and 2.1% men were identified having a diagnosis of migraine. Prophylactic medication was prescribed to 13% of migraine patients and exclusively acute medication to 37%. Although migraine related visits and sick-leave days were significantly lower than overall visits or sick-leave days, both increased by prophylactic treatment line. The number of visits rose from 13.8 to 26.2 and sick-leave days from 16.8 to 30.4 per patient-year, in those without prophylaxis vs. ≥3 prophylactic treatments. Moreover, migraine patients had 1.7-fold increase in visits and 1.8-fold increase in sick leave days on average per patient-year, when compared to the control population. Depression and anxiety were 1.8-fold more common among patients with migraine, and the frequency also increase by treatment line. CONCLUSIONS: Migraine burden increased by each failed treatment line and was associated with increased comorbidity. In addition, migraine patients had significantly higher extent of visits and sick-leave days as well as extent of comorbidities when compared to their age- and gender-matched counterparts.

Budget impact analysis of secukinumab versus adalimumab in the treatment of ankylosing spondylitis.

BACKGROUND: Biologic treatments have enhanced the treatment outcomes of patients with active ankylosing spondylitis (AS). Until recently, TNF-alpha-inhibitors have been the only biologics approved for the treatment of active AS. The objective of this study was to assess the potential financial impact of the first non-TNF-alpha biologic secukinumab (fully human IL-17A-inhibitor) vs adalimumab (TNF-alpha-inhibitor) in the treatment of AS in Finland. MATERIALS AND METHODS: In this model-based budget impact analysis, patients were treated either with secukinumab (150 mg) or adalimumab (40 mg). The number of patients and market share of different biologics were based on national reimbursement registry data. Adalimumab was the most commonly used biologic treatment for AS, and in the base case analysis all adalimumab patients are assumed to switch to secukinumab. Response rates were based on a matching-adjusted indirect comparison between secukinumab and adalimumab. Patients not achieving response were switched to another biologic treatment. RESULTS: Treating AS patients with secukinumab instead of adalimumab leads to potential savings of 18.2 million euros within a 5-year time period. The total costs within the follow-up time were 59.5 million euros and 77.7 million euros with and without secukinumab, respectively. According to sensitivity analyses, a higher adoption rate of secukinumab corresponds to higher potential savings. CONCLUSIONS: Secukinumab is a cost-saving treatment option compared with adalimumab in the treatment of AS in Finland. More patients could be treated with a biologic by allocating resources more efficiently.

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.

[Novel drug therapies and their cost-effectiveness in the treatment of lung cancer]. / Uusien lääkehoitojen kustannusvaikuttavuus keuhkosyövän hoidossa.

The treatments of lung cancer have progressed significantly during the past ten years through the enhanced understanding of the underlying biological processes. Treatment outcomes have become better in the era of targeted treatments, but these new treatments are more expensive than their predecessors. Cost-effectiveness of the new treatments has been widely evaluated internationally. Nevertheless, the results from these analyses have been contradictory. Based on the published evaluations it is neither possible to rank the new treatments nor is it possible to unambiguously claim the cost-effectiveness of the new treatments compared with traditional treatments. National cost-effectiveness analyses of lung cancer treatments have not been published in Finland.

Budget impact analysis of warfarin reversal therapies among hip fracture patients in Finland.

BACKGROUND: Hip fractures require operation within 36-48 h, and they are most common in the elderly. A high International Normalized Ratio should be corrected before surgery. In the current study, we analyzed the budget impact of various warfarin reversal approaches. METHODS: Four reversal strategies were chosen for the budget impact analysis: the temporary withholding of warfarin, administration of vitamin K, fresh frozen plasma (FFP), and a four-factor prothrombin complex concentrate (PCC). RESULTS: We estimated that, annually, 410 hip fracture patients potentially require warfarin reversal in Finland. The least costly treatment was vitamin K, which accounted for €289,000 in direct healthcare costs, and the most costly treatment option was warfarin cessation, which accounted for €1,157,000. In the budget impact analysis, vitamin K, PCC and FFP would be cost-saving to healthcare compared with the current treatment mix. CONCLUSION: The various warfarin reversal strategies have different onset times, which may substantially impact the subsequent healthcare costs.

Hospital admissions, outpatient visits and healthcare costs of community-dwellers with Alzheimer's disease.

BACKGROUND: Detailed data on the health care service use of people with Alzheimer's disease (AD) are scarce. METHODS: We assessed the health care service use of all community-dwelling persons with clinically verified AD diagnosis, residing in Finland on December 31, 2005 (n = 27,948) in comparison to matched cohort without AD. Hospitalization data during 2006-2009 were extracted from the National Hospital Discharge Register. RESULTS: Comorbidity-adjusted incidence rate ratios; IRR (95% CI) were 1.25 (1.22-1.28) for inpatient admissions and 0.72 (0.68-0.77) for outpatient visits. People with AD had more general health care admissions (IRR, 95%CI 1.73, 1.67-1.80) but less admissions to specialty units 0.82 (0.79-0.85) than the non-AD group, with psychiatry being the only specialty with more admissions in the AD group. People with AD had 16 more hospital days/person-year. CONCLUSIONS: It would be important to assess whether inpatient hospitalizations of AD patients could be decreased by better targeting of outpatient services and whether other conditions are underdiagnosed or undertreated among persons with AD.

Cost-effectiveness of oral triptans for acute migraine: mixed treatment comparison.

BACKGROUND: The cost-effectiveness of triptans in the treatment of migraine has not been assessed since generic sumatriptan entered the Finnish market in 2008. METHODS: Using systematic review and mixed treatment comparison, the effectiveness of triptans was estimated with regard to 2-hour response, 2-hour pain-free, recurrence, and any adverse event, using published clinical data. Direct and indirect costs (2010 EUR, societal perspective) and quality-adjusted life-years (QALYs) were evaluated over one acute migraine attack using a decision-tree model. RESULTS: The meta-analysis combined data from fifty-six publications. The highest probability of achieving the primary outcome, "sustained pain-free, no adverse event" (SNAE), was estimated for eletriptan 40 mg (20.9 percent). Sumatriptan 100 mg was the treatment with lowest estimated costs (€20.86), and the incremental cost-effectiveness ratio of eletriptan 40 mg compared with sumatriptan 100 mg was €43.65 per SNAE gained (€19,659 per QALY gained). CONCLUSION: Depending on the decision-maker's willingness-to-pay threshold, either sumatriptan 100 mg or eletriptan 40 mg is likely to be cost-effective.

Sponsorship-related outcome selection bias in published economic studies of triptans: systematic review.

BACKGROUND: Economic studies funded by the pharmaceutical industry are more likely to report favorable results and recommendations for the sponsor's product than are studies funded by nonindustry establishments. PURPOSE: To determine whether clinical outcome data obtained from the same meta-analyses are used differently in various economic studies of oral triptans and whether there is an association between the study sponsorship and the choice of clinical outcome measure. DATA SOURCES: Economic studies of triptans were identified by updating a previously published systematic review. STUDY SELECTION: Twelve studies that used the same meta-analyses as the source of clinical outcome data were identified. DATA EXTRACTION: Two independent reviewers extracted the essential data from the identified studies. DATA SYNTHESIS: In the 12 appraised studies, 9 alternative measures of effectiveness were derived from the same meta-analyses. Eleven studies were industry-related, and in these the selected clinical outcome consistently favored the sponsor's product. Also the reported results suggested that the sponsor's product was more cost-effective than the competitors' products. LIMITATIONS: The cost-effectiveness of triptans is dependent on both the definition of clinical effectiveness and the treatment-related costs. Only bias related to the selection of the clinical outcome measure has been taken into account in this review. CONCLUSIONS: The results of published economic studies of triptans are conflicting and biased. There is a tendency to select clinical outcome measures that support the sponsor's product. This leads to concern about the possible poor applicability of these results in decision making.

Cost-effectiveness of sunitinib in metastatic renal cell carcinoma.

Sunitinib is one of the first targeted treatments for metastatic renal cell carcinoma (mRCC) and is currently considered as the standard of care for most of the mRCC patients in the first-line setting. The introduction of targeted treatments has, in the past few years, led to improvements in disease management and survival of these patients, however, with increasing cost. Cost-effectiveness of sunitinib has been assessed on several occasions and a systematic literature search was conducted to find all published research articles as well as all research abstracts presented in various congresses. This article presents an overview of the currently existing cost-effectiveness studies of sunitinib in mRCC, along with the main results and the utilized methodology. In most of the economic evaluations sunitinib has been deemed to be a cost-effective treatment option compared with other treatments.

[Indirect comparison and network meta-analyses--new tools for the assessment of evidence on the relative efficacy of drugs]. / Epäsuora vertailu ja verkostometa-analyysit --uudet työkalut lääkkeiden suhteellisen tehon ja vaikuttavuuden arviointiin.

Meta-analysis allows the quantitative combination of results of multiple studies that address similar research questions. Traditional meta-analysis of studies involving a direct comparison of two treatment alternatives can be applied to estimate the overall relative efficacy of these two treatment alternatives. All treatment options relevant to practical treatment decisions are, however, not always compared directly against each other in clinical studies, but indirect comparison via a common comparator may be possible. To use all relevant evidence from both direct and indirect comparisons of treatment options, advanced methods of meta-analysis have been developed. These so-called network meta-analyses extend the traditional meta-analysis to cases where a network of studies enables different pair-wise direct and indirect comparisons between multiple treatment alternatives, thereby forming a network of relevant evidence.

Short-course adjuvant trastuzumab therapy in early stage breast cancer in Finland: cost-effectiveness and value of information analysis based on the 5-year follow-up results of the FinHer Trial.

BACKGROUND: Trastuzumab is a standard treatment of HER2-positive early breast cancer in many countries, and it is usually given as a one year adjuvant treatment. However, its cost-effectiveness has not been assessed in Finland. The Finland Herceptin (FinHer) trial has compared a shorter 9-week treatment protocol against no trastuzumab with promising results. The aim of this study was to assess the potential cost-effectiveness of the 9-week treatment based on the recently published five-year follow-up results of the FinHer trial. METHODS: An evaluation model of breast cancer treatment was constructed using fitted survival estimates and a long-term Markov model. The cost-effectiveness of 9-week adjuvant treatment was assessed in a Finnish setting, compared to treatment without trastuzumab. The analysis was performed from a societal perspective, and a 3% discount rate was applied for future costs and outcomes. Value of information analysis was performed to estimate the potential value of further research. RESULTS: According to the probabilistic analysis, the incremental cost-effectiveness ratio was €12 000 per quality adjusted life year (QALY), and €9300 per life year gained (LYG), when comparing adjuvant trastuzumab therapy to standard treatment without trastuzumab. The modelled incremental outcomes for trastuzumab treatment were 0.66 QALY and 0.85 LYG for a lifetime perspective. Value of information analysis showed that additional research on treatment effects would be most valuable for reducing uncertainty in the adoption decision. CONCLUSIONS: Adjuvant 9-week trastuzumab is likely to be a cost-effective treatment in the Finnish setting. Results from an ongoing trial comparing adjuvant 9-week treatment with the 12-month treatment will play a key role in addressing the uncertainty related to the treatment effect and potential cost-effectiveness of these two treatment protocols.

Budget impact analysis of trastuzumab in early breast cancer: a hospital district perspective.

OBJECTIVES: Adjuvant trastuzumab is widely used in HER2-positive (HER2+) early breast cancer, and despite its cost-effectiveness, it causes substantial costs for health care. The purpose of the study was to develop a tool for estimating the budget impact of new cancer treatments. With this tool, we were able to estimate the budget impact of adjuvant trastuzumab, as well as the probability of staying within a given budget constraint. METHODS: The created model-based evaluation tool was used to explore the budget impact of trastuzumab in early breast cancer in a single Finnish hospital district with 250,000 inhabitants. The used model took into account the number of patients, HER2+ prevalence, length and cost of treatment, and the effectiveness of the therapy. Probabilistic sensitivity analysis and alternative case scenarios were performed to ensure the robustness of the results. RESULTS: Introduction of adjuvant trastuzumab caused substantial costs for a relatively small hospital district. In base-case analysis the 4-year net budget impact was 1.3 million euro. The trastuzumab acquisition costs were partially offset by the reduction in costs associated with the treatment of cancer recurrence and metastatic disease. CONCLUSIONS: Budget impact analyses provide important information about the overall economic impact of new treatments, and thus offer complementary information to cost-effectiveness analyses. Inclusion of treatment outcomes and probabilistic sensitivity analysis provides more realistic estimates of the net budget impact. The length of trastuzumab treatment has a strong effect on the budget impact.

Current and predicted cost of metastatic renal cell carcinoma in Finland.

UNLABELLED: Information on detailed treatment costs and the economic burden of renal cell carcinoma (RCC) is rare. The current study provides treatment costs and outcomes of patients with metastatic RCC (mRCC), as well as estimates of the future burden from the perspective of Finnish health care. These results offer a baseline against which the impact of emerging treatments may be evaluated. MATERIALS AND METHODS: Information on treatment modalities, survival, and the cost of treatment was retrospectively gathered from mRCC patients (n = 83) receiving first-line interferon-alpha (IFN). Predictions of the number of new cases, premature deaths, and productivity losses were made using local epidemiological data, which were projected to the future using population growth forecasts. The future costs of mRCC treatment and the budget impact of sunitinib were estimated through modeling. RESULTS: Patients survived 11.9 months (median; 95% CI 9.2-14.7) after initiation of active IFN treatment, accruing an average total treatment cost of 951 euros. Most of the treatment costs were due to hospitalization and active IFN treatment. The aging of the population leads to nearly a 2% increase in the absolute number of new diagnoses annually, while at the same time it results in declining productivity losses. The estimated five-year population cost of IFN-based treatment was 16M euros-26M euros. Adding sunitinib to the first-line treatment protocol increased this cost by 13M eruos-41M euros. CONCLUSIONS: Despite the limited number of patients, metastatic renal cell carcinoma places a considerable economic burden on Finnish society. Treatment costs are likely to increase substantially due to the adoption of new and more expensive medications, the aging population, and enhanced survival times.