Cost analysis of leuprorelin acetate in Japanese prostate cancer patients: comparison between 6-month and 3-month depot formulations

Aims: This study aimed to evaluate the economic value for leuprorelin acetate 6-month depot compared with leuprorelin acetate 3-month depot from a societal perspective in Japanese prostate cancer patients.

Methods: The cost analysis estimated the reduction in direct and indirect costs as well as intangible costs saved by having one less injection. Claims data were used for the analyses of direct and indirect costs reduction. A discrete choice experiment based on a web-based survey estimated the monetary value of the intangible costs for one injection. Another web-based survey of prostate cancer patients, who had received treatment with leuprorelin acetate injections, was carried out to calibrate the results of the discrete choice experiment.

Results: Reductions in medical costs and loss of productivity for having one less injection in prostate cancer patients receiving leuprorelin acetate were JPY 5,670 and JPY 1,723, respectively. Intangible costs saved by using a 6-month depot formulation instead of a 3-month depot formulation for the injection of leuprorelin acetate were estimated to be JPY 19,872, including the values for a reduction in pain (JPY 3,131), injection site reactions (JPY 11,545), waiting time (JPY 9,479), and subtracting the value of medical consultation (JPY 4,283). The total cost reduction for having one less injection was JPY 27,265.

Limitations: The respondents from the internet panel provided by a survey company are not necessarily a representative population of Japanese society.

Conclusions: Leuprorelin acetate 6-month depot has an advantage in monetary value in the reduction in medical costs, loss of productivity, and intangible costs for having one less injection in prostate cancer patients compared with leuprorelin acetate 3-month depot. In the costs for treating with leuprorelin acetate, the percentage of intangible costs might not be negligible. The intangible costs will probably be actively evaluated to proceed to patient-centered healthcare in society.     

Fingolimod reduces direct medical costs compared to natalizumab in patients with relapsing–remitting multiple sclerosis in The Netherlands

Abstract

Objective:

To assess the costs of oral treatment with Gilenya® (fingolimod) compared to intravenous infusion of Tysabri® (natalizumab) in patients with relapsing–remitting multiple sclerosis (RRMS) in The Netherlands.

Methods:

A cost-minimization analysis was used to compare both treatments. The following cost categories were distinguished: drug acquisition costs, administration costs, and monitoring costs. Costs were discounted at 4%, and incremental model results were presented over a 1, 2, 5, and 10 year time horizon. The robustness of the results was determined by means of a number of deterministic univariate sensitivity analyses. Additionally, a break-even analysis was carried out to determine at which natalizumab infusion costs a cost-neutral outcome would be obtained.

Results:

Comparing fingolimod to natalizumab, the model predicted discounted incremental costs of ?€2966 (95% CI: ?€4209; ?€1801), ?€6240 (95% CI: ?€8800; ?€3879), ?€15,328 (95% CI: ?€21,539; ?€9692), and ?€28,287 (95% CI: ?€39,661; ?€17,955) over a 1, 2, 5, and 10-year time horizon, respectively. These predictions were most sensitive to changes in the costs of natalizumab infusion. Changing these costs of €255 within a range from €165–364 per infusion resulted in cost savings varying from €4031 to €8923 after 2 years. The additional break-even analysis showed that infusion costs—including aseptic preparation of the natalizumab solution—needed to be as low as the respective costs of €94 and €80 to obtain a cost neutral result after 2 and 10 years.

Limitations:

Neither treatment discontinuation and subsequent re-initiation nor patient compliance were taken into account. As a consequence of the applied cost-minimization technique, only direct medical costs were included.

Conclusion:

The present analysis showed that treatment with fingolimod resulted in considerable cost savings compared to natalizumab: starting at €2966 in the first year, increasing to a total of €28,287 after 10 years per RRMS patient in the Netherlands.     

Cost analysis of leuprorelin acetate in Japanese pre-menopausal breast-cancer patients: comparison between 6-month and 3-month depot formulations

Aims: The aim in this study is to evaluate economic value for leuprorelin acetate 6-month depot compared with leuprorelin acetate 3-month depot in Japanese pre-menopausal breast cancer patients from a societal perspective.

Methods: The cost analysis was conducted by estimating direct and indirect cost, and intangible costs associated with one 6-month injection compared with two 3-month injections. Claims data were used for the analyses of direct and indirect cost and Medical Fee Schedule Table for direct cost. Discrete choice experiments were conducted by web-based survey to determine the intangible costs. Another web-based survey was also conducted on premenopausal breast cancer patients with injections of leuprorelin acetate, to calibrate the results of discrete choice experiments.

Results: The medical costs saved for having one less injection in pre-menopausal breast cancer patients with leuprorelin acetate injection were JPY 6,183. The productivity loss saving was JPY 1,419. An estimation of intangible costs saved for having one less injection of leuprorelin acetate was JPY 58,430, which included the disbenefit due to pain (JPY 8,535), injection site reactions (JPY 44,051), waiting time (JPY 9,595), and subtracting value in medical consultation (JPY 3,751). The total cost saved for having one less injection was JPY 66,032.

Limitations: The respondents from the internet panel provided by a survey company do not necessarily reflect a population of Japanese society.

Conclusions: Leuprorelin acetate 6-month depot demonstrates a higher value than leuprorelin acetate 3-month depot through saving medical costs and loss of productivity, as well as intangible costs saved for having one less injection when treating pre-menopausal breast cancer patients. In the costs for treating with leuprorelin acetate, the percentage of intangible costs might not be negligible. The intangible costs will probably be actively evaluated to proceed to patient-centered healthcare in society.     

Economic evaluation of anti-epileptic drug therapies with specific focus on teratogenic outcomes

Abstract

Background:

Anti-epileptic drugs are known to be teratogenic, yet many women do need to continue the anti-epileptic drug use during pregnancy.

Objectives:

To perform an economic evaluation of the anti-epileptic drug choice in young women who potentially wish to become pregnant. In particular, to estimate the impact of teratogenicity on the costs per quality adjusted life year (QALY).

Methods:

A decision-tree model is used to calculate the costs per QALY, taking into account the malformation risk in offspring due to the exposure to carbamazepine, lamotrigine or valproic acid, based on the European birth cohort of 2007. Probabilistic sensitivity analyses were performed using Monte Carlo simulation.

Results:

Valproic acid is dominated by carbamazepine after rank ordering on costs. The incremental cost-effectiveness of lamotrigine vs carbamazepine was estimated at €175,534 per QALY. Although valproic acid was dominated by carbamazepine in terms of costs and related effects, it is clinically relevant to compare lamotrigine with valproic acid. In particular, treatment options are dependent on several individual and clinical characteristics and these agents are therefore not always considered as interchangeable for all specified populations. The incremental cost-effectiveness for lamotrigine vs valproic acid was estimated at €13,370 per QALY. With assuming a willingness to pay threshold of €50,000 per QALY, results from the probabilistic analysis resulted in an acceptance level for lamotrigine vs carbamazepine and lamotrigine vs valproic acid of 4% and 99%, respectively.

Conclusion:

Based on epidemiological data it is advised to whenever possible avoid valproic acid during pregnancy. Both carbamazepine and lamotrigine are estimated to be cost-effective treatment options vs valproic acid if focused on teratogenicity.     

Economic evaluation of human urinary kallindinogenase for patients with acute ischemic stroke in China

Objectives: In China, both human urinary kallindinogenase (HUK) and 3-n-butylphthalide (NBP) are recommended for clinical use to improve cerebral blood circulation during an acute ischemic stroke (AIS). The objective was to evaluate the economic value of HUK vs NBP for patients with AIS from a Chinese payer’s perspective.

Methods: An economic evaluation based on data of patients who have been treated with either HUK (n?=?488) or NBP (n?=?885) from a prospective, phase IV, multi-center, clinical registry study (Chinese Acute Ischemic Stroke Treatment Outcome Registry, CASTOR) was conducted to analyze the cost and effectiveness of HUK vs NBP for AIS in China. Before the analysis, the patients were matched using propensity score. Both a cost-minimization analysis and a cost-effectiveness analysis were conducted to compare the matched pairs. A bootstrapping exercise was conducted for the matched arms to demonstrate the probability of one intervention being cost-effective over another for a given willingness-to-pay for an extra quality-adjusted life-year (QALY).

Results: After propensity score matching, 463 pairs were matched. The overall medical cost in the HUK arm is USD 2,701.20, while the NBP arm is USD 3,436.83, indicating HUK is preferred with cost-minimization analysis. Although the QALY gained in the HUK arm (0.77176) compared with the NBP arm (0.76831) is statistically insignificant (p?=?.4862), the cost-effectiveness analysis as exploratory analysis found that, compared with NBP, HUK is a cost-saving strategy with the lower costs of USD 735.63 and greater QALYs gained of 0.00345. Among the 5,000 bootstrapping replications, 100% indicates that HUK is cost-effective compared with NBP under a 1-time-GDP threshold; and 97.12% indicates the same under a 3-time-GDP threshold.

Conclusion: This economic evaluation study indicates that administrating HUK is a cost-saving therapy compared with NBP for managing blood flow during AIS in the Chinese setting.     

Cost effectiveness of posaconazole in the prophylaxis of invasive fungal infections in acute leukaemia patients for the French healthcare system

Abstract

Background:

Acute myeloblastic leukaemia (AML) patients are at high risk of suffering from invasive fungal infections (IFI). Posaconazole demonstrated higher efficacy than standard azole agents (SAA) in the prophylaxis of IFI in this population.

The authors estimated the cost effectiveness of posaconazole versus SAA in France.

Methods:

A decision-tree model was developed to compare posaconazole with SAA with the results of a published clinical trial. Clinical events were modelled with chance nodes reflecting probabilities of IFI, IFI-related death, and death from other causes. Medical resource consumption and costs were obtained from results of the clinical trial and from a dedicated survey on the costs of treating IFI using a retrospective chart review design.

Results:

IFI treatment costs were estimated using medical files from 50 AML patients from six French centres, with a proven and probable IFI, who had been followed-up for 298 days on average. Direct costs directly related to IFI were estimated at €51,033, including extra costs of index hospitalisation, costs of antifungal therapy and additional hospitalisations related to IFI treatment. The model indicated that the healthcare costs for the posaconazole strategy were €5,223 (€2,697 for prophylaxis and €2,526 for IFI management), which was €859 less than the €6,083 in costs with SAA (€469 for prophylaxis and €5614 for IFI management). A sensitivity analysis indicated that there was an 80% probability that prophylaxis using the posaconazole strategy would be superior.

Conclusion:

The findings from this analysis suggest that posaconazole use is a clinically and economically dominant strategy in the prophylaxis of IFI in AML patients, given the usual limits of economic models and the uncertainty of costs estimates.     

Cost-effectiveness of rivaroxaban versus warfarin for stroke prevention in non-valvular atrial fibrillation in the Japanese healthcare setting

Abstract

Aims: This article aimed to examine the cost-effectiveness of rivaroxaban in comparison to warfarin for stroke prevention in Japanese patients with non-valvular atrial fibrillation (NVAF), from a public healthcare payer’s perspective.

Materials and methods: Baseline event risks were obtained from the J-ROCKET AF trial and the treatment effect data were taken from a network meta-analysis. The other model inputs were extracted from the literature and official Japanese sources. The outcomes included the number of ischaemic strokes, myocardial infarctions, systemic embolisms and bleedings avoided, life-years, quality-adjusted life-years (QALYs), incremental costs and incremental cost-effectiveness ratio (ICER). The scenario analysis considered treatment effect data from the same network meta-analysis.

Results: In comparison with warfarin, rivaroxaban was estimated to avoid 0.284 ischaemic strokes per patient, to increase the number of QALYs by 0.535 per patient and to decrease the total costs by ¥118,892 (€1,011.11) per patient (1 JPY = 0.00850638 EUR; XE.com, 7 October 2019). Consequently, rivaroxaban treatment was found to be dominant compared to warfarin. In the scenario analysis, the ICER of rivaroxaban versus warfarin was ¥2,873,499 (€24,446.42) per QALY.

Limitations: The various sources of data used resulted in the heterogeneity of the cost-effectiveness analysis results. Although, rivaroxaban was cost-effective in the majority of cases.

Conclusion: Rivaroxaban is cost-effective against warfarin for stroke prevention in Japanese patients with NVAF, giving the payer WTP of 5,000,000 JPY.     

Systematic literature review of economics analysis on treatment of mild-to-moderate bleeds with aPCC versus rFVIIa

Abstract

Objective:

Two bypassing agents, activated prothrombin complex concentrates (aPCC) and recombinant factor VIIa (rFVIIa), have shown similar efficacy and safety in the treatment of bleeding episodes in patients with hemophilia and inhibitors as demonstrated through the only two head-to-head clinical trials. Given the economic burden of bypassing treatment, it is crucial to have a valid estimate of cost effectiveness of alternative treatments. The aims of this study were to conduct a systematic review of published pharmacoeconomic literature on the cost-effectiveness of aPCC versus rFVIIa to treat mild-to-moderate bleeds in patients with hemophilia and inhibitors, with a focus on the model assumptions and their impact on results.

Methods:

An English language search was conducted for original economic studies comparing aPCC and rFVIIa published between 1995 and July 2010. Detailed information on sponsorship, study design, assumptions and their impact on results was collected for each study.

Results:

A total of 11 economic studies were included in the review. Nine studies assessed cost per bleeding episode (eight cost-minimization analysis (CMA) and one cost-effectiveness analysis (CEA)). Two studies were from longitudinal perspective. Studies on cost per bleeding episode were evaluated and systematically compared. All studies were from a third-party payer perspective. Most analyses, except one study, used a similar decision-tree model. The assumptions for all CMA studies were obtained from non-comparable single-armed trials or observational data. All studies were sponsored by the two competing manufacturers of rFVIIa (seven studies) and aPCC (two studies). The crucial parameter assumptions on treatment efficacy and dosing drove their reported findings. Eight of these nine studies favored their sponsor’s product.

Conclusion:

With one exception, published economic studies tend to favor their sponsor’s product primarily by assuming a higher efficacy and lower dosing for the sponsored agent, even though the two existing head-to-head clinical studies do not support superior efficacy for either product.     

Economic evaluation of valsartan in patients with chronic heart failure: results from Val-HeFT adapted to The Netherlands

Summary

The Valsartan Heart Failure Trial (Val-HeFT) was a multinational randomised trial of valsartan versus placebo in a total of 5,010 patients with heart failure. During the study period, valsartan resulted in significant reductions in hospitalisations due to heart failure.

The objective of this study was to evaluate the economic impact of valsartan in Dutch heart failure patients.

Resource use during Val-HeFT was multiplied by Dutch cost estimates. Mean patient follow-up was 23 months and costs for hospitalisations were €617 lower among valsartan patients. Mean total costs for valsartan and placebo patients were €8,810 and €8,441, respectively, resulting in incremental costs of €368. In patients receiving an angiotensin-converting enzyme (ACE) inhibitor but no beta-blocker, these incremental costs were even lower (€171). There were overall net savings of €1,311 in patients not receiving an ACE inhibitor at baseline.

Valsartan provides clinical benefits at modest costs in The Netherlands. In patients not receiving an ACE inhibitor at baseline, valsartan was dominant.     

Cost-minimization analysis of fingolimod compared with natalizumab for the treatment of relapsing–remitting multiple sclerosis in Sweden

Abstract

Background:

Fingolimod and natalizumab have the same European Union licence for the treatment of relapsing multiple sclerosis, and are considered by the Committee for Medicinal Products for Human Use (CHMP) to have broadly similar efficacy.

Objective:

A cost-minimization analysis was performed to compare differences in treatment costs between fingolimod and natalizumab from a societal perspective in Sweden.

Methods:

This analysis included costs associated with initiating and following treatment (physician visits and monitoring), continuing therapy (drugs and administration), and lost patient productivity and leisure time. Unit costs (in Swedish krona [SEK]) were based on regional data (median prices for physician visits and monitoring sessions). Natalizumab infusion costs were obtained from the national cost-per-patient database. Drug costs for both therapies were 15,651 SEK/28 days.

Results:

After 3 years, fingolimod use was associated with savings of 124,823?SEK/patient compared with natalizumab (total cost/patient: 566,718 SEK vs 691,542 SEK). Cost savings with fingolimod were 40,402 SEK/patient after 1 year and 301,730 SEK/patient after 10 years. Treatment with natalizumab was 18% more expensive than fingolimod therapy after 1 year and 23% more expensive after 10 years.

Limitations:

Based on the CHMP assessment, it was assumed that fingolimod and natalizumab have similar efficacy. The analysis was conducted for Sweden, and caution is needed in extrapolating the results to other countries.

Conclusion:

Fingolimod is cost-saving compared with natalizumab for the treatment of relapsing–remitting multiple sclerosis in Sweden.     

The association between smoking cessation outpatient visits and total medical costs: a retrospective,observational analysis of Japanese employee-based public health insurance data

Aims: The short-term effects of smoking cessation (SC) on overall healthcare costs are unclear. This study aimed to compare the short-term medical costs between patients with SC outpatient visits (SCOVs) and those without SCOVs, consisting of SCOV itself and overall medical costs.

Materials and methods: This study is a retrospective, observational study using a Japanese employee-based health insurance claims database (January 1, 2005–December 31, 2013). It analyzed individuals who were registered as smokers based on their medical checkup details. It compared the per-patient-per-year (PPPY) medical costs for male smokers who made ≥1 claim for SCOVs with those who made no claims. We also assessed whether the number of SCOVs by male and female smokers impacted medical costs. The Index Year was the year after the first SCOV claim and that after the first registration as a smoker (non-SCOV group). Medical costs were calculated using regression analysis and adjusted for baseline costs.

Results: In Index Year ?1, PPPY medical costs for male smokers were ～USD 323.01 (JPY 36,500, as of November 2017) higher in the SCOV (n?=?5,608) vs the non-SCOV (n?=?81,721) group; however, by Year 6 the costs were similar. From Year 4–6, PPPY medical costs for SCOVs were lower than those in the adjusted non-SCOV group. For 2,576 male and female smokers in the SCOV group, the average rates of increasing medical costs before and after the SCOV for 1, 2, 3, 4, and 5 SCOVs made were 58%, 44%, 50%, 41%, and 34%, respectively.

Limitations: The database includes limited data on individuals >65 years. Only SCOVs based on claims data and not on other outcomes were assessed.

Conclusions: Medical costs declined in the short-term following the first SCOV. Attendance at a greater number of SCOVs was associated with a lower increase ratio of medical costs.     

Estimating the quality-of-life impact and cost-effectiveness of alpha-blocker and anti-muscarinic combination treatment in men with lower urinary tract symptoms related to benign prostatic hyperplasia and overactive bladder

Abstract

Objective:

A 12-week clinical trial (TIMES) demonstrated that therapy with tolterodine extended release (TOL)?+?tamsulosin (TAM) provides clinical benefits vs TOL or TAM monotherapy or placebo (PBO) in men with lower urinary tract symptoms (LUTS) including overactive bladder (OAB). The present analysis estimated the costs and quality-adjusted life-years (QALYs) associated with these therapies from the perspective of the UK healthcare system.

Methods:

TIMES cohorts receiving TOL, TAM, TOL?+?TAM, or PBO were followed from therapy initiation to 12 weeks. A decision-tree model was used to extrapolate the 12-week results to 1 year (including need for surgery owing to treatment failure at 12 weeks) and to track patients’ outcomes (symptoms, utility, and costs). Because TIMES did not include costs and QALYs, data from the EpiLUTS epidemiologic survey (12,796 males) were used to model a mathematical relationship between LUTS (daytime and nocturnal frequency, urgency episodes, urgency urinary incontinence episodes, and International Prostate Symptom Score [IPSS]), quality-of-life, and utility. This was used to convert improvements in TIMES patients’ LUTS into utility scores and QALYs. The model included drug and surgery procedure costs and hospital length of stay.

Results:

Incremental QALYs of TOL?+?TAM vs PBO, TAM, and TOL were 0.042, 0.021, and 0.013, and corresponding incremental costs were £189, £223, and ?£70, respectively, resulting in cost-utility ratios for TOL?+?TAM of £4508/QALY gained compared with PBO and £10,381/QALY gained compared with TAM. TOL?+?TAM combination therapy was both more effective and cost-saving compared with TOL. Univariate sensitivity analyses showed that patient utility was most responsive to changes in drug efficacy on IPSS and urgency episodes. Changing the percentage of patients undergoing surgery did not substantially affect model outcomes. The main limitation of the study was that the relation between LUTS and patient utility was based on an indirect association.

Conclusions:

TOL?+?TAM combination therapy appears to be cost-effective compared with TOL or TAM monotherapy or PBO in male patients with LUTS.     

Cost effectiveness of rosuvastatin in patients at risk of cardiovascular disease based on findings from the JUPITER trial

Abstract

Objective:

This study assessed the long-term cost effectiveness of rosuvastatin therapy compared with placebo in reducing the incidence of major cardiovascular (CVD) events and mortality.

Methods:

A probabilistic Monte Carlo simulation model estimated long-term cost effectiveness of rosuvastatin therapy (20?mg daily) for the prevention of CVD mortality and morbidity. The model included three stages: (1) CVD prevention simulating the 4 years of the JUPITER trial, (2) initial CVD prevention beyond the trial, and (3) subsequent CVD event prevention. A US payer perspective was assessed reflecting direct medical costs, and up to a lifetime horizon. Sensitivity analyses tested the robustness of the model estimates.

Results:

For a hypothetical cohort of 100,000 patients at moderate and high risk of CVD events based on Framingham risk of ≥10%, estimated quality-adjusted life-years (QALYs) gained with rosuvastatin therapy compared with placebo was 33,480 over a lifetime horizon, and 25,380 and 9916 over 20-year and 10-year horizons, respectively. Approximately 12,073 events were avoided over the lifetime; 6,146 non-fatal MIs, 2905 non-fatal strokes, and 4030 CVD deaths avoided. Estimated incremental cost-effectiveness ratio (ICER) for cost per QALY was $7062 (lifetime), $10,743 (20-year horizon), and $44,466 (10-year horizon). For a hypothetical cohort similar to the overall JUPITER population, the cost per QALY ICER was $11,025 for the lifetime and $60,112 for a 10-year horizon.

Limitations:

The cost-effectiveness comparison of rosuvastatin 20?mg was against no active treatment (as opposed to an alternative statin) due to lack of comparative cardiovascular morbidity and mortality risk reduction data for other statins in a population similar to the JUPITER trial population. The analysis was conducted from the payer perspective and lack of inclusion of indirect costs limit interpretability of results from a societal perspective.

Conclusions:

Treatment with rosuvastatin 20?mg daily, is a cost-effective treatment alternative to no treatment in patients at a higher risk (Framingham risk ≥10%) of CVD.     

Economic evaluation of linaclotide for the treatment of adult patients with irritable bowel syndrome with constipation in the United States

Abstract

Objectives:

To use techniques of decision-analytic modeling to evaluate the effectiveness and costs of linaclotide vs lubiprostone in the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C).

Methods:

Using model inputs derived from published literature, linaclotide Phase III trial data and a physician survey, a decision-tree model was constructed. Response to therapy was defined as (1) a ≥14-point increase from baseline in IBS-Quality-of-Life (IBS-QoL) questionnaire overall score at week 12 or (2) one of the top two responses (moderately/significantly relieved) on a 7-point IBS symptom relief question in ≥2 of 3 months. Patients who do not respond to therapy are assumed to fail therapy and accrue costs associated with a treatment failure. Model time horizon is aligned with clinical trial duration of 12 weeks. Model outputs include number of responders, quality-adjusted life-years (QALYs), and total costs (including direct and indirect). Both one-way and probabilistic sensitivity analyses were conducted.

Results:

Treatment for IBS-C with linaclotide produced more responders than lubiprostone for both response definitions (19.3% vs 13.0% and 61.8% vs 57.2% for IBS-QoL and symptom relief, respectively), lower per-patient costs ($803 vs $911 and $977 vs $1056), and higher QALYs (0.1921 vs 0.1917 and 0.1909 vs 0.1894) over the 12-week time horizon. Results were similar for most one-way sensitivity analyses. In probabilistic sensitivity analyses, the majority of simulations resulted in linaclotide having higher treatment response rates and lower per-patient costs.

Limitations:

There are no available head-to-head trials that compare linaclotide with lubiprostone; therefore, placebo-adjusted estimates of relative efficacy were derived for model inputs. The time horizon for this model is relatively short, as it was limited to the duration of available clinical trial data.

Conclusions:

Linaclotide was found to be a less costly option vs lubiprostone for the treatment of adult patients with IBS-C.     

Budget impact analysis of long acting injection for schizophrenia in Japan

Abstract

Aims: To estimate the budgetary impact of providing additional reimbursement for long acting injections for schizophrenia patients in psychiatric hospital settings in Japan to improve patient outcomes in schizophrenia.

Methods: Budget impact analysis of change in reimbursement policy using a prevalence-based model over a five-year time horizon. The results are reported as net change in expenditure and consequent cost/savings in Japanese yen at the time of analysis.

Results: The budget impact analysis shows that an increase in reimbursement for LAIs could lead to cumulative savings of an estimated 36.6 billion JPY over five years. These savings result from a decrease in hospitalization costs and an increased usage of LAI (assumed to be 10%). Based on the sensitivity analysis, the saving estimates are most sensitive to change in market share of generic and branded oral antipsychotics.

Limitations: Historical data were used to estimate the future costs of drug and hospitalization; however, it is not the best predictor of future, hence a source of potential bias. A good level of treatment adherence with oral antipsychotics was assumed, which is generally not the case; therefore, we might have overestimated the effectiveness of oral atypical antipsychotics. Additionally, the drug cost due to reimbursement might have also been overestimated because in clinical setting, the increase of LAI use may not have reached 10% of the market share. Lastly, patients’ behavior was derived from models, which may have loosely approximated the reality.

Conclusions: An additional reimbursement for the use of LAI in schizophrenia patients is likely to be cost neutral/cost saving and should be considered as a policy option to improve patient outcomes and budget sustainability.     

Differences in episode-based care costs for multidetector computed tomographic coronary angiography versus myocardial perfusion imaging for the diagnosis of coronary artery disease

Abstract

Background: Multidetector computed tomography (MDCT) is a novel method for diagnosis and prognosis of coronary artery disease (CAD). The opportunity costs that favour MDCT over other CAD diagnostic methods is currently unknown.

Methods: This study used an episodes of care cost model based on epidemiologic and economic data evaluating individuals without known CAD undergoing MDCT or myocardial perfusion scintigraphy (MPS). It was a multicenter retrospective database review of medical and pharmacy-related claims linked by episodes of care from 2002 to 2005. CAD-related episodes of care costs were examined 1-year downstream for patients after initial MDCT that were matched to patients who underwent MPS.

Results: After adjustment for patient factors, 1-year total CAD-related episodes of care costs for MDCT were 16.4% lower than MPS, by an average of $682 (95% confidence interval $14, $1,350) per patient. While costs per CAD-related episode were similar between MDCT and MPS groups ($4,284 vs. $4,277, p=0.08).

Conclusions: Patients without known CAD who undergo MDCT as an initial diagnostic test, compared to MPS, incurred fewer CAD-related episodes of care and lower overall CAD-related costs.     

Economic evaluation of dabigatran etexilate for the primary prevention of venous tromboembolic events following major orthopedic surgery in the Netherlands

Abstract

Objectives:

Dabigatran etexilate is a new oral direct thrombin inhibitor for prophylaxis of venous thromboembolism (VTE) in patients who have elective surgery for total hip replacement (THR) or total knee replacement (TKR). Among the advantages of dabigatran etexilate over subcutaneous prophylaxis with Low Molecular Weight Heparin (LMWH) are reduced resource uses for (i) teaching patients to self-inject; (ii) home-care visits for subcutaneous administration; and (iii) absence of heparin-induced thrombocytopenia (HIT). Based on the demonstrated non-inferiority, the aim of this study was to conduct a cost-minimization analysis of oral dabigatran etexilate vs subcutaneous low-molecular weight heparin (LMWH) and fondaparinux from the Dutch healthcare perspective.

Methods:

A retrospective cohort study was conducted to measure resource use associated with subcutaneous prophylaxis. Results of this study were used in the model to elucidate specific advantages of dabigatran etexilate, next to reduced needs for self-inject teaching and lack of Heparin-Induced Thrombocytopenia. Drug and other resource utilization data were combined with local unit costs. Probabilistic sensitivity analysis was performed to account for uncertainty around relevant parameters included.

Results:

Home-care visits for subcutaneous administration problems were needed in 9.9% (95% CI?=?6.4–13.4) and 9.6% (95% CI?=?5.8–13.4) of THR and TKR patients, respectively. Based on costs for 1000 patients treated with dabigatran etexilate vs LMWHs, per patient cost-savings with dabigatran etexilate were estimated at €30.68 (95% CI?=?2.01–65.52) and €23.19 (95% CI?=?0.69–48.48) for THR and TKR, respectively. The probability that dabigatran etexilate would be cost-saving was estimated at 98.3% and 97.9% for THR and TKR, respectively. These cost-savings were even higher when including fondaparinux in the analysis, with per patient cost-savings of €69.87 (43.42–106.10) and €18.33 (1.63–41.26) for THR and TKR, respectively. Separate calculations for dabigatran etexilate vs nadroparin and dalteparin in THR resulted in probabilities of achieving cost-savings with dabigatran etexilate of 36.2% and 100%, respectively. For TKR these probabilities were estimated at 54.3% and 100%, respectively.

Conclusions:

Thromboprophylaxis with dabigatran etexilate is cost-saving in patients undergoing THR and TKR from the Dutch healthcare perspective, compared to subcutaneous LMWHs.     

The cost implications of an early versus delayed invasive strategy in acute coronary syndromes: the TIMACS study

Background:

The Timing of Intervention in Acute Coronary Syndromes (TIMACS) trial demonstrated that early invasive intervention (within 24 hours) was similar to a delayed approach (after 36 hours) overall but improved outcomes were seen in patients at high risk. However, the cost implications of an early versus delayed invasive strategy are unknown.

Methods and results:

A third-party perspective of direct cost was chosen and United States Medicare costs were calculated using average diagnosis related grouping (DRG) units. Direct medical costs included those of the index hospitalization (including clinical, procedural and hospital stay costs) as well as major adverse cardiac events during 6 months of follow-up. Sensitivity and sub-group analyses were performed. The average total cost per patient in the early intervention group was lower compared with the delayed intervention group (?$1170; 95% CI ?$2542 to $202). From the bootstrap analysis (5000 replications), the early invasive approach was associated with both lower costs and better clinical outcomes regarding death/myocardial infarction (MI)/stroke in 95.1% of the cases (dominant strategy). In high-risk patients (GRACE score ≥141), the net reduction in cost was greatest (?$3720; 95% CI ?$6270 to ?$1170). Bootstrap analysis revealed 99.8% of cases were associated with both lower costs and better clinical outcomes (death/MI/stroke).

Limitations:

We were unable to evaluate the effect of community care and investigations without hospitalization (office visits, non-invasive testing, etc). Medication costs were not captured. Indirect costs such as loss of productivity and family care were not included.

Conclusions:

An early invasive management strategy is as effective as a delayed approach and is likely to be less costly in most patients with acute coronary syndromes.     

Health services research in heart failure patients treated with a remote monitoring device in Germany—a retrospective database analysis in evaluating resource use

Abstract

Objectives:

Heart failure is an increasing burden for all healthcare systems with prevalence reaching over 20 million patients worldwide and direct costs of disease requiring ～1% of healthcare budget expenditures. Beyond traditional pharmaceutical treatment, medical devices and remote monitoring tools were introduced to ensure a closely managed control of patients. In this context, a decision-maker needs to know whether the new technology provides clinical benefit towards patients and what resource use is attached to them.

Methods:

Health services research is a complementary approach to clinical trials providing results to the impact of the technology in real life settings. As an example this study reports of a secondary data analysis of one of the largest health insurance companies in Germany, comparing resource use of heart failure patients receiving a cardiac resynchronization therapy (CRT) device coupled with a fluid status monitoring and alert function with patients receiving conventional CRT, ICD (implantable cardioverter defibrillator), or no intervention.

Results:

Disease-associated expenses can be attributed to far more than 50% to heart failure. Although implementation of the CRT device with alert function was most expensive (31,794 Euros compared to 27,659 Euros in the conventional CRT group, 24,128 Euros in the ICD group, and 3735 Euros in the no intervention group) in the first year after implementation, the least costs have been caused in this group (7000 Euros compared to more than 11,000 Euros in all other groups).

Conclusion:

This article highlights potential health services research approaches focusing on the example of a CRT device coupled with a pulmonary diagnostic and alert function. Although this retrospective analysis holds a number of limitations (e.g., small number of patients in intervention group, cost calculations only from the payer perspective), and despite the need for randomized controlled trials, it was shown that secondary data research in this field is a valuable approach.