Cost-Effectiveness Analysis of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin Regimen for Patients Infected With Chronic Hepatitis C Virus Genotype 1 in Malaysia.

OBJECTIVES: The combination of pegylated-interferon and ribavirin (PegIFN+RBV) is currently the gold standard in treating chronic hepatitis C virus (HCV) patients in Malaysia and is reimbursed by the Malaysian authorities. This analysis evaluated the cost-effectiveness (CE) of the ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin (OBT/PTV/r+DSB±RBV) regimen as compared with the PegIFN+RBV or no treatment in chronic HCV Genotype 1 (GT1) treatment-naïve and treatment-experienced cirrhotic and noncirrhotic patients in Malaysia. METHODS: A Markov model based on previously published CE models of HCV was adapted for the Malaysian public healthcare payer perspective, based on good modeling practices. Treatment attributes included efficacy, regimen duration, and EQ-5D treatment-related health utility. Transitional probabilities and health state health utilities were derived from previous studies. Costs were derived from Malaysian data sources. Costs and outcomes were discounted at 3.0% per year. Deterministic and probabilistic sensitivity analyses were performed to evaluate the impact of uncertainties around key variables. RESULTS: Based on the analysis, patients treated with the OBT/PTV/r+DSB±RBV showed less frequent progression to compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, and liver-related deaths when compared with standard care (ie, PegIFN+RBV or no treatment). At a price of MYR 1846/day, the OBT/PTV/r+DSB±RBV regimen is cost-effective over PegIFN+RBV and yields better outcomes in terms of life-years (LYs) gained and quality-adjusted life-years (QALYs) at a higher cost, which is still well below the implied willingness to pay threshold of MYR 384 503/QALY. CONCLUSION: The OBT/PTV/r+DSB±RBV regimen is cost-effective for treatment naïve, treatment experienced, cirrhotic, and noncirrhotic GT1 chronic HCV patients in Malaysia.

Comparative effectiveness of budesonide inhalation suspension and montelukast in children with mild asthma in Korea.

Objective: The comparative effectiveness of low-dose budesonide inhalation suspension (BIS) versus oral montelukast (MON) in managing asthma control among children with mild asthma was assessed in Korea.Methods: Claims from Korea's national health insurance database for children (2-17 years) with mild asthma (GINA 1 or 2) who initiated BIS or MON during 2015 were retrospectively analyzed. Pre- and post-index windows were 1 year each. Adherence, persistency, asthma control, asthma-related health-care resource utilization, and costs were evaluated using unadjusted descriptive statistics and propensity score-matched regression analyses.Results: The number of children identified was 26,052 for unmatched (n = 1,221 BIS; n = 24,831 MON) and 2,290 for matched populations (n = 1,145 per cohort). Medication adherence, measured by proportion of days covered, was low for both cohorts but significantly higher for MON versus BIS (13.8% vs. 4.5%; p < .001). Time to loss of persistency was longer for MON versus BIS (82.3 vs. 78.4 days, respectively; p < .001). Mean number of post-index asthma-related office visits was 6.6 for BIS versus 8.3 for MON (p < .001). However, a greater proportion of patients in the BIS cohort had an asthma exacerbation-related office visit than the MON cohort (78.3% vs. 56.1%; p < .001). Asthma-related total health-care costs were higher with MON versus BIS (₩ 190,185 vs. ₩ 167,432, respectively; p < .001), likely driven by higher pharmaceutical costs associated with MON (₩ 69,113 vs. ₩ 49,225; p < .001).Conclusions: Montelukast patients had better adherence, a longer time to loss of persistency, and were less likely to experience an exacerbation-related office visit in the post-index period than BIS patients.

Cost-effectiveness of roflumilast as an add-on to triple inhaled therapy vs triple inhaled therapy in patients with severe and very severe COPD associated with chronic bronchitis in the UK.

Purpose: Patients with severe COPD are at high risk of experiencing disease exacerbations, which require additional treatment and are associated with elevated mortality and increased risk of future exacerbations. Some patients continue to experience exacerbations despite receiving triple inhaled therapy (ICS plus LAMA plus LABA). Roflumilast is recommended by the Global Initiative for Chronic Obstructive Lung Disease as add-on treatment to triple inhaled therapy for these patients. This cost-effectiveness analysis compared costs and quality-adjusted life-years for roflumilast plus triple inhaled therapy vs triple inhaled therapy alone, using data from the REACT and RE2SPOND trials. Patients and methods: Patients included in the analysis had severe to very severe COPD, FEV1 <50% predicted, symptoms of chronic bronchitis and ≥2 exacerbations per year. Our model was adapted from a previously published and validated model, and the analyses conducted from a UK National Health Service perspective. A scenario analysis considered a subset of patients who had experienced at least one COPD-related hospitalization within the previous year. Results: Roflumilast as add-on to triple inhaled therapy was associated with non-significant reductions in rates of both moderate and severe exacerbations compared with triple inhaled therapy alone. The incremental cost-effectiveness ratio (ICER) for roflumilast as add-on to triple inhaled therapy was £24,976. In patients who had experienced previous hospitalization, roflumilast was associated with a non-significant reduction in the rate of moderate exacerbations, and a statistically significant reduction in the rate of severe exacerbations. The ICER for roflumilast in this population was £7,087. Conclusions: Roflumilast is a cost-effective treatment option for patients with severe or very severe COPD, chronic bronchitis, and a history of exacerbations. The availability of roflumilast as add-on treatment addresses an important unmet need in this patient population.

A longitudinal, retrospective cohort study on the impact of roflumilast on exacerbations and economic burden among chronic obstructive pulmonary disease patients in the real world.

BACKGROUND: Roflumilast is approved in the United States to reduce the risk of COPD exacerbations in patients with severe COPD. Exacerbation rates, health care resource utilization (HCRU), and costs were compared between roflumilast patients and those receiving other COPD maintenance drugs. METHODS: LifeLink™ Health Plan Claims Database was used to identify patients diagnosed with COPD who initiated roflumilast (roflumilast group) or ≥3 other COPD maintenance drugs (non-roflumilast group) from May 1, 2011 to December 31, 2012. Patients must have been enrolled for 12 months before (baseline) and 3 months after (postindex) the initiation date, ≥40 years old, not systemic corticosteroid dependent, and without asthma diagnosis at baseline. Difference-in-difference models compared change from baseline in exacerbations, HCRU (office, emergency visits, and hospitalizations), and total costs between groups, adjusting for baseline differences. RESULTS: A total of 14,211 patients (roflumilast, n=710; non-roflumilast, n=13,501) were included. During follow-up, the rate of overall exacerbations per patient per month decreased by 11.1% in the roflumilast group and increased by 15.9% in the non-roflumilast group (P<0.001). After controlling for baseline differences, roflumilast-treated patients experienced a greater reduction in exacerbations (0.0160 fewer exacerbations per month, P=0.01), numerically greater reductions in hospital admissions (0.003 fewer per month, P=0.57), office visits (0.46 fewer per month, P=0.26), and total costs from baseline compared with non-roflumilast patients ($116 less per month, P=0.62). CONCLUSION: In a real-world setting, patients initiating roflumilast experienced reductions in exacerbations versus patients treated with other COPD medications.

Roflumilast: Who Is Using It and How It Affects Health Care Resource Utilization and Costs.

OBJECTIVE: Compare baseline characteristics, health care resource utilization (HCRU), and associated costs of COPD patients treated with add-on roflumilast with those of other combination medications. DESIGN: Retrospective cohort study. METHODOLOGY: Patients aged 40 years with a diagnosis of chronic obstructive pulmonary disease (COPD) between March 1, 2011, and Nov. 30, 2012, were identified from the HealthCore Integrated Research Database and classified as roflumilast or nonroflumilast combination-therapy cohorts. Baseline characteristics were compared for all patients. HCRU and costs were compared between matched (M) roflumilast and nonroflumilast cohorts, using propensity score as a partial balancing score and then complementing the score with exact matching on specifically important variables. Generalized linear model and Poisson regression were used to estimate the adjusted differences in total costs and hospitalization rates, respectively, between the 2 matched cohorts. RESULTS: A total of 695 roflumilast and 30,542 nonroflumilast combination therapy users were identified. At baseline, the roflumilast cohort had more complex COPD and a higher number of severe and moderate COPD exacerbations relative to the nonroflumilast cohort. After matching, the roflumilast (M) and nonroflumilast (M) cohorts (n = 328 in each) had similar mean age, gender distribution, and follow-up time. The roflumilast (M) cohort had significantly higher pharmacy-related, per-patient, per-month (PPPM) costs (P < .001) and similar total cost (P = .90). After adjusting for confounding variables, no difference was observed between the 2 cohorts in total costs (P = .86) and number of hospitalizations (P = .65). CONCLUSION: Findings suggest that patients in the roflumilast cohort, relative to the nonroflumilast cohort, were more severely ill in the real-world setting. Despite higher pharmacy costs, the total cost for the roflumilast cohort was statistically similar to the nonroflumilast cohort. Future studies with longer follow-up are needed to evaluate the long-term economic impact of roflumilast use.

Impact of roflumilast on exacerbations of COPD, health care utilization, and costs in a predominantly elderly Medicare Advantage population.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) exacerbations are associated with declining lung function and health-related quality of life, and increased hospitalization and mortality. Clinical trials often poorly represent the elderly and thus have only partial applicability to their clinical care. OBJECTIVE: To compare exacerbations, COPD-related health care utilization (HCU), and costs in a predominantly elderly Medicare COPD population initiated on roflumilast versus those not initiated on roflumilast. METHODS: Deidentified administrative claims data from a large, national payer were utilized. Medicare patients aged 40-89 years with at least one COPD diagnosis from May 1, 2010 to December 31, 2012 were included. Members with at least one roflumilast pharmacy claim (index) were assigned to the roflumilast group and those without were assigned to the non-roflumilast group. Proxy index dates for the non-roflumilast group were randomly assigned for similar distribution of all patients' time at risk. Subjects with at least one pre-index COPD exacerbation had to be continuously enrolled for ≥365 days pre-index and post-index. Unadjusted and adjusted difference-in-difference (DID) analyses contrasted pre-index with post-index changes in exacerbations, HCU, and costs of roflumilast treatment compared with non-roflumilast treatment. RESULTS: A total of 500 roflumilast and 60,145 non-roflumilast patients were included (mean age 69.7 and 72.3 years, respectively; P<0.0001). Unadjusted DID favored roflumilast for all exacerbations, with greater pre-index to post-index reductions in mean per 30-day COPD-related hospitalizations (-0.0182 versus -0.0013, P=0.009), outpatient visits (-0.2500 versus -0.0606, P<0.0001), and COPD-related inpatient costs (-US$141 versus -US$11, P=0.0346) and outpatient costs (-US$31 versus -US$4, P<0.0001). Multivariate analyses identified significantly improved pre-index to post-index COPD-related total costs (P=0.0005) and total exacerbations (P<0.0001) for the roflumilast group versus non-roflumilast group. CONCLUSION: In a predominantly elderly Medicare COPD population, newly initiated roflumilast patients displayed similar or significantly better unadjusted reductions in all exacerbation-related, COPD-related HCU-related, and COPD-related costs outcomes compared with non-roflumilast patients. These analyses also suggest better adjusted COPD-related costs and total exacerbations for roflumilast-initiated patients.

Prior authorization in the treatment of patients with pDPN and FM.

PURPOSE: To determine prior authorization (PA) impact on healthcare utilization, costs, and pharmacologic treatment patterns for painful diabetic peripheral neuropathy (pDPN) and fibromyalgia (FM). METHODS: This retrospective, observational, longitudinal cohort study used medical and pharmacy claims data. Newly diagnosed patients treated for FM or pDPN between 7/1/2007 and 12/31/2011 were included. PA and no PA groups were matched by propensity score 4:1. Medical resource utilization, direct medical and pharmacy costs, and treatment pattern differences were compared. Pre and postindex differences between PA and no PA cohorts were determined by difference in difference analysis. RESULTS: Analysis of 2,315 FM patients (1,852 PA; 463 no PA) demonstrated greater increases in postindex all-cause costs ($197; P = 0.6673) and disease-related costs ($72; P = 0.4186) in the PA cohort. Analysis of 1,300 pDPN patients (1,040 PA; 260 no PA) demonstrated postindex all-cause cost increases of $1,155 more in the no PA cohort (P = 0.6248); disease-related costs decreased $2,809 more in the no PA cohort (P = 0.4312). Treatment patterns were similar between cohorts; opioid usage was higher in the FM PA cohort (P = 0.0082). CONCLUSIONS: There was no evidence of statistically significant differences between PA and no PA cohorts in either FM or pDPN populations for total all-cause or disease-related costs.

Cost-effectiveness of roflumilast as an add-on treatment to long-acting bronchodilators in the treatment of COPD associated with chronic bronchitis in the United Kingdom.

OBJECTIVE: To estimate the cost-effectiveness of adding a selective phosphodiesterase-4 inhibitor, roflumilast, to a long-acting bronchodilator therapy (LABA) for the treatment of patients with severe-to-very severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis with a history of frequent exacerbations from the UK payer perspective. METHODS: A Markov model was developed to predict the lifetime cost and outcomes [exacerbations rates, life expectancy, and quality-adjusted life years (QALY)] in patients treated with roflumilast, which showed a reduction in the exacerbation rates and lung function improvement in a pooled analysis from two clinical trials, M2-124 and M2-125. Sensitivity analyses were conducted to explore the impact of uncertainties on the cost-effectiveness. RESULTS: The addition of roflumilast to concomitant LABA reduced the number of exacerbations from 15.6 to 12.7 [2.9 (95 % CI 0.88-4.92) exacerbations avoided] and increased QALYs from 5.45 to 5.61 [0.16 (95 % CI 0.02-0.31) QALYs gained], at an incremental cost of £3,197 (95 % CI £2,135-£4,253). Cost in LABA alone and LABA + roflumilast were £16,161 and £19,358 respectively. The incremental cost-effectiveness ratios in the base case were £19,505 (95 % CI £364-£38,646) per quality-adjusted life-year gained and 18,219 (95 % CI £12,697-£49,135) per life-year gained. Sensitivity analyses suggest that among the main determinants of cost-effectiveness are the reduction of exacerbations and the case fatality rate due to hospital-treated exacerbations. Probabilistic sensitivity analysis suggests that the probability of roflumilast being cost-effective is 82 % at willingness-to-pay £30,000 per QALY. CONCLUSIONS: The addition of roflumilast to LABA in the treatment of patients with severe-to-very severe COPD reduces the rate of exacerbations and can be cost-effective in the UK setting.

Cost-effectiveness of roflumilast in combination with bronchodilator therapies in patients with severe and very severe COPD in Switzerland.

OBJECTIVE: Chronic obstructive pulmonary disease (COPD) represents a burden on patients and health systems. Roflumilast, an oral, selective phosphodiesterase-4-inhibitor reduces exacerbations and improves lung function in severe/very severe COPD patients with a history of exacerbations. This study aimed to estimate the lifetime cost and outcomes of roflumilast added-on to commonly used COPD regimens in Switzerland. METHODS: A Markov cohort model was developed to simulate COPD progression in patients with disease states of severe, very severe COPD, and death. The exacerbation rate was assumed to be two per year in severe COPD. COPD progression rates were drawn from the published literature. Efficacy was expressed as relative ratios of exacerbation rates associated with roflumilast, derived from a mixed-treatment comparison. A cost-effectiveness analysis was conducted for roflumilast added to long-acting muscarinic antagonists (LAMA), long-acting ß2-agonist/ inhaled corticosteroids (LABA/ICS), and LAMA + LABA/ICS. The analysis was conducted from the Swiss payer perspective, with costs and outcomes discounted at 2.5% annually. Parameter uncertainties were explored in one-way and probabilistic sensitivity analyses. RESULTS: In each of the comparator regimens mean life expectancy was 9.28 years and quality-adjusted life years (QALYs) gained were 6.19. Mean estimated lifetime costs per patient in the comparator arms were CHF 83,364 (LAMA), CHF 88,161 (LABA/ICS), and CHF 95,564 (LAMA + LABA/ICS) respectively. Adding roflumilast resulted in a mean cost per patient per lifetime of CHF 86,754 (LAMA + roflumilast), CHF 91,470 (LABA/ICS + roflumilast), and CHF 99,364 (LAMA + LABA/ICS + roflumilast), respectively. Life-expectancy and quality-adjusted life-expectancy were 9.63 years and 6.47 QALYs (LAMA + roflumilast), 9.64 years and 6.48 QALYs (LABA/ICS + roflumilast), and 9.63 years and 6.47 QALYs (LAMA + LABA/ ICS + roflumilast). Incremental cost-effectiveness ratios were CHF 12,313, CHF 11,456, and CHF 13,671 per QALY when roflumilast was added to the three regimens. CONCLUSION: Treatment with roflumilast is estimated to reduce the health and economic burden of COPD exacerbations and represent a cost-effective treatment option for patients with frequent exacerbations in Switzerland.

[Roflumilast in combination with long-acting bronchodilators in the management of patients with severe and very severe COPD. A cost-effectiveness analysis for Germany]. / Roflumilast in Kombination mit langwirksamen Bronchodilatatoren in der Versorgung von Patienten mit schwerer und sehr schwerer COPD. Eine Kosten-Effektivitäts-Analyse für Deutschland.

OBJECTIVE: To calculate the cost-effectiveness of roflumilast in combination with a long-acting beta agonist (LABA) versus LABA as a monotherapy in patients with severe and very severe COPD in Germany. METHODS: The cost-effectiveness of Roflumilast plus LABA vs. LABA as monotherapy was calculated by a long-term model (Markov). The effectiveness data are based on the clinical trials AURA and HERMES (M2-124 and M2-125). Roflumilast plus LABA compared to LABA monotherapy reduced the exacerbation rate by 20.7 % (95 % CI, -31,-9) and improved post-bronchodilator FEV1 by 46 ml (2). These data were used to calculate the mean life expectancy of the COPD cohort (start age: 64 years). Costs for the treatment of exacerbations in the inpatient setting and the outpatient setting were included in the model. Endpoints were incremental costs per avoided exacerbation and per quality adjusted life year (QALY). The input variables were addressed in sensitivity analyses. German data on epidemiology and management of COPD were to populate the model and the cost-effectiveness was analyzed from the perspective of German statutory health insurance (SHI). RESULTS: The model predicts a mean life expectancy of 8.1 years for patients with roflumilast plus LABA and 7.8 years for patients with LABA alone. This corresponds with a gain of 0.26 life years or 0.23 QALYs. Within this time span patients receiving roflumilast plus LABA experienced 2.43 exacerbations less than the comparator group. The incremental cost for roflumilast plus LABA is €1,852 per exacerbation avoided and €19,457 per QALY gained. CONCLUSION: The model calculation indicates that the cost-effectiveness of roflumilast as an add-on to LABA in patients with severe and very severe COPD is comparable to the cost-effectiveness of established and reimbursed treatment options in Germany. Analogue consideration of the cost-effectiveness of the treatment options LAMA, LABA and ICS are advisable.

Cost-effectiveness of available treatment options for patients suffering from severe COPD in the UK: a fully incremental analysis.

PURPOSE: Frequent exacerbations which are both costly and potentially life-threatening are a major concern to patients with chronic obstructive pulmonary disease (COPD), despite the availability of several treatment options. This study aimed to assess the lifetime costs and outcomes associated with alternative treatment regimens for patients with severe COPD in the UK setting. PATIENTS AND METHODS: A Markov cohort model was developed to predict lifetime costs, outcomes, and cost-effectiveness of various combinations of a long-acting muscarinic antagonist (LAMA), a long-acting beta agonist (LABA), an inhaled corticosteroid (ICS), and roflumilast in a fully incremental analysis. Patients willing and able to take ICS, and those refusing or intolerant to ICS were analyzed separately. Efficacy was expressed as relative rate ratios of COPD exacerbation associated with alternative treatment regimens, taken from a mixed treatment comparison. The analysis was conducted from the UK National Health Service (NHS) perspective. Parameter uncertainty was explored using one-way and probabilistic sensitivity analysis. RESULTS: Based on the results of the fully incremental analysis a cost-effectiveness frontier was determined, indicating those treatment regimens which represent the most cost-effective use of NHS resources. For ICS-tolerant patients the cost-effectiveness frontier suggested LAMA as initial treatment. Where patients continue to exacerbate and additional therapy is required, LAMA + LABA/ICS can be a cost-effective option, followed by LAMA + LABA/ICS + roflumilast (incremental cost-effectiveness ratio [ICER] versus LAMA + LABA/ICS: £16,566 per quality-adjusted life-year [QALY] gained). The ICER in ICS-intolerant patients, comparing LAMA + LABA + roflumilast versus LAMA + LABA, was £13,764/QALY gained. The relative rate ratio of exacerbations was identified as the primary driver of cost-effectiveness. CONCLUSION: The treatment algorithm recommended in UK clinical practice represents a cost-effective approach for the management of COPD. The addition of roflumilast to the standard of care regimens is a clinical and cost-effective treatment option for patients with severe COPD, who continue to exacerbate despite existing bronchodilator therapy.

Cost-effectiveness analysis of roflumilast/tiotropium therapy versus tiotropium monotherapy for treating severe-to-very severe COPD.

OBJECTIVE: To conduct a cost-effectiveness analysis comparing roflumilast/tiotropium therapy vs tiotropium monotherapy in patients with severe-to-very severe COPD. METHODS: The economic evaluation applied a disease-based Markov cohort model with five health states: (1) severe COPD, (2) severe COPD with a history of severe exacerbation, (3) very severe COPD, (4) very severe COPD with a history of severe exacerbation, and (5) death. Within a given health state, a patient may have a mild/moderate or severe exacerbation or die. Data from roflumilast clinical trials and published literature were used to populate model parameters. The model calculated health outcomes and costs for roflumilast/tiotropium therapy vs tiotropium monotherapy over a 5-year horizon. Incremental cost and benefits were then calculated as cost-effectiveness ratios, including cost per exacerbation avoided and cost per quality adjusted life year ($/QALY). RESULTS: Over a 5-year horizon, the estimated incremental costs per exacerbation and per severe exacerbation avoided were $589 and $5869, respectively, and the incremental cost per QALY was $15,815. One-way sensitivity analyses varying key parameters produced an incremental cost per QALY ranging from $1963-$32,773. LIMITATIONS: A number of key parameters used in the model were obtained from studies in the literature that were conducted under different contexts. Specifically, the relative risk estimate for severe COPD patients originates from a small trial not designed to demonstrate the impact of roflumilast on frequency of exacerbations. In addition, the model extrapolates the relative risk estimates over periods of 5-30 years, even though the estimates were only observed in trials that spanned less than a year. CONCLUSIONS: The addition of roflumilast to tiotropium is cost-effective for the treatment of severe to very severe COPD patients.

A 1-year prospective cost-effectiveness analysis of roflumilast for the treatment of patients with severe chronic obstructive pulmonary disease.

RATIONALE: Roflumilast is an oral, once-daily phosphodiesterase IV (PDE4) inhibitor under investigation for chronic obstructive pulmonary disease (COPD). This study investigated the cost effectiveness of roflumilast in patients with severe to very severe COPD from the perspective of the UK society and UK NHS. METHODS: The analysis was conducted alongside a 1-year, randomised, double-blind, placebo-controlled, multinational trial. The trial included 1514 COPD patients aged >or=40 years with a post-bronchodilator forced expiratory volume in 1 second (FEV1) % predicted

[Clinico-economic assessment of milnacipran in the prevention of depressive episodes]. / Evaluation médico-économique de milnacipran dans la prévention des épisodes dépressifs.

The objective of this study was to evaluate, for patients at risk of a new depressive episode, the net cost of maintenance therapy with milnacipran compared with a symptomatic treatment of further episodes. Using clinical decision analysis techniques, a Markov-state transition was constructed to estimate the 12 months direct costs of the two therapeutic strategies. Model construction and probabilities for performing the analysis were primarily based on a controlled phase III clinical trial demonstrating the prophylactic efficacy of milnacipran compared to placebo. Others parameters and unit costs were obtained from published sources. For each group (maintenance and episodic treatment groups), the model simulated the clinical evolution of patients on 6 successive 2-months cycles. Costs were affected for each health state period (remission, depression, abandonment of health care, suicide). The baseline analysis showed the mean costs per patient and year were 627 FF (105 US$) higher for maintenance treatment. Sensitivity analysis suggested that costs were equal under a 25% rate of hospitalization hypothesis for a depressive episode. Maintenance costs were 1,587 FF (265 US$) lower than episodic treatment costs for depressed subjects with a good initial response to milnacipran (HDRS-21 score at remission < 5); this economic benefit remained under a lower rate of hospitalization hypothesis (12%). Based on the study assumptions, maintenance treatment with milnacipran appears to be clinically and economically justified for patients at high risk of hospitalization when having a recurrence, and even more for patients with an excellent initial acute response.

Comparison of the cost-effectiveness of milnacipran (a SNRI) with TCAs and SSRIs: a modeling approach.

A simulation model based on the theory of clinical decision analysis was used to compare outcomes and costs when treating patients with major depressive episodes using either a selective serotonin re-uptake inhibitor (SSRI) or a tricyclic antidepressant (TCA), in comparison with milnacipran (a serotonin), and a norepinephrine re-uptake inhibitor (SNRI). The clinical data used were taken from published meta-analyses. This analysis supports: (1) a comparable efficacy of milnacipran and TCA with a better tolerance; and, (2) an advantage of milnacipran over SSRI for efficacy with a comparable tolerance. Based on these findings, a decision tree was constructed with the assistance of a panel of psychiatrists in order to provide a model of usual clinical practice. Estimates not available from clinical studies were obtained either from literature analysis or from the panel. Economic appraisal was performed according to the viewpoint of the French national sickness fund (sécurité sociale), and expenditure assessment was limited to direct costs (hospitalizations, antidepressant medications, visits, and laboratory tests). The results suggest that milnacipran is a cost-effective alternative: the expected cost of treatment per depressive episode is lower than either a French representative panel of TCAs (a saving of 288 FF), or SSRIs (a savings of 961 FF). The expected length of clinical remission is slightly higher than comparators. The robustness of these findings was supported by sensitivity analyses.