Two New Drugs for Tardive Dyskinesia Hit the Market.

Ingrezza and Austedo were approved last year. ICER calculations raise questions about their price.

Prophylactic Efficacy Against Herpes Zoster and Costs Difference Between Acyclovir and Valaciclovir in Hematological Patients.

BACKGROUND: Immunocompromised hematological patients are at increased risk of herpes zoster (HZ). We examined the efficacy of acyclovir and valaciclovir in preventing HZ. We also created a simulation to reduce prophylactic medicine costs. PATIENTS AND METHODS: We retrospectively evaluated 573 hematological patients who received chemotherapy, and assessed the difference in the costs between the acyclovir (Zovirax®) and valaciclovir (Valtrex®) groups. RESULTS: Forty-four out of the 573 patients (7.7%) developed HZ. Out of them, there were 37 patients (84.1%) who received corticosteroids. Moreover, in total, there were 67 patients receiving acyclovir prophylaxis and 42 patients receiving valaciclovir prophylaxis, out of which one from each group occurred with HZ. The total 5-year cost of acyclovir and valaciclovir was ¥2,869,917 and ¥4,809,952, respectively. Therefore, by changing from valaciclovir to acyclovir, medical costs could be reduced by 28.3%. Additionally, switching to generic inexpensive acyclovir would possibly reduce them to 15.0%. CONCLUSION: Chemotherapy, including corticosteroids, is associated with a high incidence of HZ. Additionally, there was no prophylactic difference between acyclovir and valaciclovir. We expect that use of generic acyclovir could reduce prophylaxis costs by 85.0%.

Valganciclovir versus valacyclovir prophylaxis for prevention of cytomegalovirus: an economic perspective.

INTRODUCTION: Valganciclovir (vGCV) and valacyclovir (vACV) are used in cytomegalovirus (CMV) prophylaxis in renal transplant recipients. The aim of this study was to compare the economic impact of both regimens during 1-year follow-up. METHODS: A total of 117 renal transplant recipients at risk for CMV were randomized to 3-month prophylaxis either with vGCV (900 mg/day, n = 60) or vACV (8 g/day, n = 57) and their data used in a pharmacoeconomic analysis. The pharmacoeconomic evaluation involved all direct CMV-related expenses in the first year after transplantation. Sensitivity analysis was employed to examine the effects of various prices of antiviral drugs and diagnostic procedures on overall CMV-related costs. Simulation of the more expensive US healthcare perspective was performed, and a scenario involving costs of acute rejection (AR) was examined. RESULTS: Overall CMV-related costs were significantly lower in the vACV arm; median United States dollars (USD) 3473 (3108-3745) vs. USD 5810 (4409-6757; P < 0.001) per patient, respectively. Our data showed that the critical determinant of the major disparity between the prophylactic regimens was the prophylaxis price. Median cost of prophylaxis in the vACV group was USD 1729 (1527-2173) compared to USD 3968 (2683-4857) in the vGCV group (P < 0.001). In sensitivity analysis of the overall CMV-related costs, the least and the most expensive pharmacotherapy and diagnostic scenarios were used; nevertheless, the vACV arm remained markedly less expensive. Simulation considering the higher physician/nurse and hospitalization fees of the US healthcare system and the scenario including expenditure associated with AR episodes also favored vACV. CONCLUSION: VACV prophylaxis for CMV is associated with a significant 44% lower cost than vGCV at the first year after renal transplantation.

Valaciclovir versus aciclovir for the treatment of primary genital herpes simplex: a cost analysis.

The current guidelines for the treatment of primary herpes simplex in the Genito-urinary department in Sheffield Teaching Hospitals NHS Foundation Trust, recommend valaciclovir as a first-line medication. This is a prodrug of aciclovir, which has been used for many years as a treatment for primary herpes simplex virus. The basis of the recommendation largely relates to valaciclovir being more bioavailable than aciclovir. However, there is no evidence to suggest this has an effect on overall outcome with regard to symptom control and viral shedding. The purpose of the service evaluation was to discover if significant cost savings could be made by changing the prescribing policy to make aciclovir the drug of choice for primary herpes simplex virus. Based on 160 patients receiving valaciclovir (500 mg BD) during April 2013 and March 2014, if they had been treated with aciclovir (400 mg TDS) instead, a saving of £828.80 (66% reduction) could have been made.

The efficacy and cost-effectiveness of valacyclovir in cytomegalovirus prevention in solid organ transplantation.

Prevention of cytomegalovirus infection using antiviral prophylaxis or the pre-emptive therapy approach is an integral part of management of patients after solid organ transplantation. Regarding renal transplantation, valacyclovir is currently the only antiviral agent recommended for prophylaxis as an alternative to valganciclovir. This review article discusses studies documenting the efficacy and safety of valacyclovir prophylaxis as well as those comparing valacyclovir with other prophylactic regimens or with pre-emptive therapy. Also addressed are the economic aspects supporting the cost-effectiveness of valacyclovir prophylaxis and demonstrating lower costs compared with other cytomegalovirus preventive strategies.

Dosage of angiotensin-II receptor blockers in heart failure patients following changes in Danish drug reimbursement policies.

PURPOSE: National reimbursement policies in Denmark were changed in November 2010 favouring a shift in angiotensin-II receptor blocker (ARB) treatment to generic losartan for heart failure (HF) patients. We examined how changes in reimbursement policies affected the fraction of HF patients up-titrated to optimal or suboptimal ARB dosage. METHODS: A historical cohort study was performed including HF patients with at least one prescription of ARB in the months of May-Jul 2010 (baseline). Patients were considered up-titrated at doses 100, 16 or 160 mg for losartan, valsartan and candesartan, respectively. Individual-level linkage of nationwide registries of hospitalization and drug dispensing in Denmark was used to describe patterns of ARB prescriptions and estimate dosage before and after November 2010. Logistic regression models were used to assess the probability for being up-titrated in the period. RESULTS: Of 6036 individuals included (mean age 73.5 [standard deviation 11.2] years; 51% males), 3346 (55.4%) used losartan, 541 (9.0%) valsartan and 2149 (35.6%) candesartan at inclusion, respectively. 2887 (47.8%) were up-titrated at baseline (May-Jul 2010), followed by 2878 (48.2%) in the three months before the policy change (Aug-Oct 2010), and 2492 (43.7%) in the first months after the policy change (Feb-Apr 2011). Odds ratios for being up-titrated according to time period were 1.02 [0.95-1.09] in Aug-Oct 2010 (before policy change) and 0.84 [0.78-0.90] in Feb-Apr 2011 (after policy change), compared with May-Jul 2010 (reference). CONCLUSION: Probability of being up-titrated in ARB treatment was reduced 20% following changes in drug reimbursement policies.

Improving drug adherence using fixed combinations caused beneficial treatment outcomes and decreased health-care costs in patients with hypertension.

We enrolled 196 patients with hypertension who were already being treated with free-drug combinations of angiotensin-II receptor blocker (ARB) and amlodipine. The free-drug combinations of ARB and amlodipine were replaced with the same dose of the fixed-dose combinations. The average home blood pressure (BP) in all patients receiving fixed-dose combinations was significantly lower than those receiving free-drug combinations (131 ± 10/75 ± 8 vs. 136 ± 11/77 ± 9 mm Hg, P < .01) accompanied with increasing drug adherence. After lowering BP by fixed-dose combinations, the costs for medications decreased by 31% over the 3 months.

Pharmacoeconomic impact of different regimens to prevent cytomegalovirus infection in renal transplant recipients.

BACKGROUND: The aim of this study was to determine the cost impact of four different strategies for prevention of cytomegalovirus (CMV) disease after renal transplantation. METHODS: Hospitalization data and medical resource utilization data were prospectively collected alongside two randomized trials. In the first trial, the patients were randomized to 3-month prophylaxis with either oral ganciclovir (1 g t.i.d., n = 36) or valacyclovir (2 g q.i.d., n = 35), and to the control group (n = 12) managed by deferred therapy. In the second trial, the patients were randomly assigned to 3-month valacyclovir prophylaxis (n = 34) or preemptive therapy with valganciclovir (900 mg b.i.d. for a minimum of 14 days, n = 36) for significant CMV DNAemia. The cost analysis involved all real costs directly related to CMV during the first year after renal transplantation. RESULTS: The mean CMV-associated costs per patient were EUR 4,581, 2,577, 4,968, and 8,050 in patients in the ganciclovir, valacyclovir, preemptive, and deferred therapy groups, respectively (p < 0.001). Valacyclovir prophylaxis was significantly less expensive than any other regimen. The cost of one episode of CMV disease was EUR 7,510 per patient. Due to excessive incidence of CMV disease, deferred therapy was the most expensive strategy (p < 0.001). CONCLUSIONS: Valacyclovir prophylaxis is less expensive strategy compared with any other regimen.

Evolutionary cost analysis of valsartan initiation among patients with hypertension: a time series approach.

OBJECTIVES: This study examines the evolutionary impact of valsartan initiation on medical costs. METHODS: A retrospective time series study design was used with a large, US national commercial claims database for the period of 2004-2008. Hypertensive patients who initiated valsartan between the ages of 18 and 63, and had continuous enrollment for 24-month pre-initiation period and 24-month post-initiation period were selected. Patients' monthly medical costs were calculated based on individual claims. A novel time series model was devised with monthly medical costs as its dependent variables, autoregressive integrated moving average (ARIMA) as its stochastic components, and four indicative variables as its decomposed interventional components. The number of post-initiation months before a cost-offset point was also assessed. RESULTS: Patients (n = 18,269) had mean age of 53 at the initiation date, and 53% of them were female. The most common co-morbid conditions were dyslipidemia (52%), diabetes (24%), and hypertensive complications (17%). The time series model suggests that medical costs were increasing by approximately $10 per month (p < 0.01) before the initiation, and decreasing by approximately $6 per month (p < 0.01) after the initiation. After the 4th post-initiation month, medical costs for patients with the initiation were statistically significantly lower (p < 0.01) than forecasted medical costs for the same patients without the initiation. LIMITATIONS: The study has its limitations in data representativeness, ability to collect unrecorded clinical conditions, treatments, and costs, as well as its generalizability to patients with different characteristics. CONCLUSIONS: Commercially insured hypertensive patients experienced monthly medical cost increase before valsartan initiation. Based on our model, the evolutionary impact of the initiation on medical costs included a temporary cost surge, a gradual, consistent, and statistically significant cost decrease, and a cost-offset point around the 4th post-initiation month.

Cost-effectiveness analysis of valsartan versus losartan and the effect of switching.

OBJECTIVES: Losartan will shortly become generic, and this may encourage switching to the generic drug. However, valsartan was shown in a meta-analysis to be statistically superior in lowering blood pressure (BP) to losartan. This paper examines the costs of treatment with these two drugs and the potential consequences of switching established valsartan patients to generic losartan. METHODS: A US payer cost-effectiveness model was developed incorporating the risk of cardiovascular disease (CVD) events related to systolic blood pressure (SBP) control comparing valsartan to continual losartan and switching from valsartan to generic losartan. The model, based upon a meta-analysis by Nixon et al. and Framingham equations, included first CVD event costs calculated from US administrative data sets and utility values from published sources. The modeled outcomes were number of CVD events, costs and incremental cost per quality-adjusted life-year (QALY) and life-year (LY). RESULTS: Fewer patients had fatal and non-fatal CVD events with valsartan therapy compared with continual losartan and with patients switched from valsartan to generic losartan. The base-case model results indicated that continued treatment with valsartan had an incremental cost-effectiveness ratio of $27,268 and $25,460 per life year gained, and $32,313 and $30,170 per QALY gained, relative to continual losartan and switching treatments, respectively. Sensitivity analyses found that patient discontinuation post-switching was a sensitive parameter. Including efficacy offsets with lowered adherence or discontinuation resulted in more favorable ratios for valsartan compared to switching therapy. LIMITATIONS: The model does not evaluate post-primary CVD events and considers change in SBP from baseline level as the sole predictor of CVD risk. CONCLUSIONS: Valsartan appears to be cost-effective compared to switching to generic losartan and switching to the generic drug does not support a cost offset argument over the longer term. Physicians should continue to consider the needs of individual patient and not cost offsets.

Estimation of financial burden due to oversupply of medications for chronic diseases.

Given the potential of financial burden due to oversupply of medications for chronic diseases, this study aims to determine the prevalence of oversupply and to estimate the magnitude of financial loss in Thailand. Electronic patient database in a university-affiliated hospital in Thailand was used. Based on the utilization of top 5 high drug expenditure in 2005, the prevalence and the financial loss of oversupply (medication possession ratio [MPR] >1.00) were estimated. In total, 1893 patients were included in this study. The average age was 65.2 years and the majority were female (56%). The prevalence of oversupply ranged from 23.2% to 62.8%, whereas the annual financial loss ranged from US $4108 to US $10 517. The total amount of loss was US $32 903 or 3.77% of total medication costs. In summary, because of the high prevalence and associated high financial loss, oversupply of medication is a significant financial burden on hospitals and society.

Valsartan plus hydrochlorothiazide: a review of its use since its introduction.

INTRODUCTION: This review focuses on the role of the fixed-dose combination (FDC) drug valsartan/hydrochlorothiazide (HCTZ) in the treatment of hypertension. Effective blood pressure control often is not achieved with monotherapy and, instead, requires combinations of drugs with different mechanisms of action to produce additive or synergistic effects. AREAS COVERED: FDC valsartan/HCTZ enhances not only efficacy for blood pressure control but also provides beneficial effects on target organs beyond that expected from arterial pressure reduction alone. Data describe key clinical trial experiences with the FDC, with particular attention to efficacy and tolerability. Literature searches of these various topics were conducted in January 2011. There is evidence of potential benefits with this combination associated with left ventricular hypertrophy, left ventricular dysfunction and renal disease. The FDC is an effective treatment for patients with hypertension and is superior to monotherapy than either drug alone. EXPERT OPINION: In addition to the benefits of each drug, valsartan/HCTZ's metabolic interactions reduce some of the negative effects of both compounds. With its increased simplicity, minimal side-effect profile and efficacy without a significant cost penalty, valsartan/HCTZ represents an excellent choice for antihypertensive therapy.

Comparison of real-world adherence, healthcare resource utilization and costs for newly initiated valsartan/amlodipine single-pill combination versus angiotensin receptor blocker/calcium channel blocker free-combination therapy.

OBJECTIVE: To compare adherence, healthcare costs and utilization of valsartan/amlodipine single-pill combination (SPC) and angiotensin-receptor blocker/calcium-channel blocker multiple-pill free-combination (ARB + CCB FC) therapy using real-world data. METHODS: A retrospective study (January 1, 2007 to April 30, 2009) was conducted using US commercial healthcare insurance claims. Patients were assigned to two cohorts: 'valsartan/amlodipine SPC cohort' and 'ARB + CCB FC therapy cohort'. The primary endpoints were adherence and persistence. The secondary endpoints were 1-year healthcare costs and utilization. RESULTS: Out of 12,628 eligible patients 3259 (26%) were included in the valsartan/amlodipine SPC cohort and 9369 (%74) in the ARB + CCB FC cohort. Risk-adjusted adherence rates were higher for valsartan/amlodipine SPC patients [OR: 1.38, 95% CI: (1.24, 1.53)]. The Cox proportional hazard model showed that valsartan/amlodipine SPC cohort patients were less likely to discontinue medication (HR: 0.87, p < 0.001). Comparison between the groups also yielded that total healthcare costs of valsartan/amlodipine SPC patients were 16-20% lower than ARB + CCB FC therapy patients (p < 0.0001). LIMITATIONS: Since claims data are collected for payment purposes rather than research purposes, the study is bound by limitations for the retrospective analysis. For example, the presence of a claim for a filled prescription does not indicate that the medication was consumed or taken as prescribed. Data on health behaviors and patient lifestyle were not available. Over-the-counter medications and clinical disease severity were not available in the dataset. Incorrect coding is also a possibility. However, we have used previously validated datasets where these effects are minimal. Heterogeneity of the sample may create bias in our estimates, however, we have used advanced statistical methods to control for observed and unobserved bias. CONCLUSION: The real-world use of valsartan/amlodipine SPC was associated with better adherence and persistence relative to ARB + CCB FC therapy among patients with hypertension. Moreover, patients taking single-pill combination therapy had lower healthcare costs and utilization.

Economic evaluation of irbesartan in combination with hydrochlorothiazide in the treatment of hypertension in Greece.

OBJECTIVES: Hypertension is a major risk factor for cardiovascular disease and a leading cause of morbidity and mortality. This study evaluates irbesartan in relation to commonly used alternative hypertension therapies losartan and valsartan given in combination with hydrochlorothiazide (HCTZ) in the general hypertensive population in Greece. METHODS: A Markov model with eight states of health was constructed: hypertension, myocardial infarction (MI), post-MI, angina, stroke, poststroke, heart failure, and death. The model has an annual cycle and estimates mean quality-adjusted survival and treatment cost, which reflect the hypertension treatment and managing cardiovascular events. Risk functions were used to conduct extrapolations. Data on treatment effectiveness, quality of life (QOL) and epidemiology were obtained from published clinical trials and studies. The database of the main Greek National Social Insurance Institute (IKA) was analyzed to estimate the cost of events. The analysis was done from a payer perspective. All outcomes were discounted, and prices correspond to 2008. RESULTS: The estimated patient cost per annum was stable angina euro 2,252, unstable angina euro 2,572, myocardial infarction euro 2,473, post-MI euro 1,677, stroke euro 12,233, poststroke euro 1,240, heart failure euro 2,655, coronary angiography euro 1,544, percutaneous transluminal coronary angioplasty euro 6,511, and coronary artery bypass graft surgery euro 11,514. For the baseline group (age 57 years, systolic blood pressure 147 mmHg, cholesterol 6.00 mmol/L, body mass index 29) of men with mild to moderate hypertension, for irbesartan, the total treatment cost was euro 15,146, for losartan euro 15,696 and for valsartan euro 15,613; the quality-adjusted life years (QALYs) were irbesartan 12.67, losartan 12.63 and valsartan 12.64. For the baseline group of women with mild to moderate hypertension, the total treatment cost was euro 12,945 for irbesartan, euro 13,424 for losartan and euro 13,379 for valsartan; QALYs were 14.29 for irbesartan, 14.27 for losartan and 14.27 for valsartan. For men with severe hypertension, for irbesartan and losartan, the total treatment cost was euro 18,679 and euro 21,488 and QALYs 12.47 and 12.37, respectively. For women, the total treatment cost was euro 16,202 and euro 19,099 and QALYs 14.16 and 14.09, respectively. Similar results were obtained in relation to other treatment groups in various sensitivity analysis scenarios. CONCLUSIONS: Based on efficacy data from clinical trials and lower attainment costs in various hypertensive patient populations, irbesartan in combination with HCTZ compares favorably with losartan and valsartan in combination with HCTZ in the Greek setting.

Comparison of amlodipine/valsartan fixed-dose combination therapy and conventional therapy.

PURPOSE: Single-pill-combination (SPC) antihypertensive drug products have been shown to improve compliance but are associated with higher acquisition costs. This study compared the clinical and economic outcomes associated with the use of an SPC of amlodipine/valsartan (trade name Exforge) with the outcomes from conventional combination therapy in patients failing to respond to initial monotherapy with either a dihydropyridine calcium channel blocker (DHP-CCB) or an angiotensin receptor blocker (ARB). DESIGN: We conducted a retrospective cohort study of hypertensive patients failing to respond to monotherapy with either a DHP-CCB or an ARB who were switched to an SPC of amlodipine/valsartan (SPC group) or to treatment that could not include any SPC (control group). The groups were matched for age, gender, race, baseline blood pressure (BP), and comorbidities. The primary outcomes of the study included the proportion of patients achieving BP targets, the absolute change in BP from baseline, the proportion of patients discontinuing drug therapy because of side effects, the proportion of patients non-compliant with drug therapy, and health care resource utilization and costs. PRINCIPAL FINDINGS: Fifty-eight SPC patients achieved BP targets compared with 47 control patients (P = 0.119). The absolute reduction in BP was significantly greater in the SPC group (-22.8 +/- 6.9/-19.3 +/- 5.2 mmHg) than in the control group (-20.6 +/- 6.4/-17.8 +/- 5.6 mmHg) (P < 0.03). Significantly fewer patients discontinued anti-hypertensive therapy because of side effects and noncompliance in the SPC group compared with the control group (both P = 0.042). SPC patients accrued fewer clinic visits, laboratory tests, and electrocardiograms but had higher drug acquisition costs. Median medical therapy costs were significantly lower in the SPC group at the end of the 6-month follow-up, primarily because of lower costs for clinic visits. CONCLUSION: The use of the SPC of amlodipine/valsartan was associated with greater absolute BP reductions and fewer antihypertensive drug discontinuations because of side effects and noncompliance compared with the use of the individual drugs. Although the acquisition cost of the SPC was greater than that of the individual drugs, SPC combination therapy resulted in fewer clinic visits, laboratory tests, and electrocardiograms. As a result, the total cost of SPC therapy was significantly less than that associated with the use of the individual drug components.

Challenges of therapeutic substitution of drugs for economic reasons: focus on CVD prevention.

BACKGROUND: Healthcare systems throughout the world are under increasing pressure to control and minimise costs. The substitution of initially-prescribed drugs with cheaper equivalents is an obvious option which presents a rapid and visible means to reduce these costs. Whether the substitution improves patient and/or population outcomes must be appraised and this paper highlights the conditions under which therapeutic substitution may require additional thought and consideration. SCOPE: In this paper, some of the medical evidence and the regulatory environment for and against the three types of therapeutic substitution - generic, within-class and between-class - are discussed. This article is not an exhaustive review of the literature, but captures some of the key clinical, pharmacological, economic, policy and ethical issues regarding generic and therapeutic substitution. Search criteria of the most commonly used terms, i.e. therapeutic substitution, switching, interchange, and bioequivalence, were applied to Embase, PubMed and Google Scholar to identify relevant publications. FINDINGS: Although population studies support therapeutic substitution in principle, there is evidence that substitution may not always result in therapeutic equivalence in individual patients, with the consequent potential for greater risks of decreased efficacy and/or increased safety concerns. Factors such as patient choice and therapeutic equivalence also play an important role in the effectiveness of the treatment and overall management of the patient. The pan-European regulatory environment provides another contradiction, encouraging widespread cost containment through reduction in drug acquisition costs, while simultaneously promoting an increased role for patients in defining and managing their own treatment. CONCLUSIONS: There is a strong rationale for careful management in some patients with cardiovascular disease. Treatment decisions should be transparent and based on strong clinical evidence. If not, drug substitution on economic grounds alone cannot be considered to be in the individual patient's interest and is therefore unethical.

Economic impact of switching from valsartan to other angiotensin receptor blockers in patients with hypertension.

BACKGROUND: The approaching availability of lower-cost generic angiotensin receptor blockers (ARBs) may affect formulary policies for patients maintained on the ARB valsartan. OBJECTIVE: Estimate the economic impact of switching from valsartan (including valsartan-based single-pill combinations) to other ARBs without apparent medical reasons. RESEARCH DESIGN AND METHODS: Patients with essential hypertension and at least 6 months of continuous valsartan treatment free of hospitalization, cardiovascular events, renal events or ARB-associated adverse events were identified from the MarketScan administrative claims database from January 1, 2004 to March 31, 2008. Those who subsequently switched to a different ARB with at least a 5% copayment decrease (switchers) were matched to those who did not switch (maintainers) according to propensity score quintiles and selected baseline characteristics. Refills were not required after the index fill for the switched-to ARB or maintained valsartan. Matched switchers and maintainers were compared in terms of medication discontinuation, healthcare resource use and costs during the 6 months following the index fill. RESULTS: A total of 99,926 valsartan maintainers and 2150 switchers (with a mean copayment decrease of $16.5 per month) were identified and matched. After matching, switching from versus maintaining valsartan was associated with an 8% higher risk of medication discontinuation (p < 0.008), 19.1 additional outpatient visits/100 patients (p = 0.002) and 9.3 additional hypertension-related inpatient days/100 patients (p = 0.030). Concurrently, switching from versus maintaining valsartan was associated with higher total medical costs by $748/patient (p < 0.001), driven largely by higher costs for hypertension-related medical services by $492/patient (p = 0.004). LIMITATIONS: Exact reasons for switching were not available and the study assessed only the short-term impacts of switching. CONCLUSIONS: Hypertension patients maintained on valsartan who switched to a different ARB with a lower copayment experienced substantial increases in medication discontinuation, healthcare resource use and costs compared to those who maintained valsartan treatment.

The cost effectiveness and cost utility of valsartan in chronic heart failure therapy in Italy: a probabilistic markov model.

To evaluate the cost effectiveness and cost utility of the use of valsartan in addition to standard therapy for the treatment of patients with chronic heart failure with low left ventricular ejection fraction (LVEF). The study was conducted by means of a cohort simulation based on a probabilistic Markov model and projecting the 23-month follow-up results of the Val-HeFT (Valsartan Heart Failure Trial) study over a 10-year time horizon. The model included four states (New York Heart Association [NYHA] classes II, III, IV, and death), and had a cycle duration of 1 month. Probabilistic simulations were performed using the WinBUGS software for Bayesian analysis. The distribution of patient parameters (sex, age, use of beta-adrenoceptor antagonists, and ACE inhibitors) in the simulated population were derived from the Italian heart failure patient population. Individual mortality data were derived from general mortality data by multiplying by a NYHA state-specific relative risk, while the probability of changing NYHA class was taken from the Val-HeFT data. Costs (2007 values) were calculated from the perspective of the Italian Health Service (IHS) and included costs for drugs and heart failure hospitalizations. Quality-of-life (QOL) weights were obtained by using published health-related QOL data for heart failure patients. A 3.5% annual discount rate was applied. Probabilistic sensitivity analysis was performed on each parameter using original-source 95% confidence interval (CI) values, or a +/-10% range when 95% CI values were unavailable. For the 10-year time horizon, patients were estimated to live for an average of 2.3 years or 1.7 quality-adjusted life-years (QALYs), with slight increases in the valsartan group. In this group, hospitalizations for worsening heart failure were predicted to be significantly reduced and overall treatment costs per patient to decrease by about and U20AC;550. In subgroup analyses, valsartan lost dominance in patients in NYHA II, and in those receiving beta-adrenoceptor antagonists or ACE inhibitors; the mean incremental cost-utility ratio for these groups was 21 240, 129 200, and 36 500 and U20AC;/QALY, respectively. Valsartan in addition to standard therapy is predicted to dominate standard therapy alone in Italian patients with mild to severe heart failure and low LVEF. There are relevant differences among various patient subgroups, and valsartan is expected to be good value for money particularly in the treatment of the most severe and less intensively treated (no ACE inhibitors, no beta-adrenoceptor antagonist) heart failure patients.

An economic evaluation of valsartan for post-MI patients in the UK who are not suitable for treatment with ACE inhibitors.

OBJECTIVES: The overall objective of this study was to estimate the costs and outcomes associated with treatment with valsartan for post-myocardial infarction (post-MI) patients with left ventricular systolic dysfunction, heart failure, or both, who are not suitable for treatment with angiotensin-converting enzyme (ACE) inhibitors, compared to placebo. METHODS: A Markov model, using data drawn from the Valsartan in Acute Myocardial Infarction (VALIANT) trial and other trials, was developed to predict the future health pathways, resource use, and costs for patients who have recently experienced an MI. Patients received either valsartan (mean dose 247 mg) or placebo. Cost data were drawn from national databases and published literature, although health outcome utility weights were derived from existing studies. Patient outcomes were modeled for 10 years, and incremental cost-effective ratios were calculated for valsartan compared with placebo. RESULTS: Over a period of 10 years, a cohort of 1000 patients treated with valsartan experienced 147 fewer cardiovascular deaths, 37 fewer nonfatal MIs, and 95 fewer cases of heart failure than a cohort who received placebo. The incremental cost of valsartan, compared with placebo, was 2680 pound per patient, although the incremental effectiveness of valsartan was 0.5021 quality-adjusted life-years (QALYs) gained per patient. Therefore, the incremental cost per QALY for treatment with valsartan was 5338 pound. When analysis was undertaken using life-years rather than QALYs, the cost per life-year gained was 4672 pound. CONCLUSIONS: For patients who are not suitable for treatment with ACE inhibitors, valsartan is a viable and cost-effective treatment for their management after an MI.

[Economics of nephroprotection in arterial hypertension and type 2 diabetes mellitus].

Based on results of large-scale controlled trials of irbesartan (I), valsartan (V) and amlodipine (A) (PRIME and MARVAL) we carried out the Markov s modeling of their pharmacoeconomic parameters in arterial hypertension (AH) combined with diabetes mellitus type 2 (DM 2) and microalbuminuria (MAU) projected for 8-years perspective. Cost and efficacy was evaluated taking into account years of life gained and outcomes of concomitant diseases and complications. Indexes of cost/efficacy (C/E) were calculated for each drug. Among investigated drugs I appeared to be the most economic at the account of retardation of development of terminal nephropathy and cardiovascular diseases. The use of I compared with V could save 565300 rub/100 patients/year. C/E of I was 26.5 and 37.4% lower that those of V and A, respectively. Costs of year of life saved was 12716, 16432, and 18325 for I, V, and A, respectively. Comparative pharmacoeconomic modeling of 8-year economic perspectives of I, V and A demonstrated financial benefits of I.