Funding a smoking cessation program for Crohn's disease: an economic evaluation.

OBJECTIVES: Patients with Crohn's disease (CD) who smoke are at a higher risk of flaring and requiring surgery. Cost-effectiveness studies of funding smoking cessation programs are lacking. Thus, we performed a cost-utility analysis of funding smoking cessation programs for CD. METHODS: A cost-utility analysis was performed comparing five smoking cessation strategies: No Program, Counseling, Nicotine Replacement Therapy (NRT), NRT+Counseling, and Varenicline. The time horizon for the Markov model was 5 years. The health states included medical remission (azathioprine or antitumor necrosis factor (anti-TNF), dose escalation of an anti-TNF, second anti-TNF, surgery, and death. Probabilities were taken from peer-reviewed literature, and costs (CAN$) for surgery, medications, and smoking cessation programs were estimated locally. The primary outcome was the cost per quality-adjusted life year (QALY) gained associated with each smoking cessation strategy. Threshold, three-way sensitivity, probabilistic sensitivity analysis (PSA), and budget impact analysis (BIA) were carried out. RESULTS: All strategies dominated No Program. Strategies from most to least cost effective were as follows: Varenicline (cost: $55,614, QALY: 3.70), NRT+Counseling (cost: $58,878, QALY: 3.69), NRT (cost: $59,540, QALY: 3.69), Counseling (cost: $61,029, QALY: 3.68), and No Program (cost: $63,601, QALY: 3.67). Three-way sensitivity analysis demonstrated that No Program was only more cost effective when every strategy's cost exceeded approximately 10 times their estimated costs. The PSA showed that No Program was the most cost-effective <1% of the time. The BIA showed that any strategy saved the health-care system money over No Program. CONCLUSIONS: Health-care systems should consider funding smoking cessation programs for CD, as they improve health outcomes and reduce costs.

[Clinical and Economic Efficacy of Ivabradine in Patients Suffered Myocardial Infarction].

OBJECTIVE: to assess the clinical and cost-effectiveness of the addition to the treatment of patients with coronary artery disease, myocardial infarction (MI). If current blocker ivabradine. MATERIAL AND METHODS: as a basis for pharmacoeconomic research results of the program are taken battleships, in which 1226 patients with MI less than 12 months ago, for 16 weeks received ivabradine in addition to standard therapy. When conducting pharmacoeconomic calculations take into account the direct medical and non-medical costs of treating patients with drugs; the call ambulance crews (CAC); on the patients stay in the hospital at admission. To determine the cost of use of ivabradine used data on daily dosages of the drug presented in the program battleships. In this case, using the retail price of drugs taken from the resource pharmindex.ru (date accessed 6/23/14). When calculating the cost of hospitalization and emergency calls using the values specified in the decree of october 18, 2013 No932 "About the state guarantees the free provision of medical care to citizens for 2014 and the planning period of 2015 and 2016.". RESULTS: according to a study LINCOR adding ivabradine to standard therapy resulted in a significant reduction in the frequency of angina attacks, the need for treatment for CACs and hospitalization. Average total cost of a full 16-week course of therapy with a patient ivabradine 1.87 times lower than with the standard therapy alone. The most obvious benefits to health care institutions: the total cost of emergency calls and hospitalization when added to treatment with ivabradine reduced 20,027.79 to 1,630.45 rubles, le 12.3 times. CONCLUSION: despite the increase in direct costs due to the cost of the drug, the addition to the standard therapy of ivabradine in patients with myocardial infarction, pharmaco is more effective than using only standard therapy, due to a significant reduction in the need for emergency calls and hospitalization.

A pragmatic, randomized, controlled study evaluating the impact of access to smoking cessation pharmacotherapy coverage on the proportion of successful quitters in a Canadian population of smokers motivated to quit (ACCESSATION).

BACKGROUND: Many smokers find the cost of smoking cessation medications a barrier. Financial coverage for these medications increases utilization of pharmacotherapies. This study assesses whether financial coverage increases the proportion of successful quitters. METHODS: A pragmatic, open-label, randomized, controlled trial was conducted in 58 Canadian sites between March 2009 and September 2010. Smokers (≥10 cigarettes/day) without insurance coverage who were motivated to quit within 14 days were randomized (1:1) in a blinded manner to receive either full coverage eligibility for 26 weeks or no coverage. Pharmacotherapies covered were varenicline, bupropion, or nicotine patches/gum. Investigators/subjects were unblinded to study group assignment after randomization and prior to choosing a smoking cessation method(s). All subjects received brief smoking cessation counseling. The primary outcome measure was self-reported 7-day point prevalence of abstinence (PPA) at week 26. RESULTS: Of the 1380 randomized subjects (coverage, 696; no coverage, 684), 682 (98.0%) and 435 (63.6%), respectively, were dispensed at least one smoking cessation medication dose. The 7-day PPA at week 26 was higher in the full coverage versus no coverage group: 20.8% (n = 145) and 13.9% (n = 95), respectively; odds ratio (OR) = 1.64, 95% confidence interval (CI) 1.23-2.18; p = 0.001. Urine cotinine-confirmed 7-day PPA at week 26 was 15.7% (n = 109) and 10.1% (n = 69), respectively; OR = 1.68, 95% CI 1.21-2.33; p = 0.002. After pharmacotherapy, coverage eligibility was withdrawn from the full coverage group, continuous abstinence between weeks 26 and 52 was 6.6% (n = 46) and 5.6% (n = 38), in the full coverage and no coverage groups, respectively; OR = 1.19, 95% CI 0.76-1.87; p = 0.439. CONCLUSIONS: In this study, the adoption of a smoking cessation medication coverage drug policy was an effective intervention to improve 26-week quit rates in Canada. The advantages were lost once coverage was discontinued. Further study is required on the duration of coverage to prevent relapse to smoking. (clinicaltrials.gov identifier: NCT00818207; the study was sponsored by Pfizer Inc.).

Economic evaluation of ivabradine in the treatment of chronic heart failure in Greece.

BACKGROUND: The objective of our study was to assess the cost-effectiveness of ivabradine plus standard care (SoC) in chronic heart failure (CHF) patients with sinus rhythm and a baseline heart rate ≥ 75 b.p.m. in Greece, in comparison with current SoC alone. METHODS: An existing cost-effectiveness model consisting of two health states, was adapted to the Greek health care setting. All clinical inputs of the model (i.e. mortality rates, hospitalization rates, NYHA class distribution and utility values) were estimated from SHIFT trial data. All costing data used in the model reflects the year 2013 (in €). An incremental cost effectiveness ratio (ICER) per quality-adjusted life year (QALY) gained was calculated. Deterministic and probabilistic sensitivity analyses (PSA) were conducted. The horizon of analysis was over patient life time and both cost and outcomes were discounted at 3.5% per year. The analysis was conducted from a Greek third party-payer perspective. RESULTS: The Markov analysis revealed that the discounted quality-adjusted survival was 4.27 and 3.99 QALYs in the ivabradine plus SoC and SoC alone treatment arms, respectively. The cumulative lifetime total cost per patient was €8,665 and €5,873, for ivabradine plus SoC and SoC alone, respectively. The ICER for ivabradine plus SoC versus SoC alone was estimated as €9,986 per QALY gained. The PSA showed that the likelihood of ivabradine plus SoC being cost-effective at a threshold of €36,000/QALY was found to be 95%. CONCLUSIONS: Ivabradine plus SoC may be regarded as a cost-effective option for the treatment in CHF patients in Greece.

Cost-effectiveness of tolvaptan in autosomal dominant polycystic kidney disease.

UNLABELLED: Chinese translation BACKGROUND: In the TEMPO (Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes) trial, tolvaptan significantly reduced expansion of kidney volume and loss of kidney function. OBJECTIVE: To determine how the benefits of tolvaptan seen in TEMPO may relate to longer-term health outcomes, such as progression to end-stage renal disease (ESRD) and death, and cost-effectiveness. DESIGN: A decision-analytic model. DATA SOURCES: Published literature from 1993 to 2012. TARGET POPULATION: Persons with early autosomal dominant polycystic kidney disease. TIME HORIZON: Lifetime. PERSPECTIVE: Societal. INTERVENTION: Patients received tolvaptan therapy until death, development of ESRD, or liver complications or no tolvaptan therapy. OUTCOME MEASURES: Median age at ESRD onset, life expectancy, discounted quality-adjusted life-years and lifetime costs (in 2010 U.S. dollars), and incremental cost-effectiveness ratios. RESULTS OF BASE-CASE ANALYSIS: Tolvaptan prolonged the median age at ESRD onset by 6.5 years and increased life expectancy by 2.6 years. At $5760 per month, tolvaptan cost $744 100 per quality-adjusted life-year gained compared with standard care. RESULTS OF SENSITIVITY ANALYSIS: For patients with autosomal dominant polycystic kidney disease that progressed more slowly, the cost per quality-adjusted life-year gained was even greater for tolvaptan. LIMITATION: Although TEMPO followed patients for 3 years, the main analysis assumed that clinical benefits persisted over patients' lifetimes. CONCLUSION: Assuming that the benefits of tolvaptan persist in the longer term, the drug may slow progression to ESRD and reduce mortality rates. However, barring an approximately 95% reduction in price, cost-effectiveness does not compare favorably with many other commonly accepted medical interventions. PRIMARY FUNDING SOURCE: National Institutes of Health and Agency for Healthcare Research and Quality.

Where vaptans do and do not fit in the treatment of hyponatremia.

The treatment of hyponatremia, an exceedingly common electrolyte disorder, has been a subject of controversy for many years. The advent of vasopressin antagonists (vaptans) has added to the treatment arsenal. This review focuses on why hyponatremia should be treated and the role of these antagonists in the treatment. Upon analysis of the available literature, we conclude that there is presently no role for vaptans in acute symptomatic hyponatremia. Although numerous therapeutic approaches are available for chronic symptomatic hyponatremia, vasopressin antagonists provide a simpler treatment option. Vaptans are efficacious in raising serum sodium in long-standing 'asymptomatic' hyponatremia. However, the cost of the only Food and Drug Administration-approved oral agent (tolvaptan) makes its use prohibitive for most patients in this setting.

Alcaftadine for the prevention of itching associated with allergic conjunctivitis.

OBJECTIVE: To evaluate the safety and efficacy of alcaftadine for the prevention of itching associated with allergic conjunctivitis. DATA SOURCES: A medical literature search was conducted in MEDLINE/PubMed (2006-February 2012) and EMBASE (2006-February 2012) using the search terms alcaftadine and Lastacaft. References from these publications were reviewed for additional resources. Additional information was collected from Web sites of the US government (http://www.clinicaltrials.gov, http://www.fda.gov) and of Allergan Inc., the manufacturer of Lastacaft (http://www.lastacaft.com). STUDY SELECTION AND DATA EXTRACTION: All identified articles and publications in English were reviewed for pharmacology, pharmacokinetics, efficacy, and safety data. Priority was placed on clinical trials. DATA SYNTHESIS: Two published clinical trials evaluated the efficacy of alcaftadine in the prevention of ocular itching and conjunctival redness associated with allergic conjunctivitis. One trial compared alcaftadine to placebo, and another trial compared alcaftadine to placebo and olopatadine HCl to placebo. Both studies showed superior efficacy, both clinically and statistically, in the prevention of ocular itching associated with allergic conjunctivitis compared to placebo. Although conjunctival redness was evaluated in the 2 trials, neither trial demonstrated both clinical and statistical significance. Both trials demonstrated a rapid onset of action of less than 15 minutes, as well as a duration of action greater than 16 hours, which supports the use of once-daily administration. Overall, alcaftadine was well tolerated, and common adverse effects, reported in less than 4% of patients, included ocular irritation, pruritus, erythema, and stinging or burning upon instillation. Ocular adverse effects were typically mild in severity and self-limiting. CONCLUSIONS: Alcaftadine is a safe and effective option for the prevention of ocular itching associated with allergic conjunctivitis, is dosed once daily, and is competitively priced among prescription medications for allergic conjunctivitis. Additional studies are needed to further evaluate the comparative efficacy among ocular antihistamine/mast cell stabilizing medications.

Systematic review of the cost-effectiveness of varenicline vs. bupropion for smoking cessation.

The purpose of this systematic review was to review the cost-effectiveness of first-line non-nicotine therapies (varenicline and bupropion SR) for smoking cessation, identify differences in the models used and their conclusions of cost-effectiveness, and to determine which variables, if any, impact conclusions of cost-effectiveness. A systematic literature search was conducted in MEDLINE, PsychINFO, the National Health Service Economic Evaluation Database, the Health Technology Database and the Tufts Cost-effectiveness Analysis Registry from the earliest possible date through May 2011. To be included, studies had to compare cost-effectiveness of varenicline to bupropion using either a Markov model or discrete event simulation and be published as a full text manuscript in English or Spanish. Study selection and data extraction were done in duplicate with disagreement resolved through discussion. Data regarding the model characteristics, results and conclusions were extracted as were details to assess the quality of the study. Model characteristics and cost-effectiveness results were compared across studies and summarised qualitatively. Ten unique studies were included, all of which were Markov models. Eight studies used the Benefits of Smoking Cessation on Outcomes (BENESCO) model and all found varenicline to dominate bupropion. The two non-BENESCO models found varenicline to be cost-effective. Conclusions regarding the cost-effectives were changed upon sensitivity analysis with the following variables: time horizon, cost of bupropion, efficacy of either drug, age and the incidence of smoking related disease. Varenicline dominated bupropion in most cost-effectiveness models. However, applicability of models to clinical practice and variables which changed conclusion of cost-effectiveness should be considered in the interpretation of results.

Economic impact of delays in listing decisions by provincial drug plans after a positive Common Drug Review recommendation: the case of a smoking-cessation treatment.

Although varenicline (Champix), a smoking-cessation treatment, was recommended for listing by the Common Drug Review (CDR) in 2007, only one CDR-participating drug insurance plan listed it in March 2011 (Saskatchewan). This study estimated the economic impact of delays in the public listing of varenicline in Canada. Using statistical data and peer-reviewed research, social costs and benefits of reimbursing varenicline were estimated. Flows of attempted and successful quitters were projected over a five-year period for three scenarios: immediate listing (2007), one- to four-year listing delays, and no reimbursement. Benefits of public reimbursement of varenicline would have been greatest in the first year ($271 million) and then decreased due to the erosion in smoking prevalence. The current three-year listing delay prevented a projected 17,729 current smokers from quitting, translating into a projected additional lifetime social burden of $700 million. The sizeable opportunity cost of delaying varenicline reimbursement implies broader economic issues for policy makers.

Vaptans are not the mainstay of treatment in hyponatremia: perhaps not yet.

Two vasopressin antagonists ('vaptans') are now in the market for the treatment of euvolemic (Europe) or euvolemic and hypervolemic (United States) hyponatremia: conivaptan for intravenous use and tolvaptan for oral application. Although their specificity and effectiveness are considered established, their indications are not. At present, we do not know which symptoms of hyponatremia and which degree of hyponatremia should serve as indications for vaptans. Other areas of uncertainty relate to the following unanswered questions: do vaptans shorten the duration of hospitalization? Is it justifiable to use them to prevent relapse of hyponatremia in (chronic) SIAD(H)? (In this text we use the abbreviation SIAD(H) instead of the recently proposed abbreviation SIAD to emphasize that vaptans will work only in the presence of ADH ('SIADH') but not in the syndrome of nephrogenic antidiuresis.) Do they decrease the high mortality associated with hyponatremia? How do we justify the cost of chronic vaptan therapy? The optimal vaptan regimen (dose, timing of controls) to treat SIAD(H) is currently not established, as is the procedure to be recommended in a too rapid correction rate of (chronic) hyponatremia. Until these requirements shall be met by additional studies, we are hesitant to consider vaptans a treatment of choice for the appropriate hyponatremias.

The cost-effectiveness of an extended course (12+12 weeks) of varenicline compared with other available smoking cessation strategies in the United States: an extension and update to the BENESCO model.

OBJECTIVES: This study aimed to estimate the cost-effectiveness of an extended (12+12 weeks) course of varenicline using the (Benefits of Smoking Cessation on Outcomes) BENESCO smoking cessation model. METHODS: Data on the efficacy of 12+12 weeks varenicline therapy in aiding smoking cessation were analyzed in conjunction with the efficacy data for 12 weeks of varenicline, bupropion, and placebo previously included in the BENESCO model, by using a mixed treatment comparison. This analysis provided updated efficacy estimates for all the interventions, and these were used to update the model to estimate the relative cost-effectiveness of all smoking cessation interventions considered, now including 12+12 weeks of varenicline. RESULTS: The updated 1-year abstinence estimates derived from the mixed treatment comparison were, for 12+12 weeks of varenicline, 12 weeks of varenicline, 12 weeks of bupropion, and 12 weeks of placebo, respectively: 27.7%, 22.9%, 15.9%, and 9.3%. The average cost of the course of 12+12 weeks of varenicline was estimated at $603.89, based on a 12-week course followed by a further 12 weeks for successful quitters. Over all subjects' lifetimes, 12+12 weeks of varenicline is less costly and more effective than (dominates) all other strategies compared in the updated BENESCO model, with the exception of 12 weeks of varenicline. In this comparison, 12+12 weeks of varenicline is a very cost-effective alternative to the 12-week course, with an incremental cost of less than $1000 per quality-adjusted life year (QALY) gained. CONCLUSIONS: A total of 12 weeks of varenicline followed by a further 12-week course for successful quitters is a highly cost-effective alternative compared with currently available smoking cessation options.

Crossing borders: factors affecting differences in cost-effectiveness of smoking cessation interventions between European countries.

OBJECTIVES: Many different factors affect the transferability of cost-effectiveness results between countries. The objective is to quantify the impact of nine potential causes of variation in cost-effectiveness of pharmacological smoking cessation therapies (SCTs) between The Netherlands (reference case), Germany, Sweden, UK, Belgium, and France. METHODS: The life-time benefits of smoking cessation were calculated using the Benefits of Smoking Cessation on Outcomes model, following a cohort of smokers making an unaided quit attempt, or using nicotine replacement therapy (NRT), bupropion, or varenicline. We investigated the impact of between-country differences in nine factors-demography, smoking prevalence, mortality, epidemiology and costs of smoking-related diseases, resource use and unit costs of SCTs, utility weights and discount rates-on the incremental net monetary benefit (INMB), using a willingness-to-pay (WTP) of euro20,000 per quality adjusted life year (QALY). RESULTS: The INMB of 1000 quit attempts with NRT versus unaided, varies from euro0.39 million (Germany) to euro1.47 million (France). The differences between the countries were primarily due to differences in discount rates, causing the INMB to change between -65% to +62%, incidence and mortality rates (epidemiology) of smoking-related diseases (-43% to +35%) and utility weights. Impact also depended on the WTP for a QALY and time horizon: at a low WTP or a short time horizon, the resource use and unit costs of SCTs had the highest impact on INMB. CONCLUSIONS: Although all INMBs were positive, there were significant differences across countries. These were primarily related to choice of discount rate and epidemiology of diseases.

Varenicline: a first-line treatment option for smoking cessation.

BACKGROUND: Varenicline acts as a partial agonist/antagonist with affinity and selectivity for alpha(4) beta(2) nicotinic acetylcholine receptors. This activity at the nicotine-receptor level may help patients achieve smoking cessation by reducing cravings/withdrawal symptoms and smoking satisfaction. OBJECTIVE: This article reviews the literature on the pharmacologic properties, therapeutic efficacy, and tolerability of varenicline for smoking cessation. METHODS: Pertinent controlled clinical trials, meta-analyses, meeting abstracts, case reports, and review articles published in English between 1966 and May 2008 were identified through searches of MEDLINE and OVID using the terms varenicline, smoking, tobacco cessation, and CP 526555. RESULTS: Eight clinical trials were identified that compared

Evaluation of cost-utility of varenicline compared with existing smoking cessation therapies in South Korea.

OBJECTIVE: This study aimed to evaluate the cost-effectiveness of varenicline compared with the other smoking cessation interventions, bupropion, nicotine replacement therapy (NRT), and willpower. METHODS: The Benefits of Smoking Cessation on Outcomes model was modified to reflect major smoking-related diseases in Korea. Transitional probabilities, resource utilization, and costs were obtained from Korean public data. The analysis was carried out from a societal perspective for the lifetime period. Also, series of sensitivity analyses, including probabilistic sensitivity analysis, were performed. RESULTS: With the exclusion of bupropion, which is subject to extended dominance, the incremental cost-effectiveness ratio (ICER) for varenicline versus NRT was analyzed as $US4809 per quality-adjusted life-year (QALY) during the lifetime. The results of sensitivity analysis are quite stable across most of the included parameters. The acceptability curves showed that the probability of varenicline being cost-effective was 83.3% at the willingness to pay of $US15,000. CONCLUSIONS: Even though the maximum willingness to pay for a QALY has not officially been defined, varenicline can be regarded as cost-effective because the ICER is at the 24.0% level of per capital gross domestic product, which is an implicit reference for decision-making in Korea.

Budgetary impact of varenicline in smoking cessation in the United Kingdom.

OBJECTIVES: To estimate the budgetary impact of varenicline in the United Kingdom (UK) in the first 5 years after its introduction to the smoking-cessation aid market, from the National Health Service (NHS) pharmacy perspective. METHODS: The economic impact of varenicline to the national health budget is estimated in a population of current, former, and new smokers. The analyses are based on data from a variety of secondary sources including national health data, clinical trials, and meta-analyses of smoking-cessation aids. The number of patients seeking aid and the treatment patterns are estimated using 2004 national health surveys, costs for medications from national prescription drug pricing tariffs, and efficacy of the various smoking-cessation aids from clinical trial data. Sensitivity analyses were performed to evaluate the impact of varying the patient parameters and costs. RESULTS: Model estimates suggest that the budgetary impact of varenicline would be 3.6 million pound in the second year after its introduction, with a 95% confidence interval of 0.63 to 7.2 million pound, and a resultant increase of 0.05% to the total NHS pharmacy budget. The model predicts that the addition of varenicline to the market would result in an additional 162,000 successful smoking-cessation attempts and 103,000 fewer smokers over 5 years, when compared to the world without varenicline. CONCLUSION: The introduction of varenicline is likely to result in greater numbers of individuals succeeding at smoking cessation, with an approximately 3.6 million pound (0.05%) increase in the NHS pharmacy budget.