Budget impact analysis of the use of oral and intravenous anti-cancer drugs for the treatment of HER2-positive metastatic breast cancer.

OBJECTIVES: Two anti-cancer drugs are currently approved for the treatment of HER2-positive metastatic breast cancer (MBC): trastuzumab-based therapy (TBT) administered intravenously as first line therapy until disease progression and lapatinib, an oral self-administered dual therapy with capecitabine (L+C) as second intention for patients who continue to progress despite TBT. In current practice, TBT is still prescribed beyond disease progression. In addition to medical reasons, the difficulty to switch eligible patients to oral drugs may also be explained by economic reasons. Thus, we aimed at comparing the budgetary impact of TBT and L+C for progressing HER2+MBC after TBT from the French Health Insurance perspective. METHODS: A budget impact analysis was performed on a 3-year time horizon (2012-2014) to simulate a dynamic cohort of 4182 HER2-positive patients with a progressing MBC treated with TBT (73%) and L + C (27%). The model was adjusted on progression-free survival (PFS). Office visits, clinical evaluations, drug acquisition, administration costs, and transportation costs obtained from the literature and published databases were considered. RESULTS: In the base case analysis (2012), the annual treatment cost per patient for TBT (€36,077) was 2-times higher than that of L + C (€17,165). Using L + C for all patients (n = 4182) would avoid €34.8 million of drug administration and transportation costs. Hospital costs represented 1% vs 88%, while community costs represented 99% vs 12% of L + C and TBT treatment costs, respectively. The lack of direct comparison PFS and treatment dosage modification data were the main limitations. However, no major changes from baseline results were observed from sensitivity analyses. CONCLUSIONS: Despite a slightly higher acquisition cost, the treatment cost of L + C remains lower than that of TBT, and it is the only approved anti-HER2 treatment for HER2-positive patients with progressing MBC. Based on this, it seems important to consider the potential savings for Health Insurance with the use of oral drug due to the reduction of outpatient hospitalizations. Such reductions may result in a subsequent budget reduction for hospitals, but may also provide those facing acute medical activity with opportunities to better manage other diseases whose treatment cannot be externalized.

Cost-effectiveness of partially-hydrolyzed formula for prevention of atopic dermatitis in Australia.

OBJECTIVE: To perform an economic evaluation of a specific brand of partially hydrolyzed infant formula (PHF-W) in the prevention of atopic dermatitis (AD) among Australian infants. METHODS: A cost-effectiveness analysis was undertaken from the perspectives of the Department of Health and Aging (DHA), of the family of the affected subject and of society as a whole in Australia, based on a decision-analytic model following a hypothetical representative cohort of Australian newborns who are not exclusively breastfed and who have a familial history of allergic disease (i.e., are deemed 'at risk'). Costs, consequences, and incremental cost-effectiveness ratios (ICER) were calculated for PHF-W vs standard cow's milk based infant formula (SF), and, in a secondary analysis, vs extensively hydrolyzed infant formula (EHF-Whey), when the latter was used for the prevention of AD. RESULTS: From a representative starting cohort of 87,724 'at risk' newborns in Australia in 2009, the expected ICERs for PHF-W vs SF were AU$496 from the perspective of the DHA and savings of AUD1739 and AU$1243 from the family and societal perspectives, respectively. When compared to EHF-Whey, PHF-W was associated with savings for the cohort of AU$5,183,474 and AU$6,736,513 from the DHA and societal perspectives. LIMITATIONS: The generalizability and transferability of results to other settings, populations, or brands of infant formula should be made with caution. Whenever possible, a conservative approach directing bias against PHF-W rather than its comparators was applied in the base case analysis. Assumptions were verified in one-way and probabilistic sensitivity analyses, which confirmed the robustness of the model. CONCLUSIONS: PHF-W appears to be cost-effective when compared to SF from the DHA perspective, dominant over SF from the other perspectives, and dominant over EHF-Whey from all perspectives, in the prevention of AD in 'at risk' infants not exclusively breastfed, in Australia.

Economic evaluation of a 100% whey-based partially hydrolyzed infant formula in the prevention of atopic dermatitis among Swiss children.

OBJECTIVE: A pharmacoeconomic analysis was undertaken to determine costs, consequences, and cost-effectiveness of a partially hydrolyzed 100% whey-based infant formula, NAN-HA®, manufactured by Nestlé S.A, Switzerland (PHF-W), branded under BEBA HA® in Switzerland, in the prevention of atopic dermatitis (AD) in 'at risk' Swiss children when compared to standard cow's milk formula (SF). METHODS: Based on a 12-month time horizon including 6 months of formula consumption, an economic model was developed synthesizing treatment pathways, resource utilization, and costs associated with the treatment of AD in healthy 'at risk' Swiss newborns who could not be exclusively breastfed. Model inputs were retrieved from the literature, official formularies, and expert opinion. The treatment pathways considered a medical treatment approach, supplemented in some instances by a change of formula. The final outcome was the expected cost per avoided case of AD, yielding an incremental cost effectiveness ratio (ICER) for PHF-W vs SF. Outcomes were presented from three perspectives: the Swiss public healthcare system (MOH), the subject's family, and society (SOC). A secondary analysis compared PHF-W to whey-based extensively hydrolyzed formula (EHF) in prevention. RESULTS: The model yielded 1653 avoided AD cases by selecting PHF-W over SF in a birth cohort of 22,933 'at risk' infants. The base case analyses generated an expected ICER of CHF 982 from the MOH perspective as well as savings of CHF 2202 and CHF 1220 from the family and SOC perspectives, respectively. PHF-W yielded CHF 11.4M savings against EHF when the latter was assumed to be used in prevention. One-way and probabilistic sensitivity analyses confirmed the robustness of the model. CONCLUSION: Under a range of assumptions, this analysis has established the dominance from the family and societal perspectives and cost-effectiveness from the MOH perspective of PHF-W vs SF in the prevention of AD among 'at risk' Swiss infants.

Economic evaluation of a 100% whey-based partially hydrolyzed infant formula in the prevention of atopic dermatitis among Danish children.

OBJECTIVE: A pharmacoeconomic analysis was undertaken to determine costs, consequences, and cost-effectiveness of a brand of partially hydrolyzed 100%-whey formula manufactured by Nestlé (PHF-W), in the prevention of atopic dermatitis (AD) in 'at risk' Danish children compared to extensively hydrolyzed formula (EHF-Whey or Casein). METHODS: Given the non-significant differences between PHF-W and EHF, the base case analytic approach amounted to a cost-minimization analysis (CMA) reporting the difference in formula acquisition costs over the period of formula consumption for the population of interest. However, sensitivity analyses (SAs) were undertaken to explore applying the nominal efficacy of PHF-W and EHF, thus leading to a cost-effectiveness analysis (CEA). Hence, an economic model based on a 12-month time horizon was developed synthesizing treatment pathways, resource utilization, and costs associated with the treatment of AD in the population of interest. The final economic outcome of the SAs was the incremental cost per avoided case (ICER) defined as the expected cost per avoided case of AD for PHF-W vs EHF, determined from three perspectives: the Ministry of Health (MOH), the family of the subject, and society (SOC). RESULTS: In the base case CMA, savings of DKK 9 M, DKK 20 M, and DKK 29 M were generated for PHF-W vs EHF from the MOH, family, and SOC perspectives. In the sensitivity CEA, PHF-W was dominant over EHF-Whey from all perspectives, while EHF-Casein displayed against PHF-W unattractive ICERs of DKK 315,930, DKK 408,407, and DKK 724,337 from the MOH, family, and SOC perspectives. Probabilistic SAs indicated that PHF-W was 86% likely to be dominant over EHF-Whey, whereas EHF-Casein had no likelihood of dominating PHF-W. CONCLUSION: Under a range of assumptions, this analysis demonstrated the attractiveness of PHF-W vs both types of EHF in the prevention of AD among 'at risk' Danish infants who are not or cannot be exclusively breastfed.

Partially hydrolysed 100% whey-based infant formula and the prevention of atopic dermatitis: comparative pharmacoeconomic analyses.

Clinical trials have demonstrated that the risk of developing atopic dermatitis is reduced when using hydrolysed formulas to feed infants with a documented risk of atopy (i.e. an affected parent and/or sibling)when breastfeeding is not practised. However, little is known about the cost-effectiveness of using hydrolysed formulas. Consequently, economic analyses in 5 European countries (Denmark, France, Germany, Spain and Switzerland) have evaluated the costs and cost-effectiveness of a specific brand of 100% whey-based partially hydrolysed infant formula, NAN-HA® (PHF-W) compared with a cow's milk standard formula (SF) in the prevention of atopic dermatitis in at-risk children. This review synthesises the findings of these studies. Cost-effectiveness analyses (CEA) used a decision-analytic model to determine treatment pathways, resource utilisation and costs associated with the management of atopic dermatitis in healthy at-risk newborns who were not exclusively breastfed. The model had a 12-month horizon and applied reimbursement rates of 60-100% depending on the country. Outcomes were considered from the perspective of the public healthcare system (e.g. the Ministry of Health; MOH), family and society. The final outcome was the incremental cost-effectiveness ratio per avoided case of atopic dermatitis (ICER) for PHF-W versus SF. A cost-minimisation analysis was also performed to compare PHF-W with extensively hydrolysed formulas (EHF). The base-case CEA produced ICERs per avoided case for PHF-W versus SF of EUR 982-1,343 (MOH perspective), EUR -2,202 to -624 (family perspective) indicating savings, and EUR -1,220 to 719 from the societal perspective. The main costs related to formula (MOH and society) and time loss (family). In the cost-minimisation analysis, PHF-W yielded savings of between EUR 4.3 and 120 million compared with EHF-whey when the latter was used in prevention. In conclusion, PHF-W was cost-effective versus SF in the prevention of atopic dermatitis and cost saving compared with EHF when used in prevention.

Comparison of scores derived from the box score-11 scale and the pain attribute of the health utilities index-3.

BACKGROUND: Pain is widespread, but has not yet been the focus of measurement in terms of patient preferences. This type of measure is needed for pharmacoeconomic analyses of pain medications. OBJECTIVE: Our objective was to compare scores from the Box Score (BS)-11 scale and the pain attribute of the Health Utilities Index (HUI)-3. METHODS: English- and/or French-speaking adult patients (aged ≥ 18 years) were recruited from pain clinics in four Canadian metropolitan areas (Toronto, Ottawa, Edmonton, Vancouver). Those providing informed consent completed both pain scales, assessing their average pain level over the previous 4 weeks. Kendall's Tau-b was calculated between score sets. Answers provided by patients were then used to determine the proportions of each of the BS-11 scores that mapped onto each of the five HUI-3 pain scores. RESULTS: Six of the 516 completed questionnaires had missing information, leaving 510 for analysis. The average age of patients was 49.5 ± 11.9 years; 70% were female. Tau-b was reasonably large and statistically significant between the scales (τ = 0.685; p < 0.001). No patients had zero scores on BS-11, and two patients scored 1, yielding inconclusive results for that score. Eight of the remaining nine BS-11 scores mapped ≥ 60% onto HUI-3 pain scores. BS-11 scores 2 and 10 had the best mapping (88% and 94%, respectively). CONCLUSIONS: BS-11 scores can be mapped onto the pain attribute of the HUI-3 with a high degree of correlation.

Persistence with prostaglandin agonist use with and without adjunctive therapy for glaucoma patients: a Canadian population-based analysis.

BACKGROUND: Glaucoma is one of the leading causes of blindness and visual disability. Few studies have examined persistence and adherence with topical medications in glaucoma patients. OBJECTIVE: The objective of this study was to compare patient persistence with prostaglandin agonist (PA) monotherapy versus with concomitant adjunctive therapy (AT) in Canada. METHODS: Data were obtained from the Québec prescription claims database. Persistence rates were determined for previously treated naive glaucoma patients at 1 year after their index date for use of any of the three available PAs (bimatoprost, latanoprost, and travoprost). Patients who had at least 334 days on their index PA were defined as being persistent during the analysis timeframe. Patient baseline demographics and persistence rates were reported. A logistic regression was used for comparing the PA and PA + AT groups, which incorporated baseline cofounders, such as age and sex, in the analyses. RESULTS: From an initial cohort of 28 534 patients, 14 893 were identified as naive to glaucoma therapy and had a PA as their index therapy. Of these, 11 197 (75.2%) continued to receive monotherapy and 3696 (24.8%) had an AT added to the PA; 59.0% were females, and the average age was 70.5 ± 11.3 years. Overall, at the end of the first year of therapy, 57.4% of patients were persistent on their index PA; however, a statistically significant difference was observed between the two subgroups, with 54.6% for those receiving PA monotherapy and 65.8% for those receiving PA + AT (p < 0.01) persistent with therapy. On average, 10.5 prescriptions per year were dispensed to persistent patients. CONCLUSIONS: In this Canadian population, persistence rates fall to approximately 60% at the end of the first year of therapy, with patients taking AT being more persistent. Similar persistence analyses are warranted on other populations, and would yield helpful data for conducting economic evaluations of non-persistence.

Methylnaltrexone in the treatment of opioid-induced constipation in cancer patients receiving palliative care: willingness-to-pay and cost-benefit analysis.

CONTEXT: When laxative regimens have failed, methylnaltrexone may be indicated for the relief of opioid-induced constipation (OIC) in patients with advanced illness receiving palliative care. OBJECTIVES: A cost-benefit analysis (CBA), based on a willingness-to-pay (WTP) approach, was performed to determine if methylnaltrexone should be added to the formulary list of drugs being reimbursed by third-party payers in Canada for the treatment of cancer patients in palliative care suffering from OIC. METHODS: The WTP study had two components: a decision board explaining treatment options (Component A) and a questionnaire to measure individual WTP using a bidding game approach (Component B). Component A had two options: Option 1 (laxatives only) and Option 2 (laxatives+methylnaltrexone injection). Only participants choosing Option 2 were invited to complete Component B. The results of the WTP survey were then incorporated into a CBA. Within a hypothetical cohort, additional monthly premiums that individuals were willing to pay for methylnaltrexone were compared with the monthly costs to the insurer for providing methylnaltrexone to all patients who would potentially be using it. RESULTS: Four hundred one Canadians, of age 18 years and older, were surveyed and yielded a WTP in additional monthly insurance premiums of Canadian dollar (CAD) $8.65 (95% confidence interval: CAD$6.17-CAD$11.13). The CBA resulted in additional CAD$89,307 with a cost of CAD$139,840 and benefits of CAD$229,147. A set of 10,000 Monte Carlo simulations resulted in average CBA savings of CAD$145,011 with a 99.86% probability of dominance. CONCLUSION: The present CBA provides pharmacoeconomic evidence for the adoption of methylnaltrexone for treating OIC in terminally ill cancer patients.

Economic evaluation of a 100% whey-based, partially hydrolysed formula in the prevention of atopic dermatitis among French children.

OBJECTIVE: A pharmacoeconomic analysis was performed to determine costs, consequences and cost effectiveness of a partially hydrolysed 100% whey-based infant formula, NAN HA, manufactured by Nestlé S.A, Switzerland (PHF-W) and branded under Nidal Excel HA in France, in the prevention of atopic dermatitis (AD) in 'at risk' children when compared to standard cows' milk formula (SF) in France. METHODS: A decision-analytic economic model depicting AD treatment pathways, as well as resource utilisation and costs associated with the treatment of AD in healthy yet 'at risk' French newborns who cannot be exclusively breastfed was constructed for a 12-month time horizon, including an initial 6 months of intervention with formula consumption. Model inputs were based on the literature, official formularies and expert opinion. The modelled treatment pathways included a dietary management approach (formula change), a medical treatment approach and a combination thereof. The final outcome was the expected cost per avoided case of AD, yielding an incremental cost per avoided case (ICER) of AD when comparing subjects who used PHF-W versus SF. Outcomes were presented from three perspectives: the French Ministry of Health (MOH), the subjects' family and society as a whole. A secondary analysis also compared PHF-W to extensively hydrolysed formula (EHF) in prevention. RESULTS: The number of avoided AD cases by selecting PHF-W over SF was 13,356 cases in a birth cohort of 185,298 'at risk' infants. The base case analysis, at 65% reimbursement, yielded expected ICERs of €1343, € -624 (savings) and €719 from the MOH, family and societal perspectives, respectively. From all three perspectives, the highest cost was attributable to formula. In case of a 35% reimbursement rate for PHF-W, the ICER was €615 from the MOH perspective, while the use of PHF-W was cost neutral at 10% reimbursement. PHF-W was cost-saving against EHF (€98-€116 million savings depending on type of EHF), when this latter was used in prevention. One-way and probabilistic sensitivity analyses confirmed the robustness of the model. CONCLUSION: Under a certain range of assumptions, this analysis based on predictive modelling has established the cost effectiveness of PHF-W in the prevention of AD in infants.

Economic impact of the introduction of an acellular pertussis vaccine in Canada: a 6-year analysis.

BACKGROUND: Between July 1997 and April 1998, Canadian public health agencies switched from the whole cell vaccine to the acellular vaccine for pertussis immunization. The acellular vaccine provided better efficacy and fewer adverse events than the whole cell vaccine did. OBJECTIVE: To determine the economic impact of replacing the whole cell vaccine with an acellular vaccine in Canada. METHODS: A decision analytic model was developed comparing costs and outcomes of pertussis vaccination for Canadian children born in the years 1991-2004. Effectiveness was measured as number of avoided pertussis cases as well as the number of avoided hospital admissions. Incremental costs per avoided pertussis case and per avoided hospital admission were calculated for Ministry of Health (MoH) and societal (SOC) perspectives. Various one-way sensitivity analyses as well as a Monte Carlo simulation were performed by varying key model parameters. RESULTS: The switch in immunization programs resulted in an incremental cost to the MoH of CAD $108 per pertussis case avoided (CAD $0.96 per child-year). From the SOC perspective, there was a savings of CAD $184 per pertussis case avoided (CAD $0.13 per child-year). The one-way sensitivity analyses provided incremental cost-effective ratios (ICERs) ranging from an incremental cost of CAD $1034 per avoided pertussis case from the MoH perspective to a saving of CAD $1583 per avoided case from the SOC perspective. The Monte Carlo simulation confirmed the robustness of these results. CONCLUSIONS: Pertussis vaccination with AcE was cost-saving from the societal perspective and cost-effective from the Ministry of Health perspective.

Willingness to pay for a treatment for pain in multiple sclerosis.

BACKGROUND: Multiple sclerosis (MS) is a chronic neurological disease that affects 240 per 100 000 Canadians. Of these patients, 10-80% (average 70%) experience pain. Sativex is a cannabis-based drug recently approved for neuropathic pain. OBJECTIVES: In this study, we determine individuals' preferences between two treatment options as well as the willingness to pay (WTP) for Sativex, expressed as the amount they would pay in insurance premiums to have access to that treatment. METHODS: The WTP instrument comprised a decision board as a visual aid, and a questionnaire. A decision board helps clinicians standardize the presentation of treatment information. In this study, the decision board described two treatment options: a three-drug combination (gabapentin, amytriptyline, acetaminophen [paracetamol] {i.e. pills}) and the three-drug combination plus Sativex (i.e. 'pills and oral spray'). Information on efficacy and adverse effects was taken from trial data; wording was guided by a panel of neurologists and tested for clarity on lay people. The instrument was administered to 500 participants from Canada's general population using the bidding game approach. Descriptive statistics were calculated. RESULTS: Mean (SD) age of participants was 39 (13) years, with a female : male distribution of 56 : 44. The decision board was presented in both English (85%) and French (15%). Of 500 interviewees, 253 (50.6%) chose the 'pills and oral spray'. Mean monthly WTP for the insurance premium for those who chose the 'pills and oral spray' was Can dollars 8 (SD +/- 15, median 4, range 0-200). CONCLUSIONS: Assuming that 51% of the general population are willing to pay additional premiums as reported in this study, the premiums collected would cover the cost of Sativex for all Canadian MS patients experiencing pain, with a surplus.

Cost-effectiveness of escitalopram for generalized anxiety disorder in Canada.

BACKGROUND: Generalized Anxiety Disorder (GAD) is a common chronic disease with a lifetime prevalence estimated to range from 4.2% to 12.7%. GAD places a substantial burden upon patients and healthcare resources. OBJECTIVE: To determine the cost-effectiveness of escitalopram for GAD in a Canadian primary care setting from two perspectives [Ministry of Health (MoH) and society (SOC)]. METHODS: A 24-week decision-analytic model was constructed using Data/TreeAge software. Patients were treated with escitalopram or generic paroxetine. Clinical rates were determined from the literature; expert opinion guided model pathway development. Effectiveness was measured as 'symptom-free days' (SFDs). Analyses from MoH perspective focused on direct costs of treatment (drugs, physician visits), while SOC also accounted for indirect costs associated with workdays lost due to GAD. Unit costs of healthcare services and wage rates were obtained from standard Canadian sources (2005 Canadian $ values). Cost-effectiveness was expressed as the incremental cost-effectiveness ratio (ICER). Extensive one-way and probabilistic sensitivity analyses were conducted. RESULTS: Escitalopram was associated with higher expected number of SFDs than paroxetine (86.4 vs. 77.0 SFD, respectively). From the MoH perspective, expected costs were Can$724 and Can$663 for escitalopram and paroxetine arms, respectively, resulting in the ICER for escitalopram vs. paroxetine of Can$6.56/SFD (Can$2362/symptom free year). From the SOC perspective, escitalopram dominated paroxetine as more effective on SFDs and less costly. Sensitivity analyses demonstrated robustness of the model. Limitations include the absence of comorbidities, which are common in practice, lack of long-term data, and assuming that dropouts in trials reflect those in practice. CONCLUSION: Escitalopram was found to be cost-effective compared with paroxetine in treatment of GAD from the Canadian MoH perspective, and dominating paroxetine from the SOC perspective. Therefore, a possible advantage may exist at the population level in the treatment of GAD with escitalopram in Canada.

Cost comparison of prostaglandin analogues: a Canadian population-based analysis.

OBJECTIVES: Glaucoma is a fairly common disease, however, little is known about the costs associated with prostaglandin analogues (PAs). The costs between the three available PAs (Lumigan (bimatoprost), Xalatan (latanoprost) and Travatan (travoprost)) were compared as monotherapy and when adjunctive therapy was used. METHODS: From the Québec drug claims database, all patients who used these drugs for 1 full year were identified. From the Ministry of Health (MoH) perspective, the average cost for all reimbursed costs (drug costs and pharmacist fees) were calculated. Those costs plus the patient out-of-pocket copayments were used for the payer + user (PU) perspective. RESULTS: Data from 4,653 patients were analysed (3,606 on monotherapy and 1,047 on combination treatment with adjunctive therapy), 59.7% were females, and the average age was 72.6 +/- 10.4 years. MoH perspective costs were $410 +/- $167 for bimatoprost, $381 +/- $145 for latanoprost and $298 +/- $121 for travoprost (all differences p<0.001), for patients on monotherapy. Costs of combination treatment with adjunctive therapy were $786 +/- $416, $686 +/- $313, and $623 +/- $521, respectively (travoprost significantly lower than each of the other two p<0.001, others=not significant). Results from the PU perspective were comparable. CONCLUSIONS: Travoprost had the lowest cost, both as monotherapy and in conjunction with other glaucoma treatments. Further comparative pharmacoeconomic evaluation is warranted.

Pain due to multiple sclerosis: analysis of the prevalence and economic burden in Canada.

BACKGROUND: Multiple sclerosis (MS) is a neurological disease affecting approximately 50,000 Canadians. Although studies have described overall MS costs, none have focused specifically on MS-related pain. OBJECTIVES: To estimate the prevalence of MS-related pain in Canada, the proportion of patients treated and responding to treatment for MS-related pain, and the associated economic burden. METHODS: Results were captured through physician and patient surveys. Patients were recruited through MS clinics and the MS Society. Patient-reported outcomes and resource utilization over the previous six months were collected by telephone interview. Costs were measured in 2004 Canadian dollars. The economic burden was extrapolated to the population using national demographics and prevalence. Spearman's rho assessed the relationship between cost and pain severity. RESULTS: Physicians estimated that 46% of their MS patients experienced MS-related pain, and that 35% received treatment for pain. Pain was reported to be relieved somewhat in 29%+/-10% of their patients, adequately in 26%+/-19% and poorly in 27%+/-13%, while 17%+/-9% received no relief. Two hundred ninety-seven participants completed the patient survey. Seventy-one per cent (211 of 297 patients) experienced MS-related pain. Eighty per cent of patients reported taking some type of medication to manage their pain, and of these, 82% reported some reduction in pain. The mean +/- SD direct cost per patient of MS-related pain was dollars 2,528+/-5,695. The mean +/- SD indirect cost per patient was dollars 669+/-875. Total costs were positively correlated with levels of self-reported pain (rho=0.291, rho<0.0001). The estimated six-month burden of pain of MS patients in Canada was dollars 79,444,888. CONCLUSIONS: The prevalence of pain is high in MS patients. This condition may be underdiagnosed and undertreated, and results in a significant economic burden on society.

The economic impact of introducing serotonin-noradrenaline reuptake inhibitors into the Brazilian national drug formulary: cost-effectiveness and budget-impact analyses.

OBJECTIVE: To determine the cost effectiveness, from the Brazilian Ministry of Health viewpoint, of three antidepressant classes for major depressive disorder (MDD), and the budget impact of introducing serotonin-noradrenaline (norepinephrine) reuptake inhibitors (SNRIs) into the current Brazilian national drug formulary, assuming a 6-month treatment duration. METHODS: An existing decision-tree model was adapted to Brazil, based on local guidelines. Clinical data were obtained from published meta-analyses. Patients included adults aged > or =18 years with MDD, diagnosed using the Diagnostic and Statistical Manual of Mental Disorders, third and fourth editions (DSM-III/IV), with moderate-to-severe disease (Hamilton Depression Rating Scale [HAMD] > or =15 or Montgomery-Asberg Depression Rating Scale [MADRS] > or =18), without co-morbidities or co-medications, receiving > or =6 weeks of treatment with SNRIs, selective serotonin reuptake inhibitors (SSRIs) and/or tricyclic antidepressants (TCAs). Clinical outcome was remission (HAMD < or =7 or MADRS < or =12). Direct costs (drugs, physician visits, hospitalisations) were included. Drug costs were obtained from the 2006 Brazilian National Drug Price List, and hospitalisation and physician costs from the 2006 Healthcare System database. Costs were valued in Brazilian Reais ($Brz), year 2006 values ($Brz1 = $US0.47). Univariate and Monte Carlo sensitivity analyses tested model robustness. RESULTS: Expected costs per patient treated were SNRIs $Brz4848; SSRIs $Brz5466; and TCAs $Brz5046, and overall success rates (primary plus secondary treatment across all decision tree branches) were SNRIs 78.1%; SSRIs 74.0%; and TCAs 76.4%. Average costs/success were SNRIs $Brz6209; SSRIs $Brz7385; and TCAs $Brz6602. SNRIs dominated in incremental cost-effectiveness analyses. Monte Carlo analysis confirmed drug classes' relative positions; however, there was considerable uncertainty. Introducing SNRIs into the formulary could generate average savings of 1% of the total budget, with a 52% probability of savings. CONCLUSIONS: SNRIs appear to be cost effective against SSRIs and TCAs when prescribed to patients with MDD in Brazil. However, their inclusion into the national drug list would generate minor savings compared with the current formulary of SSRIs and TCAs. Thus, we considered such inclusion as 'cost-neutral', since no major probability of savings or increased expenditures were observed.

Quality assessment of published health economic analyses from South America.

BACKGROUND: Health economic analyses have become important to healthcare systems worldwide. No studies have previously examined South America's contribution in this area. OBJECTIVE: To survey the literature with the purpose of reviewing, quantifying, and assessing the quality of published South American health economic analyses. METHODS: A search of MEDLINE (1990-December 2004), EMBASE (1990-December 2004), International Pharmaceutical Abstracts (1990-December 2004), Literatura Latino-Americana e do Caribe em Ciências da Saúde (1982-December 2004), and Sistema de Informacion Esencial en Terapéutica y Salud (1980-December 2004) was completed using the key words cost-effectiveness analysis (CEA), cost-utility analysis (CUA), cost-minimization analysis (CMA), and cost-benefit analysis (CBA); abbreviations CEA, CUA, CMA, and CBA; and all South American country names. Papers were categorized by type and country by 2 independent reviewers. Quality was assessed using a 12 item checklist, characterizing scores as 4 (good), 3 (acceptable), 2 (poor), 1 (unable to judge), and 0 (unacceptable). To be included in our investigation, studies needed to have simultaneously examined costs and outcomes. RESULTS: We retrieved 25 articles; one duplicate article was rejected, leaving 24 (CEA = 15, CBA = 6, CMA = 3; Brazil = 9, Argentina = 5, Colombia = 3, Chile = 2, Ecuador = 2, 1 each from Peru, Uruguay, Venezuela). Variability between raters was less than 0.5 point on overall scores (OS) and less than 1 point on all individual items. Mean OS was 2.6 (SD 1.0, range 1.4-3.8). CBAs scored highest (OS 2.8, SD 0.8), CEAs next (OS 2.7, SD 0.7), and CMAs lowest (OS 2.0, SD 0.5). When scored by type of question, definition of study aim scored highest (OS 3.0, SD 0.8), while ethical issues scored lowest (OS 1.5, SD 0.9). By country, Peru scored highest (mean OS 3.8) and Uruguay had the lowest scores (mean OS 2.2). A nonsignificant time trend was noted for OS (R2 = 0.12; p = 0.104). CONCLUSIONS: Quality scores of health economic analyses articles published in South America were rated poor to acceptable and lower than previous research from other countries. Thus, efforts are needed to improve the reporting quality of these analyses in South America. Future research should examine the region's level of expertise and educational opportunities for those in the field of health economics.

Screening for glaucoma in Canada: a systematic review of the literature.

BACKGROUND: To provide a recommendation on screening for glaucoma in Canada based on a review of recent evidence available in the literature. METHODS: A systematic literature review was performed to identify publications from MEDLINE, EMBASE, HealthSTAR, and Cochrane databases from 1990 to 2005. Relevant articles were categorized as economic studies, epidemiologic and intervention studies, or policy papers. Web sites and publications from provincial, state, national, and international health authorities were reviewed for policy recommendations and guidelines. RESULTS: We identified 39 articles (34 epidemiology and intervention, and 5 economic studies) for the review. From the economic studies, 2 were simple cost analyses and 3 were full economic evaluations (cost-effectiveness). Gaps were observed from these economic studies, where incremental cost-effectiveness analyses of modelled screening programmes were not observed. A large number of alternatives (i.e., screening techniques) and diverse outcome measures were found in the 34 epidemiology and intervention studies. This shows that evidence on the effectiveness of glaucoma screening programmes is available to be used in future modelled analyses. Neutral recommendation made by the Canadian Task Force on Periodic Health Examination regarding glaucoma screening in Canada could be related to the lack of reliable data and models used in past cost-effectiveness analyses. INTERPRETATION: A need exists to reevaluate the cost-effectiveness of a screening programme for glaucoma in Canada with updated efficacy and cost data. Health and monetary benefits could be improved compared with current practice and decision-makers would have the best available data when reevaluating the policy on screening for glaucoma.

Cost-effectiveness of treprostinil versus epoprostenol in patients with pulmonary arterial hypertension: a Canadian analysis.

BACKGROUND: Pulmonary arterial hypertension (PAH) is associated with substantial morbidity and mortality, exerting a tremendous health and economic impact on patients. In the present study, an economic evaluation of patients with PAH treated with either treprostinil or epoprostenol was performed. METHODS: A cost-minimization analysis (a cost-effectiveness subtype) was performed under the assumption that treprostinil and epoprostenol were clinically equivalent. Two cohorts of 60 patients, treated with treprostinil or epoprostenol, were evaluated over three years by using a dynamic spreadsheet model. The evaluation included both the provincial ministries of health and societal perspectives. Resource valuation data for drugs, medical supplies, consultations, and surgical and diagnostic procedures were obtained from standard lists. Costs of hospitalizations and adverse events were derived from published sources. Additional outpatient costs were considered equivalent and, therefore, were excluded from the analysis. Costs are presented in 2003 Canadian dollars discounted at 3%. Sensitivity analyses were performed testing all uncertainties in the model. RESULTS: In the base-case analysis (over three years), treatment with treprostinil resulted in an expected savings of 2,610,642 US dollars and 2,781,438 US dollars from the ministries of health and societal perspectives, respectively. On a per-patient level, treatment with treprostinil resulted in an average annual savings of 14,504 US dollars and 15,452 US dollars, respectively. The greatest savings with treprostinil came from reduced hospitalizations. Multivariate sensitivity analyses estimated cost savings in greater than 99% of scenarios. CONCLUSIONS: By initiating and continuing treprostinil treatment over a three-year period, the economic burden associated with PAH may be reduced compared with epoprostenol treatment.

Economic evaluation of Avonex (interferon beta-Ia) in patients following a single demyelinating event.

BACKGROUND: Interferon beta-Ia (Avonex) 30 microg, intramuscular (i.m.), once weekly is efficacious in delaying clinically definite multiple sclerosis (CDMS) following a single demyelinating event (SDE). This study determined the cost effectiveness of Avonex compared to current treatment in delaying the onset of CDMS. METHODS: A cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) were performed from Ministry of Health (MoH) and societal perspectives. For CEA, the outcome of interest was time spent in the pre-CDMS state, termed monosymptomatic life years (MLY) gained. For CUA, the outcome was quality-adjusted monosymptomatic life years (QAMLY) gained. A Markov model was developed with transitional probabilities and utilities derived from the literature. Costs were reported in 2002 Canadian dollars. Costs and outcomes were discounted at 5%. The time horizon was 12 years for the CEA, and 15 years for the CUA. All uncertainties were tested via univariate and multivariate sensitivity analyses. RESULTS: In the CEA, the incremental cost of Avonex per ILYgained was $53110 and $44789 from MoH and societal perspectives, respectively. In the CUA, the incremental cost of Avonex per QAMLY gained was $227586 and $189286 from MoH and societal perspectives, respectively. Both models were sensitive to the probability of progressing to CDMS and the analytical time horizon. The CUA was sensitive to the utilities value. CONCLUSION: Avonex may be considered as a reasonably cost-effective approach to treatment of patients experiencing an SDE In addition, the overall incremental cost-effectiveness profile of Avonex improves if treatment is initiated in pre-CDMS rather than waiting until CDMS.

Association between corneal thickness, mean intraocular pressure, disease stability and severity, and cost of treatment in glaucoma: a Canadian analysis.

PURPOSE: We determined the association between the mean corneal thickness (CT) and visual field mean defect (VF) severity as well as with mean intraocular pressure (IOP), disease stability, and cost of glaucoma therapy in a Canadian setting. METHODS: Data were collected from charts of patients diagnosed with primary open-angle glaucoma (POAG). CT measures, VF scores, IOP measurements, physicians' impressions, and resources used (physician visits, diagnostic tests, procedures, and medications) were recorded over a minimum of 2.5 years. CT was compared across the three VF severity levels [mild (0 to < 5 dB), moderate (5 to < 12 dB), and severe (>/= 12 dB)] using a Kruskall-Wallis test. Initial VF was regressed on Age, CT, IOP, and Optic Disc Ratio. Stability and Cost were regressed on IOP. RESULTS: Of the 411 charts, 132 included CT measures. Patients included 50 with mild, 43 with moderate, and 39 with severe disease. The mean CTs of the overall, mild, moderate, and severe groups were 545.9 mum, 554.7 mum, 549.8 mum, and 523.3 mum, respectively. There were statistically significant differences (p < 0.05) between the CT pp of the mild and severe groups as well as between the moderate and severe groups. Regression analyses suggested that CT may be a predictor of disease severity, but not of cost. It was also found that IOP may be a predictor of disease progression. CONCLUSIONS: Patients with severe VFs tend to be those who have thinner corneas. Further research is warranted, as a result of the limited sample size, to clarify the definitive association among corneal thickness, disease progression, and the cost of therapy.