Cost-Effectiveness Analysis of the South African Infant National Immunization Program for the Prevention of Pneumococcal Disease.

INTRODUCTION: Pneumococcal disease, which presents a substantial health and economic burden, is prevented through pneumococcal vaccination programs. We assessed the impact of switching from a 13-valent-based (PCV13) to lower 10-valent-based (PCV10-GlaxoSmithKline [GSK] or PCV10-Serum Institute of India [SII]) or higher-valent (PCV15 or PCV20) vaccination programs in South Africa. METHODS: A previously published decision-analytic model was adapted to a South African setting. Historical invasive pneumococcal disease (IPD) incidence data were used to project IPD incidence over time for each vaccination program on the basis of serotype coverage. Historical incidence (IPD, pneumonia, otitis media), mortality, costs, and utilities were obtained from the published literature. Cases of disease, direct medical costs (i.e., vaccination, IPD, pneumonia, and otitis media costs) (in 2022 South African rands), life-years, quality-adjusted life-years (QALY), and incremental cost per QALY were estimated over a 5- and 10-year horizon for PCV13 and the PCV10 vaccines. Additionally, a public health impact analysis was conducted comparing PCV13, PCV15, and PCV20. RESULTS: Continuing use of PCV13 would substantially reduce disease incidence over time compared with switching to either of the PCV10 lower-valent vaccines. Cases of IPD were reduced by 4.22% and 34.70% when PCV13 was compared to PCV10-GSK and PCV10-SII, respectively. PCV13 was also found to be cost saving over 5- and 10-year time horizons compared with PCV10-SII and to be cost-effective over a 5-year time horizon and cost-saving over a 10-year time horizon compared with PCV10-GSK. PCV20 was consistently estimated to prevent more cases than the PCV10 vaccines, PCV13, or PCV15. CONCLUSIONS: Switching from a higher-valent to a lower-valent vaccine may lead to disease incidence re-emergence caused by previously covered serotypes. Maintaining PCV13 was estimated to improve public health further by averting additional pneumococcal disease cases and saving more lives and also to reduce total costs in most scenarios. Higher-valent PCVs can achieve the greatest public health impact in the pediatric vaccination program in South Africa.

Validation of a Novel Forecasting Method for Estimating the Impact of Switching Pneumococcal Conjugate Programs: Evidence from Belgium.

INTRODUCTION: Since 2010, 10-valent (PCV10) and 13-valent pneumococcal conjugate vaccines (PCV13) have been available as part of infant national immunization programs. Belgium is as one of the few countries that implemented PCV13 (2007-2015), switched to PCV10 (2015-2018) and then switched back to PCV13 (2018-present) after observing increases in disease. We assessed the impacts of both historical and prospective PCV choice in the context of the Belgian health care system and used this experience to validate previously developed economic models. METHODS: Using historical incidence (2007-2018) of pneumococcal disease for Belgian children aged < 16 years, observed invasive pneumococcal disease (IPD) trends from surveillance data were used to estimate future disease in a given PCV13- or PCV10-based program. We compared observed incidence data with two modeled scenarios: (1) the 2015 switch to PCV10 and (2) a hypothetical continuation of PCV13 in 2015. Finally, we explored the potential impact of PCV choice from 2019 to 2023 by comparing three scenarios: (3) continued use of PCV10; (4) a switch back to PCV13; (5) a hypothetical scenario in which Belgium never switched from PCV13. RESULTS: Model predictions underestimated observed data from 2015 to 2018 by 100 IPD cases among ages < 16 years. Comparing observed data with scenario 2 suggests that PCV13 would have prevented 105 IPD cases from 2015 to 2018 compared with PCV10. Switching to PCV13 in 2019 would avert 625 IPD cases through 2023 compared with continuing PCV10. Scenario never switching from PCV13 would have resulted in a reduction of 204 cases from 2016 to 2023 compared with switching to PCV10 and switching back to PCV13. CONCLUSION: The findings from this study suggest that previously published modeling results of PCV13 versus PCV10 in other countries may have underestimated the benefit of PCV13. These results highlight the importance of continually protecting against vaccine-preventable pneumococcal serotypes.

Health and Economic Impact of Routine Pediatric Pneumococcal Immunization Programs in Canada: A Retrospective Analysis.

OBJECTIVE: A model was developed to estimate the historical impact (including total societal health and economic benefit) of pneumococcal conjugate vaccine (PCV) programs in the overall Canadian population between 2005 and 2015, inclusively. METHODS: Historical incidence of invasive pneumococcal disease (IPD), pneumonia, and acute otitis media (AOM) were obtained from epidemiologic databases supplemented with published and unpublished data. Two scenarios were considered: (1) the observed historical incidence from 2005 to 2015 in the setting of PCV use; (2) a hypothetical scenario in which we estimated the number of disease cases assuming no PCV use. Disease cases averted as a result of PCV programs were calculated by subtracting the number of observed historical cases from the number of estimated cases expected in the absence of PCV use. RESULTS: PCV programs were estimated to have saved 6631 lives and averted 14,990 IPD cases, 735,700 pneumonia episodes, and 3,697,993 AOM episodes. Positive clinical outcomes resulted in total cost savings of CAD $1.76 billion over 11 years. Vaccination costs were offset by the direct medical cost savings from fewer cases of IPD, pneumonia, and AOM. CONCLUSIONS: Canadian PCV programs have provided significant health benefits and resulted in a substantial value for money. Net savings achieved over the reviewed period would have provided funding for $1.76 billion in other health care costs or public health initiatives. These findings highlight the importance of considering the total value of a vaccination program, rather than vaccine acquisition costs only, when assessing the value of immunization programs.

Cost-effectiveness of vedolizumab compared with infliximab, adalimumab, and golimumab in patients with ulcerative colitis in the United Kingdom.

OBJECTIVE: To examine the clinical and economic impact of vedolizumab compared with infliximab, adalimumab, and golimumab in the treatment of moderately to severely active ulcerative colitis (UC) in the United Kingdom (UK). METHODS: A decision analytic model in Microsoft Excel was used to compare vedolizumab with other biologic treatments (infliximab, adalimumab, and golimumab) for the treatment of biologic-naïve patients with UC in the UK. Efficacy data were obtained from a network meta-analysis using placebo as the common comparator. Other inputs (e.g., unit costs, adverse-event disutilities, probability of surgery, mortality) were obtained from published literature. Costs were presented in 2012/2013 British pounds. Outcomes included quality-adjusted life-years (QALYs). Costs and outcomes were discounted by 3.5% per year. Incremental cost-effectiveness ratios were presented for vedolizumab compared with other biologics. Univariate and multivariate probabilistic sensitivity analyses were conducted to assess model robustness to parameter uncertainty. RESULTS: The model predicted that anti-tumour necrosis factor-naïve patients on vedolizumab would accrue more QALY than patients on other biologics. The incremental results suggest that vedolizumab is a cost-effective treatment compared with adalimumab (incremental cost-effectiveness ratio of £22,735/QALY) and dominant compared with infliximab and golimumab. Sensitivity analyses suggest that results are most sensitive to treatment response and transition probabilities. However, vedolizumab is cost-effective irrespective of variation in any of the input parameters. CONCLUSIONS: Our model predicted that treatment with vedolizumab improves QALY, increases time in remission and response, and is a cost-effective treatment option compared with all other biologics for biologic-naïve patients with moderately to severely active UC.

Cost-effectiveness of vedolizumab compared with conventional therapy for ulcerative colitis patients in the UK.

OBJECTIVE: To examine the clinical and economic impact of vedolizumab compared with conventional therapy in the treatment of moderately-to-severely active ulcerative colitis (UC) in the UK based on results of the GEMINI I trial. METHODS: A decision-analytic model in Microsoft Excel was used to compare vedolizumab with conventional therapy (aminosalicylates, corticosteroids, immunomodulators) for the treatment of patients with UC in the UK. We considered the following three populations: the overall intent-to-treat population from the GEMINI I trial, patients naïve to anti-TNF therapy, and those who had failed anti-TNF-therapy. Population characteristics and efficacy data were obtained from the GEMINI I trial. Other inputs (eg, unit costs, probability of surgery, mortality) were obtained from published literature. Time horizon was a lifetime horizon, with costs and outcomes discounted by 3.5% per year. One-way and probabilistic sensitivity analyses were conducted to measure the impact of parameter uncertainty. RESULTS: Vedolizumab had incremental cost-effectiveness ratios of £4,095/quality-adjusted life-year (QALY), £4,423/QALY, and £5,972/QALY compared with conventional therapy in the intent-to-treat, anti-TNF-naïve, and anti-TNF-failure populations, respectively. Patients on vedolizumab accrued more QALYs while incurring more costs than patients on conventional therapy. The sensitivity analyses showed that the results were most sensitive to induction response and transition probabilities for each treatment. CONCLUSION: The results suggest that vedolizumab results in more QALYs and may be a cost-effective treatment option compared with conventional therapy for both anti-TNF-naïve and anti-TNF-failure patients with moderately-to-severely active UC.

Cost-effectiveness analysis of umeclidinium/vilanterol for the management of patients with moderate to very severe COPD using an economic model.

BACKGROUND: Bronchodilators such as long-acting muscarinic antagonists (LAMAs) and long-acting ß2-agonists (LABAs) are central to the pharmacological management of COPD. Dual bronchodilation with umeclidinium/vilanterol (UMEC/VI; 62.5/25 µg) is a novel LAMA/LABA combination approved for maintenance treatment for patients with COPD. OBJECTIVE: The objective of this study was to assess the cost-effectiveness of maintenance treatment with UMEC/VI compared with tiotropium (TIO) 18 µg, open dual LAMA + LABA treatment, or no long-acting bronchodilator treatment in patients with moderate to very severe COPD. METHODS: A Markov model was developed to estimate the costs and outcomes associated with UMEC/VI treatment in patients with moderate to very severe COPD (GSK study number: HO-13-13411). Clinical efficacy, costs, utilities, and mortality obtained from the published literature were used as the model inputs. Costs are presented in US dollars based on 2015 prices. The model outputs are total costs, drug costs, other medical costs, number of COPD exacerbations, and quality-adjusted life-years (QALYs). Costs and outcomes were discounted at a 3% annual rate. Incremental cost-effectiveness ratios were calculated. One-way and probabilistic sensitivity analyses were conducted to assess the effects of changing parameters on the uncertainty of the results. RESULTS: UMEC/VI treatment for moderate to very severe COPD was associated with lower lifetime medical costs ($82,344) compared with TIO ($88,822), open dual LAMA + LABA treatment ($114,442), and no long-acting bronchodilator ($86,751). Fewer exacerbations were predicted to occur with UMEC/VI treatment compared with no long-acting bronchodilator treatment. UMEC/VI provided an 0.11 and 0.25 increase in QALYs compared with TIO and no long-acting bronchodilator treatment, and as such, dominated these cost-effectiveness analyses. Sensitivity analyses confirmed that the results were robust. CONCLUSION: The results from this model suggest that UMEC/VI treatment would be dominant compared with TIO and no long-acting bronchodilator treatment, and less costly than open dual LAMA + LABA treatment in patients with moderate to very severe COPD.

Cost-effectiveness of fluticasone propionate/salmeterol (500/50 microg) in the treatment of COPD.

OBJECTIVE: We examine the lifetime cost-effectiveness of treatment with fluticasone propionate/salmeterol (500/50 microg) compared with no maintenance treatment in COPD in the US. METHODS: A decision-analytic model was developed to estimate lifetime costs and outcomes associated with fluticasone propionate/salmeterol 500/50 microg treatment, salmeterol 50 microg, and fluticasone propionate 500 microg compared to no maintenance treatment in treating COPD from a third-party US payer perspective. The patient population was similar to that of the TORCH clinical trial. Model structure and inputs were obtained from published literature and clinical trial data. All costs are presented in 2006 US dollars. Outcomes included cost per life year (LY) saved and cost per quality-adjusted life year (QALY) gained. Costs and outcomes were discounted at 3% annually. Univariate and multivariate sensitivity analyses were conducted to assess model robustness. RESULTS: Compared to no maintenance treatment, treatment with fluticasone propionate/salmeterol 500/50mug results in a lifetime incremental cost-effectiveness ratio (ICER) of $33,865/QALY. Treatment with salmeterol 50 microg was found to have an ICER of $20,797/QALY. These results are robust to changes in input parameters. Fluticasone propionate 500 microg was dominated by no treatment, though the results were not robust to changes in parameters. CONCLUSIONS: Treatment of COPD with fluticasone propionate/salmeterol 500/50 microg appears to be cost-effective (

The effect of recombinant activated factor VII in the treatment of intracerebral hemorrhage on health plan budgets.

Treating patients with intracerebral hemorrhage (ICH) using recombinant activated factor VII (rFVIla) has been found to improve survival and functional outcome. To examine how the introduction of rFVIla 80 microg/kg as a treatment for ICH affects the budget of a health plan, a decision-analysis model was developed which considered both short-term hospitalization costs and long-term management of disability. Assuming a health plan enrollment of 1 million members and initial rFVIla uptake of 50% in appropriate patients, the annual health plan cost may be expected to increase by dollar 64,781 (dollar 0.005 per-member per-month). With a 5% increase in uptake each year, the annual health plan's cost may decrease compared with the current budget within three years. The implications for this sample health plan's budget are modest in the first year, and a reduction in costs is expected within three years owing to improved functional outcomes of patients.

Cost-effectiveness of recombinant activated factor VII in the treatment of intracerebral hemorrhage.

BACKGROUND AND PURPOSE: Intracerebral hemorrhage (ICH) is among the most costly and debilitating forms of stroke. Results from a recent Phase IIb clinical trial demonstrate that administration of recombinant activated factor VII (rFVIIa) reduces ICH mortality and improves functional outcome. In the current analysis, we examine the cost-effectiveness of early treatment with rFVIIa for ICH in the United States. METHODS: A decision-analytic model was developed to estimate the lifetime costs and outcomes associated with rFVIIa treatment at doses of 40, 80 and 160 microg/kg compared with current standard of care in treating ICH, from a US third-party payer perspective. The patient population was similar to that of the Phase IIb clinical trial. Model structure and inputs were obtained from published literature, clinical trial data, claims databases, and expert opinion. All costs are presented in 2005 US dollars. Outcomes included incremental cost per life-year (LY) saved and incremental cost per quality-adjusted life-year (QALY) gained. Costs and outcomes were discounted at 3% annually. Univariate and multivariate sensitivity analyses were conducted to assess model robustness. RESULTS: Compared with standard care, treatment with rFVIIa 40 microg/kg, and 160 microg/kg results in total lifetime cost-effectiveness ratios of 6308 dollars/QALY and 3152 dollars/QALY, respectively. Treatment with rFVIIa 80 microg/kg was found to be cost saving and a gain of 1.67 QALYs is achieved over a patient's lifetime. These results are robust to changes in input parameters. CONCLUSIONS: Treatment of ICH with rFVIIa 40 microg/kg and 160 microg/kg appears to be cost-effective (