Analysis of long-term clinical and cost impact of etranacogene dezaparvovec for the treatment of hemophilia B population in the United States.

Introduction: Etranacogene dezaparvovec (EDZ), HemgenixⓇ,is a gene therapy recently approved for people with hemophilia B (PwHB).Objective: To estimate long-term clinical impact and cost of EDZ in the United States (US).Methods: A decision-analytic model was developed to evaluate the long-term impact of introducing EDZ for PwHB over a 20-year time horizon. Factor IX (FIX) prophylaxis comparator was a weighted average of different FIX prophylaxis regimens based on US market share data. We compared a scenario in which EDZ is introduced in the US versus a scenario without EDZ. Clinical inputs (annualized FIX-treated bleed rate; adverse event rates) were obtained from HOPE-B phase 3 trial. EDZ durability input was sourced from an analysis predicting long-term FIX activity with EDZ. EDZ one-time price was assumed at $3.5 million. Other medical costs, including FIX prophylaxis, disease monitoring, bleed management, and adverse events were from literature. The model estimated annual and cumulative costs, treated bleeds, and joint procedures over 20 years from EDZ introduction.Results: Approximately 596 PwHB were eligible for EDZ. EDZ uptake was estimated to avert 11,282 bleeds and 64 joint procedures over 20 years. Although adopting EDZ resulted in an annual excess cost over years 1-5 (mean: $53 million annually, total $265 million), annual cost savings were achieved beginning in year 6 (mean: $172 million annually; total $2.58 billion in years 6-20). The total cumulative 20-year cost savings was $2.32 billion, with cumulative cost savings beginning in year 8.Conclusion: Introducing EDZ to treat PwHB is expected to result in cost savings and patient benefit over 20 years. Initiating PwHB on EDZ sooner can produce greater and earlier savings and additional bleeds avoided. These results may be a conservative estimate of the full value of EDZ, as PwHB would continue to accrue savings beyond 20 years.

This analysis assessed the long-term clinical and financial impact of introducing EDZ in the United States of America for people with severe or moderately severe hemophilia B. A decision-analytic model was developed comparing a scenario with EDZ and one without EDZ over 20 years. Introducing EDZ would avert 11,292 bleeds and 64 joint procedures over 20 years and would achieve cumulative cost savings in year 8, with a total cumulative 20-year cost saving of $2.32 billion.

Assessing health plan payer's budget impact of etranacogene dezaparvovec for the treatment of hemophilia B in the United States.

BACKGROUND: Etranacogene dezaparvovec is a recently approved gene therapy for people with hemophilia B (PwHB). Current standard of care is prophylaxis with factor IX (FIX) to prevent bleeding. Etranacogene dezaparvovec increases blood FIX levels such that FIX prophylaxis could be eliminated. OBJECTIVE: To estimate the budgetary impact of etranacogene dezaparvovec adoption and utilization in a commercial health plan of the United States. METHODS: A budget impact model was developed to evaluate the introduction of etranacogene dezaparvovec to treat severe or moderately severe hemophilia B. The model considered a hypothetical 1-million-member plan over a 5-year horizon. FIX therapy prophylaxis use was estimated based on a weighted average of relevant brands using US market share data. A scenario of etranacogene dezaparvovec adoption/utilization was compared with one without etranacogene dezaparvovec utilization. Two etranacogene dezaparvovec uptake (market share growth) analyses were performed: one with gradual uptake and alternatively assuming all eligible PwHB received etranacogene dezaparvovec in year 1. The one-time cost of etranacogene dezaparvovec was assumed to be $3.5 million. Other costs (FIX prophylaxis, disease monitoring, bleed management, and adverse events) were estimated from published literature. All costs were in 2022 US dollars. Bleed and adverse event rates were sourced from the HOPE-B trial comparing etranacogene dezaparvovec to previous FIX therapy prophylaxis. The model estimated annual and per-member per-month costs over 5 years. Secondary analyses were performed considering a 10-year horizon. RESULTS: In the 1-million-member health plan, an estimated 1.8 PwHB were eligible for treatment with etranacogene dezaparvovec. Gradual uptake of etranacogene dezaparvovec resulted in cumulative 5-year budget impact of $848,509 compared with a scenario without etranacogene dezaparvovec. In years 1-5, the incremental annual and per-member per-month costs ranged from $79,824 to $271,435 and from $0.007 to $0.023, respectively. In the alternative uptake analysis, etranacogene dezaparvovec became cost saving annually beginning in year 2 and cumulatively beginning in year 5, for a 5-year savings of $754,844. Secondary analyses over 10 years found both uptake analyses cost saving. Other scenarios considered did not affect results substantially. CONCLUSIONS: Introducing etranacogene dezaparvovec as treatment for PwHB would have a modest budget increase within 5 years after treatment but may become cost saving if all eligible PwHB were treated in year 1. Initiating PwHB on etranacogene dezaparvovec sooner may produce greater overall savings and earlier annual savings. Etranacogene dezaparvovec is a treatment option that may provide overall cost savings for US commercial health plans, which would increase as the plan size increases.

Decreasing ICU and Hospital Length of Stay through a Standardized Respiratory Therapist-driven Electronic Clinical Care Pathway for Status Asthmaticus.

Introduction: Status asthmaticus (SA) is a cause of many pediatric hospitalizations. This study sought to evaluate how a standardized asthma care pathway (ACP) in the electronic medical record impacted the length of stay (LOS). Methods: An interdisciplinary team internally validated a standardized respiratory score for patients admitted with SA to a 25-bed pediatric intensive care unit (PICU) at a tertiary children's hospital. The respiratory score determined weaning schedules for albuterol and steroid therapies. In addition, pharmacy and information technology staff developed an electronic ACP within our electronic medical record system using best practice alerts. These best practice alerts informed staff to initiate the pathway, wean/escalate treatment, transition to oral steroids, transfer level of care, and complete discharge education. The PICU, stepdown ICU (SD ICU), and acute care units implemented the clinical pathway. Pre- and postintervention metrics were assessed using process control charts and compared using Welch's t tests with a significance level of 0.05. Results: Nine hundred two consecutive patients were analyzed (598 preintervention, 304 postintervention). Order set utilization significantly increased from 68% to 97% (P < 0.001), PICU LOS decreased from 38.4 to 31.1 hours (P = 0.013), and stepdown ICU LOS decreased from 25.7 to 20.9 hours (P = 0.01). Hospital LOS decreased from 59.5 to 50.7 hours (P = 0.003), with cost savings of $1,215,088 for the patient cohort. Conclusions: Implementing a standardized respiratory therapist-driven ACP for children with SA led to significantly increased order set utilization and decreased ICU and hospital LOS. Leveraging information technology and standardized pathways may improve care quality, outcomes, and costs for other common diagnoses.

Estimating the Cost-Effectiveness of Switching to Higher-Valency Pediatric Pneumococcal Conjugate Vaccines in the United Kingdom.

Currently, the 13-valent pneumococcal conjugate vaccine (PCV13) is administered under a 1+1 (1 primary dose) pediatric schedule in the United Kingdom (UK). Higher-valency PCVs, 15-valent PCV (PCV15), or 20-valent PCV (PCV20) might be considered to expand serotype coverage. We evaluated the cost-effectiveness of PCV20 or PCV15 using either a 2+1 (2 primary doses) or 1+1 schedule for pediatric immunization in the UK. Using a dynamic transmission model, we simulated future disease incidence and costs under PCV13 1+1, PCV20 2+1, PCV20 1+1, PCV15 2+1, and PCV15 1+1 schedules from the UK National Health Service perspective. We prospectively estimated disease cases, direct costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio. Scenario analyses were performed to estimate the impact of model assumptions and parameter uncertainty. Over a five-year period, PCV20 2+1 averted the most disease cases and gained the most additional QALYs. PCV20 2+1 and 1+1 were dominant (cost-saving and more QALYs gained) compared with PCV15 (2+1 or 1+1) and PCV13 1+1. PCV20 2+1 was cost-effective (GBP 8110/QALY) compared with PCV20 1+1. PCV20 was found cost-saving compared with PCV13 1+1, and PCV20 2+1 was cost-effective compared with PCV20 1+1. Policymakers should consider the reduction in disease cases with PCV20, which may offset vaccination costs.

Assessing Public Health Impact of Four Pediatric Pneumococcal Conjugate Vaccination Strategies in the Netherlands.

INTRODUCTION: The 10-valent pneumococcal conjugate vaccine (PCV10, Synflorix) was introduced into the Dutch pediatric national immunization program (NIP) starting in 2011. However, there is substantial pneumococcal disease burden due to increases in non-PCV10 covered serotypes. Higher-valent vaccines for pediatrics (PCV13, PCV15, and PCV20) may alleviate much of the remaining disease burden upon implementation through broader serotype coverage. This article assesses the public health impact of different pediatric vaccination strategies (switching to PCV13, PCV15 or PCV20) versus maintaining PCV10 at different time intervals in the Netherlands. METHODS: A population-based, decision-analytic model was developed using historical pneumococcal disease surveillance data to forecast future invasive pneumococcal disease (IPD), pneumonia, and otitis media (OM) cases over a 7-year period (2023-2029) under the following strategies: continued use of PCV10, switching to PCV13 in 2023, switching to PCV15 in 2023, and switching to PCV20 in 2024. Scenario analyses were performed to account for uncertainties in future serotype distributions, disease incidence reductions, and epidemiologic parameters. RESULTS: Switching to PCV13 in 2023 was found to avert 26,666 cases of pneumococcal disease compared to continuing PCV10 over a 7-year period (2023-2029). Switching to PCV15 in 2023 was found to avert 30,645 pneumococcal cases over the same period. Switching to PCV20 once available in 2024 was estimated to avert 45,127 pneumococcal cases from 2024-2029. Overall conclusions were maintained after testing uncertainties. CONCLUSIONS: For the Dutch pediatric NIP, switching to PCV13 in 2023 would be an effective strategy compared with continued use of PCV10 for averting pneumococcal disease cases. Switching to PCV20 in 2024 was estimated to avert the most pneumococcal disease cases and provide the highest protection. However, in the face of budget constraints and the undervaluation of prevention strategies, it remains challenging to implement higher valent vaccines. Further research is needed to understand the cost-effectiveness and feasibility of a sequential approach.

Historical Population-Level Impact of Infant 13-Valent Pneumococcal Conjugate Vaccine (PCV13) National Immunization Programs on Invasive Pneumococcal Disease in Australia, Canada, England and Wales, Israel, and the United States.

INTRODUCTION: This study estimates the annual population-level impact of 13-valent pneumococcal conjugate vaccine (PCV13) infant national immunization programs (NIPs) on vaccine-type and non-vaccine type invasive pneumococcal disease (IPD) incidence across all ages using national surveillance data. METHODS: We identified countries (Australia, Canada, England and Wales, Israel, and the US) with national IPD active surveillance data that introduced the seven-valent PCV (PCV7) followed by PCV13, which also reported annual serotype- and age group-specific incidence. We extracted IPD incidence by serotype groupings [PCV13 minus PCV7 (PCV13-7) serotypes; PCV13-7 serotypes excluding serotype 3; non-PCV13 serotypes; and the 20-valent (PCV20) minus PCV13 (PCV20-13) serotypes] and by age groups (< 2 years, 2-4 years, 5-17 years, 18-34 years, 35-49 years, 50-64 years, and ≥ 65 years). For each country, we calculated the annual relative change in IPD incidence (percent change), and the corresponding incidence rate ratio (IRR), for 7 years post introduction compared to the year prior to PCV13 program initiation. RESULTS: PCV13-7 vaccine-type IPD incidence consistently decreased over time following introduction of PCV13 across countries, reaching an approximate steady state after 3-4 years in ages < 5 years, with roughly 60-90% decrease (IRRs = 0.1-0.4) and after 4-5 years in ages ≥ 65 years with approximately 60-80% decrease (IRRs = 0.2-0.4). Incidence declines were more substantial for the PCV13-7 grouping when excluding serotype 3. Non-PCV13 serotype incidence was variable by country and age group, ranging from virtually no serotype replacement compared to the PCV7 period across ages in the US to increases for other countries ranging from 10 to 204% (IRRs = 1.10-3.04) in children < 5 years and 41% to 123% (IRRs = 1.41-2.23) in ages ≥ 65 years. CONCLUSIONS: Countries with longstanding PCV13 infant NIPs have observed substantial direct and indirect benefits, which are demonstrated in this study by the reduction in PCV13-7 IPD incidence compared to PCV7 period in all age groups. Over time, non-PCV13 serotypes have emerged in response to the reduction of incidence of PCV13-unique serotypes. Higher-valent PCVs are needed to address this emerging pneumococcal disease burden as well as the direct vaccination of both pediatric and adult populations against the most prevalent circulating serotypes.

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.

Better Etiquette for Effective Paging (B.E.E.P.)-Improving Daily In-hospital Communications in the Pediatric ICU.

INTRODUCTION: Paging is a vital part of patient care that allows quick contact between physicians and other hospital personnel. There was no structured way to send a page to physicians at our institution. We hypothesized that by standardizing paging format, scheduling laboratory draw times, and using order clean-up sheets, through a bundle of interventions called Better Etiquette for Effective Paging, we would decrease the number of pages received on the pediatric intensive care unit (PICU) resident pager by 15%. METHODS: This project was a quality improvement initiative in a 25-bed multidisciplinary PICU in a tertiary children's hospital. Baseline data collection was performed in December 2015, categorized by time of day received and type of page. Interventions were paging standards to include relevant information, scheduling laboratory draw times, and order clean-up sheets. We collected postintervention data over 3 years to monitor for sustained change. RESULTS: The average number of pages decreased from a baseline of 4.71 pages/patient/d in 2015 to 3.70 in 2016 (21% decrease), 3.32 in 2017 (30% decrease), and 2.74 in 2018 (42% decrease). The average PRISM 3 score remained similar in all sets (2.52, 2.50, 2.10, and 2.35). The standardized mortality ratio was not adversely affected by the decrease in pages (0.58, 1.07, 1.19, and 0). CONCLUSION: Standardizing the format of pages and using scheduled laboratory times with order clean-up sheets has decreased the number of pages/patient/d in the PICU by 42% without adversely affecting patient care. We can continue to improve communication among the patient care team by emphasizing efficient, standardized communication using Better Etiquette for Effective Paging.

Budget Impact Analysis of Gemtuzumab Ozogamicin for the Treatment of CD33-Positive Acute Myeloid Leukemia.

BACKGROUND: Gemtuzumab ozogamicin (GO) was approved in 2017 in the US for the treatment of adults with newly diagnosed CD33-positive (CD33+) acute myeloid leukemia (AML), and adults and pediatric patients with CD33+ relapsed/refractory (R/R) AML. OBJECTIVE: The aim of this study was to estimate the budgetary impact of introducing GO to a 1-million-member US health plan over a 5-year period. METHODS: We developed models to estimate the impact of introducing GO in combination with conventional induction chemotherapy or as monotherapy for newly diagnosed AML, and as monotherapy for R/R AML. Models were built using data on drug costs and treatment-related outcomes obtained from published clinical trials and other publicly available sources. Results were reported on a per member/per year and per member/per month (PMPM) basis. RESULTS: Base-case results of the newly diagnosed model indicated that the addition of GO in the combination setting reduced the overall budget of a 1-million-member health plan. The estimated net cost (US$) savings ranged from $72,969 ($0.006 PMPM) in year 1 to $745,426 ($0.062 PMPM) in year 5. In the monotherapy setting, GO was associated with increased net costs ranging from $4118 (0.0003 PMPM) in year 1 to $31,885 ($0.003 PMPM) in year 5. Base-case results of the R/R AML model demonstrated increased net costs that ranged from $17,326 ($0.001 PMPM) in year 1 to $46,163 ($0.004 PMPM) in year 5. Scenario analyses in all settings indicated the budget impact was not overly sensitive to the selected input assumptions, with the exception of the scenario considering only the pharmacy budget impact in the combination setting. CONCLUSIONS: The introduction of GO for newly diagnosed and R/R AML would have a minimal impact on the budget of a US health plan and could result in cost savings in the combination therapy setting for newly diagnosed AML.

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.

Impacting Satisfaction, Learning, and Efficiency Through Structured Interdisciplinary Rounding in a Pediatric Intensive Care Unit: A Quality Improvement Project.

BACKGROUND: Daily rounds in many pediatric intensive care units (PICUs) vary in quality, duration, and participation. We hypothesized that implementing structured interdisciplinary bedside rounds (SIBR®) would improve our rounding process. METHODS: This was a quality improvement initiative in a 25-bed multidisciplinary PICU in a tertiary children's hospital. Baseline data included rounding duration; participation of nurses, respiratory care practitioners (RCP), parents; and physician order read-back practices. Interventions were implementing pre-rounding huddles, changing the start of the rounding week, and instituting a SIBR model. All staff, consecutive patients and parents participated over 18 months. We used Mann-Whitney, z-test, and t-tests for statistical analysis with a significance level of 0.05. We tracked data with a statistical process control chart. RESULTS: Rounds participation increased for nurses (88% to 100%), RCPs (13% to 61%), and families (24% to 49%) (all p <0.001). Physician order read-back increased (41% to 79%) (p<0.001). The median length of stay (LOS) decreased from 2.1 to 1.9 days (p=0.004) with no changes in mortality or readmissions. The proportion of top responses from family surveys increased from 0.69 to 0.76 (p<0.001). PICU rounding duration (minutes/patient) decreased from 17.1 to 11.3. Most resident physicians felt SIBR positively impacted their education (70%), was more effective than rounds without structure (97%), and that family presence positively impacted learning (70%). CONCLUSIONS: Implementing a SIBR process in our PICU resulted in greater family and staff satisfaction, improved workflow and decreased rounding time by 34% without compromising education. LOS decreased significantly with no increases in mortality or readmissions.

Healthcare resource utilization and associated cost analysis of the PROCLAIM study in patients with stage III non-small-cell lung cancer.

Objective: To analyze patient-reported swallowing difficulties, healthcare resource utilization and associated costs during the PROCLAIM study. Methods: Patients with stage III non-squamous non-small cell lung cancer received pemetrexed-cisplatin (PemCis) combined with concurrent thoracic radiotherapy followed by consolidation pemetrexed, or concurrent chemoradiotherapy with etoposide-cisplatin (EtoCis) followed by standard consolidation chemotherapy. Patient - reported swallowing function was measured using diaries. Resource utilization (hospitalizations, transfusions, concomitant medications) was compared between treatment arms using Fisher's exact test and independent t-test. Medical resource use costs were analyzed using nonparametric Wilcoxon rank sum test. Results: Patient-reported difficulty in swallowing function (diary score ≥4) was 33.8% in the PemCis arm and 29% in the EtoCis arm. Overall resource use, including hospitalizations, was similar between treatment arms; however, fewer patients in the PemCis arm received transfusions and selected concomitant medications. Concurrent phase analyses were consistent with the overall study. A significantly lower percentage of patients (31.1% vs. 40.8%) were hospitalized in the PemCis arm. Total costs were significantly higher in the PemCis arm. Other medical costs (excluding study treatment costs) during the concurrent phase were lower for patients in the PemCis arm, due to significantly lower hospitalization costs and lower use of concomitant medications. Subgroup analysis yielded similar results. Conclusions: Patient-reported difficulty in swallowing post-baseline and resource utilization were consistent with previously reported safety outcomes. In the overall study, higher total costs for PemCis were driven by study drug cost. When adjusting for treatment duration, other monthly medical costs were favorable to PemCis. Patients on pemetrexed remained longer on therapy, suggesting better tolerability. ClinicalTrials.gov identifier: NCT00686959.

Comment on Gomez et. al. "Response to article by Wasserman et. al. (2018) 'Modelling the sustained use of the 13-valent pneumococcal conjugate vaccine compared to switching to the 10-valent vaccine in Mexico'".

In a recent Letter, Gomez et. al. provided a critique of our original analysis estimating the clinical and economic impact of switching from the 13-valent (PCV13) to the 10-valent (PCV10) pneumococcal conjugate vaccine in Mexico. This comment addresses Gomez et. al.'s comments with additional information and clarifies potential misinterpretations.

Modeling the sustained use of the 13-valent pneumococcal conjugate vaccine compared to switching to the 10-valent vaccine in Mexico.

INTRODUCTION: Pneumococcal diseases caused by Streptococcus pneumoniae represent a significant health and economic burden. Mexico has benefited from the inclusion of the 7-valent (PCV7) and 13-valent pneumococcal conjugate vaccines (PCV13) since their inclusion in the National Immunization Program (NIP) in 2006 and 2010, respectively. The objective of this study is to estimate the impact of the existing program and predict future implications of a change in the current program. METHODS: A previously published model was updated to estimate the historic impact of the PCV programs relative to pre-PCV implementation. Future disease trends were forecasted based on historical serotype behaviors for each PCV13 serotype and non-vaccine serotypes across different age groups. Costs and outcomes were estimated over a 10-year period based on continued use of PCV13 compared to a switch to PCV10. RESULTS: The PCV7 and subsequent PCV13 NIP were estimated to prevent over 1.5 million cases of pneumococcal disease and 1,854 deaths, corresponding to a net savings of $34.50 Billion MXN. Continued use of PCV13 was estimated to save over 300 thousand cases of pneumococcal disease and 373 deaths compared to switching to PCV10 over a 10-year period. Despite a higher vaccine cost, maintaining PCV13 was cost-saving compared to PCV10, saving $6.71 billion MXN over 10 years. CONCLUSION: The PCV program in Mexico has provided a significant return on investment. Sustained PCV13 use was estimated to provide the greatest healthcare and economic impact in Mexico. Changes to the pneumococcal vaccination program could result in serotype replacement and reduction in herd effects.

Effectiveness of a Quality Improvement Intervention to Improve Rates of Routine Chlamydia Trachomatis Screening in Female Adolescents Seeking Primary Preventive Care.

STUDY OBJECTIVE: To determine the impact of a multicomponent quality improvement (QI) intervention on Chlamydia trachomatis screening for young women in primary care. DESIGN: Observational cohort analysis. SETTING: Urban primary care site providing adolescent primary and confidential sexual health care. PARTICIPANTS: Female adolescents aged 15-19 years. INTERVENTIONS: From December 2016 to April 2018, we designed and implemented a multiphase QI intervention. The final intervention, beginning March 2017, consisted of the following at all adolescent well visits: (1) dual registration for well and confidential sexual health encounters; (2) urine collection during the rooming process; and (3) electronic health record-based prompts for chlamydia screening. MAIN OUTCOME MEASURES: Annual chlamydia screening rates before and after the intervention, with a goal of achieving a relative increase of 10%. RESULTS: There were 1550 well adolescent encounters from December 2016 to April 2018. The preimplementation chlamydia screening rate among 15- to 19-year-old female adolescents was 312/757 (41.2%) (95% confidence interval, 20.9%-61.5%). Postintervention, this increased to 397/793 (50.0%) (95% confidence interval, 28.6%-71.5%; P < .001). The clinic chlamydia test positivity rate remained stable, at 10.7% and 11.1% in the pre- and postintervention periods, respectively. There was no significant change in median visit length in the pre- (79.2 minutes; interquartile range, 59.5-103.3) and postintervention periods (80.4 minutes; interquartile range, 61.7-102.8; P = .63). CONCLUSION: This practice-based QI intervention resulted in a statistically significant 21% relative increase in annual Chlamydia trachomatis screening rates among female adolescents, without lengthening median visit time.

Budget Impact of Adding Vedolizumab to a Health Plan Formulary as Another First-Line Biologic Option for Ulcerative Colitis and Crohn's Disease.

BACKGROUND: Vedolizumab is a biologic drug approved by the US Food and Drug Administration (FDA) for the treatment of adults with moderately to severely active Crohn's disease (CD) or ulcerative colitis (UC) who have had inadequate response to, lost response to, or were intolerant of immunomodulators or tumor necrosis factor (TNF) blocker therapy, or who had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroid therapy. The biologics approved by the FDA for CD and/or UC include adalimumab, infliximab, golimumab, certolizumab, and ustekinumab. OBJECTIVE: To assess the budget impact of including vedolizumab in a health plan formulary among current options as a preferred first-line biologic therapy for UC and CD rather than only for patients who failed anti-TNF therapy. METHODS: We developed a 3-year budget impact model for a 1-million-member health plan. Comparators included all currently approved brand-name biologic and biosimilar agents for the treatment of UC (ie, adalimumab, infliximab, and golimumab) and CD (ie, adalimumab, certolizumab, infliximab, and ustekinumab). Clinical inputs included therapy response probabilities, disease remission, and surgery risk. Given the lack of head-to-head clinical trials, we estimated indirect comparisons of treatment efficacy based on clinical trial data using the Bucher method. The drug and medical costs were obtained from published literature. The model compared hypothetical health plan costs for 2 scenarios-(1) a market mix with vedolizumab included on the formulary with currently existing first- and second-line preferred treatments, and (2) vedolizumab included only with existing preferred second-line treatments on the hypothetical formulary. These scenarios were compared in the context of 3 hypothetical health plan formulary cases. RESULTS: Including vedolizumab in a hypothetical formulary with currently preferred first-line biologic treatment options (Scenario 1) resulted in cost-savings compared with vedolizumab as a preferred second-line biologic option (Scenario 2). The total cost-savings were from $0.13 million to $1.63 million in year 1, and from $0.38 million to $4.68 million in year 3. The per-member per-month cost-savings were from $0.01 to $0.14 in year 1 and from $0.03 to $0.39 in year 3. CONCLUSION: Based on our model's results, including vedolizumab among the current health plan formulary biologic options as a preferred first-line treatment for UC and CD can result in substantial cost-savings compared with including vedolizumab as a preferred second-line treatment only.