20. Cost-Effectiveness of Recombinant Zoster Vaccine for Vaccinating Immunocompromised Adults Against Herpes Zoster in the United States

Background Individuals who are immunocompromised (IC) due to disease or therapy are at increased risk of herpes zoster (HZ), with HZ cases in IC populations also resulting in increased health care resource use and costs as compared with the immunocompetent population. This study assesses the cost-effectiveness of recombinant zoster vaccine (RZV) versus no vaccine for the prevention of HZ in IC adults aged ≥ 18 years in the United States (US). Methods A Markov model with a one-year cycle length was developed to follow a hypothetical cohort of one million IC individuals for a 30-year time horizon. The model estimates health and cost outcomes associated with RZV versus no vaccine. The base-case analysis considered hematopoietic stem cell transplant (HSCT) recipients who were assumed to remain IC for five years post-transplant. Second-dose compliance was assumed to be 100%, with efficacy and waning inputs based on clinical trial data. Epidemiological, cost, and utility inputs were obtained from standard US sources and published literature. Costs and quality-adjusted life-years (QALYs) were discounted at 3% per year. Sensitivity, threshold, and scenario analyses were conducted, including scenarios of four other IC conditions. Results In the modeled hypothetical cohort of one million HSCT recipients, RZV resulted in 116,790 fewer HZ cases and 21,446 fewer postherpetic neuralgia cases versus no vaccine, 5,545 fewer QALYs lost and a societal cost-savings of &5.4 million. The number needed to vaccinate to prevent one HZ case was estimated to be 9. HSCT population results were shown to be robust in sensitivity and threshold analyses. In scenario analyses, RZV was cost saving for renal transplant recipients. Incremental cost-effectiveness ratios for other IC populations were &33,268 per QALY gained for human immunodeficiency virus, &67,682 for breast cancer, and &95,972 for Hodgkin lymphoma. Conclusion Results suggest that RZV is a cost-effective option for vaccinating US IC adults for the prevention of HZ and associated complications. Disclosures Desmond Curran, PhD, The GSK group of companies (Employee, Shareholder) Ahmed Salem, MSc, The GSK group of companies (Employee) Stéphane Lorenc, NA, GSK group of companies (Consultant) Brandon Patterson, PharmD, PhD, GSK group of companies (Shareholder) Justin Carrico, BS, GSK group of companies (Consultant)RTI Health Solutions (Employee) Katherine A. Hicks, MS, BSPH, GSK group of companies (Consultant)RTI Health Solutions (Employee) Elizabeth M. La, PhD, The GSK group of companies (Employee, Shareholder) Sara Poston, PharmD, The GSK group of companies (Employee, Shareholder) Christopher F. Carpenter, MD, MHSA, GSK group of companies (Consultant)

A Cost–Consequence Analysis of Preemptive SLCO1B1 Testing for Statin Myopathy Risk Compared to Usual Care

There is a well-validated association between SLCO1B1 (rs4149056) and statin-associated muscle symptoms (SAMS). Preemptive SLCO1B1 pharmacogenetic (PGx) testing may diminish the incidence of SAMS by identifying individuals with increased genetic risk before statin initiation. Despite its potential clinical application, the cost implications of SLCO1B1 testing are largely unknown. We conducted a cost–consequence analysis of preemptive SLCO1B1 testing (PGx+) versus usual care (PGx−) among Veteran patients enrolled in the Integrating Pharmacogenetics in Clinical Care (I-PICC) Study. The assessment was conducted using a health system perspective and 12-month time horizon. Incremental costs of SLCO1B1 testing and downstream medical care were estimated using data from the U.S. Department of Veterans Affairs’ Managerial Cost Accounting System. A decision analytic model was also developed to model 1-month cost and SAMS-related outcomes in a hypothetical cohort of 10,000 Veteran patients, where all patients were initiated on simvastatin. Over 12 months, 13.5% of PGx+ (26/193) and 11.2% of PGx− (24/215) participants in the I-PICC Study were prescribed Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline-concordant statins (Δ2.9%, 95% CI −4.0% to 10.0%). Differences in mean per-patient costs for lipid therapy prescriptions, including statins, for PGx+ compared to PGx− participants were not statistically significant (Δ USD 9.53, 95% CI −0.86 to 22.80 USD). Differences in per-patient costs attributable to the intervention, including PGx testing, lipid-lowering prescriptions, SAMS, laboratory and imaging expenses, and primary care and cardiology services, were also non-significant (Δ− USD 1004, 95% CI −2684 to 1009 USD). In the hypothetical cohort, SLCO1B1-informed statin therapy averted 109 myalgias and 3 myopathies at 1-month follow up. Fewer statin discontinuations (78 vs. 109) were also observed, but the SLCO1B1 testing strategy was 96 USD more costly per patient compared to no testing (124 vs. 28 USD). The implementation of SLCO1B1 testing resulted in small, non-significant increases in the proportion of patients receiving CPIC-concordant statin prescriptions within a real-world primary care context, diminished the incidence of SAMS, and reduced statin discontinuations in a hypothetical cohort of 10,000 patients. Despite these effects, SLCO1B1 testing administered as a standalone test did not result in lower per-patient health care costs at 1 month or over 1 year of treatment. The inclusion of SLCO1B1, among other well-validated pharmacogenes, into preemptive panel-based testing strategies may provide a better balance of clinical benefit and cost.

Using cost-effectiveness analysis to support policy change: varenicline and nicotine replacement therapy for smoking cessation in Jordan

Background Smoking cessation pharmacotherapies (SCPs) have been established as cost-effective for the treatment of tobacco use disorder across a variety of settings. In Jordan, a resource-constrained country where smoking rates rank at one of the highest globally, the cost-effectiveness of SCPs has not yet been quantified. The lack of information about the value of SCPs has contributed to low demand for them (from public and private payers) and consequently low availability of these medications. The aim of this study was to simulate—in a hypothetical cohort of Jordanian smokers—the clinical and economic impact of using two smoking cessation regimens and to generate cost-effectiveness values that can support policy changes to avail smoking cessation medication in a country burdened with heavy tobacco use. Methods We employed a similar approach to a widely used economic model, the Benefits of Smoking Cessation on Outcomes (BENESCO) model. A hypothetical cohort of Jordanian male smokers aged 30 to 70 years and making a quit attempt using either a varenicline regimen or a nicotine replacement therapy (NRT) regimen were followed over time (until reaching 70 years of age). Markov simulations were run for the cohort, and life years gained were computed for each arm (compared to no intervention). Drug costs, prevalence of smoking, and population life expectancies were based on Jordanian data. Efficacy data were obtained from the literature. Incremental cost-effectiveness ratios as well as the potential budgetary impact of employing these regimens were generated. Several parameters were modified in sensitivity analyses to capture potential challenges unique to Jordan and that could impact the results. Results For a treatment cohort of 527,118 Jordanian male smokers who intended to quit, 103,970 life years were gained using the varenicline regimen, while 64,030 life years were gained using the NRT regimen (compared to the no-intervention arm of life years). The cost per life year gained was JD1204 ($1696 USD) and JD1342 ($1890 USD) for varenicline and NRT, respectively.

Use of the Aptima mRNA high-risk human papillomavirus (HR-HPV) assay compared to a DNA HR-HPV assay in the English cervical screening programme: a decision tree model based economic evaluation

ObjectiveTo estimate the impact of using the Aptima messenger RNA (mRNA) high-risk human papilloma virus (HR-HPV) assay versus a DNA HR-HPV assay in a primary HPV cervical screening programme.DesignOne hypothetical cohort followed for 3 years through HPV primary cervical screening.SettingEngland.ParticipantsA hypothetical cohort of women aged 25–65 years tested in the National Health Service (NHS) Cervical Screening Programme (CSP) for first call or routine recall testing.MethodsA decision tree parameterised with data from the CSP (2017/18) and the HORIZON study. Uncertainty analyses were conducted using data from the FOCAL and GAST studies, other DNA HPV tests in addition to one-way and probabilistic sensitivity and scenarios analyses, to test the robustness of results.InterventionsAptima mRNA HR-HPV assay and a DNA HR-HPV assay (cobas 4800 HPV assay).Main outcome measuresPrimary: total colposcopies and total costs for the cohort. Secondary: total HPV and cytology tests, number lost to follow-up.ResultsAt baseline for a population of 2.25 million women, an estimated £15.4 million (95% credibility intervals (CI) £6.5 to 24.1 million) could be saved and 28 009 (95% CI 27 499 to 28 527) unnecessary colposcopies averted if Aptima mRNA assays are used instead of a DNA assay, with 90 605 fewer unnecessary HR-HPV and 253 477 cytology tests performed. These savings are due to a lower number of HPV positive samples in the mRNA arm. When data from other primary HPV screening trials were compared, results indicated that using the Aptima mRNA assay generated cost savings and reduced testing in every scenario.ConclusionUsing the Aptima mRNA assay versus a DNA assay would almost certainly yield cost savings and reduce unnecessary testing and procedures, benefiting the NHS and women in the CSP.

Abstract 135: Extended Thromboprophylaxis With Betrixaban is Cost-effective in Acutely Ill Medical Patients

Objectives: The APEX trial demonstrated that prophylaxis of venous thromboembolism (VTE) with betrixaban from hospital admission through post-discharge (35-42 days) in acutely ill medical patients reduced VTE events, including symptomatic VTEs, without significant increase in major bleeding versus standard-duration prophylaxis (6-14 days) with enoxaparin. Based on these data, betrixaban has been approved by the FDA for prophylaxis of VTE in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications. Here, we analyzed the cost-effectiveness of this new thromboprophylaxis regimen with betrixaban versus standard-duration thromboprophylaxis with enoxaparin. Methods: We adopted our previously published decision-tree model to compare two thromboprophylaxis strategies from a US health care provider perspective among a hypothetical cohort of 10,000 acutely ill medical patients who are at risk of VTE: betrixaban (160 mg loading dose followed by 80 mg once daily for 35 days; $396) versus enoxaparin (40 mg daily for 9 days; $284). To estimate VTE-related deaths within 35 days that might have been averted by thromboprophylaxis, the model incorporated a clinical care path, including primary and secondary VTE prophylaxis as well as treatment of thromboprophylaxis-related adverse events. Parameter values and costs were estimated for each node in the decision tree based on publically available health data. All costs were converted to 2017 USD based on the US medical care consumer index. Results: For the base-case scenario, among a hypothetical cohort of 10,000 acutely ill medical patients at increased VTE risk, betrixaban was estimated to reduce risk of death by 0.16% and save nearly $1.8M (or $178.27 per patient treated). One-way sensitivity analyses indicated that betrixaban would dominate enoxaparin assuming: a) the cost of 35-day betrixaban was <$15.94 per dose (<$574 per 36 doses); b) the clinically relevant recognized bleeding rate was ≤3.8% or c) the VTE rate was ≤7.2%. Conclusions: Based on the rates of clinical events reported in the APEX study, extended-duration thromboprophylaxis with betrixaban from hospital admission through post-discharge in acutely ill medical patients is likely to prevent additional deaths and reduce costs compared with standard-duration thromboprophylaxis with enoxaparin.

Potential Economic Consequences of Genetic Mutations and Restricted Access to Tyrosine Kinase Inhibitor Treatments Among Patients with Chronic Myelogenous Leukemia in the USA

Introduction: The 1st generation tyrosine kinase inhibitor (TKI), imatinib, revolutionized the treatment of chronic myelogenous leukemia (CML). The 2nd generation TKIs (2G-TKI), dasatinib and nilotinib, further improved the outcomes among CML patients. Which of the 2G-TKIs is effective for an individual patient depends, among other factors, on genetic mutations that the patient may have. The National Comprehensive Cancer Network (NCCN) guidelines provide recommendations for management of cytogenetic/hematologic resistance to TKIs. The objective of this study was to assess potential economic consequences of limiting access to therapies, while taking into account frequencies of the genetic mutations that make patients insensitive to 2G-TKIs. Methods: A decision analytics economic model was developed to examine clinical and economic outcomes among patients treated with 2G-TKIs from a US payer perspective. The model was based on a hypothetical cohort of 1,000 CML patients, who are treated with dasatinib or nilotinib following treatment failure with imatinib. BCR-ABL1 genetic mutation frequencies among the patients and impact of mutations on treatment responses to 2G-TKIs were obtained from published literature. Clinical outcomes were estimated after 12 months of treatment and included complete hematologic response (CHR) and major cytogenetic response (MCyR). The annual total TKI drug costs (2014 Wholesale Acquisition Costs) per CHR and MyCR were estimated. Three hypothetical TKI access scenarios were compared: 1) open access to both 2G-TKIs; 2) access to 2G-TKIs restricted to dasatinib only (DASA-Only); and 3) access to 2G-TKIs restricted to nilotinib only (NILO-Only). Results: The model showed that among the hypothetical cohort of 1,000 TKI treated CML patients, the percentage of patients with CHR was greatest in the open access (92.6%), followed by DASA-Only (88.2%) and NILO-Only (66.7%). Similarly, the percentage of CML patients with MCyR was greatest in the open access (56.4%), followed by DASA-Only (53.4%) and NILO-Only (46.9%). These findings were primarily due to the incidence of mutations with insensitivity or resistance to dasatinib (12.4%) and to nilotinib (19.1%) (Table). Compared to the TKI costs per CHR in open access ($120,706/CHR), the costs were 5% higher ($126,753/CHR) in DASA-Only, and,40.8% higher ($169,990/CHR) in NILO-Only. Likewise, compared to the TKI costs per MCyR in open access ($198,284/MCyR), the cost were a 5.5% higher ($209,259/MCyR) in DASA-Only, and,21.8% higher ($241,515/MCyR) in NILO-Only. Conclusions: Open access to TKIs in a managed care setting is important in order to enable clinicians to choose the most appropriate TKI treatment for a CML patient. Open access to both 2G-TKIs is likely associated with greater rates of positive clinical outcomes, including CHR and MCyR, and lower costs compared to restricted access. Table. BCR-ABL1 Mutation Frequencies Among CML Patients Mutation Name Percentage of Patients with Mutation Mutation Class for 2G-TKI Response* Dasatinib Nilotinib T315I 3.3 D D M351T 7.3 A A G250E 5.3 A A F359V 4.3 A C M244V 5.0 A A Y253H 3.0 A C E255K 3.1 B C H396R 3.3 A A F317L 2.7 C A E355G 2.3 A A Q252H 1.7 B B E255V 1.6 B C E459K 1.6 A A F486S 1.5 A A L248V 1.2 A A D276G 1.2 A A E279K 1.2 A A Y253F 0.7 A B F359C 0.7 A C F359I 0.7 A B *Class A: mutation may confer same response as normal genotype to 2G-TKI. Class B: mutation may confer intermediate insensitivity/resistance to the 2G-TKI. Class C: mutation may confer substantial insensitivity/resistance to the 2G-TKI. Class D: mutation may confer non-response to the 2G-TKI. Disclosures Jabbour: Ariad, Novartis, BMS, Pfizer, and Teva : Consultancy. Dinara:Bristol-Myers Squibb: Employment, Equity Ownership. Melissa:Bristol-Myers Squibb: Consultancy, Research Funding. Jay:Bristol-Myers Squibb: Consultancy, Research Funding.