Evaluation of Cost-Effectiveness of Adjuvant Osimertinib in Patients with Resected EGFR Mutation-Positive Non-small Cell Lung Cancer.

BACKGROUND: For many patients with resected epidermal growth factor receptor mutation-positive (EGFRm) non-small cell lung cancer (NSCLC), current standard of care (SoC) is adjuvant chemotherapy; however, disease recurrence remains high. Based on positive results from ADAURA (NCT02511106), adjuvant osimertinib was approved for treatment of resected stage IB‒IIIA EGFRm NSCLC. OBJECTIVE: The aim was to assess the cost-effectiveness of adjuvant osimertinib in patients with resected EGFRm NSCLC. METHODS: A five-health-state, state-transition model with time dependency was developed to estimate lifetime (38 years) costs and survival of resected EGFRm patients treated with adjuvant osimertinib or placebo (active surveillance), with/without prior adjuvant chemotherapy, using a Canadian Public Healthcare perspective. Transitions between health states were modeled using ADAURA and FLAURA (NCT02296125) data, Canadian life tables, and real-world data (CancerLinQ Discovery®). The model used a 'cure' assumption: patients remaining disease free for 5 years after treatment completion for resectable disease were deemed 'cured.' Health state utility values and healthcare resource usage estimates were derived from Canadian real-world evidence. RESULTS: In the reference case, adjuvant osimertinib treatment led to a mean 3.20 additional quality-adjusted life-years (QALYs; (11.77 vs 8.57) per patient, versus active surveillance. The modeled median percentage of patients alive at 10 years was 62.5% versus 39.3%, respectively. Osimertinib was associated with mean added costs of Canadian dollars (C$)114,513 per patient and a cost/QALY (incremental cost-effectiveness ratio) of C$35,811 versus active surveillance. Model robustness was demonstrated by scenario analyses. CONCLUSIONS: In this cost-effectiveness assessment, adjuvant osimertinib was cost-effective compared with active surveillance for patients with completely resected stage IB‒IIIA EGFRm NSCLC after SoC.

Impact of respiratory syncytial virus disease on quality of life in adults aged ≥50 years: A qualitative patient experience cross-sectional study.

BACKGROUND: Information about the impact of respiratory syncytial virus (RSV) on quality of life in older adults is limited. This study characterized the patient experience of RSV illness in USA older adults and assessed the content validity of the InFLUenza Patient Reported Outcome (FLU-PRO) in this population. METHODS: This qualitative, non-interventional, cross-sectional study included hybrid concept elicitation and cognitive debriefing interviews with 30 individuals (age ≥50 years) with polymerase chain reaction-confirmed RSV diagnosed within 6 months of screening. Targeted literature review was first conducted to inform the development of interview materials. Webcam or telephone interviews were conducted by qualitative researchers using a semistructured interview guide. Interview transcripts were coded and analyzed using Excel and NVivo software. RESULTS: All participants reported impacts on daily activities, social activities, and relationships during RSV disease. Physical functioning was impaired in 25 (83%) participants, and 18 (60%) reported not engaging in leisure activities/hobbies. All nine participants who were working reported major impacts on work. Most (n = 28; 93%) described emotional impacts. A majority (n = 19; 63%) reported symptoms lasting beyond the acute disease stage from a week to >1 month. Symptom concepts reported generally matched FLU-PRO items and domains. Cognitive debriefing indicated that FLU-PRO was easy to understand and captured participants' experiences of RSV illness. CONCLUSIONS: This study indicates that RSV disease in adults aged ≥50 years in the USA has substantial impacts on daily life and that the concepts included in FLU-PRO are appropriate and fit for purpose as a measure of RSV symptoms in this population.

Public health impact model estimating the impact of introducing an adjuvanted recombinant zoster vaccine into the UK universal mass vaccination programme.

OBJECTIVES: In 2013, the herpes zoster (HZ) immunisation programme was introduced in the UK, recommending vaccination of adults 70 years of age (YOA) with the zoster vaccine live (ZVL), the only vaccine available at the time. The recently approved adjuvanted recombinant zoster vaccine (RZV) has a substantially different clinical profile that may offer additional benefits.This study aimed to 1) assess the public health impact (PHI) of introducing RZV in the UK compared with the current vaccination strategy and 2) explore via scenario analyses the optimal age group of vaccination in terms of PHI. DESIGN: A previously developed health economic model was adapted to the UK setting. SETTING: Calculations were based on efficacy data from pivotal clinical trials, HZ incidence and postherpetic neuralgia (PHN) probability from a UK study and HZ-associated complication rates from published literature. POPULATION: The base-case population considered a 2018-projected UK vaccination cohort of individuals 70 YOA. INTERVENTIONS: Vaccination with ZVL or RZV, assuming a first-dose coverage of 48.3% for both vaccines and 70% compliance for the second dose of RZV. OUTCOME MEASURES: Outcomes included reduction of HZ and PHN cases, complications and the use of healthcare resources over a life-time horizon. The impact of coverage and second-dose compliance was also explored. RESULTS: Compared with no vaccination, RZV would lead to a reduction of 30 262 HZ and 5409 PHN cases while ZVL would lead to a reduction of 7909 HZ and 3567 PHN cases. The number needed to vaccinate to prevent 1 HZ case is 12 with RZV and 45 with ZVL. The highest PHI with RZV could be achieved in individuals 60 or 65 YOA. CONCLUSION: Under the model assumptions, RZV is predicted to avert more HZ and PHN cases compared with ZVL. Results were robust under different scenario and sensitivity analyses.

Cost-Effectiveness of the Adjuvant Recombinant Zoster Vaccine in Japanese Adults Aged 65 Years and Older.

INTRODUCTION: The incidence of herpes zoster (HZ) rises steeply after the age of 50 years and the number of HZ cases and complications such as postherpetic neuralgia (PHN) is predicted to increase because of the ageing population. The objective of this study was to estimate the cost-effectiveness of recombinant zoster vaccine (RZV) compared with no vaccine for the Japanese population aged ≥ 65 years. METHODS: A multi-cohort static Markov model with a cycle length of 1 year was used to follow a hypothetical cohort of 1 million people aged ≥ 65 years over their remaining lifetime. Vaccination at ≥ 65 years was used in alignment with the influenza and pneumococcal vaccines recommended from 65 years. Japan-specific data inputs for the model were obtained from local data sources. Age-stratified vaccine efficacy and waning rates were based on published clinical trial data. In the base-case analysis, vaccine coverage was assumed to be 40% with a second dose compliance of 95%. Costs and outcomes were discounted at 2% annually and the incremental cost-effectiveness ratio (ICER) was calculated from both a payer's and the societal perspective. Sensitivity analyses were carried out to explore the overall uncertainty in the model. RESULTS: Vaccination with RZV was projected to prevent 48,943 HZ cases and 12,136 PHN cases per million people aged ≥ 65 years compared with no vaccination. The incremental costs and quality-adjusted life years (QALYs) gained were ¥9.99 billion and 2314 QALYs from a payer's perspective and ¥9.34 billion and 2314 QALYs from a societal perspective. The resulting ICERs were approximately ¥4,320,000 and ¥4,040,000 per QALY gained from a payer's and the societal perspective, respectively. The ICER remained below a willingness-to-pay threshold of ¥5,000,000 for most sensitivity analyses carried out. CONCLUSION: Vaccination against HZ with RZV would be cost-effective compared with no vaccination for the Japanese population aged ≥ 65 years. TRIAL REGISTRATION: GSK study identifier: HO-16-17837. FUNDING: GlaxoSmithKline Biologicals SA.