Effect of nivolumab on health-related quality of life in patients with treatment-naïve advanced melanoma: results from the phase III CheckMate 066 study.

BACKGROUND: Nivolumab has shown significant survival benefit and a favorable safety profile compared with dacarbazine chemotherapy among treatment-naïve patients with metastatic melanoma in the CheckMate 066 phase III study. Results from the health-related quality of life (HRQoL) analyses from CheckMate 066 are presented. PATIENTS AND METHODS: HRQoL was evaluated at baseline and every 6 weeks while on treatment using the European Organisation for Research and Treatment of Care (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and the EuroQoL Five Dimensions Questionnaire (EQ-5D). Via a multi-step statistical plan, data were analyzed descriptively, cross-sectionally, and longitudinally, adjusting for baseline covariates, in patients having baseline plus ≥1 post-baseline assessment. RESULTS: Baseline-adjusted completion rates for all HRQoL questionnaires across treatment arms were 65% and 70% for dacarbazine and nivolumab, respectively, and remained similar throughout treatment. The mean baseline HRQoL scores were similar for patients treated with nivolumab and dacarbazine. Baseline HRQoL levels with nivolumab were maintained over time. This exploratory analysis showed a between-arm difference in favor of nivolumab on the EQ-5D utility index and clinically meaningful EQ-5D improvements from baseline at several time points for patients receiving nivolumab. Patients treated with nivolumab did not show increased symptom burden as assessed by the EORTC QLQ-C30. No HRQoL change was noted with dacarbazine patients up to week 43, although the high attrition rate after week 13 did not allow any meaningful analyses. Patients receiving nivolumab deteriorated significantly later than those receiving dacarbazine on several EORTC QLQ-C30 scales and the EQ-5D utility index. CONCLUSIONS: In addition to prolonged survival, these exploratory HRQoL results show that nivolumab maintains baseline HRQoL levels to provide long-term quality of survival benefit, compared with dacarbazine in patients with advanced melanoma.

Economic impact of switching from valsartan to other angiotensin receptor blockers in patients with hypertension.

BACKGROUND: The approaching availability of lower-cost generic angiotensin receptor blockers (ARBs) may affect formulary policies for patients maintained on the ARB valsartan. OBJECTIVE: Estimate the economic impact of switching from valsartan (including valsartan-based single-pill combinations) to other ARBs without apparent medical reasons. RESEARCH DESIGN AND METHODS: Patients with essential hypertension and at least 6 months of continuous valsartan treatment free of hospitalization, cardiovascular events, renal events or ARB-associated adverse events were identified from the MarketScan administrative claims database from January 1, 2004 to March 31, 2008. Those who subsequently switched to a different ARB with at least a 5% copayment decrease (switchers) were matched to those who did not switch (maintainers) according to propensity score quintiles and selected baseline characteristics. Refills were not required after the index fill for the switched-to ARB or maintained valsartan. Matched switchers and maintainers were compared in terms of medication discontinuation, healthcare resource use and costs during the 6 months following the index fill. RESULTS: A total of 99,926 valsartan maintainers and 2150 switchers (with a mean copayment decrease of $16.5 per month) were identified and matched. After matching, switching from versus maintaining valsartan was associated with an 8% higher risk of medication discontinuation (p < 0.008), 19.1 additional outpatient visits/100 patients (p = 0.002) and 9.3 additional hypertension-related inpatient days/100 patients (p = 0.030). Concurrently, switching from versus maintaining valsartan was associated with higher total medical costs by $748/patient (p < 0.001), driven largely by higher costs for hypertension-related medical services by $492/patient (p = 0.004). LIMITATIONS: Exact reasons for switching were not available and the study assessed only the short-term impacts of switching. CONCLUSIONS: Hypertension patients maintained on valsartan who switched to a different ARB with a lower copayment experienced substantial increases in medication discontinuation, healthcare resource use and costs compared to those who maintained valsartan treatment.