2c. Laryngoscope, 128:852-858, 2018.

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Background To examine changes in hair cortisol concentrations (HCC) in children with chronic physical illness and identify patterns of association between HCC and mental comorbidity. Methods A sample of 50 children aged 6 to 16 years were recruited within six months of being diagnosed with a chronic physical illness. Data were collected via hair samples, structured interviews, and behavioral checklists. Results There was no change in HCC over six months. Baseline HCC was associated with internalizing—odds ratio (OR) = 1.29 (90% confidence interval (CI): 1.01–1.66)—and externalizing disorders—OR = 1.32 (90% CI: 1.07–1.64). Externalizing disorder at six months was associated with elevated baseline—OR = 1.25 (90% CI: 1.02–1.53)—and six-month HCC—OR = 1.25 (90% CI: 1.02–1.54). Associations between HCC and mental disorder weakened over time, and for internalizing disorders, changed direction (i.e., inverse association), albeit not significantly. Conclusion Results provide preliminary evidence that physiological stress, measured using HCC, may be implicated in the relationship between physical and mental illness, and these associations align with attenuated stress responses over time.

Background Economic evaluations are an integral component of many clinical trials. Costs used in those analyses are based on the prices of branded drugs when they first enter the market. The effect of genericization on the costeffectiveness (ce) or cost–utility (cu) of an intervention is unknown because economic analyses are rarely updated using the costs of generic drugs.Methods We re-examined the ce or cu of regimens previously evaluated in Canadian Cancer Trials Group (cctg) studies that included prospective economic evaluations and where genericization has occurred or is anticipated in Canada. We incorporated the new costs of generic drugs to characterize changes in ce or cu. We also determined acceptable cost levels of generic drugs that would make regimens reimbursable in a publicly funded health care system.Results The four randomized controlled trials included (representing 1979 patients) were cctg br.10 (early lung cancer, adjuvant vinorelbine–cisplatin vs. observation, n = 172), cctg br.21 (metastatic lung cancer, erlotinib vs. placebo, n = 731), cctg co.17 (metastatic colon cancer, cetuximab vs. best supportive care, n = 557), and cctg ly.12 (relapsed or refractory lymphoma, gemcitabine–dexamethasone–cisplatin vs. cytarabine–dexamethasone–cisplatin, n = 619). Since the initial publication of those trials, the genericization of vinorelbine, erlotinib, cetuximab, and cisplatin has taken place or is expected in Canada. Costs of generics improved the ces and cus of treatment significantly. For example, genericization of erlotinib ($1460.25 per 30 days) resulted in an incremental cost-effectiveness ratio (icer) of $45,746 per life-year gained compared with $94,638 for branded erlotinib. Likewise, genericization of cetuximab ($275.80 per 100 mg) produced an icer of $261,126 per quality-adjusted life-year (qaly) gained compared with $299,613 for branded cetuximab. Decreases in the cost of generic cetuximab to $129.39 and $63.51 would further improve the icer to $150,000 and $100,000 per QALY respectively.Conclusions Genericization of a costly oncology drug can modify the ce and cu of a regimen significantly. Failure to revisit economic analyses with the costs of generics could be a missed opportunity for funding bodies to optimize value-based allocation of health care resources. At current levels, the costs of generics might not be sufficiently low to sustain publicly funded health care systems.

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