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We performed a risk-benefit analysis for implementation of pathogen-inactivated ( PI) apheresis platelets ( APs) in the United States, focusing on the amotosalen/ultraviolet- A system. Risks and benefits were quantified per patient assuming a mean of 6 AP units per treatment cycle and using available clinical data, mathematical modeling, and observational studies. Current risks associated with AP transfusion can be divided into known partially addressed risks, known well-addressed risks, and unknown risks associated with acute or chronic emerging infectious agents ( EIAs). Bacterial contamination dominates the first category, at a per-patient rate of 1:250, which correlates with an estimated septic transfusion reaction rate of 1:1000. Quantitation of per-patient EIA risk was modeled to be between 1:370 (acute) and 1:667 (chronic). Due to its broad range of action PI is expected to reduce or eliminate these infectious risks and also to reduce the rate of febrile transfusion reactions and possibly alloimmunization. These benefits are weighed against 1) concerns for excess bleeding, 2) an apparent increase in acute respiratory distress syndrome in the initial report of the SPRINT clinical trial, and 3) the possible toxicity associated with the introduction of a new chemical into platelet ( PLT) units. However, transfusion of an estimated 100,000 patients with PI PLTs worldwide has occurred without reported serious adverse effects. We conclude that evidence indicates a favorable risk-benefit profile for the implementation of PLT PI and argues for a path forward toward US regulatory approval. [ABSTRACT FROM AUTHOR]

Background Herpes zoster (HZ) develops in up to 50% of unvaccinated individuals, accounting for >1 million cases annually in the United States. A live attenuated HZ vaccine (LAV) is Food and Drug Administration approved for those age 50 years or older, though Advisory Committee on Immunization Practices recommendations are only for those age 60 years or older. LAV efficacy is ~70% for persons 50–59 years of age, with lower efficacy in older adults. A new 2-dose adjuvanted subunit vaccine (SUV) has >95% efficacy in persons 50–69 years of age and remains ~90% efficacious in persons vaccinated at age 70 years. Methods To estimate the relative cost-effectiveness of SUV, LAV, and no vaccination (NoV) strategies, a Markov model was developed based on published data on vaccine efficacy, durability of protection, quality of life, resource utilization, costs, and disease epidemiology. The perspective was US societal, and the cycle length was 1 year with a lifelong time horizon. SUV efficacy was estimated to wane at the same rate as LAV. Outcomes evaluated included lifetime costs, discounted life expectancy, and incremental cost-effectiveness ratios (ICERs). Results For individuals vaccinated at age 50 years, the ICER for LAV vs NoV was $118 535 per quality-adjusted life-year (QALY); at age 60 years, the ICER dropped to $42 712/QALY. SUV was more expensive but had better ICERs than LAV. At age 50, the ICER was $91 156/QALY, and it dropped to $19 300/QALY at age 60. Conclusions Vaccination with SUV was more cost-effective than LAV in all age groups studied. Vaccination with SUV at age 50 years appears cost-effective, with an ICER <$100 000/QALY. [ABSTRACT FROM AUTHOR]