Research Roundup: FDA Expedited Drug Approvals; Effectiveness Of Flu Vaccines

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Each week, KHN compiles a selection of recently released health policy studies and briefs.

Health Affairs: Drugs Cleared Through The FDA’s Expedited Review Offer Greater Gains Than Drugs Approved By Conventional Process
We investigated whether drugs approved by the Food and Drug Administration (FDA) through expedited review have offered larger health gains, compared to drugs approved through conventional review processes. …We found that drugs in at least one expedited review program offered greater gains than drugs reviewed through conventional processes (0.182 versus 0.003 QALYs). (Chambers, Thorat, Wilkinson, et. al., 8/1)

JAMA Internal Medicine: Social Determinants Of Health In Managed Care Payment Formulas 
Using data from MassHealth, the Massachusetts Medicaid and Children’s Health Insurance Program, we estimated regression models predicting Medicaid spending using a diagnosis-based and SDH-expanded model, and compared the accuracy of their cost predictions overall and for vulnerable populations. …Overall, the SDH model performed well, but only slightly better than the diagnosis-based model, explaining most of the spending variation in the managed care population (validated R2 = 62.4) and reducing underpayments for several vulnerable populations. (Ash, Mick, Ellis, et. al., 8/7)

New England Journal of Medicine: Influenza Vaccine Effectiveness In The United States During The 2015–2016 Season 
The A(H1N1)pdm09 virus strain used in the live attenuated influenza vaccine was changed for the 2015–2016 influenza season because of its lack of effectiveness in young children in 2013–2014.  …Influenza vaccines reduced the risk of influenza illness in 2015–2016. However, the live attenuated vaccine was found to be ineffective among children in a year with substantial inactivated vaccine effectiveness. (Jackson, Chung, Jackson, et. al., 8/10)

Annals Of Internal Medicine: HCV Infection Treatment By Nonspecialist Providers 
In a real-world cohort of patients at urban FQHCs, HCV treatment administered by nonspecialist providers was as safe and effective as that provided by specialists. Nurse practitioners and PCPs with compact didactic training could substantially expand the availability of community-based providers to escalate HCV therapy, bridging existing gaps in the continuum of care for patients with HCV infection. (Kattakuzhy, Gross, Emmanuel, et. al., 8/8)

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