Det nye forumet finner du her

Tilbake til: Farma og medisin
Innlegg av: Snøffelen (27.12.17 00:52 ), lest 7712 ganger
Ticker: PCIB
Endret: 27.12.17 00:55

PCIB - Accelerated approval gir QALY, big time

Her er dokumentasjonen som viser at produkter som får regulatoriske privilergier fra FDA gir pasientene mest verdi.
Og det gjeveste privilegiet ender seg sagt opp med å gi mest, vi snakker selvsagt Accelerated Approval.

https://www.ncbi.nlm.nih.gov/pubmed/28784733

Health Aff (Millwood). 2017 Aug 1;36(8):1408-1415. doi: 10.1377/hlthaff.2016.1541.

Drugs Cleared Through The FDA's Expedited Review Offer Greater Gains Than Drugs Approved By Conventional Process.

Chambers JD1, Thorat T2, Wilkinson CL3, Neumann PJ4.

"Abstract
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 identified published estimates of additional health gains (measured in quality-adjusted life-years, or QALYs) associated with drugs approved in the period 1999-2012 through expedited (seventy-six drugs) versus conventional (fifty-nine) 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). We also found that, compared to drugs not included in the same program, greater gains were provided by drugs in the priority review (0.175 versus 0.007 QALYs), accelerated approval (0.370 versus 0.031 QALYs), and fast track (0.254 versus 0.014 QALYs) programs. Our analysis suggests that the FDA has prioritized drugs that offer the largest health gains."