NICE: More Research Needed on Tests for Pregnancy Complication

The UK’s health cost-benefit watchdog is calling for further research on two tests that could help diagnose preeclampsia in the second and third trimesters of pregnancy.

Alere’s Triage PLGF test and Roche’s Elecsys immunoassay sFlt-1/PLGF ratio measure levels of placental growth factor in the blood. Abnormally low levels of PLGF may indicate that the placenta is not developing properly and could potentially cause life-threatening fits called eclampsia.

PLGF-based tests could be used to safely rule out preeclampsia in women between 20 weeks gestation and 34 weeks plus six days gestation, the National Institute for Health and Care Excellence says in draft guidance issued Oct. 30. However, more evidence is needed on the use of the tests to confirm preeclampsia, NICE says.

List prices are $62 for the Triage PLGF test and $88 for the Elecsys immunoassay sFlt-1/PLGF ratio. Both tests were cost-saving compared with standard clinical assessment, with cost reductions per patient of $4,467 for Triage PLGF test and $3,837 for Elecsys immunoassay sFlt-1/PLGF ratio, NICE says.

NICE also recommends carrying out further research on the use of repeat PLGF-based testing after a negative test result in women presenting with suspected preeclampsia.

Meanwhile, NICE does not recommend Perkin Elmer’s DELFIA Xpress PLGF 1-2-3 test and Thermo Fisher Scientific’s BRAHMS sFlt-1 Kryptor / BRAHMS PLGF plus Kryptor PE ratio for routine adoption in the National Health Service, saying further evidence to show the clinical effectiveness of these tests is needed. A meeting of the Diagnostics Advisory Committee to evaluate the comments is scheduled for Dec. 1.

As part of the consultation, NICE is seeking comments on whether it should consider other evidence, whether it reasonably interpreted the clinical effectiveness and cost, and whether its recommendations are suitable for guidance to NHS.

Roche says it is actively involved in the consultation process and is sharing clinical and health economic data with the cost regulator.

Comments are due by Nov. 19. Read the consultation document here: www.fdanews.com/11-15-NICE-PlGF.pdf. — Jonathon Shacat