NICE: Evidence Does Not Back Routine Use of Blood Tests

The UK’s healthcare costs regulator has decided not to back three new blood tests that are intended to speed the identification of bloodstream bacteria and fungi for routine use in the National Health System.

In draft documents published last week, the National Institute for Health and Care Excellence says too much uncertainty exists over whether Roche Diagnostics’ LightCycler SeptiFast Test Mgrade, Molzym Molecular Diagnostics’ SepsiTest and Abbott Diagnostics’ Iridica BAC BSI assay could offer additional clinical benefits.

The tests are intended to identify pathogens that could lead to sepsis. Patients suspected of having sepsis are given high-potency antibiotics; however, widespread — and potentially unnecessary — use of these products has led to increased fears of antimicrobial resistance.

Carole Longson, director of NICE’s Center for Health Technology Evaluation, acknowledges that having tests to identify pathogens in hours rather than days could prove beneficial for patients in heading off sepsis. She adds that these tests could offer clinical advantages, but the committee couldn’t assess the size of the benefits, and further study may be required.

One sticking point for NICE was the applicability of the clinical outcome studies to the UK; for the most part, these assessments were conducted in Europe, and the U.S. Clinical specialists told the body that even though sepsis treatment is based on international guidelines, outcomes, including duration of a patient’s stay in the intensive care unit, usually can’t be extrapolated to the UK due to variances in antibiotic prescribing practices around the world.

In terms of obtaining results, NICE officials were told that the shorter turnaround times seen in studies may not be replicated in real-world experience, unless a molecular service is available 24 hours a day.

Comments on the draft guidance will be accepted through Oct. 21. Specifically, the committee wants input on the following questions:

• Has all of the relevant evidence been taken into account?
• Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence? and
• Are the provisional recommendations sound, and a suitable basis for guidance to the NHS?

A second NICE advisory committee will meet Nov. 4 to discuss comments received and further examine the initial findings.

The consultation document is available here: www.fdanews.com/100515-NICE-Consult.pdf. – Elizabeth Hollis