NICE Diagnostics guidance DG58

Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer

NICE diagnostics guidance – evaluation of effectiveness and efficiency

The NICE (National Institute for Health and Care Excellence) diagnostics guidance DG58 gives evidence-based recommendations to guide treatment decisions and evaluate the efficiency and cost-effectiveness of products and services in the health system of England and Wales.

Use of multigene assays (MGAs) for tumour profiling

Tumour profiling by MGAs could be used to guide decisions on adjuvant chemotherapy by identifying patients who

  • may not benefit from adjuvant chemotherapy and avoid unnecessary treatment.
  • who would actually benefit from chemotherapy, although they have a low risk of disease recurrence due to clinical factors.

How NICE determines cost-effectiveness

Cost-effective-analysis is based on determining the incremental cost-effectiveness ratio (ICER). It is calculated by dividing the difference in cost by the difference in quality adjusted life year (QALY) of the MGA compared to clinical/pathological tumour profiling.

ICER = costdifference = costsMGA — costsClinPath
QALYdifference QALYMGA — QALYClinPath

An ICER < £ 20,000 per QALY gained is considered to be cost-effective by the National Health Service (NHS).

Economic value of multigene assays MGAs

Economic modelling suggests that Oncotype DX®, EndoPredict® and Prosigna® are cost-effective compared with standard care in postmenopausal women. All 3 tests had ICERs < £ 20,000 per QALY gained when compared to not using tumour profiling tests.

MammaPrint® is likely to be less clinically effective and costs more than standard care.

Cost effectiveness of Oncotype DX®

3.18

The committee concluded that Oncotype DX® was likely to be a cost-effective use of NHS resources when used to help guide adjuvant chemotherapy decision making with postmenopausal women.

Impact on chemotherapy services

3.21

EndoPredict®, Oncotype DX® and Prosigna® were all likely to be cost effective compared with not using tumour profiling tests.

3.21

The EAG’s economic model predicted that using Oncotype DX® would result in 594 fewer women having chemotherapy per 1,000 tested, whereas with EndoPredict® or Prosigna® the reduction was around 40.

This summary of NICE diagnostics guidance ‘Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer’ (DG58) is promotional material. NICE has checked the accuracy of the content specifically relating to the NICE guidance. NICE is independent of any company or product advertised.

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