From the NICE website:
“Draft guidance from NICE´s Diagnostics Assessment Programme on four tests used to guide decisions about the use of chemotherapy in people with early breast cancer is issued today (18 February) for consultation. This follows consultations on previous drafts and the submission of a confidential access proposal by the manufacturer of Oncotype DX. The draft guidance published today recommends the use of Oncotype DX in people with oestrogen receptor positive (ER+), lymph node negative (LN-) and human epidermal growth factor receptor 2 negative (HER2-) early breast cancer, who are assessed as being at intermediate risk, to guide chemotherapy decisions where the manufacturer provides it at the price offered through the confidential access proposal.
The recommendation for Oncotype DX applies to people assessed as being at intermediate risk of distant recurrence (metastasis) by decision making tools/protocols currently in use in the NHS (for example, the Nottingham Prognostoc Index and Adjuvant! Online) and where the decision to prescribe chemotherapy remains unclear.
The draft guidance also highlights that it has not been able to support the routine use of the IHC4, MammaPrint or Mammostrat tests but recommends that they are used in a research setting to collect evidence about potentially important clinical outcomes and to determine the ability of the tests to predict the efficacy of chemotherapy in people with early breast cancer.”
Interestingly, this draft guidance is the third for this topic, following previous ‘blanket no for all tests’ and a ‘blanket only in research for all tests’. The current guidance incorporates possibly the first patient access scheme in the diagnostics programme.
The Assessment Group was ScHARR-TAG, with Sue Ward, Alison Scope, Rachid Rafia, Abdullah Pandor, Sue Harnan and Pippa Evans doing all the work. All documentation relating to this can be found here.