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

Resource impact statement

NICE has updated its diagnostics guidance on tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer previously outlined in DG10 and subsequently updated to incorporate new technologies in DG34.

Initial recommendations made related to people with ER-positive, HER2-negative and lymph node (LN)-negative (including micrometastatic disease) early breast cancer.

The updated guidance now recommends that EndoPredict, Oncotype DX or Prosigna are used alongside consideration of clinical risk factors as options to guide adjuvant chemotherapy decisions for oestrogen receptor (ER)- or progesterone receptor (PR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with 1 to 3 positive lymph nodes. They can be used for:

• women who have been through the menopause
• men
• trans, non-binary or intersex people, depending on their hormonal profile.

only if:

• information provided by the test would help them choose, with their healthcare professional, whether or not to have adjuvant chemotherapy.
• the companies provide the tests to the NHS with the discounts agreed in the access proposals.

The tests and results should be used alongside NICE’s guideline on shared decision making. An oncologist should explain to the person what their tumour profiling test results mean, and the risks and benefits of treatment options based on all available risk factors.

Some NHS trusts are already offering tumour profiling tests to inform chemotherapy decisions for people with LN positive early breast cancer. Many began doing so during the COVID-19 pandemic to help relieve pressure on infusion services. The recommendations may lead to savings at a local level from a reduction in the number of people receiving chemotherapy treatment. The level of these savings will be dependent on the extent to which tumour profiling tests to inform chemotherapy decisions for people with LN positive early breast cancer are currently being offered.   

Due to a lack of robust data on current practice and the regional variation in current practice, the size of the resource impact will need to be determined at a local level. A resource impact template is available to help organisations estimate the resource impact at a local level. 

Depending on current local practice, areas which may require additional resources and result in additional costs include: 

• time to prepare and submit the number of additional samples for testing. 
• additional capacity in laboratories to perform the additional tumour profiling tests using EndoPredict or Prosigna.
• time for the reporting and discussing of results.

Implementing the guideline may: 

• reduce the number of chemotherapy treatments for people with oestrogen receptor (ER)- or progesterone receptor (PR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with 1 to 3 positive lymph nodes. The reduction in chemotherapy treatment recommendations will be dependent on the test used.
• identify people who are most likely to benefit from chemotherapy treatment. These people can be prioritized for treatment, while people who are less likely to benefit can avoid unnecessary treatments.
• lead to improved consistency of best practice across the country.
• lead to better health outcomes and care experience. 

These benefits should also provide some savings to offset some of the potential costs identified above. 

Tumour profiling tests are commissioned by providers and reimbursed by NHS England. Chemotherapy and radiotherapy for people with breast cancer is commissioned by NHS England, other care for people with breast cancer is commissioned by integrated care boards. Providers are NHS hospital trusts.