The Health Information and Quality Authority (HIQA) has published a rapid health technology assessment on gene expression profiling (GEP) tests for breast cancer at the request of the HSE’s National Cancer Control Programme. 

GEP tests are performed on tumour samples from early-stage breast cancer patients to help decide if they would benefit from chemotherapy after their surgery. These tests can be used for people with the most common form of breast cancer in Ireland. For this type of cancer, surgery to remove the tumour is usually the first treatment and other treatments, such as chemotherapy, may follow. Chemotherapy can reduce the risk of breast cancer returning and has contributed to declining mortality. However, some patients may not benefit from chemotherapy and so could be spared its side effects. GEP tests aim to estimate the chance of the disease returning and of chemotherapy being effective in stopping the disease from returning. 

Currently, the HSE covers the cost of one GEP test called Oncotype DX®. The costs of other tests are not covered. HIQA’s rapid HTA looked at the evidence for all four tests that are currently commercially available in Ireland to provide advice to the HSE on the alternatives to Oncotype DX®.

HIQA looked at different groups of breast cancer patients who are eligible to receive GEP tests. For people with cancer that has spread to their lymph nodes, the test with the strongest evidence was Oncotype DX®. For people with cancer that had not spread to their lymph nodes the data was more limited; however, the available evidence supported the continued use of Oncotype DX®. 

HIQA noted that any decision on whether to cover the cost of GEP tests other than Oncotype DX® should also take into account differences in factors such as: 

• which patient groups a test can be used in
• the cost
• practicality of their use in Ireland. 

Shelley O’Neill, Deputy Director of HTA at HIQA, said: “Going through breast cancer treatment is extremely tough and while chemotherapy has contributed to declining breast cancer mortality, it has short- and long-term side effects. Some people may not benefit from chemotherapy. GEP tests can help identify those who may not need to go through chemotherapy and this would provide benefits for both the patient and the health system,”

Ms O’Neill continued: “We found that there is a need for greater data on GEP test use in Ireland that would allow us to fully assess the use of these tests in the future. It may also be helpful to develop guidance on test use and on understanding the test results so that we can best optimise the use of GEP testing.”

Ends.

For further information please contact:

Marty Whelan, Head of Communications and Stakeholder Engagement 085 805 5202 / mwhelan@hiqa.ie

Notes to the editor:

• The Health Information and Quality Authority (HIQA) has today published the following document: A rapid health technology assessment of gene expression profiling tests for guiding the use of adjuvant chemotherapy in early-stage breast cancer.
• Breast cancer is the most commonly diagnosed female cancer in Ireland. In Ireland, on average approximately 1,800 cases of hormone receptor-positive, and HER2-negative, stage I-IIIa breast cancer were diagnosed each year between 2015 and 2019. Currently, the majority of these patients receive Oncotype DX® testing.
• Oncotype DX® is the only GEP test currently reimbursed by the HSE. It can be used among patients with hormone receptor-positive, and HER2-negative, early-stage (stage I-IIIa) breast cancer.