Authors' objectives: (i) To assess the relative effectiveness and safety of different types of molecular profiling and subsequent management in breast cancer. (ii) To assess the economic implication, social, ethical, and organisational aspects related to molecular profiling of early breast cancer.

Authors' results and conclusions: Molecular profiling assays are significantly effective in prognosticating between low-risk and high-risk of recurrence among patients with HR+/HER2-ve early-stage breast cancer. However, further assessment is required in terms of predicting of chemotherapy benefit, Oncotype DX and MammaPrint are able to predict the chemotherapy benefit regardless of lymph-nodes status. Individual prospective assays are available but there are not head to head prospective study to compare between the assays. Retrospective study looking at the association and correlations between the assays are limited in number and has small sample size (<100). Each assay had poor to weak association with each other and should not be used interchangeably. Overall, LN- and low-risk early breast cancer patients might benefit more from molecular profiling assays. Economically wise, the molecular profiling assays were cost-effective compared to conventional method and Oncotype DX was the most commonly used. In economic evaluation, both Oncotype DX and MammaPrint incurred incremental cost if utilized for testing the whole eligible population. However, cost savings of approximately MYR 15,151,081.92 can be seen with usage of Oncotype DX in both intermediate risk of recurrence LN-negative and LN-positive breast cancer patients with 880 patients who averted chemotherapy. Therefore, maximal cost savings and potential benefits in averted chemotherapy with its complications may be achieved if targeted testing was performed using Oncotype DX in the intermediate risk of recurrence group. The budget implications to procure Oncotype DX assays for 1,574 patients would be MYR 23,610,000.00. The sensitivity analysis showed that overall cost savings can be achieved if the price of Oncotype DX is reduced to 50% of the quoted price, giving a total accrued cost savings of MYR 1,367,325.36. If price negotiation can be done, a minimum reduction of 50% of the Oncotype DX price may potentially offer eligible population greater access to Oncotype DX assay regardless of LN status or risk. The budget required for procurement of Oncotype DX assay for 3,500 patients with reduction to 50% of the quoted price is MYR 26,250,000.00

Authors' recommendations: Molecular profiling assays has a role in discriminating recurrence risk in HR+/HER2- early-stage breast cancer patients. Oncotype DX may be recommended in management of HR+/HER2- early breast cancer with the maximal potential benefit in the intermediate risk of recurrence group with purchasing price negotiation.

Authors' methods: Literature search was conducted by an Information Specialist who searched for published articles on molecular profiling in breast cancer. The following electronic databases were searched through the Ovid interface: Ovid MEDLINE® and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions® 1946 to June 2022, EBM Reviews - Health Technology Assessment (4th Quarter 2016), EBM Reviews - Cochrane Database of Systematic Review (2005 to January 2022), EBM Reviews - Cochrane Central Register of Controlled Trials (June 2022), and EBM Reviews - NHS Economic Evaluation Database (4th Quarter 2016). Parallel searches were run in PubMed, US FDA and INAHTA database. Search was limited to articles in English and in human.

Authors' identified further research: The selection of the studies and appraisal was done by two reviewers.

Project Status: Completed

Year Published: 2022

URL for published report: https://www.moh.gov.my/moh/modules_resources/bookshelf/MOLECULAR_IN_EARLY_BREAST_CANCER-update12122023/index.html#page/1

Requestor: Ministry of health, decision-making committee

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Malaysia

Organisation Name: Malaysian Health Technology Assessment

Contact Address: Malaysian Health Technology Assessment Section, Ministry of Health Malaysia, Federal Government Administrative Centre, Level 4, Block E1, Parcel E, 62590 Putrajaya Malaysia Tel: +603 8883 1229

Contact Name: htamalaysia@moh.gov.my

Contact Email: htamalaysia@moh.gov.my

Copyright: Malaysian Health Technology Assessment Section (MaHTAS)