Or to be precise, “Gene expression profiling and expanded immunohistochemistry tests to guide the use of adjuvant chemotherapy in breast cancer management” is the latest topic to report as part of the NICE Diagnostics Appraisal Programme.
Nine GEP and expanded IHC tests were included in the ScHARR-TAG assessment. Six were based on gene expression profiling: the Randox Assay (BCA) (Randox Laboratories); MammaPrint (Agendia); Blueprint (Agendia); PAM50 gene expression assay (ARUP Laboratories Inc.); OncotypeDX (Genomic Health) and Breast Cancer Index (Biotheranostics) and three were based on protein expression profiling: IHC4, the Mammostrat test (Clarient) and NPI plus (NPI+) (University of Nottingham).
A probabilistic model was developed by ScHARR-TAG to evaluate the cost effectiveness of adjuvant chemotherapy treatment guided by the new tests. Analysis was undertaken for women with oestrogen receptor positive (ER+), lymph node negative (LN–), and HER2– early breast cancer (EBC). In the comparator arm of the economic model cancer registry data was used to inform the proportion of patients receiving chemotherapy under current practice. In the intervention arm patients were classified into different risk categories based on the result of the new test. The likelihood of receiving chemotherapy was dependent on this classification. The natural history of breast cancer was then simulated using a five state transition Markov model, taking into account the reduction in the risk of recurrence associated with chemotherapy.
However, due to a paucity of data only a limited number of formal cost-effectiveness analyses were undertaken. Consequently, the draft guidance focuses on four tests; IHC4, Oncotype DX, MammaPrint and Mammostrat.
The IHC4 test appeared the most cost-effective and NICE is recommending it is used in a research setting to collect further evidence. The draft guidance does not support the routine use of the Oncotype DX, MammaPrint or Mammostrat tests in women with oestrogen receptor positive, lymph node negative and human epidermal growth factor receptor 2 negative early breast cancer.
From reading the ERG report, it appears that the existing economic evaluations and those submitted by (a minority of the manufacturers) were of poor methodological quality compared to those seen in the Technology Appraisal Programme. Manufacturers will need to treat this new NICE Programme more seriously or there will be further disappointments ahead……..
The HEDS team was Sue Ward, Alison Scope, Rachid Rafia, Abdullah Pandor, Sue Harnan, and Pippa Evans.