Result card

  • ECO6: What is the incremental cost-effectiveness ratio of uPA/PAI-1 (Femtelle), OncotypeDx™ or MammaPrint® compared to standard clinical practice?

What is the incremental cost-effectiveness ratio of uPA/PAI-1 (Femtelle), OncotypeDx™ or MammaPrint® compared to standard clinical practice?

Authors: Isaura Vieira, Mirella Corio, Maria Rosaria Perrini, Matteo Ruggeri

Internal reviewers: Hanan Bell, Marco Oradei, Michelle O'Neill, Patricia Harrington, Kristi Liiv

An analysis of the selected studies extracted from the basic literature search was performed. Seven economic studies {1;2;3;4;5;6;9} were found to be relevant to this question.

The societal perspective was adopted. A decision analytic model followed by a Markov model was designed to evaluate the cost-effectiveness/cost-utility of prognostic tests compared with standard care as defined in the scope. The model was based on information included in the literature {1;2;3;4;5;6;9} and from the TEC domain.

The model addresses the evolution of early invasive breast cancer in women and compares the costs and outcomes in terms of QALYs (expected Quality Adjusted Life Years) for a patient’s lifetime. A simplified presentation of the decision model is shown in Figures 1 and 2.

The two initial branches of the decision tree represent a choice between the use of a prognostic test (uPA/PAI-1([FEMTELLE], Oncotype DX or MammaPrint) and the use of standard care (St Gallen consensus recommendations, NCCN, Adjuvant! Online or NPI) to stratify the women with early invasive breast cancer as at high or low risk of having distant recurrence. The probability distribution should be drawn from the literature, preferably from RCTs. The selection of treatment will also depend on ER status.

After this stratification there are four different treatment scenarios: chemotherapy plus endocrine therapy for patients who are ER-positive and at high-risk of recurrence; chemotherapy alone for ER-negative, high-risk patients; endocrine therapy alone for ER-positive, low-risk patients; and no adjuvant therapy for ER-negative, low-risk patients. Anti-HER2 agents can be added to chemotherapy depending on the risk classification and HER2 status {3}. Branches that include chemotherapy lead to subtree 1 via a chance node that considers the existence of toxicity associated with chemotherapy.

The Markov model shows the clinical after adjuvant therapy with 3 stages modelled. The structure of the Markov model is the same for all the “M” nodes but the transition probabilities and state utilities differ depending on each branch.

Figure 1 – Decision tree analysis

113.ECO Figure 1

Figure 2 – Markov model

113.ECO Figure 2

The objective here is only to present a rough description of the model. The necessary cost and outcome data were not collected and the model was not constructed or run. The quantity of resources used should be drawn from the literature, namely RCTs. The unit costs should be collected from national or regional data sources. The outcomes should also be drawn from the literature, namely RCTs.

It is necessary to investigate the impact of uncertainty in the model input parameter values. The most important values to explore on sensitivity analyses are the values of the probabilities used, mainly the ones related to the definition of high and low risk of recurrence. Also, the cost of adjuvant chemotherapy because these costs vary depending on the type of regimen used {8} and the utility values are important parameters to examine with sensitivity analysis.

Due to the lack of quality evidence to identify the effectiveness of the interventions {EFF domain} it was not possible to identify the cost-effectiveness ratio.

A rough description of an appropriate economic evaluation was created in case clinical effectiveness data becomes available in the future.

It is important to keep in mind that cost-effectiveness ratios are usually not directly transferable between countries because the values, in particular the cost values, included in the model may vary by nation or region. However, the model structure presented here could be used by changing the input data to reflect the situation locally.

Vieira I et al. Result Card ECO6 In: Vieira I et al. Costs and economic evaluation In: Jefferson T, Vicari N, Raatz H [eds.]. Prognostic tests for breast cancer recurrence (uPA/PAI-1 [FEMTELLE], MammaPrint, Oncotype DX ) [Core HTA], Agenzia nationale per i servizi sanitari regionali (, Italy ; 2013. [cited 7 February 2023]. Available from: