Result card

  • ORG10: How should stakeholders (excluding patients/carers, their representative organisations and the public) be taken into account in planning the introduction of the tests (uPA/PAI-1/ Oncotype DX/ MammaPrint)?

How should stakeholders (excluding patients/carers, their representative organisations and the public) be taken into account in planning the introduction of the tests (uPA/PAI-1/ Oncotype DX/ MammaPrint)?

Authors: Jennifer Butt, Marco Marchetti, Angelica Carletto, Americo Cicchetti, Chiara Filippi

Internal reviewers: Paolo Giorgi Rossi, Claudia Wild, Anne Lee, Antonio Migliore, Stefan Mathis-Endenhofer, Cari Almazan

Analysis of selected studies extracted from the basic literature search and data from the electronic clinician survey. Two articles were found to be relevant to this question. A grey literature search was performed on 10 February 2012 via the search engine Google by one investigator using key words specific to the Organisational Aspects domain (“stakeholder”, “stakeholder involvement”, “genomic test”, “genetic test”) combined with each test (uPA/PAI-1/ Oncotype DX/ MammaPrint). One grey literature source is referred to in these results.

As highlighted in the electronic survey, all the relevant stakeholders within healthcare organisations usually work in close collaboration and as part of the same team. All those concerned are in charge of ordering, administering or interpreting the test and their decisions affect the spread of the tests in clinical practice. The electronic survey of clinicians showed that clinicians, and to a lesser extent also nursing staff and administrative staff, have a good acceptance of the tests. Nevertheless, some resistance was expressed because of economic and financial issues or the limited use of the tests. (See {COL-3} for the full survey results.)

Li et al. (2008) consider that cooperation is needed between third party payers and manufacturers, so that useful information and stronger evidence are produced or found by manufacturers in order to support the decision-making process. They suggest that manufacturers should develop supporting information systems that offer educational and advice programmes for physicians and other healthcare providers, as well as the general population, to spread knowledge and awareness about this kind of testing {15}.

In a review published by the American Society of Clinical Oncology in 2010 the authors examined the coverage policies of six private payers for the Oncotype DX 21-gene assay, highlighting that clinical evidence was the most important factor in decision making for all payers, even if they had different perceptions about the strength of evidence at the time of the coverage decision. Other factors influencing the decision about adoption were, for instance, physician adoption or medical society endorsement. Some payers reported that signs of broader adoption, such as increased number of claims, served as triggers for a closer policy review {31}.

The Institute of Medicine (2012) believes that stakeholders representing regulators, payers and providers should share their perspectives on evidence. More dialogue and coordination among stakeholders is needed to facilitate the development of the necessary evidence base. Test development and reimbursement need to focus on the clinical utility of the test and the net benefit to patients. Moreover, the analysis of evidence must be adapted to the clinical setting and to the evidence needed for that particular application {32}.

The literature provides some insight into the influence of stakeholders on the adoption and diffusion of the prognostic tests for breast cancer recurrence in clinical practice. The degree of acceptance of these tests by clinicians, nursing staff and administrative staff, as shown by the electronic survey, was considered in this assessment element as it could be a factor influencing their diffusion. Cooperation between third party payers, regulators, providers and manufacturers could facilitate the development of further clinical evidence to support coverage decisions.

Butt J et al. Result Card ORG10 In: Butt J et al. Organisational aspects 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: