Result card

  • LEG8: Are the Genetic Tests (uPA/PAI-1 ELISA/ Oncotype DX/ MammaPrint) equally accessible to all women with invasive breast cancer in the society?
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Are the Genetic Tests (uPA/PAI-1 ELISA/ Oncotype DX/ MammaPrint) equally accessible to all women with invasive breast cancer in the society?

Authors: Marina Casini, Emanuela Midolo, Marco Marchetti

Internal reviewers: Judite Neves, Ana Bação, Vesna Kovač

The domain methodology used for this question has been collection, selection and analysis of European norms and sentences.

We believe that this type of test should be equally accessible to all women, from the healthcare, legal and economic points of view. From the first two perspectives access is guaranteed because the principle of non-discrimination is applied with reference to human dignity. And medically there is a guarantee of the possibility of performing these genetic tests for all women with breast cancer. There are, however, some concerns with regard to the economic aspects. The list prices for these tests are €3180 for most of Europe and £2580 for the UK. Furthermore, using online searches, we discovered that the price of MammaPrint is €2675 and for the Oncotype DX test the cost is $3400. The MammaPrint test is reimbursed only by some private institutions as follows:

  • in Europe: ACHMEA (Netherlands), INTRA (Switzerland)
  • in the USA: United Healthcare, Humana, Coventry, Three Rivers, NPPN, Galaxy, Multiplan, Beech Street, Global Claims, Medicare, Railroad Medicare, Aetna, Cigna, BCBS, and Blue Cross Blue Shield

This data supports, in our opinion, the essential need for the adoption of a European norm to ensure equal access to care that would provide for lowering the costs of the tests or a total reimbursement of the costs. Currently, the legislative framework on equal access to healthcare is given by Article 3 of the Oviedo Convention,{1} and Articles 1 and 4 of the Additional Protocol to the Oviedo Convention on genetic testing. {2} as for access to European health we must refer to the White Paper of the Commission of the European Communities of the 23.10.2007 “Together for Health: A Strategic Approach for the EU 2008-2013”. {10}

Important
Completely
Casini M et al. Result Card LEG8 In: Casini M et al. Legal 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 (age.na.s), Italy ; 2013. [cited 2 December 2022]. Available from: http://corehta.info/ViewCover.aspx?id=113

References