Market Access Challenges in the EU for High Medical Value Diagnostic Tests

Background: Personalised medicine (PM) is an innovative way to produce better patient outcomes by using an individualised or stratified approach to disease and treatment rather than a collective treatment approach for patients. Despite its tangible advantages, the complex process to translate PM into the member states and European healthcare systems has delayed its uptake. The aim of this study is to identify relevant barriers represented by an index to summarise challenging areas for the implementation of PM in Europe. Methods: A systematic literature review was conducted, and a gaps-and-needs assessment together with a strengths-weaknesses-opportunities-and-threats analysis were applied to review strategic reports and conduct interviews with key stakeholders. Furthermore, surveys were sent out to representatives of stakeholder groups. The index was constructed based on the priorisation of relevant factors by stakeholders. Results: A need for stakeholder-agreed standards at all levels of implementation of PM exists, from validating biomarkers to definitions of ‘informed consent'. The barriers to implement PM are identified in 7 areas, namely, stakeholder involvement, standardisation, interoperable infrastructure, European-level policy making, funding, data and research, and healthcare systems. Conclusions: Challenges in the above-mentioned areas can and must be successfully tackled if we are to create a healthier Europe through PM. In order to create an environment in which PM can thrive for the patients' best outcomes, there is an urgent need for systematic actions to remove as many barriers as possible.

“…This calls for international interoperability, e.g. managing data safety, standardised data collection, international trials, and European funding procedures [74,76,77]. …”

Section: Resultsmentioning

confidence: 99%

“…Currently, different methodologies for HTA are used, and appropriate methods concerning comparators should be stated clearly across Europe [3,74,76]. Exchanging information between countries can support decision making on reimbursement across borders and ensure timely access for patients to effective PM treatment [3,74,76]. …”

Section: Resultsmentioning

confidence: 99%

An Index of Barriers for the Implementation of Personalised Medicine and Pharmacogenomics in Europe

Horgan¹,

Jansen

Leyens

et al. 2014

“…Thus, France has reduced the rate of VAT payable on medical devices, whereas other countries including Germany have maintained the maximum rate of VAT. Moreover, there are differences in health technology assessment (HTA) systems both between and within countries that would benefit from standardization; at present, there is no precedent for value capture, as the future regulatory framework for high-risk tests, including those used in genomic medicine, is likely to evolve [18,19]. …”

Section: Coverage Pricing and Reimbursement Strategies For Genomic Tmentioning

confidence: 99%

Test Pricing and Reimbursement in Genomic Medicine: Towards a General Strategy

Vozikis

Cooper

Mitropoulou

et al. 2016

This paper aims to provide an overview of the rationale and basic principles guiding the governance of genomic testing services, to clarify their objectives, and allocate and define responsibilities among stakeholders in a health-care system, with a special focus on the EU countries. Particular attention is paid to issues pertaining to pricing and reimbursement policies, the availability of essential genomic tests which differs between various countries owing to differences in disease prevalence and public health relevance, the prescribing and use of genomic testing services according to existing or new guidelines, budgetary and fiscal control, the balance between price and access to innovative testing, monitoring and evaluation for cost-effectiveness and safety, and the development of research capacity. We conclude that addressing the specific items put forward in this article will help to create a robust policy in relation to pricing and reimbursement in genomic medicine. This will contribute to an effective and sustainable health-care system and will prove beneficial to the economy at large.

“…The current approach does not reward value creation, nor does it incentivise evidence generation to support the demonstration of value. As a consequence, most European patients are effectively denied access [4]. Innovative molecular diagnostics provide medical and economic value to patients, their physicians, and health care payers, and this should be reflected in the pricing.…”

Section: Rewarding the Value Of Molecular Diagnosticsmentioning

confidence: 99%

“…Health care systems in Europe are not designed to support personalised medicine approaches and related innovative diagnostic technologies [4]. This is reflected in a lack of appropriate patient access and clear pathways for reimbursing molecular diagnostics.…”

Section: Introductionmentioning

confidence: 99%

Enabling Equal Access to Molecular Diagnostics: What Are the Implications for Policy and Health Technology Assessment?

Plun-Favreau¹,

Immonen-Charalambous

Steuten

et al. 2016

Molecular diagnostics can offer important benefits to patients and are a key enabler of the integration of personalised medicine into health care systems. However, despite their promise, few molecular diagnostics are embedded into clinical practice (especially in Europe) and access to these technologies remains unequal across countries and sometimes even within individual countries. If research translation and the regulatory environments have proven to be more challenging than expected, reimbursement and value assessment remain the main barriers to providing patients with equal access to molecular diagnostics. Unclear or non-existent reimbursement pathways, together with the lack of clear evidence requirements, have led to significant delays in the assessment of molecular diagnostics technologies in certain countries. Additionally, the lack of dedicated diagnostics budgets and the siloed nature of resource allocation within certain health care systems have significantly delayed diagnostics commissioning. This article will consider the perspectives of different stakeholders (patients, health care payers, health care professionals, and manufacturers) on the provision of a research-enabled, patient-focused molecular diagnostics platform that supports optimal patient care. Through the discussion of specific case studies, and building on the experience from countries that have successfully integrated molecular diagnostics into clinical practice, this article will discuss the necessary evolutions in policy and health technology assessment to ensure that patients can have equal access to appropriate molecular diagnostics.