In December of last year, during the Luxembourg Presidency of the EU, the European Council issued its conclusions on personalised medicine for patients, highlighting how ‘the development of personalised medicine may offer new opportunities for the treatment of patients in the European Union.

The conclusion stressed that the adoption of personalised medicine on an EU-wide basis would allow healthcare professionals to offer better-targeted treatment, avoid medical errors and reduce adverse reactions to medicinal products.

There is no doubt that personalised medicine has the potential to improve outcomes for Europe’s patients, but its promise must be balanced against a number of highly relevant challenges that may limit its positive impact on 21st century medicine.

Issues such as increasing costs, inequitable access across European countries and regions and the need for a relevant ethical, regulatory and reimbursement environment are among the barriers to implementing this fast-moving and innovative form of treatment at European and national levels.

Given the need to address these important issues, the Brussels-based European Alliance for Personalised Medicine (EAPM) recently assembled a multi-stakeholder panel from its growing membership to identify and precisely define the critical barriers that limit personalised medicine uptake, while also developing putative solutions that will enhance patient access to targeted treatment across Europe.

The output from their discussions have now been captured in a series of articles in a special issue of Public Health Genomics.

The articles complement the activities of EAPM's Working Group on Access, which is surveying the European landscape and developing policy recommendations in this complex domain.

Personalised medicine approaches have already been particularly effective in certain cancers, and have brought practice-changing clinical benefits to patients.

However, the spiralling costs associated with personalised or precision cancer medicine, even for new standard medicines, highlight the need to address the cost-value dilemma.

There is a need to move beyond a simplistic ‘what the market can bear' approach to a more nuanced value-based pricing philosophy.

Employing this approach and embedding this philosophy into cancer care pathways can help reward innovation that has truly transformative potential and allow the benefits of a value-centred strategy to accrue for patients and society in general.

Also, despite the undoubted benefits of the precise application of in vitro diagnostic (IVD) tests, the companion diagnostics landscape in Europe is fragmented.

There is a clear dislocation between the innovative medical intervention and its companion diagnostic, compounded by issues of market access and lack of appropriate reimbursement frameworks.

In many countries, approval for an innovative medicine is not linked to the availability of an upstream companion diagnostic test, thus emphasising this disconnection between the regulatory and reimbursement pathways for innovative medicines and IVDs.

Speaking from the American Society of Oncology Congress in Chicago, Mark Lawler from Queens University Belfast said "As we increasingly look to adopt a personalised medicine based approach to treating common diseases such as cancer, it is vital that we look at the best ways of achieving effective but affordable care for our patients. If we can successfully cross this cost-value rubicon, we can  develop new value based care models that deliver both for our patients and for society as a whole".

Source: Karger