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A national cancer biomarker platform in Spain: When will it become a reality?

28 July 2015 Tania Rodrigues

Whilst in the midst of research into our next multi-client study, Pathways to Precision Medicine: Navigating Payer Needs and Healthcare Systems through Molecular Diagnostics, I have encountered an ambitious proposal driven by two prominent medical societies- the Spanish Medical Oncology Society, SEOM, and the Spanish Society of Anatomic Pathology, SEAP- in the quest to dramatically change the molecular diagnostic landscape and ultimately provide a global vision of cancer treatment in Spain.

The medical societies are proposing the creation of a national platform of biomarkers for cancer to integrate the information originating from a defined network of molecular diagnostic reference centres. The aim of the platform is to pool together currently dispersed and local information on biomarkers, integrate available resources, and generate useful clinical information in a transparent and non-fragmented fashion. One of the short-term objectives of the proposal is to identify a potential network of molecular diagnostic reference centers based on certain quality criteria for established biomarkers (see table below).

The initiative is seeking to present an accurate picture of patients diagnosed with cancer through biomarkers to the Spanish health authorities, which would allow them to analyse the cost and the clinical efficacy of a targeted therapy. They would be provided with all the information available on biomarkers for already approved medicines and those in development. The list of techniques proposed to be added to the database includes the following predictive biomarkers of response to therapy: BRAF, KRAS, NRAS, EGFR, HER2 and ALK.

Although the platform was predicted to be launched in early 2015, the latest I have heard through primary research is that more meetings will be underway shortly between the SEOM, SEAP and the Spanish Ministry of Health, Social Services and Equality (MoH) to discuss finer details of the proposal itself. The first meeting with the MoH took place in January 2014. Specifically, the database is proposed to contain data on response, efficacy, and the status of a biomarker for all treated cancer patients in Spain.
Current situation

The idea to create a national platform came after findings of a SEOM-SEAP nationwide survey in 2013 revealed that not all Spanish cancer patients have access to the molecular diagnostics required for the most appropriate treatment due to a myriad of reasons, mainly logistical and organizational in nature.

At present, the momentum behind biomarker status testing is in the hands of the pharmaceutical industry and hospitals with the capacity to develop them for their patients. There are multiple biomarker platforms due to manufacturer-led initiatives that provide fragmented information and services. This has been reported to translate into a significant inequality of access amongst autonomous communities (CCAAs), including in some cases amongst hospital centres within the same CCAA.

A national platform that organises the provision of molecular diagnostic services within reasonable timelines and acceptable costs would add value and transform the current situation in Spain. It would consolidate an activity that has been so far mainly undertaken by the pharmaceutical industry in isolation.

However, for the pharmaceutical industry as a whole to invest in this common platform, besides addressing intellectual property and data sharing aspects, the SEOM and SEAP will have to promise considerable savings and access to the whole array of data. But the medical societies have to also lobby the MoH for investment and allow them to manage the project itself; that will ultimately improve reimbursement decision-making and the analysis of health outcomes, considering that cancer therapies represent 6.5% of the Spanish healthcare expenditure and 10% of the total drug's bill, according to SEOM data.

Tania Rodrigues is a senior life sciences research analyst for IHS
Posted 28 July 2015

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