The process of assessing and reimbursing new medicines in Ireland has come under major scrutiny in recent years. As more and more innovative medicines are developed, many with expensive price tags, the national agencies in Ireland that are responsible for this area (DoH, HSE, NCPE) have struggled to keep apace with their respective duties and responsibilities.
Tasked with making difficult decisions, the HSE is often portrayed as lacking transparency – at times seeming to respond to the most vocal campaigners and political pressure. This is a situation which is far from ideal, as it can lead to inequitable decision-making and the marginalisation of groups which are not in a position to advocate for themselves or do not agree with pressurised lobbying tactics. Patients are concerned by the unfolding situation and firmly believe that their active involvement in the process can lead to more timely and fairer decisions as well as help to manage the expectations of patient communities. Elsewhere, many national agencies (Canada, England, Scotland, Sweden) have encouraged and supported this involvement and are now firmly wedded to progressing patient involvement.
In recent years, Irish patient communities and national agencies have taken a number of important steps in the journey towards effective patient involvement in Health Technology Assessment (HTA) and post-HTA (reimbursement) decision-making. Patients have indicated their willingness to get involved, with many applying to undertake specific training and education to improve their understanding of how medicines are developed, assessed and made available to patients.
National agencies have started to review their policies and processes, with many opting to carve out new and improved spaces for the patient voice. In particular, the NCPE has made notable improvements; including the introduction in 2015 of a template for patient submissions to assessment committees, the employment of a Stakeholder Engagement Lead for Rare Diseases in 2018, the ongoing delivery of a patient education module on health technology assessment (in collaboration with IPPOSI), and a public consultation in late 2018 to fine-tune the patient submission process. NCPE is also transparent with respect to the timelines and status of assessments, and efforts are underway to make information more readily available and to communicate more proactively with patients.
The HSE has been less forthcoming and challenges exist in ensuring patient involvement in decision-making at this level, as patients remain excluded from (and unaware of) the work of the Corporate Pharmaceutical Unit, the Drugs Committee and the Leadership Team. Initial work to involve patients in the area of Rare Diseases has begun within the Rare Disease Technology Review Group.
The challenge now is for all stakeholders to come together to build upon this initial work, to bring all partners into the fold, and to align and manage our different expectations for the future.