The reimbursement landscape in Europe is complex. There are different models, medicines are evaluated in different ways and the timelines for approval vary widely. Most crucially, the level of patient involvement is not where it needs to be. This simply has to change.
Patients provide the human face for evidence – identifying outcomes that are important to them, addressing gaps in the clinical evidence base, helping verify or refute assumptions in economic models and informing the determination of added value.
Vynamic’s vision for the future is one that places the patient at the heart of the reimbursement process across the full value chain – but to achieve that vision, all stakeholders need to advocate for major changes across the entire sector, and there are many implications to consider before embarking on such a journey.
The degree to which patients and patient organisations (POs) can be involved in the HTA review process varies across Europe, and there are as many situations as there are countries (see figure 1 for a high-level overview). Patients and POs contribute to discussions by highlighting, for example, their experience of the disease, their needs and what risks they would consider acceptable in view of the expected or potential clinical benefits.
Some countries like France or Sweden have a formalised process where patients and POs can vote within HTA committees. In contrast, other European countries like Austria, Italy or Portugal do not usually share HTA information nor consult patient representatives. Following the appraisal of a medicine, in some instances patients and POs have the right to appeal or provide input at re-evaluations.
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