There are different models used across European countries to perform HTAs. These models establish a framework that shapes whether, when, and how much weight the types of evidence (clinical, economic, and others) are given.
All countries consider some form of economic evidence within their HTA process. However, the weight of this evidence differs from country to country. In some systems, economic evidence is the key factor to decide whether a therapy should be reimbursed, while in others, they offer support for price negotiations.
Model based on health economics
In this model, both clinical and economic analyses are performed, and other aspects may also be evaluated. Nonetheless, to determine whether a therapy is reimbursed or not, economic evaluations such as the CEA and CBA are central.
In countries where this model is used, such as in Ireland and the Netherlands, decision makers mainly focus on whether a therapy offers good value for money. If the cost per QALY gained is below a certain level, the therapy is usually considered cost-effective and more likely to be reimbursed. In some countries, these levels can vary and may be adjusted for therapies aimed at rare diseases.
Model based on clinical effectiveness
In this model, clinical benefit, which examines whether a therapy offers meaningful improvement, is assessed first and considered the key factor.
In countries where this model is used, such as in France and Germany, economic evaluations are used as supporting evidence when it comes to price discussions and budget allocation. In general terms, economic evidence serves as a guide to decide on pricing rather than reimbursement eligibility.
Hybrid model
In this model, which is an emerging one, elements from both economics and clinical effectiveness are considered.
In countries where this model has been used, therapies are evaluated more holistically, considering equally important factors such as quality of life, disease severity, social aspects, budget impact, and other relevant aspects. This model is particularly beneficial for rare diseases, where traditional models may not fully capture patient and caregiver impact.
