Table 2.

Potential barriers of patient involvement in HTA in CEE countries.

	Categories	Potential barriers
PAYER/HTA BODY PERSPECTIVE	Limited willingness to involve patients	- Limited impact of societal factors on pricing and reimbursement decisions (i.e., the reimbursement decision is evaluated only from the payer perspective per legal framework) - Lack of understanding of the added value of involving patients in the HTA process - General lack of trust in the objectivity and relevance of “patient stories” (e.g., fear of emotional aspects negatively affecting the decision-making process) - Patient involvement in HTA is not mandatory/is not mentioned in the local HTA guideline
	Conflict of interest & confidentiality	- Fear of potential conflict of interest issues due to industry funding of patient organizations - Fear of the violation of confidentiality by patient representatives
	Difficulties to finding the “right” patient representative	- Lack of support and supporting tools (e.g., registries or network) to help patient recruitment - Difficulty to identify representatives from the disease area needed (e.g., some patient communities may have “louder voices” than others) - Lack of understanding of different patient roles (whether the patient is representing their own views or their patient community's) - Patient representatives might not be representative of the whole patient community in terms of socioeconomic status and other basic characteristics (e.g., higher educated, somewhat younger, health-literate patients tend to take on these roles)
	Lack of human resources at relevant public institutes	- Fear of the patient involvement process needing too much support time amidst the tight HTA decision timelines - Payer or HTA organizations do not have enough human resources/time to involve patients (even though they would intend to)
	Not knowing how to involve patients	- Lack of experience/training/skills from the HTA and payer organizations' side in knowing how and when to incorporate patient perspectives - Lack of local (regional or country-specific) guidelines on best practices of patient involvement to HTA
PATIENT PERSPECTIVE	Lack of understanding the decision context	- Patient representatives' lack of basic knowledge in HTA - Patient representatives' lack of knowledge of the local regulatory processes including how they can get involved - Patient representatives' lack of knowledge in the medical language - Patient representatives do not speak/understand English which limits the amount of information (training, other countries' experience, scientific literature) they can access
	Lack of knowledge and guidance of evidence-based advocacy	- No methodological guidance to support the activities of patient organizations in collecting data (e.g., survey) valuable for HTA - Patients' lack of experience in searching and/or interpreting information from independent resources (i.e., scientific articles)
	Lack of resources to be spent on meaningful patient representation	- No fair compensation for time offered and logistics issues (e.g., traveling time and costs, documents not sent on time for review, preparatory calls or meetings during working hours) -General lack of capacities due to financial constrains
	Lack of ethical guidance for representativeness	-No clear rules on how to represent a patient community and how to distinguish it from representing their individual patient perspective plus confidentiality prevents patient representatives from discussing/sharing views with others before attending HTA procedures/meetings