Patient Access, Unmet Medical Need, Expected Benefits, and Concerns Related to the Utilisation of Biosimilars in Eastern European Countries: A Survey of Experts

Table 3

Potential policy actions to maximise the societal benefit of biosimilars [9].

Areas for intervention	Potential policy actions
Public administration of biosimilar medicines	Expedited price and reimbursement process to facilitate the timely market entry of biosimilars
	Introduction of administrative tools and policy measures to incentivize the choice for more affordable biosimilars
Clinical guidelines	Multisource biologic medicines should be first-line biologic therapy for all patients. More expensive patented biologic medicines with no proven significant clinical benefit compared to biosimilar medicines should be only second line options
	Single switch of patients from an original biologic medicine to its more affordable biosimilar alternative under medical supervision should be mandated after patent expiry
	Physicians should not only be informed about scientific evidence on biosimilars but also guided on how to educate appropriately their patients on these medicines
Evidence base of policy decisions	Cost-effectiveness or cost-utility analysis is applied to judge the full economic value of biosimilar medicines except in those cases, when biosimilar medicines are compared to their original biologic alternative for treatment-naïve patients.
	Budget impact analysis is applied to estimate (1) the savings from biosimilar medicines, if there is no patient access limit to biologic medicines, or (2) the incremental budget, if patient access to biologic medicines is restricted
Management of uncertainty related to policy decisions	Ex ante risk management: calculation of threshold for the risk of immunogenicity, where not switching patients to biosimilar medicines is the preferred option from the payers’ perspective
	Ex post risk management: mandate of vigorous pharmacovigilance data collection and risk-management plan in case of increased risk of immunogenicity. The risk-management plan may even include risk-sharing agreements with manufacturers of biosimilar medicines