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

Abstract

This policy research aims to map patient access barriers to biologic treatments, to explore how increased uptake of biosimilars may lower these hurdles and to identify factors limiting the increased utilisation of biosimilars. A policy survey was developed to review these questions in 10 Central and Eastern European (CEE) and Commonwealth of Independent States (CIS) countries. Two experts (one public and one private sector representative) from each country completed the survey. Questions were related to patient access, purchasing, clinical practice, and real-world data collection on both original biologics and biosimilars. Restrictions on the number of patients that can be treated and related waiting lists were reported as key patient access barriers. According to respondents, for both clinicians and payers the primary benefit of switching patients to biosimilars would be to treat more patients. However, concerns with therapeutic equivalence and fear of immunogenicity may reduce utilisation of biosimilars. Similar limitations in patient access to both original biologics and biosimilars raise concerns about the appropriateness and success of current biosimilar policies in CEE and CIS countries. The conceptual framework for additional real-world data collection exists in all countries which may provide a basis for future risk-management activities including vigorous pharmacovigilance data collection.

Effects of Message Framing on Patients’ Perceptions and Willingness to Change to a Biosimilar in a Hypothetical Drug Switch

“…A lack of acceptance and negative perceptions toward biosimilars may enhance the nocebo effect following a switch and increase nonadherence (15,16). Although studies highlight physicians' lack of confidence in explaining biosimilars and the importance of patient acceptance to ensure uptake (17)(18)(19)(20), limited research has addressed these areas.…”

Influence of biosimilar infliximab launch on the utilization pattern of biological medicines: the case of Hungary

“…Results of the longitudinal analysis demonstrated an increasing utilization of biologicals during the study period in all indications. This implicitly confirms the existence of hidden access barriers toward biologic medicines with high budget impact in Hungary [14]. Economic rationale suggests that increased utilization of more affordable, multisource biologicals is an appropriate policy intervention to tackle access barriers in countries with limited resources [41].…”

“…If an active substance loses its market exclusivity and other reimbursed original biologicals do not have-, or have only minimal proven added benefit compared to the multisource alternatives, multisource biologicals are more costeffective; thus, they should be recommended as first-line therapy for treatment-naive patients in financial protocols describing how medicines with reimbursement can be prescribed [14]. In this case all other, still patent-protected biologicals should be used in second-line treatment, after the failure of the multisource product.…”

“…Sustainability of financing pharmaceuticals is more and more challenging for third-party health-care payers; hence, patient access to high-priced biologicals could be limited [11]. In several lower-income European countries with severe resource constraints, a wide spectrum of access restrictions have been implemented to ensure sustainability of pharmaceutical expenditures [12][13][14]. Such restrictions specified by financial guidelines and protocols include volume restrictions on the number of patients treated with reimbursed biological treatment per treatment centers, limited duration of treatment with reimbursement, or the use of biologicals only in subsequent treatment lines after the failure of multiple non-biologic standard treatments.…”

Biosimilars for inflammatory bowel disease: how can healthcare professionals help address patients’ concerns?

“…However, despite biosimilars being a potentially more affordable and readily available therapy for patients with IBD [5], patients still have concerns with regard to the safety and efficacy of these agents [12]. To adequately address patients' concerns, HCPs must be knowledgeable and confident in explaining what biosimilars are, including how a biosimilar might be beneficial for the patient (for example, increased access to treatment and more treatment options [22]) and be ready to explain patientaccessible clinical data.…”