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

Table 2

Questions of the reimbursement policy survey.

General questions related to all biologics and specific biologic therapies
(Q1) Please select which type of access limit is applied on the patient population in the therapeutic use of original biologics/biosimilars in your country! (multiple choice)	(A) Access limit on the number of treated patients – i.e. patients above the volume limit cannot be treated with biologics
	(B) Access limit on treatment duration/cycles – i.e. treatment duration/cycles is maximised by payers
	(C) Waiting lists for eligible patients – i.e. timely access to biologics is not guaranteed for patients
	(D) Patient co-payment for biologics – i.e. high co-payment limits patient access
	(E) Patient co-payment for related services – i.e. high co-payment limits patient access to necessary diagnostic services
	(F) Limited institutional access – e.g. biologics can be prescribed only in limited number of specialist centers
	(G) Other (please specify)
(Q2) What are the main (or expected) benefits of a clinician/payer from switching patients treated with original biologics to a biosimilar product? (multiple choice)	(A) More patients are treated with biologics
	(B) Savings in health care budget
	(C) Wider spectrum of treatment options
	(D) Other (please specify)
(Q3) Is indication extrapolation accepted in your country by payers/clinicians for biosimilars? (single choice)	(A) Yes + Answers in details
	(B) No + Answers in details
(Q4) What are the main concerns (expected concerns) of a clinician/payer of switching patients treated with original biologics to biosimilars in your country? (multiple choice)	(A) Fear of immunogenic reactions
	(B) Concerns about manufacturing quality
	(C) Concerns with similarity/therapeutic equivalence
	(D) Fear of losing efficacy
	(E) Other (please specify)
Specific questions related to experiences with biosimilar infliximab
(Q5) Please provide information about switching patients from original infliximab to its biosimilar alternative in your country! (single choice)	(A) Switching patients on maintenance original infliximab treatment is not allowed
	(B) Switching patients on maintenance original infliximab treatment is allowed
	(C) Switching patients on maintenance original infliximab treatment is incentivized
	(D) Switching patients on maintenance original infliximab treatment is mandatory
(Q6) How switching to biosimilar infliximab is implemented for patients on maintenance original infliximab treatment? (single choice)	(A) Patients on maintenance original infliximab treatment are switched to the cheapest biosimilar alternative and stay on the same infliximab product (i.e. single switch)
	(B) Patients on maintenance original infliximab treatment are always switched to another biosimilar infliximab product when a cheaper biosimilar alternative becomes available (i.e. multiple switch)
	(C) Patients on maintenance original infliximab treatment stay on the original infliximab product even after the availability of cheaper biosimilar alternatives (no switching)
	(D) Other (please specify)
(Q7) Is tendering system applied for purchasing biosimilar infliximab for specific patient groups (e.g. Rheumatoid Arthritis, Psoriatic Arthritis, Colitis Ulcerosa, Crohn’s Disease patients)? (multiple choice)	(A) Tendering system to purchase biosimilar infliximab is not applied
	(B) Centralized tendering system is applied at national level i.e. one purchasing body coordinates the tendering
	(C) Decentralized tendering system is applied at regional level with national coordination i.e. tendering rules are set nationally, but implemented regionally
	(D) Other (please specify)
General questions related to all biologics and specific biologic therapies
(Q8) Does your country apply incentives to generate real world evidence related to the use biosimilar products? e.g. quality of life data, survival data etc. (multiple choice)	(A) No, such incentives are not applied
	(B) Yes, incentives are applied for collecting real world evidence at national level
	(C) Yes, incentives are applied for collecting real world evidence through international collaborations
	(D) Other (please specify)
(Q9) What are the potential data sources for real world evidence of biosimilars in your country? (multiple choice)	(A) Patient registries
	(B) Payers’ database
	(C) Other (please specify)
(Q10) Is the safety profile and the real world effectiveness of biosimilars assessed or evaluated after the registration? (multiple choice)	(A) No
	(B) Yes, safety profile is assessed
	(C) Yes, effectiveness is evaluated
	(D) Yes, cost-effectiveness is evaluated
	(E) Other (please specify)

different spreadsheets, original biologics were replaced with original infliximab, trastuzumab, or rituximab; biosimilars were replaced with biosimilar infliximab, trastuzumab, or rituximab.