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