Table 1 Experts' responses to the survey
Domains and questions | Percentage of experts advocating |
|---|---|
Domain 1: the overall perception of biosimilars | |
Biosimilar medicines: | (N = 16) |
a. Have the potential to increase patient access to biological medicines | 100% |
b. Do not increase patient access to biological medicines | 0% |
c. Reduce patient access to biological medicines | 0% |
Biosimilar medicines: | (N = 16) |
a. Are usually less effective than originators | 6% |
b. Are usually equally effective to originators | 69% |
c. Have the potential to be more effective than the originator | 25% |
Switching patients from biological medicines to biosimilar alternatives | (N = 16) |
a. Is associated with a significantly increased risk of immunogenicity | 12.5% |
b. Is not associated with an increased risk of immunogenicity in case of a single switch under medical supervision | 56.25% |
c. Is not associated with an increased risk of immunogenicity even if the patient is switched multiple times | 25% |
d. Is not associated with an increased risk of immunogenicity even if the patient is switched multiple times without medical supervision | 6.25% |
Domain 2: pricing | |
How much mandatory discount from the originator price would you recommend for the first biosimilar? | (N = 16) |
a. No mandatory discount | 6.25% |
b. Mandatory 10% discount | 6.25% |
c. Mandatory 20% discount | 12.5% |
d. Mandatory 30% discount | 44% |
e. Mandatory 40% discount | 31% |
How much mandatory discount from the price of the current reference biological product would you recommend for subsequent biosimilars? | (N = 13) |
a. No mandatory discount | 8% |
b. Mandatory 5% discount | 8% |
c. Mandatory 10% discount | 38% |
d. Mandatory 15% discount | 23% |
e. Mandatory 20% discount | 23% |
Do you suggest a revision of the biosimilar prices periodically? | (N = 15) |
a. No, the price revision should only happen with the launch of a new biosimilar alternative | 20% |
b. Yes, every 6 months | 0% |
c. Yes, every 1 year | 27% |
d. Yes, every 2 years | 53% |
e. Yes, every 3 years | 0% |
Domain 3: reimbursement | |
What do you think the role of Health Technology Assessment (HTA) would be for biosimilars? | (N = 16) |
a. No HTA is required | 0% |
b. HTA is required only when the biosimilar manufacturer intends to extend the reimbursement indication (Patient population) compared to the originator | 81% |
c. HTA is always required | 19% |
If a biosimilar manufacturer offers a 50% discount on the originator price, do you agree to provide immunity against removal from the formulary list? | (N = 15) |
a. No | 20% |
b. Yes, immunity should be offered for 1 year | 27% |
c. Yes, immunity should be offered for 2 years | 33% |
d. Yes, immunity should be offered for 3 years | 20% |
How the more expensive biological medicine/s should be disincentivized by healthcare payers? | (N = 15) |
a. Exclude from the formulary | 13% |
b. Can be prescribed only as second-line therapy in the therapeutic guidelines | 60% |
c. Can be prescribed with a high co-payment (internal price referencing) | 27% |
What should be the exclusion rule for more expensive biological products? | (N = 16) |
a. 10% price differential | 12.5% |
b. 20% price differential | 18.75% |
c. 30% price differential | 31.25% |
d. 40% price differential | 18.75% |
e. 50% price differential | 18.75% |
Should we extend the financing protocol to all biologicals within the same therapeutical group with similar efficacy and safety (e.g., erythropoietin, TNF alfa medicines in rheumatoid arthritis) in a way that is more expensive biologicals can be prescribed only after a cheaper alternative fails for any reason? | (N = 16) |
a. Yes | 44% |
b. No | 56% |
What type of monitoring is applied for prescribing patterns against the financing protocol? | (N = 17) |
a. No monitoring is applied for prescribers to adhere to financing protocols | 0% |
b. Prescribing practices are monitored against financing protocols only in case of signals of extreme prescribing practice | 12% |
c. Prescribing practices are proactively & routinely monitored against financing protocols | 88% |
In case of deviation from the financing protocol, should financial disincentives be applied to prescribers? | (N = 18) |
a. Yes | 94% |
b. No | 6% |
Domain 4: biosimilars uptake | |
Which measures should be applied to enhance prescribers’ acceptance of biosimilars? Choose all that apply* | (N = 17) |
a. Generate real-world evidence about biosimilars | 88% |
b. Conduct a systematic literature review on the immunogenicity related to switching patients to biosimilar alternatives | 64% |
c. Developed clinical guidelines about switching | 60% |
d. Introduce financial protocol to advocate the first-line use of biosimilars for de novo patients | 82% |
e. Mandate to switch patients on chronic biological treatments to cheaper biosimilar alternatives | 47% |
f. Share information on how biosimilar adoption decreases the pharmaceutical expenditure | 60% |
g. Share information on how biosimilar adoption improves patient access to biological medicines | 94% |
h. Disseminate results of cost-effectiveness studies comparing biosimilars and originators | 70% |
i. Others (please specify) | 2.1% |
Which of the following aspects should be addressed with the patients to enhance their acceptance of biosimilars?* | (N = 18) |
a. No need for patients’ education about biosimilars | 5% |
b. Explanation of decreased cost | 44% |
c. Using co-payments for biological medicines with a higher cost | 61% |
d. Full price should be paid by patients for biological medicines with a significantly higher cost | 11% |
e. Better access should be explained—treating more patients from the same budget, earlier initiation of biological treatment or longer treatment duration | 94% |