TY - JOUR
T1 - Is There Any Research Evidence Beyond Surveys and Opinion Polls on Automatic Substitution of Biological Medicines? A Systematic Review
AU - Tolonen, Hanna M.
AU - Falck, Jenni
AU - Kurki, Pekka
AU - Ruokoniemi, Päivi
AU - Hämeen-Anttila, Katri
AU - Shermock, Kenneth M.
AU - Airaksinen, Marja
N1 - Funding Information:
The authors of the majority (89%, 24/27) of the studies were affiliated with academia, a government authority, a hospital or university hospital, or a hospital pharmacy [, –, , , , , ]. Three studies (11%) did not report any government-, academic-, or health system-affiliated authors [, , ]. The pharmaceutical industry was reported as one of the affiliations in three studies [, , ]. Studies that reported any funding were partly or fully funded by either a public sector, i.e., government authority, university grant or bursary (3/27) [, , ], research fund [], pharmaceutical industry (5/27) [, –, ], or a lobbying organization (3/27) [, , ]. One study [] had received both public and pharmaceutical industry funding. In the rest of the included studies, authors declared no funding received for the study [, , , –, , , , , ] or the funding was not reported in their article [, ]. However, potential conflicts of interest among authors were reported in 63% (17/27) of the studies [, , , –, –, , ]. Half of the studies conducted among prescribers (6/12) were funded by a pharmaceutical company or a lobbying organization [, , , , , ].
Funding Information:
Open access funding provided by University of Helsinki including Helsinki University Central Hospital. Hanna M. Tolonen has received a research grant from the University Pharmacy, Helsinki, Finland.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/9
Y1 - 2021/9
N2 - Background: Biosimilars are expected to decrease growing health care expenditures. Given that uptake of biosimilars has been modest, automatic substitution has been suggested to increase their use, but the practice is not yet allowed or implemented in many jurisdictions. Methods: A systematic review was performed by searching databases Scopus, Medline (Ovid), CINAHL, and Web of Science. Peer-reviewed, original studies written in English and published during the period January 1, 2006 to April 24, 2021 reporting any interventions, pilots or any other studies including experiences or perceptions of any relevant stakeholders on automatic substitution of biologics were included without limitation by setting or geography. The quality of the included studies were evaluated by pre-determined criteria. Results: Altogether, 27 studies fulfilled the inclusion criteria, of which 23 were surveys, and four semi-structured interviews reporting mainly stakeholders’ perceptions on automatic substitution. Most of the studies (56%, 15/27) were from Europe. Studies were conducted among prescribers (n = 12), pharmacists (n = 5), patients (n = 4), payers (n = 1), and mixed stakeholders (n = 5). The primary objective of the majority (81%, 22/27) of the studies was to investigate some other biosimilar topic than automatic substitution. The reported perceptions of substitution were mainly negative. Studies evaluating risks, safety or effectiveness, or reporting real-life experiences of biologic substitution were lacking except one intervention and two prospective risk management studies. The overall quality of the studies was low to moderate, and the results were not generalizable due to convenience sampling not representing the populations of interest, and low response rates. Conclusions: The current research evidence on the automatic substitution of biologics is scarce and of low to moderate quality, reflecting low stakeholder knowledge and their cautious attitude towards biosimilars. The safe and efficient implementation of automatic substitution requires well-designed practices, pilot studies, and evolving legislation.
AB - Background: Biosimilars are expected to decrease growing health care expenditures. Given that uptake of biosimilars has been modest, automatic substitution has been suggested to increase their use, but the practice is not yet allowed or implemented in many jurisdictions. Methods: A systematic review was performed by searching databases Scopus, Medline (Ovid), CINAHL, and Web of Science. Peer-reviewed, original studies written in English and published during the period January 1, 2006 to April 24, 2021 reporting any interventions, pilots or any other studies including experiences or perceptions of any relevant stakeholders on automatic substitution of biologics were included without limitation by setting or geography. The quality of the included studies were evaluated by pre-determined criteria. Results: Altogether, 27 studies fulfilled the inclusion criteria, of which 23 were surveys, and four semi-structured interviews reporting mainly stakeholders’ perceptions on automatic substitution. Most of the studies (56%, 15/27) were from Europe. Studies were conducted among prescribers (n = 12), pharmacists (n = 5), patients (n = 4), payers (n = 1), and mixed stakeholders (n = 5). The primary objective of the majority (81%, 22/27) of the studies was to investigate some other biosimilar topic than automatic substitution. The reported perceptions of substitution were mainly negative. Studies evaluating risks, safety or effectiveness, or reporting real-life experiences of biologic substitution were lacking except one intervention and two prospective risk management studies. The overall quality of the studies was low to moderate, and the results were not generalizable due to convenience sampling not representing the populations of interest, and low response rates. Conclusions: The current research evidence on the automatic substitution of biologics is scarce and of low to moderate quality, reflecting low stakeholder knowledge and their cautious attitude towards biosimilars. The safe and efficient implementation of automatic substitution requires well-designed practices, pilot studies, and evolving legislation.
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U2 - 10.1007/s40259-021-00493-8
DO - 10.1007/s40259-021-00493-8
M3 - Review article
C2 - 34398421
AN - SCOPUS:85112587291
SN - 1173-8804
VL - 35
SP - 547
EP - 561
JO - BioDrugs
JF - BioDrugs
IS - 5
ER -