Biosimilars Would Reduce Health Care Costs But Are Yet Poorly Known – Patient Survey Study Among Biological Medicine Users

Abstract

Background

From the beginning of the year 2024, gradually implemented amendment to the Medicines Act will enable interchange of biological medicines in pharmacies in Finland. The legislative change aims to reduce health care costs.

Methods

Opinions of the biological medicine users regarding substitution in pharmacies and knowledge about biological medicines were determined by a patient survey in community pharmacies and via patient organizations in Finland.

Results

In total, 199 users of biological medicines responded to the survey. The respondents did not always know which product they were using, an originator or a biosimilar. This was more prominent among patients with biosimilars determined according to brand names. The more recently the biological medicine had been prescribed, the more likely a biosimilar was in use. Only about 40% of the respondents would enable pharmacies to substitute their biological medicine to a lower cost product. The most common obstacle to the idea of interchange in pharmacies was that the respondents wanted to keep the product the doctor had prescribed for them. In general, biosimilar users were more accepting towards possible interchange than originator users.

Conclusion

Although the most recent treatments appear to be initiated with biosimilars, interchange in pharmacies could enable an efficient way to lower health care costs. However, guidance and awareness regarding biosimilars and biological medicines in general would improve patients’ willingness towards the change, but also help pharmacists and prescribing doctors in their meaningful role.

Plain Language Summary

• The use of biological medicines and the costs thereafter are rapidly growing.

• In Finland, switching between an originator and a biosimilar currently requires doctor’s prescription, but interchange in pharmacies will be possible in the beginning of year 2024.

• Due to notable differences in prices between biological medicines, active switching to lower cost products in pharmacies would restrain health care costs remarkably.

• Oriola Expert Services ran a survey with an electronic questionnaire among patients using biological medicines.

• Survey data were collected in pharmacies and via patient organizations.

• Oriola research team found out that patients do not generally know the differences between biological medicines, and if they are using an originator or a biosimilar.

• Despite the upcoming pharmacy substitution, future cost savings rely on decisions made by doctors at the time of prescribing biological medication.

• To ensure patient compliance, sufficient patient information about biosimilars is required.

Keywords:

• biological medicine
• originator
• biosimilar
• reference product
• interchange

Abbreviations

EMA, European Medicines Agency; EU, European Union; GDPR, General Data Protection Regulation; HMA, Heads of Medicines Agencies; IBD, Inflammatory Bowel Diseases; Q, quarter.

Ethics Approval and Informed Consent

The study was carried out in accordance with national and EU requirements for ensuring the well-being and rights of the participants. In addition, the survey was conducted following the guidelines of the Finnish National Advisory Board on Research Integrity.¹² Data collection was based on individual consent of each respondent; thus the legitimate purposes of the data collection and use were both informed consent and scientific research. Before data collection, Oriola provided an EU GDPR-based data protection impact assessment with risk assessment about the study database. According to the local legislation, an external ethical review was not needed in case of a volunteer anonymous survey.

Consent for Publication

The authors state that the details of any images can be published as they are prepared by authors themselves.

Data Sharing Statement

The survey data were collected for this research project only. The data are not shared.

Acknowledgments

We are deeply grateful to all respondents for participating the survey. Oriola Research Pharmacies, the Finnish Rheumatism Association, and the IBD and Other Intestinal Diseases Association as well as other parties collaborating in the data collection are acknowledged for their valuable help. BSc Pharm Iiro Mytty, BSc Pharm Mia Nevalainen, and Study Nurse Merja Pihlaja from Oriola are acknowledged for their professional assistance in study coordination. Further acknowledgements are addressed to MSc Pharm Ilona Iso-Mustajärvi and MSc Pharm Jarno Ruotsalainen from Oriola for their helpful and supportive advice. BSc Pharm Emily Laajanen and BHC Nina Uurtamo from Viatris Oy are acknowledged for their kind participation in study meetings and active role as the sponsor contacts throughout the project. (At the time of revision, Mia Nevalainen’s current post is at Wellpharma Oy and Nina Uurtamo’s at Biocon Biologics Finland.)

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

The authors declare no conflicts of interest in this work.

Additional information

Funding

This study was financially supported by Viatris Oy. The sponsor was not involved in any of the stages from study design to submission of the paper for publication. After the original submission, during the review round, Viatris completed biosimilars transaction with Biocon Biologics in Europe.