Communication Strategies Are Highly Important to Avoid Nocebo Effect When Performing Non-Medical Switch from Originator Product to Biosimilar Product: Danish Results from Applying the Parker Model a Qualitative 3-Step Research Model

Background/Purpose:

Introducing a non-medical switch from originator to a biosimilar product in the management of chronic arthritis, i.e. switching patients in remission or low disease activity, may generate economic advantages, but on the other hand jeopardize patient engagement and empowerment. To explore impact of performing a non-medical switch from etanercept originator to a biosimilar in Danish patients with a chronic arthritis, and to explore the economic impact.

Methods:

The Parker model, a 3-step qualitative research approach, was used to study the impact of switching from etanercept originator to a biosimilar in patients with remission or low disease activity. Concept mapping (CM), a structured group process focused on patient-relevant themes, was used to identify treatment-related issues and concerns. Subsequently, the retrieved information was utilized in a series of iterative participatory design (PD) sessions. Finally, these two methods were complemented by stakeholder evaluations (SE) based on semi-structured group and solo-interviews with a series of disease-management stakeholders.

Results:

The study included 10 rheumatoid arthritis (RA) patients, 5 spondyloarthritis patients (SpA), 1 ankylosing spondylitis (AS) patient, 2 doctors, 2 nurses, 1 medical secretary, and 4 key public stakeholders involved in the disease-management of the selected rheumatic diseases. Saturation was reached after 3 CM workshops, including patients switching from etanercept originator to a biosimilar, generating 122 statements, out of which 7 concepts were generated; information from doctors/nurses, concerns/side effects, effect of medication, etanercept biosimilar, economy, own perception of switch, and discomfort. In addition, 1 extra workshop was conducted including 5 RA patients switching from etanercept biosimilar back to originator or to a third biologic agent, generating 45 statements, from which 4 concepts were generated; patient experiences/concerns, information, meeting with healthcare professionals/therapists, and etanercept biosimilar. These data were used in the iterative PD sessions, resulting in 5 newly proposed personalized communication strategies. Finally, SE demonstrated that implementing a non-medical biological switch involves both dialogue and clear communication in relation to logistic and background information. Communication needs to be well prepared, allowing sufficient time for providing all involved with an opportunity to discuss relevant educational materials. Health economic analyses estimated that the annual savings are between approx. DKK 8,900 and DKK 64,600 per patient depending on type of administration.

Conclusion:

Patient participation in the 3-step qualitative Parker Model identified important aspects regarding communication strategies to consider when introducing a biosimilar to the market for the treatment and management of RA and SpA. The importance of systematic education and communication with all directly involved stakeholders was highlighted. The cost of implementing switching is very limited and savings incurred by the significantly lower prices of biosimilar compared to originator makes the switch instantly economically viable.