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Investigators Develop Training Tool to Improve Prescriber-Patient Communication About Biosimilars
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The tool is designed to address the nocebo effect, which was a concern of prescribers and other health care professionals.
Investigators developed a digital training tool to improve communication between providers and patients when switching biosimilars and prevent the nocebo effect, according to preliminary results of a study published in JMIR Formative Research. The model is currently undergoing validation.1
Biosimilars, Digital Tool, Patients, Health Care Professionals, Education | Image Credit: © Pixels Hunter | stock.adobe.com
Although biosimilar therapies are not identical to the reference products, more prescribers have an understanding that biosimilars will increase access and affordability for patients. Currently, the FDA requires manufacturers to study both the biological and physiochemical comparability between the proposed biosimilar and reference product, with at least 1 clinical trial that determines efficacy and tolerability. However, interchangeability and substitution at the pharmacy level has been highly debated.2
The assumption of interchangeability is that a biosimilar without that indication is not deemed as safe or effective when compared with the reference product. Interchangeability status is a designation from the FDA that allows pharmacists to substitute a reference product with a biosimilar, similar to generic products, without the approval from the prescriber. As such, education is key to help increase comfortability and awareness for the uptake of biosimilars.3
In the current study, investigators proposed a tool to optimize prescriber-patient communication, which would help train prescribers to communicate a reference-to-biosimilar switch to patients in a more effective way. The study authors detailed the design and implementation of the gaming-based communication digital tool.1
The tool was developed and tested between December 2020 and May 2023 in 4 separate phases: interviews with health care professionals; interviews with patients who had a switch as well as those who did not experience a switch; development of the digital training tool; and validation and implementation, which is still ongoing. The tool was also tested by a scientific committee, including 2 rheumatologists, a dermatologist, and a gastroenterologist.1
In phase 1, investigators conducted 11 interviews with health care professionals, which included physicians and nurses. They were asked about their experiences with using biosimilars and switching, reasons for switching, how they feel about explaining switching to patients, whether the patient understood, and what their concerns were. They were also asked about the nocebo effect, resistance to change, efficacy, safety, cost, and efficiency.1
In phase 2, investigators split the groups into 2 focus groups: one for patients and one for health care professionals. They were conducted by external researchers with experience for group moderation. Messages were tested with patients in part 1 and proposed to health care professionals in part 2.
In phase 3, the team developed the training tool and assigned responses a level of efficacy based on the focus group results. Users had to try the tool in several scenarios until a certain level of efficacy was reached.1
Investigators found that the main reason for switching was economic reasons or due to regional or local regulations. Health care professionals stated that it took approximately 5 to 10 minutes to explain the change, and only 2 of 11 professionals referred to educational material to assist with the conversation. Several professionals found that patients experienced the nocebo effect, primarily those who had previously well-controlled conditions or did not understand the switch.1
Additionally, 9 patients were included in the focus group, with 5 patients who did not experience switching. For those who did not experience switching but who discussed a hypothetical switch, positive reception to the switch was associated with discussion of ineffectiveness or dissatisfaction with the current product to support the switch, obtaining the same results with the switch, and guaranteed reduction in adverse effect when starting a biosimilar. For those who already went through a switch, positive reception was associated with the quality and volume of information received and trust in the specialist’s professionalism and knowledge. Negative associations included uncertainty about the benefits and impact on disease progression, fear of the change being a trial or to test a drug, and lack of information about the reason for switching or perception of the switch being merely economic.1
In the focus group of 13 professionals, investigators used their comments to simplify messages, change them for comprehensibility, and add more messages. Professionals disagreed with views around savings and sustainability. Investigators used these discussions to develop a training syllabus, create additional arguments to complement the valid ones from the focus group, and had this validated by the scientific committee. In the second step, investigators developed a mock-up of modulars with 3 to 5 questions with answers chosen at random where there is always 1 optimal answer, all answers are relevant to the category, the impact on trust or the nocebo effect, and a feedback screen that was displayed after each decision.1
In the final phase of creation, investigators added additional features, including a library of arguments and learning systems, different profiles of patient-focused topics, and educational resources that included a link to an accredited biosimilar course. The tool is still undergoing verification.1
