Consensus report: clinical recommendations for the prevention and management of the nocebo effect in biosimilar‐treated IBD patients

Abstract

Background:The nocebo effect is a negative effect of a pharmacological or nonpharmacological medical treatment that is induced by patients' expectations, and that is unrelated to the physiological action of the treatment. The nocebo effect can negatively affect treatment outcomes.Aim: To develop evidence-based consensus recommendations for the prevention and management of the nocebo effect in biosimilar-treated patients with IBD. Methods:The "NOCE-BIO Consensus Group" was composed of 19 members from five European countries, and with different fields of expertise. A literature review on the nocebo effect, with specific focus on information about its prevention and management in biosimilar-treated IBD patients, was performed. Preliminary statements were formulated and voted on during a consensus group meeting held in Milan, Italy, in July 2018. A statement was accepted if >75% of participants voted 4 ("agree") or 5 ("strongly agree") on a scale of 1-5.Results: Consensus was reached on 11 recommendation statements. Seven statements reached consensus after one voting round and four statements reached consensus after two voting rounds. All statements were supported by very low-quality level of evidence.The panel agreed that patient-health-care provider relationship is a key driver of acceptance of biosimilars, which limits the risk of negative bias and the nocebo effect. Lack of knowledge among patients and health-care providers about the effectiveness and safety of biosimilars should be minimized. Education about biosimilars needs to be tailored to the individual patient, and positive framing is recommended. Conclusions:The nocebo effect is under-recognised in the era of biosimilars, although it may negatively impact on the cost-savings of biosimilars. Future research should focus on the magnitude, the risk factors, the impact, and the management of the nocebo effect in biosimilars-treated IBD patients.

Medication safety risks to be managed in national implementation of automatic substitution of biological medicines: a qualitative study

“…Our study indicates that the personnel in healthcare units and community pharmacies need substantial detailed information on biosimilars, which is consistent to previous findings 30–32. The outcome of automatic substitution may be negatively influenced if the provided information is ambiguous or not sufficiently detailed 33.…”

<p>Biosimilars to Antitumor Necrosis Factor Agents in Inflammatory Bowel Disease</p>

“…The focus should be on the common aspects between biosimilars and biological RPs with regard to their efficacy, safety, and immunogenicity, and on discussion of the advantage of the lower cost of the biosimilars. 69 Patients were found to be more likely to accept the switch if the decision was taken by their primary-care physician instead of a pharmacist. 70 If a Decision Is Made to Switch to Biosimilars, How Should It Be Implemented?…”

The Importance of Countering Biosimilar Disparagement and Misinformation

“…Continued dissemination of disparaging, misleading, or incorrect information may lead to unwarranted concerns that patients will not attain maximal efficacy on a biosimilar or may have an adverse event that they would not have had with the reference biologic [ 43 , 44 , 50 ].…”

“…Biosimilar disparagement and misinformation may cause patients to fear that they will receive an ineffective, inferior, or unsafe product. Patients could specifically request not to be treated with a biosimilar, or if they do receive a biosimilar, a negative preconceived opinion of the biosimilar may lead to poor clinical outcomes [ 43 , 44 , 50 ].…”