The Economic Impact of the Introduction of Biosimilars in Inflammatory Bowel Disease

Severs, Mirjam; Oldenburg, Bas; Bodegraven, Ad A. van; Siersema, Peter D.; Mangen, MJ; Colitis,

doi:10.1093/ecco-jcc/jjw153

Cited by 40 publications

(44 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…However only supported by indirect evidence, the nocebo effect can also lead to unnecessary cessation of biologic treatment, thereby altering IBD patients' outcomes in clinical practice and in clinical trials . The consensus group expressed concerns that the nocebo effect may also negatively impact on the cost‐savings of biosimilars, while the main objective of implementing biosimilars in IBD is economically driven . Indeed, the nocebo effect can cause physicians to discontinue what is otherwise an appropriate therapy, prompt attempts to treat patients with additional drugs because of adverse events, or result in supplementary patient clinic visits.…”

Section: Discussionmentioning

confidence: 99%

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

Pouillon

Danese

Hart

et al. 2019

Aliment Pharmacol Ther

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionmentioning

confidence: 99%

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

Pouillon

Danese

Hart

et al. 2019

Aliment Pharmacol Ther

View full text Add to dashboard Cite

show abstract

“…These drugs, used to treat rheumatoid arthritis (worldwide prevalence rate estimated at 0.5–1.0% of the population) and Crohn’s disease (estimated incidence rate 6.3/100,000 person-years) [17, 23, 24], showed the most substantial expenditure increase, with more than 250 times (25098.7%), accounting for one third of purchases since 2010. For this class, price was the main factor boosting expenditure.…”

Section: Discussionmentioning

confidence: 99%

Trends in medicines procurement by the Brazilian federal government from 2006 to 2013

et al. 2017

View full text Add to dashboard Cite

The costs of medicines pose a growing burden on healthcare systems worldwide. A comprehensive understanding of current procurement processes provides strong support for the development of effective policies. This study examined Brazilian Federal Government pharmaceutical procurement data provided by the Integrated System for the Administration of General Services (SIASG) database, from 2006 to 2013. Medicine purchases were aggregated by volume and expenditure for each year. Data on expenditure were adjusted for inflation using the Extended National Consumer Price Index (IPCA) for December 31, 2013. Lorenz distribution curves were used to study the cumulative proportion of purchased therapeutic classes. Expenditure variance analysis was performed to determine the impact of each factor, price and/or volume, on total expenditure variation. Annual expenditure on medicines increased 2.72 times, while the purchased volume of drugs increased 1.99 times. A limited number of therapeutic classes dominated expenditure each year. Drugs for infectious diseases drove the increase in expenditures from 2006 to 2009 but were replaced by antineoplastic and immunomodulating agents beginning in 2010. Immunosuppressants (L04), accounted for one third of purchases since 2010, showing the most substantial growth in expenditures during the period (250-fold increase). The overwhelming price-related increase in expenditures caused by these medicines is bound to have a relevant impact on the sustainability of the pharmaceutical supply system. We observed increasing trends in expenditures, especially in specific therapeutic classes. We propose the development and implementation of better medicine procurement systems, and strategies to allow for monitoring of product price, effectiveness, and safety. This must be done with ongoing assessment of pharmaceutical innovations, therapeutic value and budget impact.

show abstract

“…Biosimilars, market competition, and price reductions improve the cost-effectiveness of biologic therapy in RA. In IBD, existing data support the potential for biosimilars to deliver cost savings and improve patient access to biologics [133,134], and cost-effectiveness analyses are expected to be continuously updated. The cost-effectiveness of early biologic treatment in IBD is also being explored [135], whereas a model extrapolating data from the CALM trial in CD showed that "tight control," using biomarkers to direct adalimumab treatment, was cost-effective versus standard clinical management over 2-and 5-year timeframes, with cost-effectiveness improving over time [136].…”

Section: Pharmacoeconomists' Perspective: Cost Of and Access To Biolomentioning

confidence: 99%

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

Kim

Alten

Avedano³

et al. 2020

Drugs

View full text Add to dashboard Cite

Biologics have transformed the treatment of immune-mediated inflammatory diseases such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Biosimilars-biologic medicines with no clinically meaningful differences in safety or efficacy from licensed originators-can stimulate market competition and have the potential to expand patient access to biologics within the parameters of treatment recommendations. However, maximizing the benefits of biosimilars requires cooperation between multiple stakeholders. Regulators and developers should collaborate to ensure biosimilars reach patients rapidly without compromising stringent quality, safety, or efficacy standards. Pharmacoeconomic evaluations and payer policies should be updated following biosimilar market entry, minimizing the risk of imposing nonmedical barriers to biologic treatment. In RA, disparities between treatment guidelines and national reimbursement criteria could be addressed to ensure more uniform patient access to biologics and enable rheumatologists to effectively implement treat-to-target strategies. In IBD, the cost-effectiveness of biologic treatment earlier in the disease course is likely to improve when biosimilars are incorporated into pharmacoeconomic analyses. Patient understanding of biosimilars is crucial for treatment success and avoiding nocebo effects. Full understanding of biosimilars by physicians and carefully considered communication strategies can help support patients initiating or switching to biosimilars. Developers must operate efficiently to be sustainable, without undermining product quality, the reliability of the supply chain, or pharmacovigilance. Developers should also facilitate information sharing to meet the needs of other stakeholders. Such collaboration will help to ensure a sustainable future for both the biosimilar market and healthcare systems, supporting the availability of effective treatments for patients.

show abstract

The Economic Impact of the Introduction of Biosimilars in Inflammatory Bowel Disease

Abstract: The introduction of biosimilars for infliximab can be expected to have a major impact on the cost profile of IBD. The economic impact will depend on local pricing, procurement policies and the physician's willingness to switch patients to biosimilars.

Cited by 40 publications

References 20 publications

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

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

Trends in medicines procurement by the Brazilian federal government from 2006 to 2013

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

Contact Info

Product

Resources

About