Biosimilars in IBD - making the transformative effect of anti-TNFs more widely available for patients
Anti-TNFs have transformed the treatment landscape in IBD. But economic considerations have previously limited their use. So how can we ensure that these biological drugs reach as many patients as possible? Here we look at how the increasing availability of biosimilars could enable their use earlier and more frequently in the treatment pathway.
In recent years, anti-TNF therapy has become a mainstay of treatment in IBD. Anti-TNFs are often a first-line treatment for moderate-to-severe ulcerative colitis and Crohn’s disease. Key Opinion Leader Professor Tursi believes these biological drugs should be used more regularly by physicians, partly to avoid the recurrent use of steroids.1
A review article by Papamichael et al estimated that the use of biosimilars in the place of biologics could reduce the cost of anti-TNF therapy in IBD by up to 70%, depending on the country.2 While in 2014, access to biologic drugs was not possible in 10 out of 46 European countries, due to cost constraints, three years later Abdul Hafidz et al reported that patient access to biologic treatments had grown by as much as 100% following the availability of biosimilars.3
Patient versus prescriber perspectives
One of the major areas to address, to ensure that more patients with IBD have access to anti-TNFs through the increased prescribing of biosimilars, is patient education. A survey presented in February 2019, by a representative of a French IBD patient’s organization, included comments from patients. One of the more striking comments was around how patients feel if they are prescribed a biosimilar – they said that it gave them the impression that they are considered not to be worth more costly options.4 Clearly it is vital to change this perspective, to ensure biosimilars can reach more patients who stand to benefit.
On the plus side, the perspective of prescribers has significantly evolved in recent years. Many gastroenterologists were originally reluctant to extrapolate clinical data obtained in rheumatology in order to prescribe biosimilars to patients with IBD. However, the European Crohn’s and Colitis Organization (ECCO) have since stated that data for the usage of biosimilars in IBD can be extrapolated from another indication.4 The influence of this organization is helping to change prescribers’ attitudes towards being comfortable with the use of biosimilars in IBD.
While the attitudes of prescribers are key, the role of nurses cannot be underestimated in this arena. In fact, the Nurses-European Crohn’s and Colitis Organization recommend that nurses facilitate the patient’s choice of a biologic or biosimilar therapy. Nurses are pivotal in managing the concerns and challenges of transitioning to biosimilars. Recent evidence reported by Frapaise demonstrates that nurse-led patient education can result in patients feeling confident about, and therefore adherent to, their biosimilars.4
As we have seen, anti-TNFs have revolutionised inflammatory disease therapy, and biosimilars are bringing the advantages of these treatments to more patients. However, there is still a reluctance among patients, particularly those switching from a reference biologic, to accept biosimilars.
Sullivan et al, for example, found that the mean percentage of patients reported by gastroenterologists who would readily accept a biosimilar was 60% if they were treatment-naïve versus 43% if they were already receiving a biologic.5 It is clear that careful patient communication is needed when prescribing biosimilars to ensure that patients feel comfortable and positive about taking them.
Realising the potential of biosimilars - ensuring more patients benefit from anti-TNF treatment in IBD
With the right communication, there are many advantages of biosimilars that can be realised. For example, facilitating patient access, providing more affordable treatment options and encouraging innovation.6,7 By reducing treatment costs, there is the opportunity for the increased uptake of high value biologics,6,7 the reinvestment of cost savings in the development of new and innovative therapies,6 and for saving health systems vast sums of money – a trend which is set to keep on increasing for the foreseeable future.8
Offering broader access to biological products for patients can lead to additional treatment choices for patients and HCPs,6,7 increased access to treatment options that were not previously available,6 more access for patients at earlier stages of the therapy cycle,9 and the potential to improve the lives of patients all over the world.10
Finally, the development of biosimilars can create a more progressive, competitive environment, encouraging investment in the development of new biologic products. This can lead to innovation among reference product manufacturers,6 increased patient access to biosimilars and the most modern medicines,6,7 increased uptake of best-value biologics,6,7 reinvestment of cost savings in the development of new and innovative therapies,6 and improved patient care.6
1. Arnott I, et al. Key Considerations in the Management of Inflammatory Bowel Disease: Interviews with Key Opinion Leaders. EMJ Gastroenterol 2019;8[Suppl 2]:2-11.
2. Papamichael K, et al. Review article: pharmacological aspects of anti-TNF biosimilars in inflammatory bowel disease. Aliment Pharmacol Ther 2015;42:1158-1169.
3. Abdul Hafidz MI, et al. Are we ready for biosimilars in gastroenterology? EMJ Gastroenterol 2017;6:83-89.
4. Frapaise FX. Biosimilars: Patient Perspectives, Challenges and Emerging Solutions: Current Opinions. J Drug Res Dev 2019;5(1): dx.doi. org/10.16966/2470-1009.148.
5. Sullivan e, et al. Assessing gastroenterologist and patient acceptance of biosimilars in ulcerative colitis and Crohn’s disease across Germany. PLoS ONE 2017;12(4): e0175826. https://doi.org/10.1371/journal.pone.0175826
6. IMS Institute 2016. Delivering on the potential of biosimilar medicines. Available at: https://www.medicinesforeurope.com/wp-content/uploads/2016/03/IMS-Institute-Biosimilar-Report-March-2016-FINAL.pdf (Accessed February 2019).
7. IMS Health 2016. The impact of biosimilar competition. Available at: https://www.medicinesforeurope.com/wp-content/uploads/2016/08/IMS-Impact-of-Biosimilar-Competition-2016.pdf (Accessed February 2019).
8. Deloitte. The cost-effectiveness of biosimilars: Delivering value for money from pharma spending. Available at: https://blogs.deloitte.co.uk/health/2019/09/the-cost-effectiveness-of-biosimilars-delivering-value-for-money-from-pharma-spending.html (Accessed December 2020)
9. The Biosimilars Council. The benefits of biosimilars. Available at: https://biosimilarscouncil.org/wp-content/uploads/2018/01/Module-5.pdf (Accessed December 2020).
10. McKinsey & Company. What’s next for biosimilars in emerging markets? Available at: https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/whats-next-for-biosimilars-in-emerging-markets (Accessed January 2021).