As biosimilars continue to gain acceptance and adoption in rheumatology, clinicians can optimise treatment strategies, improve patient access, and contribute to the sustainability of healthcare systems
Biological medicines have revolutionised the management of rheumatological conditions, offering unprecedented efficacy and improved outcomes for patients compared to traditional treatments. These biologic therapies target specific components of the immune system involved in the pathogenesis of rheumatic diseases, providing a targeted approach to treatment.
In conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis, biological medicines have demonstrated remarkable efficacy in controlling disease activity, reducing symptoms, and preserving joint function. They have transformed the treatment landscape in the last 20 years, particularly for patients who do not respond adequately to conventional disease-modifying anti-rheumatic drugs.
Biological agents, including tumour necrosis factor-alpha (TNF-α) inhibitors, interleukin-6 (IL-6) inhibitors, and B-cell depleting agents, have become cornerstone therapies in the modern management of rheumatological conditions. Their use has been associated with significant improvements in clinical outcomes, including reductions in disease activity scores, joint damage progression, and disability.
Moreover, biological medicines have expanded the therapeutic options available to patients, offering personalised treatment approaches tailored to individual disease characteristics and patient preferences. Their introduction has ushered in an era of precision medicine in rheumatology, where treatment decisions are guided by disease activity, prognostic factors, and therapeutic goals.
Despite their efficacy, biological medicines are not without limitations. Their high cost may present challenges in healthcare settings. Biological medicines consistently feature in the ‘Top 10’ of drug expenditure reports in secondary care in Ireland.
The benefits and impact of biosimilars in rheumatology
The introduction of biosimilars in recent years means there is a greater choice of biological medicines for patients and prescribers. A biosimilar medicine is a biological medicine that is developed to be highly similar to an existing biological medicine in physicochemical and biological terms.
Manufacturers of biosimilars must perform an extensive head-to-head comparability with the reference medicine and demonstrate to regulators that they have similar quality, safety and efficacy to the reference medicine, such that there are no clinically meaningful differences between the two.
Biosimilars tend to be much less expensive than the reference medicine due to lower expenditure in research and development. Furthermore, biosimilars have fostered competition within the biologic market, driving down costs with price competition among biologic drugs, and further opportunity for savings. This benefits all stakeholders as more patients will have access to more treatments and there is potential for healthcare providers to reinvest savings to further develop health services.
Biosimilars have thus facilitated greater access to biologic therapies, addressing concerns regarding affordability and healthcare sustainability. By offering comparable efficacy and safety to their reference products, biosimilars empower clinicians to provide optimal treatment options to a broader patient population.
Importantly, the introduction of biosimilars has not compromised the quality of patient care. Extensive regulatory requirements ensure rigorous evaluation of biosimilar safety, efficacy, and quality, providing clinicians with confidence in their therapeutic choices.
Biosimilars have emerged as a promising avenue in rheumatology, offering substantial benefits and impactful contributions to patient care through providing a cost-effective alternative while maintaining comparable efficacy and safety profiles.
European approach to biosimilars
Since the European Union (EU) approved the first biosimilar medicine in 2006, the EU has pioneered the regulation of as well as ongoing assessing, authorising, and monitoring of biosimilars. Over the past 15 years, the EU has approved the highest number of biosimilars worldwide, amassing considerable experience of their use and safety.
The European Medicines Agency (EMA) and the Heads of Medicines’ Agencies (HMA), in a joint statement issued on 19 September 2022, confirmed that biosimilar medicines approved in the EU are interchangeable with their reference medicine or with an equivalent biosimilar.
Approved biosimilars have demonstrated comparable efficacy, safety, and immunogenicity compared with their reference products. Thus, EU experts consider that when approval for a biosimilar is granted in the EU, additional systematic switch studies are not required to support
the interchangeability.
According to the experts, this recognition will allow more patients to have access to biological medicines.
EU Member States continue to decide which biological medicines are available for prescribing in each territory and whether automatic substitution is allowed at pharmacy level.
In Ireland, the Health Products Regulatory Authority published an updated version of their Guide to Biosimilars for Healthcare Professionals in August 2020. This guide defines interchangeability as “the possibility of exchanging one medicine with another that is expected to have the same effect. This could mean replacing a reference medicine with a biosimilar (or vice versa), or replacing one biosimilar with another.” The guide states that, once approved, biosimilars can be used interchangeably with the reference medicine, or with biosimilars of that reference medicine.
Biosimilars in Ireland
After a slow start, Ireland has made substantial progress in implementing cost-effective measures in relation to biosimilars for rheumatology conditions in recent years.
The HSE Medicines Management Programme (MMP) provides guidance on community-supplied biological medicines (including biosimilars) reimbursed on the Primary Care Reimbursement Service (PCRS) High Tech Drug Scheme (HDTS).
Since 2016, the MMP has supported the appropriate introduction of subcutaneous biosimilars into clinical use in Ireland to enable safe and effective prescribing, while also promoting cost-effective initiatives.
Biological medicines containing TNF-α inhibitors were the highest expenditure category on the HTDS in 2017, accounting for approximately €224.65 million or one-third of the total expenditure on this scheme. This represented 10.9 per cent of the total expenditure on medicines by the PCRS.
Adalimumab was the most frequently prescribed of all medicines on the HTDS in 2017, with a prescribing frequency of 104,767 and total expenditure of approximately €137.5 million that year.
In 2018, the MMP started a process to evaluate therapeutic areas where there was potential for biosimilar medicines to be introduced to allow for their safe, effective, and cost-effective use. In deciding on the best-value biological (BVB) medicine, the MMP invited submissions from all relevant stakeholders including clinicians, professional bodies, and the pharmaceutical industry to the process. The MMP noted the potential savings arising from the availability of biosimilars, but concluded that these savings, however, could only be realised by increased utilisation of BVB medicines, including biosimilars.
In May 2019, the MMP identified a BVB medicine for adalimumab and etanercept. Since then, as official HSE policy, the MMP, where a biosimilar becomes available for a biological medicine that is reimbursed through the community drug schemes, may evaluate the biological medicines in question and issue a recommendation as to the particular brand that it regards as the BVB for each approved drug.
In recognition of the efficiencies that result from the prescribing of the BVB medicines, the gainshare arrangement was introduced in June 2019 to fund service delivery or enhancement, when consultant-led teams initiated a patient on, or switched them to a BVB medicine on the High Tech Hub. The gainshare arrangement ended on 30 June 2023.
After a slow and geographically varied start, there has been a significant increase in the prescribing of biosimilar medicines nationally under the HDTS since June 2019. In April 2023, 81.1 per cent of Irish patients in receipt of adalimumab 40mg PFP/PFS under the HDTS were prescribed a BVB medicine; with the remainder (18.9 per cent) prescribed Humira.
As of 12 June 2023, over 24,800 patients had been prescribed one of the identified MMP BVB medicines for adalimumab or etanercept.
This demonstrates that significant clinical experience is being obtained for biosimilars of adalimumab in a short timeframe, the MMP said.
In a letter to rheumatologists last summer, Prof Michael Barry, Clinical Lead, HSE MMP, thanked them for embracing the MMP recommendations in relation to the BVB medicines. He said this commitment to prescribing the BVB medicines is leading to significant savings for the health service. “This reduces the financial burdens on the HSE arising out of the funding of reimbursed medicines and can assist in facilitating access to new, innovative medicines for patients.”
He added that given the significant ongoing financial challenges facing the health service, “it is vital that prescribing of the BVB medicines is optimised.”
Further information on the BVB medicine initiative including information for healthcare professionals, and resources to support initiating patients on or switching them to the BVB medicines, are available on the MMP website (www.hse.ie/mmp).
References
HSE Medicines Management Programme. Best-value biological medicines: Tumour necrosis factor – Inhibitors on the high-tech drug scheme. 2 May 2019. Available at: www.hse.ie/eng/about/who/cspd/medicines-management/best-value-medicines/best-value-biological-medicines/mmp%20report%20bvb%20medicines%20tnf%20alpha%20inhibitors%20may%202019.pdf
European Medicines Agency and the Heads of Medicines Agencies. Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU. 19 September 2022. Available at: www.ema.europa.eu/en/documents/public- 24 statement/statement-scientific-rationale-supporting-interchangeability-biosimilar-medicineseu_en.pdf
HSE Medicines Management Programme. Best-value biological medicines letter – rheumatology. 28 June 2023. Available at: www.hse.ie/eng/about/who/cspd/medicines-management/best-value-medicines/best-value-b
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