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Clinical value beyond price alone: biosimilars improve patient access to treatment

Read time: 10 mins
Last updated:30th Mar 2021
Published:30th Mar 2021
Developed by EPG Health for Medthority in collaboration with Biogen®. This content is intended for healthcare professionals only, and it has been funded and reviewed by Biogen® for scientific accuracy.

Introduction

Immune-mediated inflammatory diseases (IMID) are a group of chronic conditions characterised by altered immune regulation causing chronic inflammation in targeted organs or systems. IMIDs affect approximately 3–7% of the global population, with an estimated incidence of 80 per 105 person-years1,2.

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Common IMIDs include rheumatoid arthritis (RA), inflammatory bowel disease (IBD) and psoriasis (PsO)3. IMIDs can result in significant morbidity, reduced quality of life (QoL) and premature death. Multiple IMIDs can co‐exist within the same patient, or within the same family4. Thus, these conditions impose a significant burden on patients, healthcare professionals, and societies5,6.

Genetic factors are essential determinants of IMIDs4. Epidemiological, clinical, and experimental evidence shows an association between IMID and environmental factors, such as smoking, diet, drugs, geographical and social status, stress, and microbial agents3,7

Although the aetiology of IMID is unknown, developments in molecular research show that an imbalance in inflammatory cytokines is central to their pathogenesis3,7. Th 1 cells, a subset of CD4+ T lymphocytes, an immunoregulatory cytokine, are associated with immunopathogenesis in IMIDs4. Th 2 cells could have important anti‐inflammatory functions in the disease (Figure 1)4. Modulation of T cell function is an ongoing target for clinical intervention.

Insight_Biosimilars_Fig1.png

Figure 1. Th 1 and Th 2 cell responses (Adapted from Kuek et al.4). APC, antigen presenting cell; IL, interleukin; MHC, major histocompatibility complex; Th, T helper cell; TNF, tumour-necrosis factor.

The clinical benefits shown by infliximab, an anti‐tumour necrosis factor‐α (TNFα) medicine, in several ostensibly unrelated IMIDs, is strong evidence of a common pathophysiology in autoimmune diseases4.

Biological treatments: benefits and challenges

The therapeutic aims for treating IMIDs are4:

  • rapid control of inflammation
  • prevention of tissue damage
  • improvement of QoL
  • long‐term disease remission

As many patients do not achieve all therapeutic aims with traditional treatments, targeted biological medicines, introduced more than twenty years ago, have emerged as revolutionary treatments of IMIDs8–11. Pivotal clinical trials of biologics demonstrate improvements in efficacy, quality of life, and adverse events, in patients with IMIDs12–17. Due to these clinical benefits, biologics are recommended for use in many clinical guidelines for IMIDs18–21.

However, due to the complexity of biological medicine development and manufacturing processes, the cost of these medicines is relatively high22. Biologics account for a significant portion of global medicine spending. From an estimated global drug budget of US$1 trillion in 2018, innovative biologics accounted for 29% (US$296 billion)23. In the US market, although biologics account for only 2% of all prescriptions, spending on biologics was US$125 billion in 2018, a 50% increase since 201424.

The high cost of biologics for IMIDs, combined with European regulations governing access to these medicines, have resulted in underuse of biologics throughout Europe25,26. Many European countries limit access to biologics through national reimbursement criteria that are more stringent than national or international clinical guidelines27. For example, following European League Against Rheumatism (EULAR) guidelines, 32% of patients with RA in Europe are eligible for biologics; however, according to national reimbursement criteria, only 59% of this group are eligible28. Some European countries require patients to have more treatment failures, or more disease activity27, to be eligible for reimbursement; in other countries, biologics are not reimbursed at all. Some patients in Eastern Europe need to make high co-payments, which may exacerbate inequities in the access and use of biologics29.

The high cost and regulatory environment of biologics has created (or exacerbated), patient needs, including: access to treatments, early initiation of treatment, treat-to-target (T2T), maintenance of disease remission, and disease burden30,31

Biosimilars for immune-mediated inflammatory diseases

As many biologics have now reached, or are near to reaching, patent expiry, several 'biosimilar' therapies have been developed for use in patients with IMIDs. A biosimilar can be defined as a ‘biotherapeutic product that is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product32.

Biosimilar medicines are developed and manufactured following a strict approval process. Following approval, pharmacovigilance is conducted for monitoring the safety profile of new biosimilars.

Biosimilars have enabled lower-cost biologics to enter the market, thereby reducing healthcare spending and freeing savings for reinvestment into other healthcare services31,33,34. The affordability of biosimilars is contributing to the management of healthcare budgets and balanced levels of competition and supply31,33–35.

The economic benefits of biosimilars are evident in Europe. For example, in a national tender process, Norway negotiated a price reduction of 69% for infliximab compared to the reference product36. In Italy, half of the savings from improved biosimilar uptake are reallocated to increase, by 20%, the budget dedicated for innovative biologic medicines37.

The advantages of biosimilars compared to biologics exceed cost or economics alone: biosimilars can benefit some patient needs associated with biologics33,34. This article focuses on benefits to treatment access.

Biosimilars can improve access to treatment

Evidence indicates that biosimilars have increased patient access to both biosimilar and already licensed biologic medicines23,38.

Following the introduction of the granulocyte colony-stimulating factor (GCSF), the first biosimilar marketed in Europe, the cost of GCSF treatment decreased by 28%, while uptake increased, from 50%–200% in Belgium, Demark, Ireland, and the Netherlands, to 300–1600% in Poland, Romania, Slovakia and Slovenia, 39. In Sweden, the biosimilar filgrastim has reduced treatment costs and led to a fivefold increase in GCSF uptake40.

Cost savings generated from biosimilars can facilitate expansion of national reimbursement criteria to achieve parity with European clinical guidelines, thereby potentially improving early access to treatments. For both patients and healthcare professionals, this could benefit outcomes in some patients. For example, patients with early or moderate IMIDs show improved clinical and functional outcomes through use of biosimilars41,42. Improved access and savings from biosimilars can reduce the need for costly procedures and hospitalisations in patients who have benefited from earlier access to biologics43. Biosimilar use may facilitate access to more potent biological treatment for patients with IMIDs44.

Conclusions

Immune-mediated inflammatory diseases (IMIDs) are chronic conditions characterised by altered immune regulation causing chronic inflammation in bodily organs or systems. Despite the clinical benefits of biological medicines for IMIDs, the cost of these medicines is relatively high. The high cost of biologics, combined with a stringent regulatory environment in Europe, have created several patient needs, such as access to treatment for IMIDs. As many biologics have now reached patent expiry, several cost-effective biosimilars have been developed and are available for patients with IMIDs.

Biosimilars have enabled lower-cost biologics to enter the market, thereby reducing healthcare spending and releasing budgets that can be reallocated to other disease areas or healthcare services. Cost savings from biosimilars could lead to parity between reimbursement criteria and European clinical guidelines, potentially improving early access to treatments and outcomes in some patients with IMIDs. Improved access can reduce costly surgery and hospitalisations in patients who have benefited from earlier access to biologics.

It is hoped that biosimilars will continue to reduce inequities in the use of biologic medicines for IMIDs and potentially to meet patient needs associated with biologics.

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Developed by EPG Health for Medthority in collaboration with Biogen who provided some of the content. Medthority received educational funding from the sponsor in order to help provide its healthcare professional members with access to the highest quality medical and scientific information, education and associated relevant content.

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