Clinical value beyond price alone: anti-TNF biosimilars enable early treatment

Biosimilars can be effective in reducing the cost burden of TNF-α inhibitors (anti-TNF) in the treatment of immune-mediated inflammatory diseases (IMIDs).

• Early anti-TNF treatment provides clinical and radiologic benefits in patients with rheumatoid arthritis (RA), improving both quality of life and clinical outcomes
• Anti-TNF biosimilars help reduce treatment costs, enabling patients to access treatment earlier in their disease course
• The availability of TNF-α inhibitor biosimilars have impacted guideline recommendations, with the UK NICE guidelines now recommending earlier biologic treatment, providing early treatment access to more patients

Over the last 20 years, significant improvements in IMID therapy have been observed with the introduction of disease modifying drugs (DMARDs), especially biologic DMARDs (bDMARDs)¹.

Compared with conventional synthetic DMARDs (csDMARDs), bDMARDs offer¹:

• improved therapeutic responses
• improvements in health-related quality of life
• reductions in disability
• decreased mortality

Anti-TNFs are the most prescribed bDMARDs, controlling joint inflammation and preventing or delaying RA-associated bone erosion (Figure 1)¹.

Figure 1. Bone erosion in rheumatoid arthritis (Adapted²).

Access to biologic agents is a key consideration in improving treatment and outcomes for patients with rheumatic diseases. As treatment cost is a barrier to effective bDMARD use, biosimilar DMARDs provide a new route to achieving treatment goals – leading to significant decreases in reimbursement prices, widening patient access, and reducing treatment inequalities (Figure 2)^1,3–5.

Figure 2. Health economic impact of anti-TNF biosimilars in the European Union (2016) (Adapted⁵).

In the European Union, more than 60 biosimilars have been approved for use, with several others currently under evaluation⁶.

Early treatment improves patient outcomes

Increasing evidence demonstrates that early RA diagnosis, prompt treatment initiation, and early achievement of remission are the major predictors of clinical, functional, and radiographic outcomes⁷.

The long-term outcomes of early DMARD treatment in patients with RA have been reported over 20 years. Patients receiving treatment within 6 months of symptom onset have a significantly lower risk of functional disability compared with later treatment (>6 months)⁸.

Such findings support the concept of a therapeutic ‘window of opportunity’, demonstrating that earlier treatment leads to improved and sustained outcomes. Patients receiving later treatment report higher radiologic scores and increased functional disability over time compared with those receiving earlier treatment⁸.

For patients with severe RA and a high risk of developing rapid joint destruction, addition of biosimilar DMARD therapy during the early disease stages provides significant clinical benefit, particularly with respect to radiographic progression⁹.

Anti-TNF biosimilars enable earlier treatment

Current clinical attitudes favour earlier use of biologics in patients with high disease activity despite csDMARD therapy¹⁰.

Earlier addition of a biosimilar DMARD to standard csDMARD therapy is associated with a reduction in direct and indirect costs per patient¹⁰. Moreover, the clinical value of highly effective anti-TNF biosimilar DMARD therapy, added to the benefits of lower acquisition costs, are expected to improve therapeutic choice in less severe disease¹⁰.

Select biosimilar DMARDs are already providing substantial cost savings in some European countries. For example, Denmark obtained a 64% discount following a mandatory nationwide switch from the branded infliximab biologic to the associated biosimilar⁴.

Therapy with DMARDs should be started as soon as the diagnosis of RA is made¹²

The trend for biosimilar DMARDs to reduce the average cost per patient, whilst also providing long-term benefits in clinical outcome, may result in expanded patient access to treatment and significant cost savings within tightening restrictions to healthcare budgets^10,11.

Guidelines recommend early treatment

International guidelines, including those from the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR), highlight that early treatment is a mainstay of any management approach for RA^12,13.

In addition, the ACR advocates use of the most appropriate, cost-effective treatment option, including biosimilar DMARDS; treatment switching in stable patients is considered reasonable if cost savings are available¹³.

For the first time in the UK, adalimumab, etanercept, infliximab, abatacept or their respective biosimilar DMARDs have been recommended for the treatment of moderate RA (in combination with methotrexate). Previously, NICE recommended biologic treatments for severe disease only; guidance was reviewed following recent clinical trial evidence suggesting biologics provide similar benefits for both moderate and severe disease¹⁴.

Click the following links to view the licensed biosimilar DMARD indications for adalimumab, etanercept or infliximab.

Alternatively, learn more about the benefits of Biogen's portfolio of anti-TNF biosimilars