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The arrival of biosimilars
Editorial commentary by Dr Sarah Mackie (Leeds, UK)
It’s widely recognized that rheumatology drug budgets have increased dramatically during the last ten to fifteen years, largely driven by the biologics spend. Wanting to prescribe biologics for patients who need them, we have all wondered what would happen when patents began to expire. That time has now arrived, at least for those biologics that appeared first on the scene, and now our prescribing landscape is changing fast. This series of articles and video interviews is a useful introduction to the current state of the art, and thus far, the news is good. In Norway, for example, all patients receiving inflixamab have been switched to the biosimilar, without evidence of efficacy or safety issues.
One of the changes, at least for rheumatologists practicing in the UK, is cultural: we are now having to learn to pay much more attention to biologic brand names. The default approach of UK medical practice is, in general, to prescribe using generic names where possible; following this principle, most of us have tended to think of biologics using their non-proprietary names. But now we have biosimilars, the situation is not so easy, and old mental habits must be re-learned.
The rationale for switching is the prospect of substantial cost savings to a healthcare system with limited budget. In this context, it would seem logical for patients being commenced on biologics to receive the most cost-effective option. For patients already receiving reference product biologics, switching to more cost-effective options may also help. Patients need to be appropriately informed about any planned switch from a reference product to a biosimilar; both prescriber and patient have to agree to the switch, or at least be offered some sort of "opt-out" clause. In practice, here in the UK this is happening on a regional basis: first there is common guidance across regions, then, locally, each hospital department of rheumatology has the choice about exactly how to implement this guidance. Pharmacists, biologics specialist nurses and home care provider companies will play a key role in addressing any concerns patients or carers may have. The biologics nurses will also need enough time in their week to register every patient starting a biosimilar with the British Society for Rheumatology Biologics Registry (BSRBR). The value of these national registries in providing large-scale, real-world data is crucial.
Looking forward, what effect will these changes have on our clinical practice? On the one hand, as prescribers we might ultimately have less choice in which biologic/biosimilars we prescribe, if particular options are substantially more cost-effective than others. Exactly which option is chosen as the most cost-effective may also itself change over the next few years as further biosimilars come onto the market and competition drives prices down further; although for a further drop in price to prompt a new switch in prescribing policy, the cost saving would have to be sufficient to justify the resources needed to implement that change.
Importantly, perhaps the cost savings from this new, more competitive market may help to widen future access to treatments for those patients with "moderate" disease activity scores but whose RA impacts severely on their lives (those with predominant foot involvement, for example, which does not get scored in the DAS28 so may not push them across the threshold for biologics).
Whether the glass is half-empty or half-full, though, what's certain is that UK biologics specialist nurses will be even busier than usual this year.
Prof. Sarah Mackie (UK), September 2016