MEDICINES MANAGEMENT
Biosimilar medicines: opportunity knocks
Dr Paul Schofield of Napp Pharmaceuticals Limited discusses the need for collaboration in the introduction of biosimilar medicines.
T
here is no escaping the increasingly difficult financial position facing the NHS, and with cost savings to be found, commissioners often turn to the medicines budget.
However, with the uptake of generics already widespread and the new PPRS deal between the Department of Health and the pharmaceutical industry, the question is whether there are any further savings to be found. The answer could come in the shape of biosimilars.
The uptake of biosimilars has so far been slow, particularly in the UK, but patent expiry for some of the world’s leading biological medicines, commonly termed biologics, begins next year with the entry of biosimilar infliximab, and this means that there is an opportunity to realise significant savings. In 2013, five of the top 20 UK medicines were biologics and accounted for over £1bn of NHS expenditure. Understandably, budget holders are keen to contain this spend, but they also recognise that the ability to realise this opportunity relies on them proactively engaging with their clinical colleagues.
Engagement starts with the acceptance of two underlying principles established by the European Medicines Agency (EMA). Firstly, biosimilars are biologics; biosimilar is a regulatory term used to describe biological medicines that are copies of those that are already in use. Secondly, biosimilars approved by the EMA are far from being low-quality versions of the originals. Their production is carried out to the same exacting standards as any biologic, and the regulatory requirements for proving biosimilarity are equally stringent.
The regulatory approval process involves robust comparisons of the physicochemical characteristics, in vitro bioassays of the biosimilar and the originator to confirm functional similarity, and evidence from clinical trials that confirms that this translates into pharmacokinetic and therapeutic equivalence.
Alongside these principles, appropriate guidance from key health technology assessment bodies is needed to guide the direction of travel for the introduction of biosimilars. Although they should be considered on a case-by-case basis, full assessment of an individual biosimilar would seem unnecessary in situations where a) an originator has proved cost effective, b) the biosimilar has received EMA authorisation with the same therapeutic indications, and c) the biosimilar is being supplied below the list price of the originator.
There also needs to be a clear focus on patient safety and engagement. Prescribing by brand, using appropriate national patient registries and yellow card reporting allow for traceability of a patient’s treatment and
enable pharmaceutical companies to work with the NHS to ensure ongoing long-term safety monitoring. Patients need to understand and have confidence in the treatment they are receiving, so open and informed discussions with their clinical team, grounded in sound science, are essential. Health professionals therefore need access to balanced information and will also need to build their experience with, and confidence in, biosimilars, drawing on real-world clinical evidence from their peers in the UK and further afield. Commissioners and pharmaceutical companies can contribute to this by providing valuable information, and supporting the generation and sharing of data.
The first of the next wave of biosimilars is less than a year away, and a successful introduction now would set the framework for those to come, enabling the NHS to realise savings that can be diverted to fund new medicines or services.
This success relies on companies, NHS budget holders and clinical teams working together and ensuring that patients can have confidence in the treatment they are receiving.
As a company with collaboration at our heart, we believe we can all work together in this new era to ensure that quality of patient care can go hand in hand with sustainability of healthcare.
FOR MORE INFORMATION
T: 01223 424444 E:
medicalinformationuk@napp.co.uk
national health executive Nov/Dec 14 | 85
Dr Paul Schofield
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