Oncologists have been urged to embrace biosimilar drug substitution to help control the spiralling costs of cancer care. However, they have been warned that the optimal realisation of such a programme requires successful educational initiatives and the development of effective working partnerships with pharmacists and patients .
A literature review by researchers at Bristol University, UK, found that in many countries, cancer medicine was the leading driver of increased healthcare costs, and that taking the US as an example, direct medical spending for cancer had risen 222% in the last 20 years, faster than any other branch of medicine in developed countries over the same period .
These spiralling costs are unsustainable. Successful, but high-cost, cancer biologicals are helping cancer patients to survive longer, and this, coupled with an ageing and growing population, means that the cost of cancer care is rising exponentially.
For example, researchers have compared the cost over time of treating metastatic colon cancer using standard chemotherapy regimens . Using the Mayo Clinic regimen of 5-FU and leucovorin as a benchmark (US$63 drug cost for an eight-week treatment regimen), costs rose with each improvement. Second-generation regimens containing irinotecan or oxaliplatin cost US$9,497 to US$11,899 for an eight-week course, while third-generation regimens containing bevacizumab or cetuximab cost US$21,339 to US$30,790. The rise from US$63 to US$30,790 represented an almost 500-fold rise in drug cost (30,790/63 = 488.730159) [1, 2].
Given that oncologists have a WHO-stipulated duty to be part of a healthcare system that ‘obtains the greatest possible level of health from the resources devoted to it, i.e. to be as cost-effective as it can be’; rationing highly effective biological on the basis of cost alone is not a sufficiently ethical strategy [1, 3].
This has prompted renewed calls for biological drug equivalent substitution programmes. With the help of local pharmacists, individual physicians or hospitals can save on costs of established treatment programmes with a policy of biological drug equivalent substitutions using available biosimilars . Annual savings of Euros 1.6 billion per year are predicted if the EU could realise just a 20% price reduction of five patent-expired biopharmaceuticals .
Looking forward further to 2020, there are 20 biological drugs in the EU, which will have come off patent. Biosimilar substitution could generate more than US$300 million in revenue in Europe alone. Such savings will be hard to resist, and for many countries, delaying the implementation of such programmes risks a real crisis in healthcare delivery .
In the absence of observational (phase IV) data, EMA’s stipulation that all marketing applications for new generation biosimilars contain individual risk management plans may help to increase prescriber confidence in the compounds .
The objective of a risk management plan is to protect patients from harmful events by ensuring that the benefits of a medicine exceed its risks by the greatest achievable margin. Typically, a plan consists of two parts: in part I, the safety profile of the medication is described and pharmacovigilance activities are proposed, e.g. collecting spontaneously reported adverse events, the development of post-authorisation safety studies. Part II evaluates the necessity for risk minimisation activities and provides an action plan for each potential safety concern. The proposed risk management plans for all new biosimilars are freely available on the EMA website.
Although biosimilars are ‘copies’ of existing biopharmaceuticals, the recombinant processes used in their manufacturing often differ from that of the originator compound. This means that despite the achievement of an identical pharmacological effect, biosimilars have the potential to cause adverse events that may not match the originator compound.
This hypothesis was proved in 1998 when a reformulated version of the innovative erythropoietin alpha product (Eprex) was launched worldwide. With such widespread use, it soon emerged that the incidence of drug-related pure red cell aplasia had increased. Although the debate surrounding the aetiology of this immunological reaction is yet to be resolved, an unfortunate lesson was learned: manipulating a biopharmaceutical formulation may put patients at risk.
Since the introduction of the EMA’s risk management plans in 2005, safety-related biosimilar issues have been minimal. These successes have provided a safe foundation for confident biosimilar prescribing, with some experts believing that biosimilars can now be viewed as equally as efficacious and safe as their reference (originator) compound.
The French medicines review journal, La Revue Prescrire, has demanded that EMA makes ‘all’ observational safety information public—not just a compound’s proposed risk management plan. This includes Periodic Safety Update Reports which would contain confidential information about additional safety measures implemented during the phase IV observational period, e.g. the initiation of additional clinical studies, planned long-term follow-up of treated patients, etc. We believe that not publishing these data is counter-productive to a biosimilar’s success.
Even at the time of launch, any new clinical entity is a ‘work in progress’, with observational data continuing to be collated throughout the compound’s lifespan. In the first couple of years post-launch, clinical experience with a biosimilar is at its lowest, and given that biosimilar manufacturers are not currently obliged to publish observational data, prescribers may have to rely on their own limited anecdotal biosimilar experiences. The originator compound, on the other hand, may have extensive published phase IV data, so clinicians relying on a solid evidence base may choose to continue to prescribe the tried-and-tested innovator compound.
With this in mind, readers are reminded that all pre- and post-launch biosimilar data can be considered for publication by GaBI Journal. If you are interested in contributing a research article in a similar area to GaBI Journal, please send us your manuscript submission to firstname.lastname@example.org.
Competing interests: None.
Provenance and peer review: Article abstracted based on published scientific or research papers recommended by members of Editorial Board; internally peer reviewed.
Author: Steve Dawber, BSc (Hons), GaBI Journal Editor
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