Recent FDA and EMA approvals of the anti-angiogenic biologic bevacizumab for relapsed platinum-resistant ovarian cancer in 2014 gave new hope to patients with a bleak prognosis. The high cost of bevacizumab currently puts it beyond the reach of many eligible patients – but, as its patent expiry approaches, new manufacturers are able to begin developing less costly versions known as biosimilars. For regulatory approval, biosimilars need to demonstrate comparable safety and efficacy to the originator biologic in a head-to-head clinical trial.
Research into targeted treatments for specific genetic subtypes of ovarian cancer is gaining pace but probably the most significant recent development in the field was approval in 2014 from both the FDA and EMA for use of the anti-angiogenic biologic bevacizumab (anti-VEGF monoclonal antibody) in relapsed platinum-resistant ovarian cancer, the most refractory subgroup.3 Based on the results of an international Phase III study – which showed a 62% improvement in progression-free survival with bevacizumab plus chemotherapy versus chemotherapy alone4 – this development represented the first significant therapeutic advance for these hard-to-treat patients since the turn of the century.3 Bevacizumab is also approved in the EU for both treatment-naïve and relapsed, platinum-sensitive ovarian cancer.
"Bevacizumab is an anti-VEGF antibody and it is effective in ovarian cancer because that is a highly VEGF-driven disease."
Dr Eric Pujade-Lauraine, Professor of Medicine,
Universite Paris Descartes, France12
Unfortunately many patients with cancer are not able to reap the benefits of modern research. The reason, of course, is cost. Around the world, healthcare authorities and insurers are declining to fund cutting-edge cancer therapies because of their high price tags – and patients who decide to self-fund are frequently faced with a significant financial burden.6,7,8 In some developing countries, cancer biologics may be out of reach for virtually the entire population. Even in the Western world, large discrepancies in patient access to biologics exist.9,10
The UK’s National Institute for Health and Care Excellence (NICE) has repeatedly declined to fund bevacizumab on the National Health Service (NHS) for eligible patients with ovarian cancer as well as for other licensed indications such as colorectal cancer and non-small cell lung cancer.11 Similarly, in the USA, bevacizumab is prescribed by oncologists for many cancer types but its cost remains a barrier to patient access.12 A recent survey of US managed care organizations (MCOs) indicated that two-thirds would lower co-insurance charges for bevacizumab if it were less expensive.13
UK: "There's a drug that can add years to the lives of those with ovarian cancer – so how can it be fair that treatment is a 'postcode lottery'?"14
USA: "Somehow, the road towards the cure to cancer should not be paved in our patients' financial despair. I have to believe there is a better way."7
WHO: "...the spiralling costs of the cancer burden are damaging the economies of even the richest countries and are way beyond the reach of developing countries"15
India: "In developing countries like India, where the per capita GDP is USD 543 (March 2006), the majority of patients cannot afford to pay USD 730 for a single vial of bevacizumab"16
The prices of novel cancer biologics reflect the scientific innovation and the investment required to support biotechnological research and development. But it puts them beyond the reach of many people. Pursuit of innovative new drugs is clearly of great importance, but so is broadening patient access to the treatments we have now.
There’s no quick-fix solution – but, as biologic drugs like bevacizumab start to approach patent expiry, the opportunity arises for new manufacturers to develop more affordable biosimilars. In a position paper published by the European Society for Medical Oncology (ESMO) in early 2017, Professor Fortunato Ciardiello, ESMO’s President stated: “Biosimilars are must-have weaponry in financially sustaining healthcare systems on a global scale as well as significantly improving outcomes for an increasing number of patients throughout Europe and the rest of the world.”
Bevacizumab is targeted for biosimilar development in a number of indications. Importantly, its efficacy does not depend on the presence of specific genetic mutations and its tolerability is well defined and generally manageable.17,18
QuintilesIMS is actively supporting the development of biosimilar versions of bevacizumab in ovarian cancer and we invite you to join us as a clinical investigator. The patients you enroll in these studies will all receive active therapy, either with the branded biologic or a biosimilar candidate at no cost to them or to their insurers. Even if you perceive that patient access to biologics like bevacizumab is not a critical issue in your own country, getting involved in biosimilar clinical trials will give you the opportunity to help maintain the high standards of biosimilar studies, gain experience in an area of research projected to expand significantly, and be part of a global mission to bring the benefits of modern cancer treatment to a far wider population.