For patients with advanced non-small cell lung cancer (NSCLC), the anti-angiogenic biologic bevacizumab can sometimes make a significant clinical difference when added to chemotherapy, including improvements in overall survival. 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.
However, the reality is that many of the world’s cancer patients 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. Even in the Western world, large discrepancies in patient access to biologics exist. In some countries, funding is generally made available but in others, a cancer diagnosis can wipe out entire life savings and sometimes force people to sell their homes, while in some developing countries stark choices may have to be made between medical treatment and basic needs like food and shelter. Sometimes modern treatment is declined because patients are reluctant to leave surviving family members with the burden of an insurmountable debt. It is particularly unfortunate that lung cancer disproportionately affects those least able to afford it.5The highest prices are for new generation biologics, which can cost in the region of USD $100,000 per patient per year6 and are often not considered a viable option by national reimbursement agencies. Added to this, many patients with lung cancer require another costly biologic (G-CSF) for prevention or management of neutropenia,7 as well as various palliative treatments now widely recommended at an early stage.8
UK: "A breast cancer drug that can extend life by almost six months has been turned down for use on the NHS because it is too expensive."9
USA: "I wish it were one-tenth the cost, and if it were I would be giving it to almost everybody"10
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"11
"Why can't we have this drug? Anger as cancer medication that saves thousands remain banned"12
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.
"If we don't figure out a way to make this work for more folks, we are going to end up in a situation where we may have miracles to offer, but no way to pay for them"
J. Leonard Lichtenfeld MD,
Deputy Chief Medical Officer of the American Cancer Society12
There’s no quick-fix solution – but, as some modern NSCLC biologic drugs 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.”
QuintilesIMS is actively supporting the development of biosimilar versions of bevacizumab in NSCLC 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 clinical trials, 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.