Why ‘similar’ can make a big difference

Submitted: 7 October 2019; Revised: 14 October 2019; Accepted: 15 October 2019; Published online first: 25 October 2019

Background

Colorectal cancer may not be as widely known or talked about as some other types of cancer, but it is incredibly common and unfortunately still claims many lives each year. It is the second most common form of cancer in women in Europe, after breast cancer, and the third most common in men, after lung and prostate cancer. For both men and women in Europe, colorectal cancer is the second most common cause of cancer death [1].

However, the overall picture is actually improving. Although the mortality rate is still high, it is falling and has done so since the 1990s. This is due in part to higher awareness and better screening programmes, although we still have a long way to go on both. While better screening is enabling earlier diagnosis for many, which inevitably increase the likelihood of better outcomes, the outlook for those diagnosed at a later stage, or whose cancer advances, has improved also.

Advanced colorectal cancer is not always the death sentence it once was – and one of the major reasons for this has been the introduction of biological treatments. Before the introduction of biological medicines, median survival in phase III trials never exceeded 24 months. The introduction of biological medicines has improved median survival in metastatic colorectal cancer to more than 30 months in phase III trials [2] and many anecdotal real-world outcomes are considerably better.

As with all innovative medicines, there is a price to pay – and it is one that has proven to be too expensive for many healthcare systems around the world. This has led to huge inconsistencies in access to biologicals. A study by the European Society for Medical Oncology (ESMO), the Union for International Cancer Control, the Institute of Cancer Policy of King’s College London, and the European Society of Oncology Pharmacy, compared the availability and costs across Europe for licensed drugs to treat 14 common cancer settings, including colorectal cancer. The results showed a clear divide for newer biological and targeted drugs between some European countries, where there was widespread availability either free of charge or at subsidised cost, and other countries, particular in Eastern Europe, where many of these drugs were either unavailable or available only at full cost to patients [3]. This inevitably has an impact on outcomes.

Biosimilars could be a game-changer

The advent of – generally less expensive – biosimilars has increased the prospect of better access to biological medicines. Despite some initial misgivings and confusion around biosimilars, they are approved according to the same European Medicines Agency (EMA) standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. The evidence suggests they have repeatedly demonstrated no meaningful differences in patients’ clinical outcomes compared to reference products. But uptake remains slow and patients, particularly in poorer countries, continue to be denied access to biologicals. While many discussions continue around the topic, as is often the case with such matters, the patient voice is somewhat lost.

At Digestive Cancers Europe, we felt it was important to provide a position paper that clearly sets out the current situation with regards to biosimilars in colorectal cancer, and to provide the patient perspective. That is why we worked with several patients (and carer) advocates from all over Europe, along with some of the leading healthcare professionals in the area, to develop a position paper on biosimilars.

At its heart is the need for equality and for the patient voice to be heard. We believe equality of access to medicines is a fundamental right for all patients, and we believe there is an important role for biosimilar medicines to play in achieving this in colorectal cancer. Patient safety is the main priority and it is vital that biosimilars continue to be evaluated with the same exact standards as the reference medicines. It is also important that patients are fully informed about the medicines available to be able to make an informed decision themselves. Information should be clear and easily available. Patients must have the opportunity to access clear information about biosimilars, including the potential risks and benefits, and key relevant clinical evidence presented in a patient-friendly manner. Vitally, patients should not be forced to switch. We believe that if a patient is currently taking an original reference biological medicine, and is stable and responding well to treatment, then they should never be forced to switch to a biosimilar medicine.

Ultimately, the current inequalities in terms of access to essential biological medicines mean that biosimilars are an appealing option, as the increasing competition and associated lower price may help to improve access. If implemented widescale, we are optimistic that biosimilars could help to close the inequality gap in access to the highest standards of care in colorectal cancer.

Competing interests: DiCE is funded by numerous pharma/medical device companies and from various projects. Some of the funding partners can be found on the website: https://digestivecancers.eu/about-us

Provenance and peer review: Not commissioned, internally peer reviewed.

References
1. World Health Organization. Colorectal cancer [homepage on the Internet]. [cited 2019 Oct 14]. Available from: http://www.euro.who.int/en/health-topics/noncommunicable-diseases/cancer/news/news/2012/2/early-detection-of-common-cancers/colorectal-cancer
2. Mahipal A, Grothey A. Role of biologics in fi rst-line treatment of colorectal cancer. J Oncol Pract. 2016;12(12):1219-28.
3. Cherny N, Sullivan R, Torode J, Saar M, Eniu A. ESMO European Consortium Study on the availability, out-of-pocket costs and accessibility of antineoplastic medicines in Europe. Ann Oncol. 2016;27(8):1423-43.

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