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Facing the new wave of biosimilars

Don’t drown out the patient voice, says advocacy group


Biosimilars are sailing down the pipeline, and many will be approved in Europe in the coming two years. In February, Europe saw a significant milestone in the availability of biosimilar medicines when the European Medicines Agency authorised the first biosimilar to treat cancer. Meanwhile, a series of recent position changes suggest that the weight of opinion in Europe is shifting toward the use of these less expensive versions of biologic medicines.

As an organisation that represents clinicians and patients, the Global Alliance for Patient Access (GAfPA) closely follows the debate. Biosimilars and biologics present both opportunities and challenges for European patients, clinicians and healthcare systems.

GAfPA is a project of the Alliance for Patient Access (AfPA) a non-for-profit organisation that seeks funding through associate membership dues, grants, donations and sponsorships. AfPA currently receives funding from nearly 30 different pharmaceutical companies and organisations.

GAfPA campaigns across Europe to ensure patient access to appropriate clinically approved therapies. Over the past year alone, GAfPA has hosted patient advocacy workshops in Barcelona, Copenhagen, Budapest and at the EU Parliament. These workshops educate patient representatives about biosimilar medicines, explore the policy questions around their use and allow participants to compare experiences from their own countries.

Over the last year, one issue in particular has become focal in these conversations: informed patient consent. GAfPA strives to ensure that this point, and the patient voice, does not get drowned out in growing international dialogue.

The tenor of that dialogue has evolved rapidly. The European Crohn’s and Colitis Organisation (ECCO), the European Society for Medical Oncology (ESMO) and the British Society for Rheumatology (BSR) have all altered their positions to be more supportive of the use of biosimilars. Position changes from three such influential groups have, in turn, attracted attention from policymakers across Europe. These men and women understandably seek to capitalise on the potential cost savings and increased patient access that increased use of biosimilars might bring.

In the rush to fully realise biosimilars’ benefits, however, policymakers should not overlook the patient’s role in the decision-making process. In particular, they would do well to consider four points raised by the ECCO, ESMO and BSR positions papers.

Switching should be

a medical decision

All three organisations acknowledge the potential economic savings offered by switching patients from an original biologic medicine to a biosimilar. Likewise, they all generally support switching. The BSR, the UK’s influential professional medical association for rheumatologists, however, has a few stipulations. The group’s new position paper states that stable patients should be switched on a case-by-case basis and that switching should take place only ‘based on clinical reasons and not solely as a measure to save money’.

This caveat is an important one, and it reflects many of the concerns raised by patient representatives during GAfPA workshops. At each of these meetings, patients from across Europe have spoken out against policies that compel or incentivise switching a stable patient without his or her informed consent.
At one GAfPA workshop, advocates from the Danish Crohn’s and Colitis organisation described how nearly 3,000 patients were switched overnight from their original biologic to a biosimilar in 2015. Many of these patients were not told about the switch, while others found that their physician had not listed the change in his or her notes.

The failure to engage patients around this switch fuels inaccurate reporting of adverse events, placing future patients at risk. In many cases, this experience also damaged the trust between patient and clinician.

HCPs and patients need to collaborate

All three position papers are clear - any decision about a patient’s treatment should be made by an informed healthcare professional in consultation with the patient. GAfPA welcomes this emphasis on the central role of patients, particularly from bodies representing the physician perspective.

Other groups from across Europe have highlighted the value of shared decision-making, including the European Federation of Crohn’s and Colitis Associations, which represents 33 national patient groups. The federation has undertaken patient surveys that offer valuable insights on patient attitudes toward biologics and biosimilars. The group’s latest survey found concerning results about patient education around biosimilars. Nearly two-thirds of patients surveyed had not heard of biosimilars, while over 40% called for patients to be given information about their treatment.

GAfPA has and continues to work with the European Federation of Crohn’s and Colitis Associations to increase patient awareness about these medicines and to provide tools for patient advocates to advance shared decision-making in their countries.

Multiple switching requires further data

Physicians and patients alike have highlighted concerns about multiple and cross-switching among biologics and biosimilars. The increasing number of biosimilars in development raises the possibility that patients may be switched not once, but several times, so that healthcare systems maximise cost savings.

There is currently a lack of robust evidence to reassure the patient community about the safety and efficacy of multiple switching. One trial, the NOR-SWITCH study, has made a significant contribution to the evidence base for switching. NOR-SWITCH is a randomised, double-blind study of nearly 500 patients, designed to evaluate the effects of a single switch from an original biologic (Remicade) to its biosimilar (Remsima) across six inflammatory diseases. Some policy makers have interpreted NOR-SWITCH results as confirmation of switching’s safety and efficacy. Yet questions around multiple switches remain unanswered, as we noted in a report on the study’s limitations.

The ECCO position paper directly references this gap, stating: ‘Scientific and clinical evidence is lacking regarding reverse switching, multiple switching and cross-switching among biosimilars in [inflammatory bowel disease] patients.’ Without robust evidence, the potential effect of these types of switching cannot be predicted. Policymakers need a strong evidence base before this sort of switching takes place.

Adequate tracking and tracing systems

The ECCO position reinforces GAfPA’s view that all biologics - including biosimilars - should be subject to detailed tracking and tracing in case of adverse events. The BSR also highlights the need for robust monitoring, recommending that all patients treated with biosimilars be included on the group’s Biologics Registry to ensure patient well-being.

The topic emerged at a roundtable on biologics and biosimilars in the UK parliament that GAfPA attended, where patient groups, healthcare professionals, industry representatives and policymakers agreed about the value of robust pharmacovigilance. A detailed analysis of five European countries’ current frameworks is forthcoming from Professor Michael Kaeding of the University of Duisburg. This new study finds that, despite progress in tackling the under-reporting of adverse drug reactions, a clear challenge remains in ensuring all adverse reactions to biologic medicines are clearly reported to medicine regulators and pharmaceutical companies.
This challenge must be addressed to prevent putting patients at risk.

The tide of opinion

Overall, GAfPA applauds the position papers from the European Crohn’s and Colitis Organisation, the European Society for Medical Oncology and the British Society for Rheumatology for highlighting key considerations on biosimilar medications. Patients, clinicians and policymakers can maximise the opportunity offered by biosimilars only if there is confidence among all stakeholders that patient benefit drives decisions about their use. To instil the necessary confidence, patients must be more closely involved in decisions about their care, available evidence on the impact of switching must continue to grow and monitoring systems around these medicines should be strengthened.

The tide of opinion may be behind the use of biosimilars, but stakeholders must ensure that this does not wash away legitimate and unanswered questions about their use.

Article by
Brian Kennedy

Is executive director of GAfPA

21st June 2017

From: Regulatory



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