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BMJ investigation revives controversy over barriers to use of bevacizumab in UK
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A new controversy on the long-standing question of use of Avastin vs. Lucentis in the treatment of retinal conditions was sparked in the U.K. by a two-part investigation recently published in the BMJ.
BMJ investigations editor Deborah Cohen noted that no progress has been made in the U.K., by national agencies and NICE, toward removing barriers that restrict prescription and use of Avastin (bevacizumab, Genentech/Roche), although the cheaper drug could release more than £100 million for other patient services, despite advocacy by more than 100 clinical commissioning groups and patient associations. Although Avastin can theoretically be used off label, unclear criteria and confusion over terminology leave ophthalmologists with no official guidance on its use in this capacity, the BMJ article said.
The strongest allegations were against pharmaceutical industries. Roche and Novartis were accused of refusing to fund studies demonstrating the safety and efficacy of bevacizumab for the eye, undermining and diverting attention from evidence produced by trials comparing bevacizumab and ranibizumab (CATT, IVAN), and lobbying potential investigators against such trials, including the ongoing TANDEM trial.
The Royal National Institute of Blind People (RNIB), a leading charity in the U.K., was alleged to have colluded with Novartis in hindering the TANDEM trial.
In a response published on their website, the RNIB strongly rejected these claims: “The reason we raised an ethical challenge to the TANDEM trial is because we believe it takes unnecessary risks with patients’ eyesight, which could ultimately lead to them going blind.”
In a statement released to Ocular Surgery News, Novartis said that the BMJ allegations were taken seriously and that the company is “closely reviewing the content of the article.”
Novartis also reaffirmed, as already reported in the BMJ, its commitment to high standards of ethical business conduct and said to have “a comprehensive compliance program in place to help ensure that associates comply with the Company’s Code of Conduct and all applicable laws.”
In the same statement, it was said that patient safety is “of paramount importance for Novartis.” In view of this, drugs may be licensed for use in patients “only after undergoing risk/benefit assessment by national regulatory bodies based on the safety, efficacy and quality of the drug which results from a comprehensive preclinical, clinical and quality development program.”
In an interview with Ocular Surgery News, Dominic McHugh, MD, MBBS, FRCS, FRCOphth, DO, consultant ophthalmic surgeon at King’s College Hospital, London, said that “the issue is not whether or not Lucentis is more expensive and whether or not Avastin is as effective as Lucentis, but whether the drug is approved for use or not.”
At the time guidelines were issued by NICE, Lucentis (ranibizumab, Genentech/Novartis) was the only anti-VEGF drug that had been subject to rigorous trials. However, since more recent trials have shown equivalent levels of efficacy for Avastin, McHugh said that “NICE should probably revise previous guidelines and produce follow-up recommendations for Avastin.”
McHugh believes that in the near future, with new drugs being developed, the Lucentis-Avastin controversy will become a non-issue.
“To a certain extent, the argument is already becoming past history because we have Eylea (aflibercept, Regeneron/Bayer), an approved drug that requires less frequent administration than Lucentis or Avastin and is increasingly becoming the treatment of choice,” he said. – by Michela Cimberle
References:
https://www.rnib.org.uk/our-response-todays-article-bmj
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