Avastin versus Lucentis
BMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e3162 (Published 02 May 2012) Cite this as: BMJ 2012;344:e3162
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As a medical oncologist, I find it almost unbelievable that Bevacizumab might be considered a "cheap" alternative to another drug!
When I consider how much money is being wasted in many Countries to administer such a useless drug as Bevacizumab for patients with colon cancer, breast cancer (which is no more approved in the USA but still is in Europe), et cetera!
I hope the time will come when Oncologists will require true and clinically relevant progresses from drugs before rushing to prescribe them at the expense of tax-payers!
Competing interests: No competing interests
Dear Dr Godlee,
Ingrid Torjesen [BMJ 2012;344:e3012; BMJ 2012;344:e2959] and Robert Campbell [BMJ 2012;344:e2941] have recently stoked the Avastin-Lucentis embers. This is a model case of how sometimes industry not only has no interest in applying for a new indication but actually has a specific interest in not doing so. Cross-interests between companies selling drugs with similar clinical effects may prevent one company from applying for the same indication for its product. It is disappointing that public health services cannot adopt the cheaper bevacizumab (Avastin, Roche) in place of ranibizumab (Lucentis, Novartis), just because its marketing authorisation holder does not want to apply to extend the indications to neovascular age-related macular degeneration (AMD). Even if according to European regulatory standards bevacizumab could already have been approved for the EU market, if the company does not take the initiative no autonomous regulatory action is possible. Action recognizing the new indication would be needed, particularly in situations in which off-label use is not permitted, i.e. when it aims at patients’ needs that are already met by an alternative licensed medicine, as in the case of AMD.
As we have already stated [BMJ 2010;341:c3721] we believe that whenever commercial interests hamper or even oppose public health expectations, regulatory authorities - the European Medicine Agency through the centralised procedure or the national agencies through their decentralised procedures - should be enabled to recognise the indications that meet patients’ needs best, meaning more effectively, more safely, or at lower cost.
We trust the scientific community to lobby for a new EU regulatory law recognising independent scientists, scientific societies and health authorities themselves as potential applicants for marketing authorisations on the basis of independent clinical studies.
Silvio Garattini and Vittorio Bertele’
Istituto di Ricerche Farmacologiche Mario Negri, Milano
Competing interests: No competing interests
The moral hazard of putting a product that was not approved for treating wet AMD on the same footing as one which was, even if it seems in the best interests of patients or the public purse , cannot be ignored.
The fact Avastin has been shown, in a somewhat retrospective manner, to be relatively safe and effective years after ophthalmologists began to experiment with it as a cheap alternative to other VEGF inhibitors but without the restraint of prospective, randomized controlled trials, is something that could not have been foreseen at the time.
Doctors frequently use medicines ‘off label’ for genuine clinical reasons, a policy drug companies promote at their peril .
When things go well, and retrospective data substantiate the wisdom of doctors’ decisions in trying something new then the world will know about it. But are we as likely to hear if things go wrong, especially when they do so in the context of a setting which is neither controlled nor open to peer and public scrutiny?
While ophthalmologists have now been justified in injecting an unapproved systemic cancer drug with potentially serious side effects, into some of their more vision-impaired patients’ eyes without any real proof of efficacy or safety the fact some continued to do so after Lucentis was approved for this purpose, while others desisted, raises as many concerns as it does questions.
Cost is one but things are rarely that simple. If Avastin, the subject of publicly funded trials, is approved for NHS funding, niggling safety doubts still remain.
In any case the demand for and cost of anti-vegf treatment is set to soar as more diabetics with macular oedema are added to a growing AMD base. These treatments are recurrent, open-ended, technology and labour intensive with the drug cost just one factor in the equation.
Given ongoing publicity surrounding the treatment ophthalmologists should ensure patients’ expectations remain realistic-anti vegf treatment is not a cure-and continue to use it sensibly.
Will drug companies, likewise, be willing to undertake expensive trials if there is a chance competitors might jump the gun with biosimilars, emboldened by lax regulation, perhaps?
This would accelerate the trend towards ‘me too’ drugs rather than encouraging new, cost effective products for treating cancer, diabetes, mental illness or even AMD?
The outcome of the Avastin v Lucentis debate has consequences that extend far beyond the eye-care arena. How healthcare spending is funded, rationed and prioritised is just one.
Competing interests: No competing interests
Re: Avastin versus Lucentis
We read with interest the article “Avastin versus Lucentis “ by Godlee.
We completely agree with the author that the “miracle” of anti-VEGF treatment has been shadowed by the dispute Avastin vs Lucentis.
However, we would like to emphasize in another dispute, which in our opinion is even more important : Anti VEGF treatment VS no treatment at all.
Working in a hospital in the hurricane of the economic crisis, we have patients who are unemployed, uninsured, immigrants (sometimes illegal) and generally with people who suffer from diseases like AMD or diabetic retinopathy and need treatment with an anti-VEGF but cannot afford the burden of monthly injections of Lucentis.
What should be done with these patients? Since the evidence up to now is that bevacizumab is as safe as Lucentis, should these people be left untreated or given the option of the cheaper Avastin? What is ethical for a doctor to do? Treat the patient with an off label treatment or give no treatment at all?
In Greece, Lucentis can be prescribed only for AMD, diabetic macular edema and vein occlusion. What should be done with patients who need treatment for another cause? Ie choroidal neovascularisation secondary to myopia, or angiod streaks or diabetic vitreous hemorrhage; should these patients receive Avastin or should be left to the natural course of their disease.
So the dilemma Avastin vs Lucentis nowdays seems to be a theoretical dilemma; a dilemma of prosperity.
In many cases Avastin is the only affordable solution for the patient, with impressive results in saving their vision. We strongly believe that bevacizumab should get approval for use, despite the resistance of the pharmaceutical companies.
Competing interests: No competing interests