article in the BMJ, with free link here
Margaret, you are spot on as usual with your article on bevacizumab and ranibizumab. It made me wonder:
Who funds the MHRA?
Why is NICE not allowed to assess the evidence on unlicensed treatments?
The MHRA – http://www.mhra.gov.uk/Aboutus/Freedomofinformationanddataprotection/Freedomofinformation/PublicationSchemeinformationguide/index.htm#spend
NICE can’t decide what to evaluate – that comes from the DOH. as far as I know…
I’m sorry, I don’t buy this. Part of the marketing authorisation is a great deal of safety and efficacy data that Avastin simply does not have. Off label use often has unexpected consequences (Mediator, anyone?), which is one of the reasons EMA approval is along and expensive process. I think some degree of circumspection may be advisable.
There’s little symptany for research-based drug compnies, but to make them jump through hoops for years to get the product approved, then point to something else and say “actually, I think we’ll use that instead, we’re not too worried about the lack of safety/dosage data” is hardly a recipe for effective drug development. Change the model by all means, pressure them to cut the price, but this is an ill considered path.
Where does the off-label use stop, and where does responsibilty lie when things do go wrong?
Lucentis and Avastin are made by the same company. That is a key point, I think.
You would really have to ask why they chose to develop a ‘super custom’ version of the antibody for AMD, rather than trial Avastin, which is the parent molecule they already had.
A cynic might say that having already set the ‘unit price’ for Avastin would have meant it would have had to be fairly cheap for AMD, since you need much less of it to inject an eye than to give a whole-body dose in cancer therapy. The cynic would also point out that the ‘custom’ stuff (Lucentis) could instead be sold at ‘what the market will bear’, a bit like Avastin for cancer.
Obviously the events WRT off-label Avastin prescribing make for many interpretations, but a pretty obvious one would be the PharmaCo doing its best to maximize profits by insisting on selling exclusively its expensive product rather than its quite-probably-equally-effective cheaper one – and using all its influence and PR muscle to get the patient groups and the papers to do its lobbying work for it. The latter bit would hardly be a new scenario, see e.g. herceptin for breast cancer and other examples.
Indeed, both products are made by Genentech (owned by Roche, who are in turn partially owned by Novartis – a minority stake). I’m not sure why this is significant; they are not marketed by the same company, and it’s not uncommon for manufacturers to licence products to other companies, inside and outside pharma. Novartis has an interest in eye care, Roche has no interest in the field. However – if I understand correctly – you suggest that Genetech, having discovered Avastin, should have abandoned research on Lucentis?
On pricing, you can argue about whether Lucentis is correctly priced; however in the UK, that was what was agreed with the UK government, not necessarily what the manufacturers requested. Indeed, just because Genentech were responsible for developing both medicines, they were not responsible for the pricing of neither of them. Roche negotiated prices with government in Europe on behalf of Avastin, Novartis for Lucentis. I understand the question of price, but I don’t think there has been any accusation of collusion or anti-trust behaviour.
My understanding of the regulatory process (hardly encyclopaedic) is that it would not be possible for Roche/Genentech to pursue to differing indications for Avastin simultaneously; it would need approval for its oncology side first (validating its safety), then pursue one in AMD. Furthermore, given the vastly differing regimes involved, any new indication for Avastin would have required considerable amounts of new data.
While there are similarities between the two, Lucentis is different and distinct from Avastin, therefore Novartis could pursue the AMD indication thus two new therapies can make it to market more quickly. Yes, they would make a profit, but if they did not have the opportunity, then they would not have bothered in the first place; bear in mind what was invested to get the Medicines Agency approval in the first place.