Big Pharma Threatens Legal Fight Over Affordable Blindness Drug in the UK

Two major drug companies are threatening legal action if an NHS body offers a less expensive blindness prevention drug than the leading products on the market in the UK.

The NHS currently faces significant financial hardships, and the agency is being forced to recoup costs where possible. One strategy is to swap brand name drugs for generics, or to offer alternative — but no less effective — drugs by using off-label prescriptions.

For example, twelve health administrative bodies in the North of England decided to offer the drug known as Avastin – widely used in the U.S. to treat age-related macular degeneration, AMD. Technically, the drug isn’t licensed for this purpose in the UK, as the manufacturer did not apply for a license — something that isn’t that unusual.

Drug licenses are costly both in terms of money and time, and sometimes drug companies will choose to forego licensing in certain markets — particularly if the drug under review has multiple uses and has already been approved for another purpose, as is the case for Avastin.

It’s important to note that the drug is licensed by the European Medicines Agency for cancer treatment, but that license doesn’t cover macular degeneration.  

Nevertheless, a 2012 study funded by the NHS showed that the drug could be used as effectively and safely as its leading competitors. What’s more, because of Avastin’s far cheaper price, it could save the NHS millions every year. Avastin costs about £70 per injection, while Lucentis may exceed £700.

Unfortunately, there’s one hiccup in this plan: The bigger drug companies are not happy.

The BBC reports:

Pharmaceutical firms Bayer and Novartis are threatening legal action, claiming prescribing [Avastin] “undermines” guidelines.

Bayer produces Eylea and Novartis produces Lucentis, which are both licensed to treat AMD.

Bayer said it had to “act to challenge the decision taken by these CCGs” and was “currently considering its position including the possibility of legal proceedings”.

On the one hand, it’s important to maintain the integrity of licensing agreements to ensure that the public has confidence that the health care provided them has undergone rigorous testing. Bayer and Novartis are reportedly arguing that members of the public may not know they are receiving a drug that isn’t strictly licensed for treating eye conditions.

The commissioning groups have said they will be making the public fully aware of the situation and will offer them the choice. Nevertheless, Bayer raises particular concerns about elderly patients not fully understanding what they are being asked..

But the commissioning groups responsible for considering this drug have hit back, claiming that this isn’t about patient wellbeing at all.

The Telegraph reports:

In a letter to Bayer, lawyers for the north east CCGs said the accusation is “grossly insulting” and “appears to suggest that elderly patients must be assumed to lack mental capacity or that patients with eye problems must also have cognitive defects.

Doctors have expressed increasing frustration with the NHS restrictions on off-label drug use because they frequently bring about situations like this. Specifically, the NHS will allow for off-label prescription — but only if no other licensed drug is available. If a licensed drug is available and as effective as the other drug being considered, NHS regulations compel clinicians to go for the licensed drug.

But some public health advocates express concern that big pharmaceutical companies can take advantage of this mechanism to ensure their products are the ones being used. That’s because they have the money to secure licenses for their drugs in the first place, thereby blocking competitors from reaching the market. In this case, the CCG bodies accuse Bayer and Novartis of doing just that, claiming that they aren’t concerned about patient choice but rather their own commercial interests. 

Commentators have suggested that should this come to a head in the courts, the legal fight could actually benefit the NHS — so long as the agency wins. Off-label prescriptions can be problematic if used too liberally, but for a cash-strapped national health service that has substantial clinical evidence to support the use of a generic drug outside its licensing, it could be a significant resource boost.

It  would also check the power of drug companies that, critics allege, have been gaining power in the UK health sector — and, arguably, not always to the benefit of patients.

This legal tussle is a complex one, but at the heart of the issue, there seems to be one major question: how to best serve the public and deliver them the health care they deserve — without being compromised by financial wrangling and commercial interests.

Photo Credit: Jordan Whitfield/Unsplash

49 comments

Marie W
Marie W20 days ago

Thanks

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Kimberly W
Kimberly Wallace6 months ago

TY

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Margaret G
Margaret Goodman6 months ago

This I just anecdotal evidence, but Avastin cured the macular degeneration in my left eye. Big Pharma’s grasping for every bit of profit needs to be curbed.

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Winn A
Winn A6 months ago

tks

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Winn A
Winn A6 months ago

Noted

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Danuta W
Danuta W6 months ago

Thanks for this article.

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Angelika K
Angelika Kempter6 months ago

Thanks for sharing

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Anne M
Anne M6 months ago

And while they're fighting,, people are just dying to see !!

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Belinda Lang
Belinda Lang6 months ago

To Big Pharma profit is the only thing.

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Muff-Anne York-Haley

Big Pharma is run by Bandits!

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