What do you think should happen to the Cascade?

RE: What do you think should happen to the Cascade?

Judith Joyce — Fri, 06 Dec 2024 09:20:04 GMT

Wouldn't prescribing human generics to clients on benefits bring about the same argument as the winter fuel payments - the people who fall down the hole in the middle, aren't eligible for benefits but yet can't afford vet licensed drugs?

https://www.who.int/news/item/28-09-2020-who-publishes-pricing-policy-guideline-to-improve-affordable-access-to-medicines WHO has long campaigned against pharmaceuticals making excessive profits on drugs so perhaps CMA can pick up on that one re your price cap suggestion. It's only a guideline currently though I think so not binding on anyone.

As the big companies only develop drugs with a big enough market to make profit, it could be counterproductive to force it on them. I think I have read of one saying that there is no incentive to produce more veterinary antibiotics?

Agree definitely not black and white

RE: What do you think should happen to the Cascade?

Martin Hamilton — Thu, 05 Dec 2024 14:16:24 GMT

Personally, having moved to a country where there's a cascade but it's a recommendation and not a legal requirement, I say get rid of it (at least from the perspective of being forced to abide by it).

In Canada common sense prevails. If using something that's not a licensed veterinary product we require written client consent (usually obtained when the client signs up at the practice in the client intake documentation). We use human genetics often, but have to acknowledge that if there are adverse effects then you don't have a drug company to fall back on - it's on you as the prescribing vet. Prefer veterinary products for this reason (as well as flavouring), but for many drugs (trazodone, gabapentin, amoxyclav, paracetamol), using the generic is a no brainer. Same for compounded products (much easier to give tuna flavoured medication to cats, for example, than to try and pill them).

RE: What do you think should happen to the Cascade?

Andrea Tarr — Wed, 04 Dec 2024 13:47:55 GMT

Specials companies (like Bova, Summit etc) are licensed by the VMD to manufacture bespoke medicines (this is an assurance that they use pharmaceutical standards of manufacturing), but the medicines that they sell are unlicensed - there is no regulation of their quality, efficacy or safety.

RE: What do you think should happen to the Cascade?

Arlo Guthrie — Wed, 04 Dec 2024 11:08:10 GMT

rhona kerr Sorry if I am being thick here, but you are saying that you can't prescribe Bova or Summit-made paracetamol, gabapentin etc before a human version of the drug? The reason I am doing a written double-take here is because I've not heard of it being this way round before (ie having to prescribe a human version over an animal version). I presume that is because Bova and Summit make unlicensed specials and they come second to human drugs? I wonder whether the unlicensed specials are more or less expensive than the human versions.

RE: What do you think should happen to the Cascade?

rhona kerr — Wed, 04 Dec 2024 10:37:11 GMT

Paracetamol flavoured liquid, and tablets, gabapentin the same, different tablet sizes of licensed meds, etc, etc. All are below the human drug on the cascade......

RE: What do you think should happen to the Cascade?

David Bailey — Wed, 04 Dec 2024 10:31:18 GMT

Hi Arlo. Cascade wasnt designed for banning of animal imports. it was designed to navigate around the issues of availability of licensed vet meds with an appropriate marketing authorisation in that jurisdiction. one down stream and serendipitous application of cascade is to keep it alive and in use as a non tariff trade barrier against animal product imports from non EU countries who may use human meds and antibiotics in their food producing animals. This concept of trade protection originated post WWII with the idea that EU countries that trade with each other tend to be less likely to attack each other. The EU cannot refuse to import other countries products for no valid reason in fear of reprisals so ' legitimate' reasons need to be given. Cascade is used ( not designed) as just one reason. It Wasn't designed to be used this way but politics and trade have utilised it well. and it is just one of many reasons to prevent or halt or restrict food trade from outside the EU without fear of reciprocal trade sanctions or reprisals from the intended exporter. Can you separate out pets from livestock? probably not- because everyone in the UK will develop a preference to go out of farming and start to raise industrial levels of pet livestock and enjoy getting around cascade.

RE: What do you think should happen to the Cascade?

Arlo Guthrie — Wed, 04 Dec 2024 10:00:25 GMT

[quote userid="4386" url="~/f/non-clinical-questions/31090/what-do-you-think-should-happen-to-the-cascade/246142#246142"]I personally welcome and appreciate your comment on everyone can take joy from pet ownership - unfortunately both vets and owners are being deprived of this by over-regulation, greed and unreasonable expectations from both owners and modern vets. (maybe the latter comment would be better replaced by 'society'). [/quote]

Russell leadsom thank you, although I perhaps would have not put the word 'greed' and 'vets' in the same sentence!

It's an interesting philosophical point ... is there any reason why pets should be affordable? I remember one or two here (was it you Alastair Welch) arguing that there is no reason why pet care should not be more expensive and animal-ownership limited to the rich.

Of course when we think of other consumer purchases, there are few that I can think of where we would argue that prices should be reduced so that the poor can afford them. Why should that Bentley be cheaper? Or that 20ft TV? And why should the companies that make them be less profitable?

My feeling (as if anyone cares?!) is that pets are different. They fulfil such an important role in society (companionship, life lessons for children, working dogs etc).

And I don't think the main issue here is about companies taking too much profit (whatever 'too much' is).

I think the main issue is deciding what the profession is or should be offering the public. Is it the gold-standard, linear-accelerated, over-regulated, every-diagnostic, open-heart surgery?

Or could the profession be just as profitable by going back to basics and offering a more basic level of care with fewer overheads.

I think so (obviously) and I think that would make for a far more rewarding job / career for vets.

[quote userid="25917" url="~/f/non-clinical-questions/31090/what-do-you-think-should-happen-to-the-cascade/246143#246143"]We can’t often deviate from easy decisions with regard to animal welfare without the word trade being included. While it may appear to make sense to use the cheaper human drug on our pet dog. . We then lose nearly all credible footing when we try to ban animal food products from other countries being imported because of the drugs they use if we allow any relaxation in cascade here.[/quote]

David Bailey interesting - so you are saying that pet owners are the collateral damage from a cascade that was actually designed for food producing animals. Surely it would not be so difficult to remove the cascade from pets, and thereby not affecting trade etc.

[quote userid="5850" url="~/f/non-clinical-questions/31090/what-do-you-think-should-happen-to-the-cascade/246146#246146"]What galls me most is that companies like Bova and Summit are creating licensed or widely used drugs in different forms that are more compatible for our patients, and yet are below the human drugs on the cascade.....it seems very backwards. [/quote]

rhona kerr What is an example of that, please? Interested.

RE: What do you think should happen to the Cascade?

rhona kerr — Wed, 04 Dec 2024 06:27:16 GMT

What galls me most is that companies like Bova and Summit are creating licensed or widely used drugs in different forms that are more compatible for our patients, and yet are below the human drugs on the cascade.....it seems very backwards.

RE: What do you think should happen to the Cascade?

Alastair Welch — Tue, 03 Dec 2024 20:02:44 GMT

In other news

https://www.vetsurgeon.org/b/veterinary-news/posts/domes-pharma-launches-two-products-to-alleviate-anxiety-in-pets

RE: What do you think should happen to the Cascade?

Nemo — Tue, 03 Dec 2024 18:40:00 GMT

I don’t think the cascade serves the patient or the owner. Pharmaceutical companies manage to make a return on investment on their products in countries without a cascade so that shouldn’t be an argument for keeping it.

RE: What do you think should happen to the Cascade?

David Bailey — Tue, 03 Dec 2024 18:00:53 GMT

The medicine act received a very swift overhaul around 1968 in response to the thalidomide event. At this time it included human medicines and veterinary medicines were pasted on as an included afterthought as it was very rushed legislation. And this created the concept of quality, safety and efficacy. ( QSE) in our licensed vet meds. Fast forward to Harold Shipman and we had the veterinary medicine regulations in the late 90’s and early noughtys that regulate Sale,Supply and Distribution. ( SSD) Again, another human medicine lead event that had a large impact on vet med distribution. While there are around 68 million people in the UK there is, in any one year. The production, treatment slaughter and trade in about 1 billion animals a year. This does not include pet animals. Since WWII the UK and the common agricultural policy has promoted the island nation of the UK to be food resilient after the adverse experiences of WWII Britain was forced to accept that she was a small, isolated and exposed Island vulnerable to submariner attacks on supply ships. So while the VMD is wrapped pretty tightly in granting marketing authorizations for veterinary medicinal products that can trickle through 1 billion animals a year and down stream consumers and the VMD do work hard to prevent an exposure of the uk population and that of receiving nations to an adverse event in our food products. It is the potential damage to trade that is a third driving force( on top of QSE and SSD) in this equation in my view.
we won’t accept trade in animal products from countries that maintain lower welfare standards, especially transport of animals and welfare at slaughter and we don’t allow imports from countries with certain disease status. We won’t allow imports of countries who use growth promoters, antibiotics or hormones above the levels that we allow to be used here. And we won’t accept trade in animal products from countries that use unapproved meds. Especially human antibiotics. We can’t often deviate from easy decisions with regard to animal welfare without the word trade being included. While it may appear to make sense to use the cheaper human drug on our pet dog. . We then lose nearly all credible footing when we try to ban animal food products from other countries being imported because of the drugs they use if we allow any relaxation in cascade here. Production animals and trade exceed the number of humans and pet animals in the uk combined. The use of antibiotics ( licensed or unlicensed) has become a political non tarrif trade barrier to legitimately prevent import of foodstuffs from outside the EU. ( Same for TB control) without starting a trade war From countries who use dodgy drugs in their production animals. Meanwhile UK Pets become collateral damage as cascade is currently enforced to protect trade in the production animal sector and as long as this debate is maintained by scientists and fact based data ( bottom up decisions) then without recognizing the political lead decisions that are included ( trade and trade barriers) are top down type decisions then at a political decision making level, trade is protected and facts really don’t matter.

RE: What do you think should happen to the Cascade?

Russell leadsom — Tue, 03 Dec 2024 17:49:54 GMT

[quote userid="2100" url="~/f/non-clinical-questions/31090/what-do-you-think-should-happen-to-the-cascade/246120#246120"]OR, it can recognise that animals are ultimately replaceable and do not warrant this huge investment. Reduce the regulatory burden. Practice pragmatic medicine. Bring prices down. And thereby make pet ownership something everyone can take joy from. [/quote]

Totally agree! time (overdue) to bin it!

I personally welcome and appreciate your comment on everyone can take joy from pet ownership - unfortunately both vets and owners are being deprived of this by over-regulation, greed and unreasonable expectations from both owners and modern vets. (maybe the latter comment would be better replaced by 'society').

RE: What do you think should happen to the Cascade?

dogknobbler — Tue, 03 Dec 2024 17:08:54 GMT

Janine

The cascade does not concern new drugs - the company is protected by the patent anyway. There will not be any generic alternatives to a new drug.

The problem is that companies are making excessive profits by getting a vet product license for drugs that already exist and then compelling vets to buy it rather than the cheaper generic which has been safely in use for years.

RE: What do you think should happen to the Cascade?

Judith Joyce — Fri, 29 Nov 2024 10:00:01 GMT

Agree with you there Arlo, I seem to recall (again a long time ago) DECHRA being quite upfront about their business model of making human products available to vets by relatively less expensing licensing. Admit that was the marketing message at the time, but they were never going to market on the basis of company profit levels. It was niggling that I couldn't remember the constiuent companies that we dealt with before DECHRA - website shows Dales and Arnolds (and others) which sound familiar. Think it's fairly transparent and agree they filled a gap in the market.

Without a lot of numbers, I think its difficult to be objectively judgemental but depends how Milton Friedman you feel about profit levels in big Pharma I guess.

RE: What do you think should happen to the Cascade?

Arlo Guthrie — Thu, 28 Nov 2024 19:16:12 GMT

Eamon McAllister I've seen this somewhere before. The only problem I have with it, is that it doesn't give any numbers, it's just a relative statement.

Yes, it is cheaper to run a development project than a research one, high probability of success, relatively low cost etc etc.,

Sure, and there's nothing wrong in any of that. I mean, any businessperson with half a brain would look for those kinds of attributes.

The real question is how much cheaper? And are reductions in the cost of development reflected in the price of the product to the consumer?

I think we all rather suspect not, but without the numbers, I don't see how this is a smoking gun.

RE: What do you think should happen to the Cascade?

Eamon McAllister — Thu, 28 Nov 2024 16:26:58 GMT

This is a bit hard to read because I have pasted it from elsewhere. It’s also a bit hard to swallow because it confirms all the suspicions.

RE: What do you think should happen to the Cascade?

Michael Woodhouse — Thu, 28 Nov 2024 14:23:47 GMT

[quote userid="14693" url="~/f/non-clinical-questions/31090/what-do-you-think-should-happen-to-the-cascade/246130#246130"]Yes you can provide a £27 script for the 89p packet of paracetamol but it doesnt feel great and providing it direct isnt much cheaper[/quote]

It would be exceptionally rare I'd prescribe 16 Pardale tablets. A 25 kg dog on Pardale V for a month would be on 180 tablets per month (2 tablets every 8 hours, 30d), or to put it another way you would have to go to the shops every 2 days for the 16 pack of tablets. People come out with these ludicrous examples, but they'd be spending more on time or petrol if the 89p was a 'real' example.

RE: What do you think should happen to the Cascade?

Judith Joyce — Thu, 28 Nov 2024 11:57:09 GMT

Hi,

I have some different recollections from some of you, but it was a long time ago and I could be mistaken, especially about the detail.. During discussions at the time it was said that the prescribing restrictions were introduced to regulate drug residues in food animals on the basis that a veterinary drug would have a stated withdrawal time on a data sheet whereas a human medicine wouldn't. There was some discussion about limiting restrictions to food animals.

AMELIA 8? (altered in time, but still known as the Cascade) was the original enabling bit of the EU legislation giving vets more freedom to prescribe, hugely varied in application. (I got really fed up with nonUK certificate candidates saying ti their case books that they didn't have to abide by it because it was UK legislation when it was EU law. (usual thing I suppose UK gold plates legislation and some others in some EU countries carry on as they were.)

There is still a case to alter the Cacade to allow more freedom of prescribing in non-food animals (although there was some discussion at the time about what is a non-food animal EUwide!)

Anyone know what it costs to develop and licence, a veterinary drug, or license a human drug for veterinary use, these days. Last time I heard ithe former was massive but too long ago to remember the figure. Only worthwhile for drugs with a very big market ( more grounds for allowing more use of human drugs in pet animals)

Be interested to know if anyone else has a similar recollection

RE: What do you think should happen to the Cascade?

Lesley Strong — Thu, 28 Nov 2024 11:49:21 GMT

Yes you can provide a £27 script for the 89p packet of paracetamol but it doesnt feel great and providing it direct isnt much cheaper

RE: What do you think should happen to the Cascade?

janine redman — Thu, 28 Nov 2024 11:32:06 GMT

I was always concerned when advising dog owners give paracetamol to their dogs knowing that too many people assume cats are small dogs ! I always emphasise that it is lethal to cats but I have seen enough cats poisoned with it to be worried about over the counter medication being used by well meaning people. Luckily it tastes foul so most cats will not take it

RE: What do you think should happen to the Cascade?

Michael Woodhouse — Thu, 28 Nov 2024 11:23:37 GMT

[quote userid="5012" url="~/f/non-clinical-questions/31090/what-do-you-think-should-happen-to-the-cascade/246122#246122"]What galls me the most, is the way deviating from the cascade regs has been criminalised. If I tell a client to give their old arthritic dog paracetamol. or to go to a chemist and buy a £5 bottle of eye drops because they cannot afford £45 for a 7g tube of eye ointment, I am commiting a criminal offence.[/quote]

I think things do need change, BUT I don't think it is ever responsible directing clients verbally to go to the chemist/internet and source medicines and use them based simply on verbal instructions. What happens when the 1 paracetamol isn't enough and they up it to 2, then 3 then 4 etc. I think we should have freedom of choice to prescribe what is available to us. I believe that should either be dispensed from the practice, properly labelled, or via a properly charged for written prescription with dosage instructions etc. I think OK to say "give a paracetamol tonight and see me at 9.00am" but not instruct the owner to start a medication completely out of veterinary supervision.

RE: What do you think should happen to the Cascade?

Lesley Strong — Wed, 27 Nov 2024 16:42:16 GMT

Scrap it. Just an excuse for drug companies to gouge clients with rebranded generics. V few truly new drugs come down the pike

RE: What do you think should happen to the Cascade?

David Mills — Wed, 27 Nov 2024 14:08:46 GMT

[quote userid="9440" url="~/f/non-clinical-questions/31090/what-do-you-think-should-happen-to-the-cascade/246125#246125"]However we do need to incentivise companies to create more medications that have been properly researched and for which safety and efficacy are assessed and therefore the companies are entitled to turn a profit[/quote]

This can easily be done via patent, as per the US and other areas. Or simply a time-sensitive cascade, say 2-3 years, then it's a free for all - such already happens with patent/cascade anyway to an extent (think of pimobendan, maropitant etc), with a backstop that if a human drug already exists then you don't get a patent.

[quote userid="9440" url="~/f/non-clinical-questions/31090/what-do-you-think-should-happen-to-the-cascade/246125#246125"]If company A spends millions bringing a licence for a new drug then it would be inappropriate for the vets to immediately use the human form if there was one .[/quote]

Most new vet-specific drugs are a byproduct of human drug research where the compound has normally reached latter stage trials and been found to be not suitable. For instance, pimobendan was a human trial drug but causes gynacomastia in people - so they use levosimendan. The key is that they know the drugs work in animals and the safe dose - as it's already been trialled. So whilst they then do further clinical trials these are so much cheaper and easier than in humans. Don't be fooled to think a company spends millions on vet-specific drugs, the latter are a way of salvaging money already spent on trying to develop a human drug.

RE: What do you think should happen to the Cascade?

janine redman — Wed, 27 Nov 2024 13:52:16 GMT

I think the cascade is valid for new medications to protect the manufacturer for the cost of producing new drugs . I do not consider it valid for drugs that have been used for years unless they have done additional research on efficacy and safety . However we do need to incentivise companies to create more medications that have been properly researched and for which safety and efficacy are assessed and therefore the companies are entitled to turn a profit . If company A spends millions bringing a licence for a new drug then it would be inappropriate for the vets to immediately use the human form if there was one .

RE: What do you think should happen to the Cascade?

David Mills — Wed, 27 Nov 2024 09:27:46 GMT

[quote userid="5012" url="~/f/non-clinical-questions/31090/what-do-you-think-should-happen-to-the-cascade/246122#246122"]Maybe our professional bodies should be doing this?[/quote]

When did the veterinary establishment last ask you what concerns you, what would make your life easier, or even your opinion?

There is no appetite for change at a legislative level - look at how many years we've been trying to pass a new VSA - so the best we can probably hope for is to return to the pre-Dean days where cost can be used to justify moving down the cascade (remember cost appears nowhere in the legislation). With that comes more clinical notes and regulation as to why you went down the cascade, possibly requirements to keep generics and licensed...etc etc.

Interesting the CMA fella has thrown a cat amongst the pigeons and the scrambling it has caused - hopefully he won't be muzzled by the bureaucracy.