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IN TOUCH – A Legal Judgement for Novartis

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TX:Ìý 25.09.2018Ìý 2040-2100

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PRESENTER:Ìý ÌýÌýÌýÌýÌýÌýÌý PETER WHITE

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PRODUCER:Ìý ÌýÌýÌýÌýÌýÌýÌýÌýÌý KEVIN CORE

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Peter White

Good Evening.Ìý Tonight, a legal breakthrough for sufferers of an eye condition affecting tens' of thousands of people!Ìý And a fond farewell to a good friend of the programme, script writer and star in his own right Dennis Norden who died last week.

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But first, a High Court decision about two drugs could be about to save the NHS hundreds of millions of pounds.Ìý It was almost exactly 11yrs ago, that this programme first due attention to the huge disparity between the costs of two drugs, which could both be used to treat the same eye disease.Ìý Lucentis and Avastin are both used in treating what's known as 'Wet AMD', a form of macular disease, which threatens the sight of around 40,000 people a year in the UK.Ìý But while a dose of Lucentis costs the NHS several hundred pounds, a dose of Avastin could be had at around £30. But doctors who wanted to prescribe this cheaper drug were told they'd have to do this at their own risk, because no licence had been sought for its use in the eye.Ìý The reasons! There were still suspicions that there were side-effects connected with Avastin used in the eye, which could not be risked.Ìý But several trials comparing the two drugs found that the cheaper Avastin is as effective and safe as the more expensive Lucentis - an opinion shared now by NICE, the National Institute for Health and Care Excellence.ÌýÌý But Avastin is not licensed for use in the eye in the UK.Ìý Now two drug companies Novartis and Bayer, who market Lucentis and another drug Eylea respectively, went to the High Court to prevent 12 clinical commissioning groups in the Northeast from prescribing Avastin for the eye.Ìý But there case has failed.Ìý In a decision, which some say will save the NHS hundreds of millions of pounds, the judges ruled that health authorities can provide Avastin on grounds of cost, and they can cite NICE's ruling that it is safe and effective for use in the eye.Ìý

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Haseeb Ahmad is Managing Director of Novartis Pharmaceuticals in the UK.Ìý I asked him, why they brought this case?

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Haseeb Ahmad

I think we brought this case because we don't see that the policy that was being proposed by these 12 commissioning groups, so these NHS managers in the Northeast of England.Ìý We didn't believe and do not believe that it's in the interest of patients, so this is almost an unprecedented situation where...

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Peter White

But they wanted to provide a drug, a drug cheaply that's not a terrible thing to want to do is it?

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Haseeb Ahmad

What is being proposed is that patients for the first time, their having to accept an unlicensed medicine that hasn't been through the same regulatory scrutiny as licensed medicines when licensed medicines are available.Ìý Now within the UK, any of us who are consumers of the National Health Service, we have a right within the NHS constitution to medicines that have been approved by NICE.

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Peter White

But why hasn't Avastin been licensed for use in the Eylea in the UK, when it's been used all over the world for the last 10yrs?

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Haseeb Ahmad

Avastin is not a Novartis medicine, so I can't comment on the commercial strategy of other companies.

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Peter White

But you have been very supportive of the idea of its not being used, so I can assume that you're in agreement with the fact that it isn't licensed?

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Haseeb Ahmad

We're very supportive that patients should have choice and physicians should also have choice, so regulation is there for a reason.Ìý What we're seeing in this case, is that potentially both Hospital Trusts, physicians and patients will be put under pressure to accept that medicine hasn't been through the same regulatory standards that licensed medicines go through.

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Peter White

But isn't part of the choice.Ìý Isn't part of choice affordability?Ìý And the problem for the NHS, which you know is very stretched, is that it's faced with a very expensive drug and can't use a much cheaper one?

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Haseeb Ahmad

Well I think when it comes to cost as I'm...as I'm sure you're your aware, you've been following this case for many years.Ìý Medicines, which are approved by NICE, which the current licensed medicines are, they are demonstrated to be cost effective as I'm sure you know.Ìý These innovations, the current licensed medicines over the last 10/11yrs have reduced the rate of blindness in the UK by a half.Ìý That's something that it should be valued and has been recommended by NICE and is demonstrated to be cost effective.

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Peter White

But NICE has now accepted that Avastin is as effective as Lucentis.

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Haseeb Ahmad

So NICE are not a regulatory authority.Ìý So the MHRA are the competent authority in the UK, that's a licensing authority in the UK. They look at the efficacy, safety and quality of medicines, so they get thousands of pages of dossiers to show all the clinical studies and all the robustness of the studies that we've done.Ìý And it's for them to decide whether products are licensed, so it hasn't been through the full NICE process.Ìý It happens to be a statement, which is based on consensus opinion of commissions.Ìý It's also stated in the NICE guidelines that they do not recommend the use of unlicensed medicines.

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Peter White

But now the problem is that Avastin hasn't been through any of these processes, because nobody's ever sought a licence for it.Ìý So it's not surprising that it hasn't been licensed or tested in the...in the formula that you want to see!

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Haseeb Ahmad

So I can only really comment on what has been tested and what has gone through the regulatory scrutiny and gone through the competent authorities.Ìý So the regulatory authorities are there to look at efficacy, safety and quality.Ìý And the only medicines that have gone through that to the required standard is a current licensed therapy's.

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Peter White

But you brought the case in order to stop Avastin's use by this group of of of health authorities, which which indicates that you're in support of it not being licensed?Ìý Effectively, you're using the fact that it's not been licensed as an argument.

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Haseeb Ahmad

The judgement from last week stated that this clinical commissioning group, so these NHS managers' having a policy in place is not unlawful.Ìý The judge determined that it's okay to have the policy.Ìý What the judge also said, is implementation of the policy is the responsibility and the accountability of Hospital Trusts and clinicians to determine, whether it is lawful to implement.Ìý So if you like, the hot potato's been thrown from these NHS managers to the hospital.Ìý Also within the case, its proposed to that them patients would have consent to treatment.Ìý And so if you look at that chain of events, you see the hot potato and the responsibility being thrown onto patients.Ìý Now patients, particularly patients who are in a very stressful situation, who are faced with the potential of losing their sight, they should not be put in a position where they may have take a unlicensed...unlicensed medicine.

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Peter White

Yeah!Ìý You brought the case on the basis that it's not licensed.Ìý And obviously, what we're arguing about here is should it?Ìý Should it be licensed on the grounds of its effectiveness at least?Ìý And you do I take, you don't argue now do you with the effectiveness of Avastin?

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Haseeb Ahmad

I think the the thing that we need to focus on in a case and I think it's not been reported certainly at the weekend that there are I think lots of easy headlines.Ìý It's very easy to make a headline about potential savings in the NHS.Ìý What hasn't been commented on is the pressure potentially that could be put onto patients.Ìý But also what has not been reported on.Ìý When we look at our Licensing Authority in the UK, it is very much of the envy of the world.Ìý One of the great things we have with now...

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Peter White

Yes but, but can they look at it if it's not been...if a license hasn't been requested?

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Haseeb Ahmad

If I just...If I just finish!Ìý One of the great things that we have within the UK is as well as our NHS is the regulatory system.Ìý The MHRA is very much the envy of the world.Ìý They have the competency when it comes to looking at efficacy, safety and quality of medicines.Ìý They look at various offices to suggest that NHS managers can do the same.Ìý We should all be concerned about this judgement.

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Peter White

Do you lie awake at night ever wondering that some people might be losing their sight because doctors are being heavily discouraged from using a perfectly effective drug?

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Haseeb Ahmad

These licensed medicines that have been available for the last 10/11yrs, patients have been receiving them.Ìý They do have good access into the U...in the UK to these medicines that has reduced the register rate of blindness by 50%.Ìý What really concerns me is the precedent this can set not just within ophthalmology for, but for patient's right across the board.

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Peter White

Are you going to appeal?

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Haseeb Ahmad

So we're gonna assess all the options available to us.Ìý And clearly, appealing is one of those options.

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Peter White

Haseeb Ahmad, Managing Director of Novartis Pharmaceuticals UK.

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But we spoke to the other company involved in the court case, Bayer; they said "No one was available to speak to us".

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Professor Philip Rosenfeld is an ophthalmologist and teaches in the University of Miami.Ìý And he was crucial in discovering the effectiveness of Avastin in the eye.Ìý Well we've been following these developments for a decade now, and he told me how we got to this point?

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Professor Philip Rosenfeld

Well back in the early part of the 2000s, we were the leading investigators looking at a molecule for Genentech called 'Rufab'.Ìý It's now known as the Lucentis.Ìý And at that time, Rufab was showing extraordinary effects on Wet Macular Degeneration of patients.Ìý It was at that time that I went into the literature.Ìý And I discovered there really was very little difference between what is now Lucentis and Avastin, they were both derived from the same mouse monocular antibody.Ìý So I approached Genentech with an idea of using Avastin systemically as an intravenous infusion.Ìý The idea was that if we could infuse the drug, then we could treat patients without having to stick a needle in their eye.Ìý Moreover, since Wet Macular Degeneration is often found in both eyes.Ìý A single intravenous infusion would be able to treat both eyes.Ìý Genentech at the time wasn't interested in investigating Avastin for Wet Macular Degeneration.Ìý

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Peter White

Were you concerned though about testing this in the eye?Ìý You know that's not the use that it it had been too in the past, so wasn't there an element of risk just in in the testing process in the first place?

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Professor Philip Rosenfeld

Well we didn't start by testing the drug in the eye!Ìý We were using it systemically intravenously much like Avastin is used in cancer patients.Ìý And what we found was systemically, the drug worked extraordinarily well.Ìý Our patients were delighted with the results.Ìý And in many ways, the systemic intravenous use of Avastin was better than injecting it into the eye.Ìý But shortly after we started the study, some side-effects of systemic high dose Avastin were discovered.Ìý And there was a black box warning placed on Avastin, when given in a high dose intravenously.Ìý And when we presented our data, people were very excited with the systemic use of Avastin.Ìý But ophthalmologist in general don't want to deal with the side-effects', which were high blood pressure, heart attack and stroke.Ìý So then we started exploring other ways of delivering Avastin in patients with Wet Macular Degeneration.Ìý And in doing the calculations, we realised that if we injected the same volume of Avastin as we were injecting of Lucentis into the eye.Ìý We would be giving the patient the same amount of drug that would be effective in the eye at a fraction of the cost.

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Peter White

That was Professor Philip Rosenfeld.Ìý

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So with Avastin now apparently cleared for use by the NHS, isn't this a cause for celebration at the Macular Society, which represents hundreds and thousands of patients.Ìý

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Cathy Yelf is the Society's Chief Executive and she doesn't think it's that simple. I asked her, what she thought of the judgement.

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Cathy Yelf

Our reaction is a degree of ambivalence to be perfectly honest!Ìý Our view really is that the proof of the pudding is in the eating, and will this actually help age related Macular Degeneration patients?

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Peter White

You see people might be a bit surprised at the caution of which you've answered that question, because a lot of people are kind of jumping for joy.Ìý And what they will say is, surely if people have been asked to benefit from a drug, which is more expensive than another drug, then a lot of money must have been wasted and that money could have been spent on people with visual impairment.

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Cathy Yelf

Well hypothetically, that is true.Ìý These drugs have been sort of head to head for a a decade or or more!Ìý And the argument has changed over...over the years.Ìý To begin with, I think the argument was that Avastin was not as good as Lucentis and then Ey...Eylea and I don't think that that argument holds way anymore.Ìý I think there have been enough trials that show the drugs are equally effective and equally safe.Ìý And then people pointed to the problem of so called backdoor regulation of drugs that this is not licensed officially for use in eyes.Ìý And that there is certainly merit in upholding the drug regulatory framework because it protects patient's from unlicensed and untested and untried drugs.Ìý This isn't an untested or an untried drug's though!Ìý So yes it is, it is right that hypothetically had we had Avastin from the get go, then there would have potentially have been a lot more money available in the system.Ìý What we don't know of course is whether that money would actually have been spent in eye care or whether it would have disappeared off to other specialities.Ìý Certainly, you know I can understand completely why the NHS wants to do this!Ìý I mean there is a very large discrepancy in the cost of the drugs.Ìý But in terms of AMD the benefits there, well it depends on whether its stays in AMD the savings.Ìý

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Peter White

And the drug company Novartis and don't they have a point there that we do actually need very tough rules to ensure that drugs have been tested to destruction before we take them?

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Cathy Yelf

Well yes, yes they do I mean it is very important.Ìý Drug regulation as it's known in the modern world came in after the Thalidomide scandal and so everybody can see that there are very good reasons why drugs need to be very tightly, tightly regulated.Ìý Mrs Justice Whittle's judgement is very long and very complex.Ìý But it seems in the summary that she is suggesting that the European Medicines Agency is not necessarily the only arbiter on what is a safe and efficacious drug?Ìý And that there are other elements of for example, Clinical Commissioning Groups or NICE for example in the UK, that could also be competent to make those decisions.

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Peter White

So well, I mean the people listening to this of course who we would be most concerned about are patients, existing ones and maybe patients of the future.Ìý And obviously the question to you is what will this judgement mean to them?

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Cathy Yelf

The difference it will make to patients will depend on entirely on what the NHS decides to do with those...that spending.Ìý So there is one immediate benefit, which is that under the existing licensed drugs, the regulation is that people who have better vision and now just to say in any one eye better than the legal driving limit can't currently be treated, they are sent away and told to comeback when their eyesight gets worse.Ìý Now all the evidence shows that the sooner that you treat somebody with Wet AMD, the better their vision will stay over over the years to come.Ìý And it is nonsense to send them away and and let their vision get worse.Ìý So that rule won't apply if Avastin is used and so we would say that everybody who presents for with with active Wet AMD at a hospital clinic should be treated regardless of how good their vision is that's the first thing and that could be an immediate benefit.Ìý And frankly, it doesn't matter what you jab into their eye, if they don't get it the right time they're going to lose their sight away. So we must have that investment back in AMD clinics.

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Peter White

Cathy Yelf of The Macular Society.Ìý

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And finally today, the Society has just lost one of its great friends and so have we!Ìý Dennis Norden, one of radio and TVs finest comedy script writers has died.Ìý He became a particular favourite on this programme after his sight began to fail about 10yrs ago, coping with his trademark wry humour.Ìý At the top of his game as he approached 90, he joined us in front of a large audience to mark 'In Touch's 50th Anniversary'.Ìý And tonight, we're gonna leave you with Dennis.

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Dennis Norden

I first noticed things were going wrong actually when I found myself banging into people all the time.Ìý And it occurred to me on the way here that I, I was a collider well before that hedron!Ìý But I was at the time when the sight degenerated and I found out that I had Macular Degeneration, which is an interesting thing because when you tell a lot of people, they don't get it the first time.Ìý And actually after that interview that we did Peter.Ìý I got in a taxi and the driver said "I, I heard you with that Peter White".Ìý He said "My brother-in-laws got that Muscular Desperation".

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Peter White

And we we had Eric Sykes who also has this and and he he talked throughout the whole interview about Muscular Disciform so...

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Dennis Norden

Yeah, yeah!

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Peter White

There are lots of versions of it.

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Dennis Norden

We were in the RAF together, Eric and I in the same tent at one time!Ìý So we'd known each other a long time and he's got Age-Related Macular Degeneration as as well.Ìý And we had to do a thing together where he was on a platform and I had to make an entrance and he got up and said and they made you know Dennis and all and so and so.Ìý And he got up and stretched out his hand and just said "Dennis" and I came on and said "Eric" and we walked right past again.Ìý

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