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听INSIDE HEALTH 鈥� Programme 2

PRESENTER:听 MARK PORTER
PRODUCER:听 FIONA HILL

TX:听 10.07.18听 2100鈥�2130

听Porter

Hello. Coming up in the next half hour:

Insomnia 鈥� I visit a leading sleep clinic to discover how bad nights tend to breed bad nights.

Clip

I had one woman who said I am at war with the bedroom.听 As soon as she goes upstairs to bed the stress levels go up, it becomes somewhere you lie awake at night, you鈥檙e looking at the clock, you鈥檙e anxious about what鈥檚 happening the next day and how you鈥檙e going to cope.听 And the bed just becomes a negative place rather than a positive place.

Porter

And terminating a pregnancy 鈥� women in Scotland and Wales can now have an abortion at home rather than in a clinic or hospital. 听Should England follow suit?

Clip

It felt empowering to be given the choice between having the termination at home or at the clinic.听 I chose to be at home 鈥� a decision that assured and comforted me.听 To be in the hospital environment might have intensified the feeling of the whole process and possibly made it that bit more traumatic.

Porter

But first a new initiative led by the Royal Marsden that could slash the NHS cancer drug bill by hundreds of millions of pounds a year.

New biologic drugs, like Herceptin, used to treat breast cancer, and rituximab, used to treat lymphoma, are transforming therapy, but this progress comes at considerable expense. Biologics are very expensive with courses of some drugs costing tens of thousands of pounds. But, as patents expire, cheaper copycat versions, known as biosimilars, look set to provide the same benefit at much lower cost.

Biosimilars are the biologics鈥� equivalent of generics. 听Drug companies can typically only patent their new discovery for 20 years, and it can take them half that long just to test the drug and get it approved and licensed, leaving them just 10 years to recoup their billion dollar or so research and development and marketing costs before rivals start copying them. 听And those rivals don鈥檛 have the same R&D costs so can produce their copy at a fraction of the price. 听Viagra, for instance, used to be around 拢25 for a pack of four, today generic versions, which contain exactly the same active ingredient, sell for a tenth of that.

While generic versions of normal drugs are exact copies, it鈥檚 much harder produce copycat biological molecules derived from living organisms like the antibody rituximab used to treat lymphoma. 听And while the copycat versions are almost identical, they are never exactly the same. 听But they are as near as dammit, and close enough to do the same job while offering considerable savings.

Little wonder, conversations like this are now taking place in oncology clinics across the country.

Ally

My name鈥檚 Ally, I鈥檓 one of the sisters in Bud Flanagan outpatients at the Royal Marsden.

Paul

My name鈥檚 Paul, I鈥檝e been a patient at the Marsden since March 2016 when I was diagnosed with acute lymphoblastic leukaemia.听 I鈥檝e been in remission since about April 鈥� April, May time 鈥� 2016.

Ally

Paul, what I鈥檓 going to run through today is just talking to you a bit about your treatment and what we鈥檙e going to be offering you.听 You鈥檙e currently been treated with rituximab and the Trust is now using biosimilars for this particular drug.听 Do you understand what biosimilars are?

Paul

No, I鈥檝e never had it explained to me.

Ally

Okay.听 So, biosimilars 鈥� they鈥檝e been around quite a long time, so they鈥檝e been approved here in the UK since 2006.听 Basically, they run through very similar rigorous testing to check the efficacy of the drug and鈥�

Porter

Chief Pharmacist at the Royal Marsden, Jatinder Harchowal, is leading a national staff education programme to encourage the switch to biosimilars and it is already saving a fortune.

Harchowal

So, with biosimilar rituximab we found the price of the biosimilar was over 50% cheaper than the originator biologic.听 And if I give you the saving that鈥檚 been achieved with that, as of the end of February 2018 80% of rituximab use in NHS in England is the biosimilar and that鈥檚 achieving close to 拢80 million savings for the NHS.

Porter

And who鈥檚 making these drugs?

Harchowal

Some of the companies that have made biosimilar rituximab they are well-known pharmaceutical companies, they鈥檙e like Napp, Sandoz and there are other companies coming into the market for making biosimilars now.听 So, the latest biosimilar, trastuzumab, where the brand name was called Herceptin, a lot of people will be familiar for breast cancer, the biosimilar version of trastuzumab has got at least three different companies who are all well-known who are producing biosimilars.

Porter

And in the case of Herceptin I mean how much might a course of Herceptin cost for a typical patient and the biosimilar would be what sort of price?

Harchowal

We鈥檙e in the process of it just being introduced, so the first couple of biosimilar trastuzumabs have just come to market and again we are seeing prices close to 50% cheaper than the original biologic.

Porter

And that matters because these drugs cost thousands or sometimes tens of thousands of pounds.

Harchowal

That鈥檚 right, they do and they run into thousands of pounds per patient per year and if you look at it across the NHS in England for trastuzumab the intravenous form of trastuzumab we think the NHS in England probably spends close to 拢60 million and if you are seeing savings of almost 50% well then that could be up to 拢30 million savings back to the NHS.

Porter

Looking at rituximab, you say that about 80% of what鈥檚 being used in the NHS currently is the biosimilar version, which begs the question why it鈥檚 not 100%, if it鈥檚 that much cheaper, if it鈥檚 half the price and we鈥檒l get on to the evidence in a minute but if it works as well and is just as safe surely that鈥檚 what we should all be using?

Harchowal

It鈥檚 a really interesting question because biosimilars have been around for 10, 13 years in different indications and you always see a variation in uptake.听 Different organisations will have different approaches.听 What I must say is the 80% uptake for rituximab is probably the quickest and largest uptake of a biosimilar that we are aware of to date.

Porter

But that鈥檚 in the main because you鈥檝e really driven that move, it鈥檚 a lot of hard work, it鈥檚 a lot of persuading of clinicians, I doubt the people funding the drugs bill needed much persuading but the patients themselves?听 I mean just looking at the introduction of generics in general practice, that can sometimes be tricky, I can only imagine what it must be like to introduce a biosimilar to someone who鈥檚 got cancer.

Harchowal

Yes.听 When we were preparing materials to help the country adopt biosimilars early, in particular biosimilar rituximab, I can鈥檛 stress enough the importance of engaging with our clinical colleagues but also our patients and our patient groups to ensure they understand that number one they鈥檙e not getting any lesser treatment and number two, the safety profile of the biosimilar is as good as the originator.

Porter

And we鈥檙e sure about that on the evidence that we have that these biosimilars are just as effective and just as safe as the originals?

Harchowal

Absolutely.听 So, the European Medicines Agency will only approve a biosimilar if it鈥檚 been demonstrated to be highly similar to the originator biologic.听 And importantly it鈥檚 got a similar safety profile.听 And if I bring that back to our experience with rituximab, within the first three months of using rituximab biosimilar in the Royal Marsden and University College London Hospitals we documented the first 796 infusions that were given to patients and we found that鈥檚 exactly the same effect and no difference in the adverse event profile.听 So, we saw no increase or in the type of side effects that the patients experience.听 And you鈥檙e right 鈥� that鈥檚 a really important thing for us to keep monitoring.

Porter

You鈥檝e been working in the field of cancer, these biological drugs are used in lots of different conditions 鈥� arthritis, immune problems, bowel disease 鈥� all sorts of different things, is there a similar thrust happening there as well?

Harchowal

Yes, the success we鈥檝e had with the uptake of biosimilar rituximab showed a particular model of how you can get consistent and quite rapid uptake of biosimilar.听 And if we look ahead to later this year, in 2018, the drug that we spend the most on in the NHS in England is a drug called Adalimumab and the first biosimilars for Adalimumab will become available at the end of 2018.听 Now considering that the spend on Adalimumab exceeds 拢300 million a year, predominantly in rheumatoid arthritis there is potential to make quite significant savings for that one drug.听 And if I step back a little bit and look at it from an NHS wide perspective we could probably save 拢2-300 million a year per using the best value biologics which in this case might well be the biosimilars and we look like we have a good opportunity to make those savings.

听Porter

Jatinder Harchowal, Chief Pharmacist at the Royal Marsden, where another switch is already in progress.

Ally

How do you feel about that, do you have any concerns or鈥�?

Paul

No, I think the way you鈥檝e run through it and explained it to me I think is 鈥� allays any fears that I might have, to have it explained in layman鈥檚 terms is excellent.听 So, it seems that everything is in order with it, so for me that鈥檚 more than adequate.听 I鈥檓 happy to switch, yeah, yeah, absolutely, yeah.

Porter

Paul and oncology staff nurse Ally. 听And there is more information on biosimilars on the Inside Health page of the Radio 4 website.

Now, how have you been sleeping recently? 听Lots of people have struggled thanks to the hot muggy weather but imagine if that tossing and turning through the night was the norm, rather than the exception.

Imogen first experienced insomnia in the early 鈥�90s.听 She was prescribed sleeping tablets and carried on taking for a number of years in increasing doses.

Imogen

I had periods when I was on perhaps 3.75 of zopiclone a night, sometimes double that.听 Then I had a period of time that I took nothing at all because I was very happy, I was not stressed.听 But at the worse, which was a couple of years ago, I was taking two lots of seven and a half milligrams of zopiclone, which is far too much.听 And even then they began to lose their effect.

Porter

Imogen鈥檚 sleep problems were worse at times of emotional stress 鈥� the more pressure she was under, the more difficulty she had sleeping. 听An all too common scenario.听

Imogen was created at the Sleep Disorder Centre in East Grinstead, in Sussex, one of the biggest NHS sleep clinics in England. 听Clinical Director Dr Peter Venn showed me around.

Venn

Okay Mark, so we鈥檙e now in one of the sleep study bedrooms.听 It鈥檚 got a hospital bed in it because we have to have hospital beds but we try to make it as much like home as possible and the room is decorated a little bit off colour, so that it鈥檚 blue rather than the standard hospital white.听 Now in here there may not look to be very much at the moment but there鈥檚 actually some quite sophisticated monitoring around.听 If you look up behind you there you can see a camera, which has a microphone attached to it so that we can hear snoring and we have the video recording of the patient.听 And that鈥檚 very useful, particularly for complex disorders, such as parasomnias, which are what I call things that go bump in the night, people who sleep walk, sleep talk, have confusion arousal, scream and shout in the night.听 If you can capture it on video it鈥檚 often very useful for the diagnosis.听 But the patient will be in the bed, they will have a number of wires going to their head to monitor their brainwaves, around their face which helps us to distinguish when the eyes are moving for dreaming sleep, down the limbs and over the cardiovascular part of the body, so that we can monitor the heart and oxygen saturations, movements, etc.

Porter

One thing that intrigues me about this sort of setup, I mean I can see it鈥檚 great for you for monitoring the person, to see exactly what鈥檚 happening to them when they鈥檙e asleep but do any of them manage to get to sleep here because it鈥檚 an alien environment?

Venn

Yes, I knew you were going to ask that and the very strange thing about this is that the more wires you put on somebody they more they seem to sleep.听 We have 40 patients a week coming through here and they say actually it was the best night鈥檚 sleep I鈥檝e had for ages.听 It鈥檚 most strange.

Porter

In the past insomnia was often regarded as just a symptom of some other underlying issue 鈥� pain from an arthritic hip, noisy neighbours or stress 鈥� but it is now increasingly regarded as a disorder in its own right. 听Sleep clinicians use the three Ps model to describe how it develops.

Venn

There are predisposing factors that might lend themselves to being an insomniac, particularly it鈥檚 slightly more common in females, although we do see a lot of men with insomnia. 听Personality 鈥� which is another P 鈥� is a very definite one, these people tend to be anxious, they鈥檙e driven, they tend to take themselves very seriously and there鈥檚 an element of worry that comes through.听 So, that type of personality predisposes itself to insomnia.听 The second thing that happens is that there is a trigger factor 鈥� a precipitating factor 鈥� the second P and that is a life event 鈥� divorce, money worries, worry about your children, your parents, all sorts of things 鈥� that would naturally make us sleep badly.听 But we get over that and life goes back to normal and most people will go back to normal sleep.听 But if you have the predisposing factors you may transfer that anxiety onto sleep after the life event has been dealt with and then they become anxious about their sleep and that鈥檚 the third P, which is the perpetuation of the problem.听 And sleep drives bad sleep, it becomes a behavioural thing, it becomes an expectation that every night you go to bed you鈥檙e going to sleep badly, you鈥檙e negative about the bed.听 I had one woman who said I am at war with the bedroom and those were the words she used.听 So, as soon as she goes upstairs to bed the stress levels go up because instead of the bed being an inviting place where you go to sleep and you have relaxation, nice rest, it becomes somewhere you lie awake at night, you鈥檙e looking at the clock, you鈥檙e anxious about what鈥檚 happening the next day and how you鈥檙e going to cope.听 And the bed just becomes a negative place rather than a positive place.

Porter

And despite often only sleeping for three to four hours a night most people with insomnia are not excessively sleepy during the day 鈥� they don鈥檛 nap or drop off like you would think they would. They feel tired as in fatigued, but not tired as in drowsy. 听Why?

Venn

Well I think that the hyperarousal state, the anxiety state, actually feeds through into the daytime as well.听 And that鈥檚 what I mean when I say that insomnia is not really a 12-hour condition it鈥檚 a 24-hour condition.听 If you look at the criteria for actually diagnosing insomnia you must have daytime consequences if you鈥檙e a short sleeper, if you鈥檙e an insomniac at night.听 If you鈥檙e somebody who sleeps four hours a night and you鈥檙e jolly and you don鈥檛 have any problems in the daytime really you can be labelled just as a short sleeper, you don鈥檛 need that much sleep.听 Of course, the famous case is Margaret Thatcher.听 But actually in this clinic room, that we are sitting in now, when I do an insomnia clinic, it鈥檚 the only clinic of the week where we actually have the box of tissues out because there鈥檚 a very, very high level of anxiety amongst patients, they are very distressed, they鈥檝e had the condition for many years, they may have been put on sleeping tablets by their general practitioner but there is a downer now on using sleeping tablets, so general practitioners are much less likely to give them sleeping tablets.听 And they really do suffer these patients, they鈥檙e patients that we do take seriously.

Imogen

I knew that I slept well when I was very happy in my life but I needed to be able to sleep well when I wasn鈥檛.听 I needed to be confident in myself and trust myself that I could sleep through the night and I wanted to be able to do that without any medication whatsoever.听 Now all of that was a big ask but as I say now or never, make or break.

Porter

So, what is the modern approach to treating insomnia, once you鈥檝e tackled any underlying health issues that may be aggravating it?

Venn

Our approach here is what is now I think probably the dictum around the world in the sleep literature and that is not to use sleeping tablets but to use cognitive behavioural therapy.听 This involves seeing a clinical psychologist, they learn strategies for sleep, they learn about sleep hygiene, about sleep relaxation and also how to alter the perceptions, the negative connotations, about sleep and that鈥檚 very effective.

Porter

When you say very effective, what sort of results do you get, I mean what sort of proportion of patients can expect to see a significant improvement?

Venn

Well 60-70% of patients will report at the end that they feel much better even, interestingly, if their sleep is not that much extended.听 What they do find is that they have a much more relaxed attitude to it, so the anxiety is allayed and with that the daytime symptoms start to diminish.

Porter

What happens if they can鈥檛 get to a clinic like yours and they seem to sleep well on a sleeping tablet, what happens to them long-term if they鈥檙e taking these drugs long-term?

Venn

Well there are problems with sleeping tablets.听 The most commonly used one is zopiclone and a lot of patients who do come to see us with the insomnia clinic are actually on zopiclone or zolpidem.听 There are slightly more old-fashioned tablets 鈥� temazepam particularly 鈥� and I actually yesterday saw a patient who was on 20 milligrams of diazepam, which is Valium, for sleep, only recently started by a general practitioner and my eyebrows shot up a little bit.听 But there are a variety of tablets that are used.听 Now most patients will report that they do work but they work in the shorter term.听 And I have a model which is basically a fence that patients have to get over to go from where they are to good sleep.听 And what happens with drugs like zopiclone and the other sleeping tablets is that they will put you to sleep because they are pharmacologically sedative but they鈥檙e tipping you over the fence, they don鈥檛 remove the fence, the fence is the barrier to sleep, the psychological barrier to sleep.听 And the difference between the tablets and CBT is that the tablets tip you over the fence but if you use them chronically the fence will get higher and you do need more of them because you come tolerant to them.听听 Whereas CBT gets to the root cause of the problem and removes the fence, so that you can go straight through to the bit where you鈥檙e sleeping well.听 And that鈥檚 I think a model which works quite well for patients.

Imogen

At the moment I鈥檓 sleeping like a baby, I鈥檓 very, very pleased to say.听 Delighted.听 Big smile on my face, as you can see.听 My bed has gone from being a hellish place, that I didn鈥檛 want to go near, to now a very inviting, pleasant place to be.听 I feel better, I feel refreshed, energetic.听 I still have the odd night, but then I employ some of the strategies that my sleep therapist gave me and whereas before I would sometimes say oh no, what鈥檚 going to happen, and oh no, oh no, now I think no, you鈥檝e proved to yourself that you can sleep the night, you can trust that and if that doesn鈥檛 work I will think about one of my places I like being or things I like doing or I plan the next bit of my garden, for example, whatever and very often I nod off.

Porter

Sleep鈥檚 moving up the health agenda slowly but services like yours are still few and far between and difficult to access.听 How do we compare to other countries in this respect?

Venn

Oh, we鈥檙e quite a long way behind Europe and we鈥檙e quite a long way behind Australia and the States.听 The problem we have in this country is that we have no training in sleep medicine for doctors and people like me have come into it as enthusiasts 鈥� I鈥檓 an anaesthetist by training 鈥� but because we don鈥檛 have a training programme there is nobody coming up with an interest in sleep to replace this old band of enthusiasts like me, who are not very far short of retirement.听 Whereas in other countries there are proper sleep training programmes.

Porter

And that lack of expertise is leading to hundreds of thousands, if not millions, of people being mismanaged in an almost weekly basis.

Venn

Yes, one of my standard paragraphs that I write back in letters to GPs who say this patient is addicted to zopiclone can you help them, and I write back and I say well we can try with CBT and we can try and get them off zopiclone but the easiest way to get patients off sleeping tablets is not to put them on them in the first place because once they are on them there鈥檚 a great deal of resistance amongst patients to actually coming off them, even if they鈥檙e not working very well, they feel psychologically dependent upon them.听 And it is a big problem.

Porter

Dr Peter Venn talking to me at his Sleep Clinic at Queen Victoria Hospital in East Grinstead. And there is more information on CBT for insomnia on our website.

Around one in four women in the UK will terminate a pregnancy at some stage of their lives, with most now having a medical abortion 鈥� using hormones to induce a miscarriage. Up until recently both doses of hormones used had to be given in a clinic or hospital, but since last autumn women in Scotland can now take their second dose at home. 听Just last week, Wales followed suit, and there are now calls for England to do the same.

GP, Dr Margaret McCartney, is in our Glasgow studio. 听Margaret, can you explain the different options for women?

McCartney

Surgical and medical abortion are both very safe but more women have been opting for medical abortion over the last 20 years or so.听 So, surgical abortion is an operation carried out either under general but more commonly local anaesthetic.听 Medical termination is different, it involves taking two sets of medication.听 The first is a tablet taken by mouth, which is a hormone blocker and the second is a drug, a prostaglandin, called misoprostol.听 And that induces bleeding and causes the pregnancy to end.听 And it鈥檚 that second drug, that misoprostol, that used to be given in clinic, which is now an option to be taken at home for women in Scotland and Wales, if they choose to do so.

Porter

So, these women opting for medical abortion will still go in to a clinic or a hospital for the first round of the treatment and for the assessment, etc., but they鈥檒l be able to then take the second one at home?

McCartney

The only change is the location of where the second drug is taken.听 So, I went to speak to Dr Audrey Brown, a consultant in sexual and reproductive healthcare, at the Sandyford Sexual Health Service in Glasgow about where the impetus for this change in abortion practice came from. 听

Brown

As a doctor working in abortion care for a number of years I鈥檝e met a number of women who鈥檝e asked 鈥� do I have to go to hospital for my treatment.听 Many women have asked over the years 鈥� can you not give me the medication to take home with me and I could put it in myself at home.听 Until this new guidance from the Chief Medical Officer we鈥檝e not been able to do that, so the woman has had to make a journey back in to complete the second part of treatment.

McCartney

And why would that be an issue for some women?

Brown

I think there鈥檚 a number of reasons for why it could be an issue.听 Of course, it鈥檚 not easy, particularly if you don鈥檛 have access to your own car or transport to make several journeys back and forward to clinics or hospitals, it isn鈥檛 easy for women.听 But I think as well as that when women administer the second part of the treatment the bleeding and cramping can start pretty quickly, some women within an hour of the treatment will be experiencing bleeding and some abdominal pain.听 Obviously, if you鈥檝e had to make a journey to hospital or clinic to administer the medicine then there is the potential that you could start bleeding and cramping on the way home.听 I鈥檝e certainly met people previously where this has been the case and indeed one woman described a very upsetting event where she was travelling home on the bus and went into bleeding which then soaked through her clothes and she was left feeling very vulnerable, embarrassed, when she was making that journey home.

McCartney

Are there any other countries that are doing as Scotland is currently doing?

Brown

Actually, many countries across the world do allow the second part of medical abortion to be taken at home.听 In the US standard practice for early medical abortion would be that the second medication is taken at home.听 Likewise, Sweden and Norway.

McCartney

Any disadvantages that anyone鈥檚 been concerned about so far?

Brown

I think a potential disadvantage could be if services were to see this as a potential money saving venture.听 I certainly would be very keen that this is not seen as a way of saving on hospital beds.听 We鈥檙e very clear in our clinic that this is a choice for women and we would never want any women to feel that she had to choose a home abortion.听 We鈥檙e very upfront with women that there鈥檚 a choice between completing your treatment at home.听 For some women that鈥檚 not appropriate, it鈥檚 not what they want to do and they opt to be an inpatient for the day.听 It鈥檚 very important that the woman鈥檚 choice is paramount.

McCartney

Dr Audrey Brown.

And a woman who since last October has opted for this new home abortion option talked to Inside Health about her experience.听 She didn鈥檛 want to give her name and so a colleague has voiced her words for her.

Anon Glasgow woman [read]

It wasn鈥檛 an easy choice to have a termination but timing in life wasn鈥檛 right.听 It felt empowering to be given the choice between having the termination at home or at the clinic.听 I chose to be at home and I felt assured and comforted by this decision.听 I felt that to be in the hospital environment might have intensified the feeling of the whole process and made it feel that bit more traumatic.听 I had a clear sense of what to expect and I returned to the clinic on the Saturday to take the first tablet orally and was given a brown bag to take home with all the medication I needed.听 There were leaflets to explain everything clearly and also contact numbers if I needed advice.听

On the Monday I followed the straightforward instructions, I felt safe and comfortable in the private setting of my own home, in my own space.听 This afforded me dignity and privacy and also I was allowed to cope in my own way with the choice I had made.听 And my husband could support me.听 If I鈥檇 been in a hospital setting this wouldn鈥檛 have seemed okay because he was massaging my feet and lower back with essential oils, we cried and he hugged me tightly and we chatted.听 It was all perfectly okay and supportive and natural.听 But would we have been able to support each other like that in a ward?听 I feel not.

On the Monday I lightly bled with bad cramps but nothing had come away.听 On the Tuesday I was awoken in the early hours having passed everything.听 If my memory serves me right the clinic telephoned either that day or the next to ask how it all went.听

Porter

A woman who spoke anonymously to Inside Health about her experience in Scotland.

Margaret, why do you think it鈥檚 been Scotland that鈥檚 blazed the trail here?

McCartney

Well the Abortion Act is the same across Scotland, England and Wales but abortion care is a devolved issue.听 So, it may be that smaller countries and smaller administrations might be more likely to know each other, the relevant ministers might be able to relate stories of problems more effectively and particularly for women who live in rural areas and perhaps have long journey times home after they were given that second abortion tablet in a clinic.

Porter

But if you had to predict what鈥檚 likely to happen would you say England鈥檚 going to follow suit?

McCartney

I don鈥檛 think there鈥檚 any way they wouldn鈥檛.

Porter

Watch this space.听 Margaret McCartney talking to me earlier from our Glasgow studio.

Just time to tell you about next week when we examine why continuity of care is good for both patient and doctor and look at the increasingly important area of mental capacity. 听What happens when people are deemed incapable of making, or comprehending, important decisions affecting their lives and welfare.

听