Skip to main content


Volume 620: debated on Tuesday 31 January 2017

[Sir Edward Leigh in the Chair]

I beg to move,

That this House has considered access to Duodopa.

It is a pleasure to serve under your chairmanship, Sir Edward. I thank the Minister for sparing the time to respond to this limited debate this afternoon. The subject is a serious one, especially for those people who contend with advanced Parkinson’s disease and have so few effective medications on which they can rely to give them some control over their symptoms.

For the benefit of anyone who might not be familiar with the condition, I will briefly explain what Parkinson’s is. Parkinson’s disease is a degenerative neurological disorder. It affects all aspects of daily living, including talking, swallowing and writing. People with the condition often find it hard to move freely, but there are also other issues, such as pain, depression, dementia, hallucinations and continence problems. The severity of symptoms can fluctuate from day to day, and people can experience rapid changes in functionality in the course of a day.

There is no cure, but there is a small selection of treatments suitable for a few people in the advanced stages of the condition. Those treatments include the drug Duodopa. I was involved in the campaign to allow routine prescribing of Duodopa without recourse to special, case-by-case requests by clinicians. Since 2015, the treatment has been available to those people in England who are deemed suitable.

I called today’s debate to discuss the new proposal by the National Institute for Health and Care Excellence to advise clinicians not to offer Duodopa at any stage. That recommendation is being made despite the scarcity of treatment options and the proven effectiveness of Duodopa. I accept that the Minister has no control over NICE recommendations, but I wish to highlight some anomalies.

First, in clinical practice, Duodopa is used only when all other interventions have been shown to be ineffective, or clinically unsuitable options. Despite that, evidence presented in the draft guideline compares Duodopa to deep brain stimulation, which is another treatment for advanced Parkinson’s, and to the best medical treatment, which for advanced Parkinson’s is often apomorphine.

I thank the hon. Gentleman for bringing this matter to Westminster Hall for consideration. I hope that the Minister will be able to respond positively. As a result of the background information that I got in relation to this issue, I would like to ask this question: does he agree that the evidence from clinicians and experts that NICE made a pivotal mistake in comparing Duodopa to treatments such as deep brain stimulation means that the institute needs to step back now and withdraw the proposal before even more anxiety and turmoil is caused to people with Parkinson’s?

I thank the hon. Gentleman for that intervention. I will come to that point later and respond to it.

That incorrectly assumes that the populations given the treatments are the same, which is not the case, as UK clinicians recommend Duodopa only if their patient cannot have deep brain stimulation or apomorphine. It is therefore illogical to say that deep brain stimulation or apomorphine is better value for money, as they are not suitable for direct comparison. As one person with Parkinson’s explained,

“I was at the end of the road before I had the Duodopa. I was literally wheeled into hospital to have the pump fitted and the Duodopa titrated, and about a week later I came out walking. I responded very quickly and noticed a huge improvement in my quality of life, and I always live in dread that it will be taken away.”

In these circumstances, I very much hope that something can be done to bring NICE to the mainstream view on the subject.

I have been involved for 15 or 20 years in supporting Parkinson’s disease patients or those living with Parkinson’s disease, and I think it is terrific that Members of Parliament initiate debates that raise its profile, raise awareness and ask the Minister to come before us and share views on where we are. I therefore congratulate the hon. Gentleman on securing and introducing the debate.

I thank the hon. Gentleman very much for his kind words and support.

This issue is of great importance to a relatively small number of people, but given that the treatment is currently available through NHS England, to withdraw it on the basis of an apparently flawed assessment would cause concern among a much wider community, as it might be seen as setting a precedent for decisions on other treatments in future. I would welcome the Minister’s comments on that.

Secondly, although it is well known that Duodopa is more expensive than some other therapies, it is not offered to everyone, and we believe that some of the economic modelling does not take into account the discounts that the manufacturer offers NHS England.

Duodopa was classified by the EU as an orphan treatment, meaning that the number of people for whom it is a suitable treatment is fewer than five in 10,000. There are known issues with using standard health technology assessment methodology to evaluate the efficacy of orphan medications—issues that are thought to place orphan medicines at a disadvantage compared with treatments in more widespread use.

In Scotland, Duodopa was considered by the Scottish Medicines Consortium and approved on the basis of its processes for evaluating orphan treatments. NICE concluded that for Duodopa the cost per quality-adjusted life year—the generic measure of the value for money of medical interventions, based on quality and quantity of life lived—was more than £500,000, but the SMC concluded that the cost was less than £80,000 when using a calculation appropriate for an orphan drug. Indeed, a recent parliamentary question revealed that, from July 2015 to December 2016, just 75 people in England had been given Duodopa.

Thirdly, if Duodopa treatment is denied, that means there will be increased costs from social care and other things on which the person with Parkinson’s will become dependent, to say nothing of the quality of life or dignity of that person, which cannot be so easily reduced to a monetary figure. As Professor David Burn, the national clinical director for the UK Parkinson’s Excellence Network, has commented:

“To not offer Duodopa as a treatment option is putting people with Parkinson’s in England at a disadvantage compared with other developed countries.”

I acknowledge that the Department of Health has no direct control over NICE, and I recognise that NICE needs to be independent of political considerations. However, since NHS England has in recent years determined that Duodopa can be routinely used for patients where appropriate, and both NHS Scotland and the SMC consider the treatment to be appropriate, NICE appears to be out of step with the prevailing opinion. Specifically, I look forward to the Minister’s guidance on what options are open to the Government when the basis of a proposal made by NICE is so flawed. The consequences of these proposals going ahead would be catastrophic for the dozens of people for whom this drug was their last resort, and would add pressure to an already buckling social care system.

It is a pleasure to serve under your chairmanship this afternoon, Sir Edward. I add my congratulations to those of my hon. Friend the Member for Montgomeryshire (Glyn Davies) to the hon. Member for Ealing, Southall (Mr Sharma) on securing the debate. It is right that we use the opportunity to discuss matters such as this one in Parliament and to ensure that we, whether that be NICE or the Department, get this right.

May I start by agreeing with the hon. Member for Ealing, Southall? He made the point that it would be completely wrong for NICE to make an evaluation based on flawed data, flawed information and a flawed methodology. If that were the case—we will talk about that during the next few minutes—it would require action. He also made the point that it is right that we have a body such as NICE that attempts to validate the treatments that are available in a coherent and consistent way.

The hon. Gentleman mentioned the quality-adjusted life year issue. There has to be a method of comparing drugs that are available, for example, for Parkinson’s with those available for cerebral palsy or muscular dystrophy, and we have to be fair to the community as a whole. That is what the NICE process is intended to do. It is also important to make the point that at the moment, the drug is available in NHS England. It has been commissioned since 2015 by the specialised commissioning team. That will continue—the updated NICE guidance will not change it—until NHS England’s specialised commissioning group makes a different decision, if that is what happens.

I will make a few points about Parkinson’s first of all. We know that it is a terrible, progressive disease and that there is no real understanding of what causes it. The occurrences of it are rising. Some 130,000 people in England have been diagnosed with Parkinson’s disease, which is caused by the death of a type of cell—those containing dopamine—in our brains. As the hon. Gentleman said, the disease causes tremors, stillness, slow movement, speech impediment and so on. Of those 130,000 people who are suffering from Parkinson’s disease, something like one in 1,500 are given Duodopa. There are currently 75 people in England who receive it, and the cost is roughly £28,000 for each of them.

The process is that when a diagnosis of Parkinson’s is made, NHS England typically refers the patient to a specialist centre for neurological care and an evaluation. A set of processes are carried out by the neurosurgeons in an attempt to remedy the dopamine issue that will have caused the Parkinson’s. The typical and main treatment is a drug called levodopa, but for a number of people there are side effects and it eventually stops working. As a follow-up remedy, as the hon. Gentleman said, either apomorphine, brain stimulation or Duodopa is prescribed, or a combination of those three things. How they interact with one another is quite complex, but those are the typical prescriptions if the main treatment is not successful.

As I said, the cost of Duodopa is something like £28,000 per patient per year, and 75 people are receiving it, so that is around £2 million a year, which is not massive in the great context of NHS spend. Nevertheless, it is important that we compare it with other treatments and make sure that it is the most effective for patients. That is what NICE has done. It had previous guidance on the treatment of Parkinson’s from 2006 and over the past year or so has produced draft guidelines, which the hon. Gentleman referred to, on the use of the drug. Those guidelines were put out to consultation, which closed in November. It is true, as the hon. Gentleman said, that those draft guidelines said that in NICE’s view, at no stage in the treatment is Duodopa to be recommended. The reason given was that, under NICE’s evaluation criteria, the cost of the drug is too high.

I have the NICE report in front of me, and the actual analysis is quite complex. The hon. Gentleman said that the report talks about the figure of £500,000—or alternatively £80,000, as I think I heard him say—per quality-assisted life year. I think it also comes up with lower numbers, but the truth is that it does not come up with a number that is anything close to the normal threshold at which a drug is approved for use, which is typically £20,000 to £25,000 per quality-assisted life year. The hon. Gentleman mentioned the methodology that was used. The consultation process drew in points from members of the public, from the profession and indeed from the company that markets the drug, which did say that there were methodology issues—I think it used the phrase “issues with the mathematics”. Those points will all be referred to the NICE committee and will be taken into account if and when the final analysis is confirmed or changed.

However, I will say that a quality-assisted life year figure in the order of £80,000 is quite a long way away from where it needs to be. There are various remedies for that. In similar debates I have made the point that one option is for the drugs companies involved to review their pricing. These things are not necessarily set in concrete. When they price a drug they are doing two things, and the cost of actually manufacturing the drug is often quite small compared with the invested intellectual capital that they are trying to recover. There is a choice, because if the drug is not prescribed they are not recovering either of those costs. I simply make the point that there is an opportunity for the company to do that.

As the hon. Gentleman said, it is true that NICE’s recommendation is that a combination of apomorphine and deep brain stimulation is more effective as a treatment and in terms of cost. We are having this debate on the draft guidance, and even if that guidance is confirmed, it will then have to go to the NHS England specialised commissioning group, which will have another opportunity to look at it in the round. As he said, Duodopa is a little unusual in that it is currently being prescribed. It is not as though it is a new treatment—it was prescribed in advance of the NICE recommendation.

I will say a little bit about NICE. It is very easy to knock it and say, “These guys don’t know what they’re doing. They don’t understand what is going on. It is obvious that if they were a bit more diligent or a bit better trained they would not have given this answer.” I looked at who was on the committee for the Parkinson’s guidelines. There were 18 people; it comprised consultant neurosurgeons, neurology pharmacists, people from patient groups and physiotherapists, so there were a number of people with a great deal of experience in managing Parkinson’s disease. It is important that the decisions on how we make drugs available are made by scientists, based on rigorous criteria and an attempt to look at the science rigorously, and not by Members of Parliament, as I think everybody in the Chamber would agree.

I intervene only to reinforce the Minister’s point. I remember being involved in campaigning against NICE and calling it out for everything I could when bowel cancer drugs were not available. That was driven by my personal interest, but in time I have come to realise—partly because my son who works for a drug company lectures me about this—that the principles behind NICE are absolutely vital. If we ever move away from that, we will finish up in a complete free-for-all, with all sorts of pressure and inducements from Members of Parliament not to follow proper procedure.

I can only concur that many of us benefit from lectures from our children, and it is nice to know that my hon. Friend does. I agree with the point made by the hon. Member for Ealing, Southall. If NICE has made a mistake, if something has been wrong in its analysis—this is why draft guidelines are published—and if things are brought to its attention that are not adequately reflected in its work, it has the opportunity to change that and will do so. Given the points that we have just heard, that is the right process.

When the finalised position is established, NHS England will consider whether to accept the NICE guidance. It will make a decision on what it does regarding the cohort that receive the drug and new patients, for whom there is potentially a difference in treatment. That process is many months away, frankly. It will not occur until NICE has finalised its guidance and published the complete position.

I finish by agreeing with the intervention made by my hon. Friend the Member for Montgomeryshire. These decisions are very difficult. Only 75 people receive the drug, but for them it is potentially life-changing, as it would be for the people who will need it in future, and I do not want to underestimate that. I can only repeat the points made in the NICE guidance; it believes that there are other equally effective treatments, such as a combination of apomorphine and brain stimulation. I am not a clinician, so it is not possible—and not right—for me to have a view on that, other than to say that until we are able to show that NICE has somehow been wrong in what it has done, it is right that we as a Parliament and as a group of MPs accept and respect that process, because we know that diligent scientists and clinicians have tried to get it right.

I thank the hon. Member for Ealing, Southall for raising this important subject; it is good that we have had the chance to talk about it today.

Question put and agreed to.