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Cystic Fibrosis Drugs: Orkambi
Seema Kennedy Excerpts
Monday 10th June 2019

(10 months ago)

Westminster Hall
Read Full debate
Department of Health and Social Care
Mrs Sharon Hodgson Portrait Mrs Hodgson - Hansard
10 Jun 2019, 6:35 p.m.

I was going to come on to that, but if a point is worth making once, it is worth making twice. I will make it to the Minister as well, so she will have plenty of time to think about it.

As we all agree, patients and their families should not be put in the position—as some are—of having to pay thousands of pounds for their treatment. Family income should not determine who lives and who dies. That is why the NHS was founded—so that all could have access to the same excellent treatment, regardless of means. That was true 70 years ago when the NHS was formed, and it is still true today.

As the hon. Member for Sutton and Cheam pointed out, our NHS is there for us all and should not be held to ransom by a pharmaceutical company, but neither should access be denied because of unfit processes and systems in the NHS. Over the years, as a shadow public health Minister, I have met many patient groups, including those with cystic fibrosis, who are missing out on life-changing medicines because their condition is not rare enough and is therefore not deemed by NICE to be cost-effective. We need an appraisal process that is fit for purpose and that will capture rare diseases such as cystic fibrosis effectively.

Without drugs such as Orkambi, patients and their families are being harmed physically and psychologically. Every day without the drugs that patients need makes their condition worse and threatens their lives. What steps will the Minister take to ensure that patients with rare diseases have access to the medicines that they need and deserve? It is about access not just to Orkambi, but to other precision medications such as Symkevi and the next generation of cystic fibrosis drugs that could help patients who are suffering.

Vertex recently announced the headline results for its fourth cystic fibrosis medicine, a triple combination therapy that could radically transform the lives of nine in 10 people who live with cystic fibrosis in the UK, delivering unprecedented improvements in acute lung health. That is amazing news, but patients fear that they will never be able to access this ground-breaking drug. I urge Vertex to put patients first and consider the real-life impact of this cost dispute on patients and their families.

Vertex and NHS England must come to an agreement urgently, because patients have already waited far too long. If an arrangement cannot be made soon, will the Minister personally step in and pursue the alternatives that my hon. Friend the Member for Bristol East mentioned, such as a Crown use licence or a clinical trial? Cystic fibrosis patients need urgent access now to the drug that they have been denied for three years. It is time the Government considered all alternatives.

The Parliamentary Under-Secretary of State for Health and Social Care (Seema Kennedy) Hansard
10 Jun 2019, 6:42 p.m.

It is always a particular pleasure to serve under your chairmanship, Mr Hanson. I thank my hon. Friend the Member for Sutton and Cheam (Paul Scully) for opening the debate on behalf of the Petitions Committee. I pay tribute to the more than 100,000 people who signed the petition, and I thank all right hon. and hon. Members who have spoken in the debate; I am sure that they will be rushing back for the wind-ups.

I have been very touched by the stories that we have heard today and the compassion shown by my hon. Friend and all hon. Members in speaking about cystic fibrosis and its physical effects, emotional effects and effects on mental health for those who live with it and for their families. It is a debilitating condition, and I know how absolutely desperate sufferers and families are for access to treatments.

I recognise the great work undertaken by the Cystic Fibrosis Trust and its strong voice in supporting families and bringing cystic fibrosis to the attention of parliamentarians. I also pay tribute to my young constituent Lucy Baxter, who was on “BBC Breakfast” this morning and who lives with cystic fibrosis. She spoke to me very soon after I became a Member of Parliament and is an absolute inspiration to me and to the whole cystic fibrosis community.

Today’s debate has been heartfelt and passionate. The stories that we have heard clearly make the case that Orkambi and other drugs for people with cystic fibrosis should be available on the NHS at a price that is fair and affordable. The Government and I share that view. As the Chair of the Health and Social Care Committee, the hon. Member for Totnes (Dr Wollaston), set out so clearly, we must remember that the NHS must use its budget fairly for the good of all patients. That is why we rightly have a system whereby experts, not politicians, determine the fair price for medicines, based on robust evidence. That system has helped many thousands of patients to benefit from rapid access to effective new medicines.

Karl Turner Portrait Karl Turner - Hansard
10 Jun 2019, 6:45 p.m.

Forgive me, but I genuinely do not know the answer to this—I find it completely confusing. If the Republic of Ireland and Scotland can get an interim agreement, why cannot we sort this out for patients here in England?

Seema Kennedy Hansard
10 Jun 2019, 6:45 p.m.

I will talk about the interim measures, but I think the more important thing that we need to grip is having a permanent solution for everybody living with cystic fibrosis.

Throughout the negotiations, which are rightly being led by NHS England, the Government have been crystal clear that Vertex must re-engage with the NICE process. I know that hon. Members have questions about that process, and I will try to address some of the points that have been raised. The hon. Member for York Central (Rachael Maskell) raised more detailed points for me to consider; if I do not address them, I will write to her with more detail, but there are some points about the NICE process that I will address later in my remarks.

Jim Shannon - Hansard
10 Jun 2019, 6:46 p.m.

Would it be possible for the Minister to give her Department’s and her own opinion on the buyers’ group that is seeking to buy similar drugs from Argentina for cystic fibrosis? Have the Government given that possibility any consideration?

Seema Kennedy Hansard
10 Jun 2019, 6:47 p.m.

I shall turn later in my speech to that specific avenue that some sufferers have gone down.

Dr Wollaston Hansard
10 Jun 2019, 6:47 p.m.

The Minister referred to the importance of Vertex engaging with NICE. Does she share my concern that when I wrote to Vertex and NICE about the failure to make progress, Vertex assured me that it had contributed “substantial new evidence” on the three products in question, yet I subsequently heard from NICE that it had received only

“an overview of the clinical evidence”,

rather than genuine engagement? Will she join me in calling on Vertex to properly engage with the process, so that we can get the full evidence base on which to make these decisions?

Seema Kennedy Hansard
10 Jun 2019, 6:49 p.m.

I agree with the Chair of the Health and Social Care Committee and urge Vertex to re-engage with the NICE process. To date, unfortunately, it has continued to refuse to accept the process or has suggested unacceptable conditions on the NICE value assessment of its product, which would render the outcome meaningless. That comes despite NHS England’s latest proposals offering to reimburse Vertex ahead of a positive NICE recommendation, which for a deal of this size is unprecedented; agreeing to implement real-world data collection, as the Committee has called for, to help Vertex to demonstrate the value of its medicines; and offering significantly increased prices in comparison with their offer last July.

NICE has a 20-year history and is internationally renowned and independent. Its methods and processes for the development of its guidance have been in place for 20 years, but it recognises that it needs to evolve. It continues to review its procedures to ensure that they remain fit for purpose; it is now undertaking a review of its technology appraisal methods in line with the commitment in the 2019 voluntary scheme, and it encourages all stakeholders to engage. NICE has recommended 75% of the drugs for rare diseases—some of which I will touch on later—that have been assessed through its technology appraisal programme for the eligible patient population.

Last week, the Association of the British Pharmaceutical Industry made it clear that

“NICE is the cornerstone of NHS efforts to ensure the price being charged by a company represents the value being delivered.”

Commenting on the current situation, it said that

“the APBI would always encourage companies to fully engage with NICE at all stages of the process.”

Furthermore, it commented on the current structure of NHS England’s proposed deal with Vertex, saying that

“the structure of the offer represents exactly the sort of flexibility the industry has been calling for, for some time.”

However, Vertex is willing to accept only its own valuation of Orkambi; I draw your attention, Mr Hanson, to comments directed at Vertex by Members from across the House, including those made by the shadow Minister, the hon. Member for Washington and Sunderland West (Mrs Hodgson).

Jeremy Lefroy (Stafford) (Con) Hansard
10 Jun 2019, 6:50 p.m.

I am grateful to the Minister for giving way and I apologise for not being here at the beginning of the debate, because of important statements in the main Chamber.

My constituent William Smith, who is a pupil at Cooper Perry Primary School, has cystic fibrosis. Along with his entire class, he presented me with the facts of his case and with letters to the Government, and they made it quite clear that they expect not only the Government but Vertex to come to a decision on this matter. Is it not absolutely vital that a company such as Vertex should engage with the Government given that the lives and futures of people such as William Smith, my 10-year-old constituent, are at stake?

Seema Kennedy Hansard
10 Jun 2019, 6:52 p.m.

My hon. Friend makes a very good point. Members from across the House have told very moving stories of their constituents, the lives they lead, and the stresses and the strains put on them by the lack of an agreement on this matter. However, other drug companies are developing medications for rare diseases, and agreements have been reached on those. I will turn to them very shortly.

We can look at what happened in Spain earlier this year, when Vertex did not accept the terms of Spain’s health outcome-related proposal. The Spanish proposal, which is similar to the recent NHS England offer, is based on the ongoing collection and interpretation of real world data. Why is that not acceptable to Vertex? I also note that dialogue between Spain and Vertex has been ongoing for three years, which is similar to the situation here in England.

We will never walk away, but Vertex must now agree to engage with NICE and we urge it to accept all the flexibilities that NHS England has put on the table. There is nothing unusual about Vertex that means that this is not the right thing for it to do. Recently, we have seen deals reached as part of the NICE appraisal process, including that for ocrelizumab, which is an innovative multiple sclerosis drug, that for Spinraza, which is for people with spinal muscular atrophy, and that for axicabtagene ciloleucel chimeric antigen receptor t cell, or CAR-T, treatments.

Given that Vertex remains an extreme outlier in both pricing and behaviour, it is no wonder that patients and families have been looking at alternative solutions to secure access to this drug, and we have heard about the buyers’ club. Hon. Members have also talked about Crown use licensing, and the hon. Member for Bristol East (Kerry McCarthy) talked about large-scale clinical trials.

Unless Vertex changes its approach and behaves responsibly, I have a moral obligation to look at these other options. Of course NHS England and NICE will carry on the negotiations, because a negotiated outcome is the desired option. However, I have no alternative but to look at these other options on the table.

Clive Lewis Portrait Clive Lewis - Hansard
10 Jun 2019, 6:53 p.m.

I thank the Minister for giving way. I raised the issue of compulsory licensing, which the Government have within their armoury. Of course it would be a measure of last resort, but given that we are dealing with people’s lives, the quality of their lives and a company that is quite simply being intransigent, and greedy, surely that option should be considered. That would send a message to those pharmaceutical companies—that global pharma industry—that if they are going to be greedy and put people’s lives at risk, despite being made fair offers, this option could be used by our Government.

Seema Kennedy Hansard
10 Jun 2019, 6:53 p.m.

I thank the hon. Gentleman for his intervention. As my hon. Friend the Member for Sutton and Cheam said in his opening speech, which was very well made, we recognise the importance of British pharmaceutical companies and that companies invest hugely in developing new drugs. However, as the other examples of drugs for rare diseases that I have given show, it is possible to go through the NICE appraisal process and reach an agreement with NHS England. As one hon. Member who is no longer in their place said, this is an offer for a long-term agreement.

Vertex is an outlier, and I would like to put that on the record.

Mrs Sharon Hodgson Portrait Mrs Hodgson - Hansard

Will the Minister give way on that point?

Seema Kennedy Hansard
10 Jun 2019, 6:54 p.m.

Yes, and I hope that I will be able to remember the hon. Lady’s question.

Mrs Sharon Hodgson Portrait Mrs Hodgson - Hansard

At this point I should clarify, for the benefit of the campaigners who I have spoken to about the Crown use licensing option, that it is not an immediate solution from their point of view; I understand that it would take at least a couple of years. If an agreement can be reached, there would be an immediate outcome. That is why the campaign is called Orkambi Now; it is about trying to get the drug now. Although the Crown use licensing option would be an option to consider if nothing else can be found, it would not give the sufferers and their families the drugs as quickly as we would like.

Seema Kennedy Hansard

As always, the shadow Minister makes an excellent point. Crown use licensing is not something that any Government would consider lightly. It is very rarely used in health. It has probably not been used—my officials will correct me if I am wrong—since the 1970s.

The ideal thing is to get a deal, and deals have been done with other pharmaceutical companies; that is the point I want to make. As I have said, Vertex is an outlier in this regard, but that does not mean that I do not have an obligation to look at other options. I will do that.

Kerry McCarthy Portrait Kerry McCarthy - Hansard

Will the Minister give way?

Seema Kennedy Hansard

Can I just make a tiny bit of progress first?

Kerry McCarthy Portrait Kerry McCarthy - Hansard

It is on this issue.

Seema Kennedy Hansard

All right, given that we have more than half an hour left.

Kerry McCarthy Portrait Kerry McCarthy - Hansard

I really welcome the fact that the Minister is saying so passionately that she feels she has a moral obligation to act. The question is: when? I say that because Vertex has been in these talks for a very long time now. How much longer will it be given before the Minister decides to look at the other options?

Seema Kennedy Hansard
10 Jun 2019, 6:56 p.m.

Well, I have already said it, so I suppose that means—

Kerry McCarthy Portrait Kerry McCarthy - Hansard
10 Jun 2019, 6:56 p.m.


Seema Kennedy Hansard
10 Jun 2019, 6:56 p.m.

Now. We will look at other options to consider what other methods we can use. As the hon. Member for Washington and Sunderland West said, Crown use licensing has other risks, so the best option is to get a deal. However, we will look at other methods that might enable families to receive the drugs they need.

Some Members have said that Orkambi is available in other countries and asked, “So why not here?” Although that is true, it is also true that other countries have faced problems in agreeing an acceptable price with Vertex; around 50% of the global cystic fibrosis population is unable to access Orkambi. It is not approved for reimbursement in Spain, which I have touched on, or in Portugal, and it is not used routinely in France. It is also of note that the Canadian equivalent of NICE has rejected the drug, saying that the benefit of Orkambi is small and uncertain.

We do not have sight of specific commercial agreements where Orkambi is approved and we do not have the same population needs, as we know, because of the specific population that the UK has; compared with other countries, the UK has a very high proportion of people with cystic fibrosis. So I am not able to make comparisons with other countries. Cystic fibrosis affects about 10,500 people in the United Kingdom—a far higher figure than in other countries. It represents 12% of the global cystic fibrosis population. The UK is a very important market for Vertex.

I thank all Members who have spoken so passionately here today. In particular, I thank the people who have joined us here in the Gallery; I pay tribute to them for all that they do to support their family members. I also thank those people, such as Lucy Baxter, who work so hard to raise awareness of this issue. I thank members of the Health and Social Care Committee, which is carrying out a very thorough and transparent inquiry into this issue, helping to shine a light on it.

As we have heard in great and moving detail today, cystic fibrosis is a devastating, life-limiting condition, and the bravery of those affected should be an inspiration to us all. Drugs that improve sufferers’ quality of life should be available where appropriate, and I urge Vertex to do everything it can to price its medicines fairly and in a way that reflects the health benefits to patients.

NHS England and NICE will, of course, continue their efforts to reach an agreement with Vertex. Access to treatment for all patients is, and always will be, a priority for this Government. My Department has a moral obligation to look at other options now, and that is what we shall do.

Paul Scully Portrait Paul Scully - Hansard
10 Jun 2019, 6:59 p.m.

You have joined us halfway through the debate, Mr Hanson, and it is a pleasure to serve under your chairmanship.

I thank all colleagues across the Chamber for their contributions. I thank the Cystic Fibrosis Trust for pulling together such a fantastic and insightful meeting this morning, and all those who participated, including the Minister’s constituent, Lucy Baxter. Lucy described cystic fibrosis phenomenally well, capturing it in one sentence: it is like breathing through a straw and then going running. It is that tiny lung capacity that really starts to illustrate the issue that these people live through, from day to day.

We have heard a lot about NICE and possible changes for that portfolio drug—system proposals. We have heard a lot about the need for Vertex to yield somewhat in the negotiations; as the Minister said, it is the outlier. I caution colleagues as they look at the alternatives, whether Crown use, compulsory licensing or a buyers’ club. Yes, we need those weapons in our armoury for the negotiations, but there is always the possible unintended consequence of fallout—the risk for future research into rare diseases of all sorts—if we start to undermine a market that clearly, however, needs to be looked at in relation to big pharma and how it can hold the NHS over a barrel. We just have to be careful about unintended consequences.

I also thank Alasdair Mackenzie, the Community and Outreach Engagement manager for Parliament. He joined me this morning at the deliberations with the Cystic Fibrosis Trust because of his personal interest. His partner, Becky, died of cystic fibrosis just a few years ago. His insight, and his sharing of Becky’s experience, were invaluable to me in my contributions this morning.

I wish, again, to put on the record my thanks, and to give all speed to the Minister, NICE and NHS England in our negotiations with Vertex. I hope that we can bring this matter to a resolution and give that life-saving drug—that quality-of-life drug—to all those thousands of people across the country as soon as possible.

Question put and agreed to.


That this House has considered e-petition 231602 relating to access to Orkambi and other drugs for people with cystic fibrosis.