Oral Answers to Questions

Debate between James Frith and Steve Brine

Tuesday 23rd October 2018 Commons Chamber

[Steve Brine]

This comes back to the matter of public health budgets—£16 billion during the current spending review period, with local authorities best placed to make local decisions on what is needed in their local area. That is the same in the right hon. Gentleman’s area as it is in mine.

[James Frith (Bury North) (Lab)]

Last month, the Mayor of Greater Manchester adopted the five recommendations of my report, “Living Well and Dying Well”, which seeks to include hospice care provision more formally in our NHS and social care planning. Will the Minister meet me and representatives of our hospices to see how we might best make use of these brilliant community health assets?

Access to Orkambi

Debate between James Frith and Steve Brine

Tuesday 17th July 2018 Commons Chamber

[The Parliamentary Under-Secretary of State for Health and Social Care (Steve Brine)]

I say from the outset that there are 22 people in the Chamber for this Adjournment debate. Normally, it is me, the proposer of the debate and the hon. Member for Strangford (Jim Shannon). I say to the hon. Member for Bury South (Mr Lewis) that it is nice for other people to be here with us. I will say at the start that I will not take any interventions. A lot of Members have come to listen to this debate, and they want to hear the Minister. There are things that I as the Minister need to put on the record, and I am going to put them on the record before we finish at 8.5 pm.

I thank the hon. Gentleman for securing this debate and for giving me the opportunity to speak once more on an important issue that matters to me and my constituents as much as it does to his. May I again place on the record the sterling work undertaken by the Cystic Fibrosis Trust? Its support for cutting-edge research, campaigns to drive up standards of care and support for the CF community is fabulous. We are lucky to have it.

Once more, we have heard hon. Members make compassionate—that is a very good word—pleas urging an immediate resolution in the ongoing discussions between NHS England and Vertex to make Orkambi available on the NHS in England. To the hon. Member for North Down (Lady Hermon), who raised this in an intervention, I say that, absolutely, I will make sure my officials are talking to the permanent secretary—the very hard-working and probably overworked permanent secretary—at Stormont, because we need to make sure we have a joined-up approach. I wholeheartedly agree with everyone’s calls for exactly that: every effort must be made to ensure that precision medicines are made widely available to cystic fibrosis patients.

Many people have raised concerns this evening and in many other places about NICE’s process for the assessment of drugs for rarer diseases. I said this in the last debate in Westminster Hall and I will say it again: it is a key commitment of this Government to ensure that people with comparatively rarer conditions, such as CF, get the same quality, safety and efficacy in medicines as those who have more common conditions. I assure the House that where a company is willing to set a fair price for a drug, NICE’s technology appraisal process has been proven to be suitable for the assessment of drugs for rare diseases.

[James Frith]

Will the Minister give way?

[Steve Brine]

I said I would not give way, and I will not do so.

I thought the hon. Member for Bury South made a good point when he said if NICE did not exist, we would have to invent it. I agree. Indeed, NICE has been able to recommend a number of drugs for patients with rare diseases through its technology appraisal process, including pirfenidone for pulmonary fibrosis and mifamurtide—why they cannot produce easier names, I will never know—for a rare form of bone cancer, to name but two.

I know that it is distressing, to put it mildly, for patients and their families, as well as campaigners, when NICE is not able to recommend a treatment. Unfortunately, there will continue to be occasions when NICE is not able to a recommend one for routine use on the NHS. As we know, NICE has not so far been able to recommend the use of Orkambi for treating CF, because the benefits were not sufficient to justify its considerable cost. At list price, the cost per quality-adjusted life year of Orkambi is many times higher than the upper end of the threshold used by NICE in deciding whether to recommend a treatment. NICE does not stick rigidly to a cost per QALY threshold, and it applies plenty of flexibility in deciding whether to recommend treatments where the decision is a borderline one. However, it must be stressed that the cost per QALY is not an arbitrary measure, but a tool to assess what the impact would be on other NHS patients if the NHS were to spend money on a particular treatment.

I want to talk about the discussions with Vertex. As Members know, NHS England has been in intensive discussions with Vertex to encourage it to lower the cost of Orkambi to a level that would allow NHS England to fund its use without adversely impacting other patients. I and the Under-Secretary of State Health, Lord O’Shaughnessy, who sits in the other place—he leads on this area for us—have been keeping an extremely close eye on these discussion, as I promised the House in the Westminster Hall debate I would do. As Members will remember, we wrote to Vertex in April, urging it to commit to pricing that is responsible and proportionate. I have the personal assurance from NHS England that it is committed to seeking a way forward in these negotiations, and I think it has shown flexibility.

Sadly—I am not ratcheting up the rhetoric or name-calling, as this is just fact—Vertex has been unwilling to price responsibly thus far, which has, as we have heard today, meant that patients have missed out on two years of treatment. Vertex claims that it has made the NHS

“the best offer in the world”—

but it has yet to substantiate that claim. I would challenge Vertex to waive confidentiality—which it can do: I cannot—so that we can all see, in the interests of transparency, the kind of prices it is trying to charge the NHS and, as a result, our constituents.

As mentioned this evening by the hon. Member for Bury South, NHS England wrote to Vertex yesterday to set out a proposed five-year deal with an option to extend, which provides the potential for Vertex to secure revenues from the NHS in the region of £500 million over the next five years. NHS England has made the content of this proposal public, to give patients and taxpayers the opportunity to make a judgment about the fairness of this offer. The proposed deal, if accepted, would guarantee immediate and expanded access, as clinically appropriate, to the two licensed medicines, Orkambi and Kalydeco—as was said earlier, Orkambi is not the only show in town. It would also provide immediate access for Symdeco from the date it is licensed for use in the UK, which is expected in coming weeks.

If Vertex is not willing to accept the deal, it must return to discussions with NICE and go through that process. Let me be clear that I truly hope it does not come to that, but until Vertex adjusts its prices, NICE will not be able to recommend the drug’s use. I repeat that we have put a figure on the table. The ball is in Vertex’s court. It has made a preliminary response today, saying that it is good to see that NHS England is negotiating. NHS England has been negotiating throughout. It is not Ministers who are negotiating on this.

Oral Answers to Questions

Debate between James Frith and Steve Brine

Tuesday 20th March 2018 Commons Chamber

[James Frith (Bury North) (Lab)]

Seventy MPs from across the House in yesterday’s Westminster Hall debate all agreed that we need Orkambi on the NHS now. Can the Minister tell me what he will be doing differently for sufferers of cystic fibrosis and when we will hear news of a breakthrough? Sufferers of cystic fibrosis are slowly drowning in their disease without access to Orkambi.

[Steve Brine]

It was a very good debate, and the hon. Gentleman spoke very well in it on behalf of his constituents. We have made a counter-offer to Vertex. I call on Vertex to be reasonable, and I call on Vertex and NHS England to get back round the table and get this sorted.

 Orkambi and Cystic Fibrosis

Debate between James Frith and Steve Brine

Monday 19th March 2018 Westminster Hall

[Steve Brine]

I thank 163 of my own constituents who signed the petition and who have been in touch with me, and one who has been to my constituency surgery. I may be the Health Minister responding to the debate, but I am also a constituency MP and a parent of two young children.

I pay tribute to the Cystic Fibrosis Trust, which does a tremendous job on behalf of all our constituents. I know we are not meant to address the Gallery. I will not do so, but if I did I would thank those who have made the trip in the snow and ice, probably not all from SW1, to come to Westminster today. It is a credit to them that they have made time to do that.

I recognise the progress that Vertex has made to date in its mission—I believe it is a mission—to discover ultimately a cure for cystic fibrosis, and recognise the treatments that it brings to the market. I know Vertex understands the importance of the UK market, and NHS England as a customer, to its future and to that mission.

This petition is calling on the British Government—that would be me—

“to call for a resolution to ongoing negotiations between Vertex Pharmaceuticals, NHS England and NICE as a matter of the utmost urgency. It is essential that a fair and sustainable agreement is found.”

I am here today to do exactly that. It is not a difficult call to agree to. The negotiations must remain constructive and be undertaken with the utmost urgency, for all the reasons we have heard—I will not repeat them all—or, as my hon. Friend the Member for Mid Dorset and North Poole (Michael Tomlinson) said, people living with cystic fibrosis will suffer.

It seems to me that the main ask I have heard from pretty much every hon. Member speaking today is, “Get involved.” I am not the Minister directly responsible. That falls to Lord O’Shaughnessy, the Parliamentary Under-Secretary who sits in the other place, but I can say on his behalf and on mine that we are involved, and you can bet your life that we will continue to be involved. I do not think I can be clearer.

[James Frith]

The Minister says, “You can bet your life” that he will continue to be involved. Any further delay is literally betting lives and the ever-diminishing lung capacity of those who go without Orkambi. What will he commit to do differently from today, and when will Orkambi be prescribed by the NHS?

[Steve Brine]

The hon. Gentleman knows that I cannot give the answer to his when question. I will come to the other bits of his question. His point about the reducing lung function is well made, and has been made by almost everybody. The Government wholeheartedly support efforts to ensure that the precision medicines we have heard about are made widely available to CF patients and other patients. It is true that high-cost precision medicines represent a challenge to the NHS, but they are also a tremendous opportunity to deliver high-quality outcomes through highly specialised treatment. I hope I can go some way to ensuring that people with comparatively rarer conditions such as CF get the same quality, safety and efficacy in medicines as those who have more common conditions, and to doing so in a way that is sustainable for the NHS.

There has been much talk about NICE, which has a difficult job, as the hon. Member for Bury South rightly said, but as we know, England has the second-highest number of cystic fibrosis patients in the world and there is sadly no cure. Current treatments generally target the complications rather than the cause of the disease. Of course, I can appreciate the huge daily burden of treatment for patients and their families, and the uncertainty that they live with. Uncertainty is a huge burden—the hon. Member for Dudley North (Ian Austin) mentioned the mental health burden. It is so important that patient voices are heard during any appraisal process to ensure that that burden is fully understood.

NICE’s technology appraisal programme makes recommendations for the NHS on whether drugs represent an effective use of NHS resources in what we must remember is a publicly funded health system, as many hon. Members have said. There are other parts of the world where, if someone could not afford it or their insurer could not afford it, this would not even be a discussion. That system means that patients can have the confidence that the price paid by the NHS is consistent with the improvement in health outcomes a medicine brings, ensuring fairness as well as the best possible use of funding for patients and the NHS.

Those are very difficult decisions to make, but it is essential that patients are getting the maximum benefit from every pound of our constituents’ money that is spent by the NHS. NICE takes its decision independently of Ministers. The Government rightly have no say in whether a new medicine is recommended for the NHS at the price proposed by the manufacturer. NICE published its final guidance on the use of Orkambi in July 2016 and, as we have heard, did not recommend it for use in treating cystic fibrosis. That, of course, is not the end of the story, and I do not want it to be. I will return to that in a moment—although, ironically in a three-hour debate, time is short for me to give our position.

Since 2013, NHS England has been responsible for securing high-quality outcomes for patients with cystic fibrosis. Six years ago, it agreed to fund Ivacaftor and Kalydeco for cystic fibrosis patients with the relevant genetic mutation. An additional possibility that may further the pool of treatment options for CF in the near future is the double combination therapy branded Symdeko, which has shown positive results and is currently undergoing European Medicines Agency licensing.

More broadly, the number of medicines for cystic fibrosis patients expected within the next three years is promising, with products being developed by a range of manufacturers as well as Vertex. NICE is aware of 31 other technologies by 19 different companies—not Vertex—that are in the pipeline for cystic fibrosis. Clearly, the prices for any new treatment will also be considered by NICE and we must ensure that the arrangements NHS England enters into now do not restrict options for patients to have the best available medicine in the future. The hon. Member for Bury North made that point very competently.

The NHS is in discussions with Vertex about Orkambi. Vertex has approached NHS England with a proposed deal to reduce its prices. While I cannot share the details of this proposal due to their commercially confidential nature—believe you me, I wish I could—I can assure hon. Members that, at the level that Vertex has proposed, the products are still far from cost-effective. Therefore, there is more talking to do.

Last week NHS England made a counter-proposal, which would ensure that the drugs could be used at a price that is cost-effective. I understand that NHS England has agreed to meet with Vertex—I would jolly well hope so, and of course it is not over email—to discuss that counter-proposal further. I have seen the statements made this weekend—I must say I am no fan of Twitter diplomacy in this or any other form of diplomacy. The statements this weekend were not exactly encouraging, but they must not be the end of the story.

While it is not for Ministers to approve, I truly believe this can be a mutually satisfactory arrangement for both parties. I know I speak for my colleague, Lord O’Shaughnessy, when I say that we are both impatient for a breakthrough and are watching the matter like hawks. I get the message loud and clear: the House has said, “Get involved.” The House has that assurance from me.

I thank all hon. Members who have spoken so passionately. They have helped the cause on behalf of their constituents. On Orkambi in particular, I hope above all that hon. Members can see that this is a live issue and that it is work in progress.