Access to Orkambi

James Frith Excerpts

Tuesday 17th July 2018 Commons Chamber

[Mr Lewis]

I agree entirely. We sometimes spend vast amounts of public money reacting to a problem, and the rhetoric is all about prevention and early intervention, but we end up doing the opposite. This is a very good example of that.

[James Frith (Bury North) (Lab)]

rose—

[Mr Lewis]

I will give way to my hon. Friend and then I have to make progress.

[James Frith]

I congratulate my hon. Friend on securing this debate. Does he agree that there is a human cost to this gridlock for cystic fibrosis sufferers, who are victims of this disease and this disagreement? Frankly, NHS England should get in a room with Vertex and they should stay in there until they come out with an agreement to end this gridlock, so that cystic fibrosis sufferers do not see this debate just as yet another conversation but as delivering change and transformation of their lives.

[Mr Lewis]

My hon. Friend clearly wants to finish my speech off for me. Of course, he is absolutely right to make that point. The most important thing to see from this debate is action, not words. I will go on to talk about what those actions should be.

--- Later in debate ---

[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.