Accelerated Access Review

Debate between Jo Churchill and Lord Austin of Dudley

Tuesday 13th December 2016 Westminster Hall

[Ian Austin]

The hon. Gentleman is completely right to say that Orkambi could reduce hospital admissions, and could shorten the amount of time people spend in hospital when they have been admitted.

In its statement, NICE referred directly to the trust’s proposal as a potential solution to the shortage of long-term data. With the NICE process exhausted and seven months wasted, we hoped that the way would be clear for direct negotiations between the drug manufacturer Vertex and NHS England, which would allow for a speedy resolution to the situation. However, Department of Health officials then demanded that the drug be put through a rapid review process, which, at 16 weeks, is anything but.That process is based on exactly the same criteria that had just seen Orkambi denied to those who need it. Vertex has declined to enter the process, because of the certainty that it will come to nothing.

New data published in October at the North American cystic fibrosis conference, which my right hon. Friend the Member for Leigh (Andy Burnham) mentioned, are based on 96 weeks of trials and show that Orkambi slows the decline in lung health by up to 42%. That is comparable with the 47% slow in decline caused by the transformational treatment Kalydeco, which is widely available in the UK for a less common mutation of cystic fibrosis. Those data were unavailable to NICE but clearly illustrate that drugs such as Orkambi need the chance to prove their worth in the long term. That also underlines the fact that we now have a situation where people with cystic fibrosis face discrimination by genotype, because they are being denied the same level of treatment that people with a different genetic mutation of cystic fibrosis receive.

Twelve months after licensing, negotiations are at a standstill. I understand that Vertex is keen to offer a substantial discount, but for commercial reasons would need to do so confidentially. It would like to take up the trust’s offer of monitoring the effectiveness of Orkambi for a trial period. That could build on the American data and allow NHS England to conduct final negotiations based on an accurate reflection of the drug’s effectiveness.

[Jo Churchill (Bury St Edmunds) (Con)]

I would like to thank the hon. Gentleman for securing such an important debate. One of the beauties of cystic fibrosis data is that they capture 99% of all people with the disease, so could truly be used as an exemplar. The accelerated access review calls for accurate monitoring via data, and this offers an ideal chance to do that.

[Ian Austin]

The hon. Lady is completely correct. It is good that she is here in the Chamber, making these important points.

Vertex is also keen to explore flexible reimbursement schemes, which would allow the NHS to manage the overall budget impact of the treatment. However, the inflexible current system insists that any offer has to be made public, rejects the trust’s solutions and offers no scope for flexible reimbursement schemes. That brings me to the accelerated access review, which was commissioned to speed up access to innovative new drugs and treatments such as Orkambi. The review was finally published in October, after a long delay, and recommends that NICE reviews its processes. It calls directly for the current system to change, to include more emphasis on the confidential commercial arrangements, flexible reimbursement arrangements and collection of real-world data that I and other Members have referred to. Those recommendations could be the key to reaching a deal that delivers Orkambi to those desperate to receive it.

When the review was commissioned last year by the Minister’s predecessor, the hon. Member for Mid Norfolk (George Freeman), he spoke of how accelerating the uptake of transformational technologies in the 21st century would attract investment in research and innovation to help us earn the prosperity we need as an advanced economy. When the review was published in October, NHS England’s chief executive, Simon Stevens, said that creating headroom for faster and wider uptake of important new patient treatments would create opportunities for the UK’s globally successful life sciences sector. The failure to deliver Orkambi undermines that vision.

We have a rigid and inflexible system, and warnings that it is not fit for purpose have been ignored throughout the process. Instead of embracing the opportunity for an innovative solution, we have been offered further negotiations based on criteria that have already failed once. That is a waste of time and taxpayers’ money and sends completely the wrong signal to a global life sciences industry currently questioning future investments here in the UK. Hugh Taylor, the review’s chair, set out the need for commitment and collaboration across Government, the NHS and the life sciences industry to make the review’s proposals a reality.

The review sets out criteria for transformational treatments that should be fast-tracked for access. Orkambi meets those criteria. It presents the perfect opportunity to put many of the review’s proposals to the test, to illustrate the commitment and collaboration needed and to demonstrate how we can come together and adapt in the light of new information. It is predicted that 95% of people with cystic fibrosis could benefit from a personalised medicine within five years. Coming up with a solution for Orkambi—one that makes sense to the NHS as well as reflecting the investment that goes into these treatments—will give us a genuine opportunity to beat this condition.

I am sure people will benefit from the review’s proposals in the years to come, but that must not be at the cost of Orkambi, which is available now. Many people with cystic fibrosis, as well as their families and carers, such as my constituents Carly Jeavons and Samantha Carrier, are watching this debate. Many of them are forced to spend weeks and months of each year in hospital, and most of all they want a chance to be able to do the everyday things we all take for granted, such as raising a family, planning a holiday or breathing without struggling. They have already endured needless delays, and as time goes on those delays present an obstacle to investment in future treatments to beat cystic fibrosis. That is not the vision set out by the accelerated access review.