Clinical Technology Appraisals (NICE)

Eric Ollerenshaw Excerpts

Monday 1st September 2014 Commons Chamber

[Eric Ollerenshaw (Lancaster and Fleetwood) (Con)]

I welcome the Minister to his place. I hope that he does not feel that he has drawn the short straw by having the 10 o’clock slot. I am pleased to be here to have the opportunity to raise an issue of growing concern to NHS patients throughout the country, particularly those suffering from cancer. It will be a debate about how new drugs and treatments are approved, or not, by the National Institute for Health and Care Excellence. That organisation’s acronym is NICE, but, sadly, for many patients, the decisions it makes often seem anything but that.

Tonight’s debate is particularly timely given the announcement last week about the expansion of the cancer drugs fund. That is of course welcome, but it does serve to highlight the ongoing problem. That announcement comes on the back of a number of recent decisions by NICE not to fund important new cancer drugs. Both Kadcyla for metastatic breast cancer and Abiraterone for routine use in prostate cancer are high- profile examples, so the whole issue of the affordability of the drugs bill is back in the news, and especially how NICE carries out its cost-benefit analysis and comes to its decisions.

My original reason for raising this issue was the current review of NICE’s technical appraisals, the consultation on which closed earlier in the summer. I will make some specific points on that, but first I want to set out the problem as I see it and give some wider context. Put simply, I do not believe that the appraisal system is fit for purpose, at least not for cancer drugs. In 2011-12, NICE rejected 60% of the cancer medicines that it assessed. What makes it worse is that the rate at which they have been turned down has actually increased since 2010. That is largely because the methods used to work out the cost-benefits of each drug are too restrictive. The use of what are called “quality of adjusted life years” does not take into account many potential benefits for patients and their families. The appraisal process is also far too long—it can take a year to conclude that a new drug priced by a company at X is not cost-effective. Subsequent resubmissions by a company, based on a new price or new clinical data, can then take just as long.

Most of these drugs are already licensed for use in the UK but can be obtained only through private health care. It was that repeated failure to give patients on the NHS the same access to cancer drugs that led to the creation of the cancer drugs fund. That was a hugely welcome move, and I commend the Government for it. Because of the fund, 55,000 patients have since 2010 been able to access drugs that they would not otherwise have had. But we have to admit that the CDF is, in a sense, a sticking plaster. It was only ever envisaged as an interim measure until NICE got its act together and became more user-friendly. Even with the welcome new boost to its total funds, the CDF is scheduled to expire in 2016. That expiry date is fast approaching and many, particularly among the charities, are worried about what will happen after that date.

There is another level of uncertainty. Drugs on the CDF can be de-listed at any time. The failure of NICE to approve treatments means that the fund has been working at or above its planned financial capacity. Again, I am grateful that the Government have recognised that with the announcement last week, but the chair of the fund seemed to hint last week that time may be called on some of the drugs on the list very soon. That would be a disaster for possibly thousands of patients and their families around the country. I understand that these things need to be considered in detail, but I would be very grateful if the Minister could address this specific issue in his response. In particular, will he clarify the process and likely time scale for any de-listing of drugs?

What does this mean in practice? The Minister knows that I have a particular concern for improved treatments for pancreatic cancer patients. He may remember an Adjournment debate back in March when we discussed the new drug Abraxane. When used in combination with standard chemotherapy, it has been shown in trials to extend eligible patients’ lives by an average of just over two months, although in some cases it is significantly more.

At the time of the debate in March, I expressed my support for Pancreatic Cancer UK’s “Two More Months” campaign, which gave a number of examples of what two more months in life would have achieved for various people, and asked Ministers for the drug to be added to the CDF. Imagine my delight when that happened. As I understand it, between the end of March and the end of June this year, 118 patients have accessed Abraxane on the NHS. That would not be happening if the CDF did not exist.

Abraxane is currently under consideration by NICE for routine use for eligible metastatic pancreatic cancer patients on the NHS—a move that would make it easier for patients to access the drug. I believe that a decision on whether to approve Abraxane for use will be made in the next few weeks. However, if we use the quality-adjusted life-year system, the price of an additional two months of life looks set to be deemed too costly. Most drugs are capped at £30,000 a year, and Abraxane is estimated at slightly above £50,000.

Although NICE allows a higher cost threshold of about £50,000, that is only for drugs that meet its current end-of-life criteria, which demand that a new drug provide at least three months’ extra survival on average. The evidence so far does not show that Abraxane does that. However, if we consider that the average survival time for a pancreatic cancer patient from diagnosis is just two to six months, we can imagine that an extra two months’ survival is massively significant. Instead of having arbitrary targets in terms of months, why do we not look at percentages of the average survival rate as a means of dealing with these more difficult cancers and diagnoses?

If Abraxane is rejected by NICE, as I fear it might be, we will be back to relying on the cancer drugs fund to provide it. It will end up like other treatments that are available for pancreatic cancers, only one of which has been approved by NICE. Non-drug alternatives such as NanoKnife and CyberKnife, which have been discussed in this Chamber, are in use in private practice but have not been approved by NICE for clinical use on the NHS. Patients are forced to spend tens of thousands of pounds of their savings to access those treatments privately.

We are in a position where new treatments might start to make a small difference in survival rates for pancreatic cancer—there have been no improvements in those rates over the past 40 years—but such improvements will have been despite, not because of, NICE. That must change.

Indeed, change is now in prospect. NICE is currently looking at introducing a new way of assessing drugs, called value-based assessment. The consultation on it closed in June and I understand that some next steps are due to be announced very soon.

I have looked at the proposals, but I must say to the Minister that there are worries that the new system will not improve the current situation. Briefly, my concerns are these. First, the proposals maintain a quality-adjusted life-years system as the basis of an appraisal. That will still mean that many benefits to patients and their loved ones highlighted by patient groups might not be taken into account. Secondly, it is proposed that specific end-of-life criteria be removed and incorporated in a wider “burden of illness” measure. There is no guarantee that this measure will capture the unique requirements of end-of-life drugs. Thirdly, the way the proposals are framed could well mean that the age of patients with a particular condition could count against the drugs, which is a particular concern given, as everybody knows, that the likelihood of getting cancer increases with age. Perhaps more importantly, I see nothing in the proposals that suggests that the new appraisal process will be any quicker than the current one, and time is one thing that many cancer patients do not have.

I have serious reservations about the proposals. The crucial question is this: will the new system make more cancer treatments available or fewer? If there were confidence that the new set of criteria would solve the problem, we might not be facing the need for extra funds, but as things stand, the extra CDF money remains the lifeline. If the new system does not solve the problem and the CDF ends in 2016, we will be back to square one, with thousands of patients not getting the drugs they need and deserve—drugs which over the past four years have been proved to make an immense difference to patients’ and their families’ and friends’ lives.

These fears are shared by many cancer charities and patients groups. I hope that their responses to the consultation will be given the consideration they deserve. If they are, it should be possible to devise a system that genuinely works. That means a system that works faster. The NICE process is extensive, but it takes too long. Why on earth when a drug is rejected at one price does the whole elongated process that I have mentioned have to start again when it is resubmitted at a new price? There is an argument that that simply encourages companies to pitch a high price to begin with, and therefore creates further delays as the argument goes on to get the price down. Why can we not have a system where there are sensible negotiations between NICE and the drug companies immediately after a drug is licensed, along the lines of systems used in many continental countries?

The system should also give more weight to patients’ and carers’ needs and experiences. At the moment, the process is almost exclusively focused around clinical effectiveness—that is understandable—and value for money. Patient engagement is ostensibly taken into account, but it needs to be given a higher priority. The Scottish Medicines Consortium has just changed its system along those lines, and that might be a good model to consider.

Lastly, a specific end-of-life weighting really must be maintained in the new system. It cannot, however, be so prescriptive that it excludes new treatments for cancers with extremely poor prognoses, such as pancreatic cancer. NICE’s current three-month rule makes that a specific problem that the new system must tackle.

To sum up, of course the NHS does not have an unlimited budget—we all understand that—and it is right to seek value for money for taxpayers. Drug companies must also be realistic when pricing their drugs, but as I have said, the current system provides incentives for them to pitch high. This review of appraisals gives us an opportunity to make them work better. We urgently need reform because for too many cancer sufferers NICE simply is not working.

Until that improved system is in place, the cancer drugs fund will remain vital, and the extra money will be well spent. I hope that it will be extended beyond 2016 to make sure there is at least one fast and effective route for cancer drug approvals. However, that can only ever be a temporary fix. There must be a more reliable long-term system to get cancer patients the treatments that they so desperately need. Such decisions can literally be life-and-death ones, and too often we are not getting them right. Cancer need not be a death sentence, but the rejection of a drug based on a flawed assessment might be one.

For many patients, extra days and months are not just numbers in a cost-benefit equation, but precious moments with loved ones. NICE must recognise that the timeline is arbitrary, and it must start to build on the success of the cancer drugs fund.