Cancer Drugs

David Mowat Excerpts

Tuesday 19th January 2016 Westminster Hall

[Pauline Latham]

I will come on to that later. If my hon. Friend does not mind waiting a few moments, he will hear what I have to say.

Delisted drugs are still potentially available on an individual basis via an individual funding request. Is the Minister able to say how many of those requests have been successful as a proportion of all requests, and for which drugs? I know he is working extremely hard on this matter, about which he cares passionately, and I thank him for that.

Although there has been recent progress, the UK still lags behind most other developed nations on use of and access to cancer drugs. In fact, we do not do as well on outcomes for cancer as many other nations. Nationally, cancer is still the largest killer, accounting for 29% of all registered deaths in 2014, the last year for which Office for National Statistics figures are available. Tracking the history of the Cancer Drugs Fund, a fund for which I have repeatedly supported investment, we can see that it has been on a rocky road to get to where we are now. Drugs have been removed, and the general consensus is that the fund has become unsustainable.

For the first three years, the fund underspent its budget—the opposite problem from the one we have now. In fact, between October 2010 and March 2013, the 10 strategic health authorities that administered the fund underspent by £128 million, or 28% of the fund’s total budget. That is a lot of money that could have been spent treating cancer patients. There was significant geographic disparity in the use of the fund. In the east midlands, which covers my Mid Derbyshire constituency, the number of patients supported by the fund per 1,000 new cancer cases in 2012-13 was just 27. That was the lowest figure in the country and represented a failure of the East Midlands strategic health authority, which was then in control of administering the fund, to promote its use to clinicians and patients. Several of my constituents died prematurely because they were refused funds for the drugs they needed when the fund was always underspent, despite pleading from me on behalf of people who were spending their own money on those drugs.

Since NHS England and Public Health England took control of the fund, the change has been dramatic. Having one central authority administering the fund removes the geographic differences whereby treatment authorities were promoting the fund and treatments at different levels. The effect is such that patient numbers skyrocketed. As last year’s high quality National Audit Office report on the Cancer Drugs Fund notes, the number of patients approved for funding increased by about 30% each year from 2011 to 2015, which should be viewed as a success for patients. Thanks to the fund, 84,000 patients have been able to access treatments that they would otherwise have been denied. The success is such that, in 2014-15, almost one in five patients started a new cancer drug through the Cancer Drugs Fund. What was meant to be a temporary measure is now a mainstay of cancer treatment in England.

Obviously, such growth comes with a price; the cost of funding the scheme spiralled out of control. Following the Government’s decision to extend the fund to March 2016, NHS England increased the annual budget from £200 million to £280 million for 2014-15 and 2015-16. In January 2015, it increased the budget for 2015-16 again, to £340 million, meaning that the fund now has an expected lifetime budget of £1.27 billion.

Was taking drugs off the list a solution to the fund’s problems? It was certainly the easiest way to regain control of costs, but it hit patients hardest rather than solving the problems with NICE’s approval processes, which was the underlying reason for the fund’s creation. The rapid response to regain control of the budget also means that no new treatments were added to the Cancer Drugs Fund from January 2015. The decision to keep drugs on the fund’s list or remove them was based on their clinical effectiveness and cost, but from the start the fund did not keep records of treatment outcomes. Surely it is hard to obtain a full understanding of drugs’ full efficacy if a full analysis is not available by which to judge them. The failure to collect data on patient outcomes until July 2015 is truly disgraceful and undermines any proper evaluation of the fund’s success.

I am particularly attracted to the question asked by the right hon. Member for Don Valley (Caroline Flint) during a Public Accounts Committee oral evidence session on the Cancer Drugs Fund last year. She asked why the Department of Health did not

“knock the heads of the SHAs together to ensure that there was some sort of common collection of data”,

instead of just recommending it. Fortunately, NHS England and Public Health England have resolved the problem—today, every new Cancer Drugs Fund patient is automatically identified on the systemic anti-cancer therapy database—but five years to fix a problem is far too long, and a failing of the fund.

Although data outcomes are now mandated, the rate of return has been far from perfect. In 2014-15, many records lacked important data. Most shockingly, 93% of patient records submitted did not have an outcome summary. Will the Minister inform us whether there will be penalties for trusts that consistently fail to produce the required data on cancer treatments?

The lack of data collection also undermines efforts to establish whether the price paid for drugs is equal to their outcomes. As the chief executive of the NHS admitted himself, the NHS has not been good enough at negotiating a price for drugs. Many drugs have been delisted because they were deemed too expensive. The drug Imnovid, which would benefit my constituent Graham, costs the NHS £115,000 a year, compared with £90,000 in Spain.

The failure to negotiate the best price was demonstrated by the fact that when threatened with removal from the list, some manufacturers were able to offer a lower price for their drugs. I understand that Imnovid was already offered at a discounted price, but I cannot blame drug manufacturers for not immediately offering the lowest price that they can afford. They need profits to use on research and development and to show value for their investments. Will the lack of positive outcomes from the price negotiations be addressed in the new CDF proposals? Also, can the Minister provide information on the number of negotiations between NHS England and drug manufacturers that have been positively resolved, and which drugs they relate to?

The new Cancer Drugs Fund proposals aim to distribute more evenly the financial risk of placing a drug in the fund, but the Rarer Cancers Foundation strongly suggests that the NHS has not been flexible in negotiating with pharmaceutical companies on value propositions for treatments in the fund. Can the Minister confirm whether NHS England rejected multi-treatment cost reductions from drug companies because they would have fallen outside NHS England’s standard operating procedure? Likewise, from evidence given to the Public Accounts Committee, it is clear that some companies have offered financial schemes stating that if the medicine does not work as expected, its cost will be returned to the NHS, but have been turned down in favour of straight discount schemes. Together, such schemes would offer a win for the taxpayer and would have allowed more drugs to be made available for the fund.

My final comments concern the proposed reforms of the appraisal process for drugs on the fund, which under current plans will be put solely in the hands of NICE. The proposal is that the CDF should become a managed access fund for new cancer drugs, as my hon. Friend the Member for Solihull (Julian Knight) mentioned, with clear entry and exit criteria. It would be used to enable access to drugs that appear promising but for which NICE indicates that there is insufficient evidence to support a recommendation for routine commissioning. At the end of the period, the drug would go through a short NICE appraisal, using the additional evidence.

For those looking for treatment for rarer cancers, such as myeloma, there are a number of questions about the new proposals that need to be addressed to ensure access to new treatments. As I understand it, under the new proposals, only a limited number of patients will have treatment funded through the CDF, and the industry is expected to fund additional patients. The consultation sets out NHS England’s proposal to limit funding for each drug on the CDF to the number of patients required to be treated in order to gain further evidence for use in NICE appraisal. The consultation is not clear what data NICE might require to be gathered during the CDF funding phase or the indicative size of patient populations. It is therefore difficult to assess whether the proposals would result in more or fewer patients getting access to treatment than the current arrangements.

What consideration is there of drugs for rarer cancers, which will have smaller patient pools creating only a small amount of data? Does the appraisal process have flexibility for such drugs? It is not clear whether pharmaceutical companies will be willing to fund patients for the 24 months required to allow data to mature if they think the likelihood of NICE approval at the end remains small. That could result in patients losing out once again on innovative treatments, or a situation in which drugs are put on the fund list and taken off in 24-month cycles, leading to uncertainty for patients about which drugs they have access to, just like the uncertainty caused by the current delisting.

I would like reassurances from the Minister that patients seeking treatment after the number of patients required to be treated in order to gain further evidence has been reached will not be denied treatment given to others in their situation. Does he believe that the changes to the NICE process outlined in the consultation are sufficient to ensure that more cancer treatments will receive positive NICE recommendations? Patients should be at the centre of any new decisions about the fund. Finally, I ask the Minister how the views of patients will be given greater weight in the new CDF arrangements.

[David Mowat (Warrington South) (Con)]

I have been listening carefully to my hon. Friend. Does she agree that the crux of the matter is that the NICE evaluation criteria for those sorts of drug have not been adequate? The whole genesis of the Cancer Drugs Fund is in a failure of NICE. We need to get the NICE criteria right; then we would not need a drugs fund in the current format.

[Pauline Latham]

My hon. Friend is absolutely right. NICE has not done what it should have done. I hope that the Minister will be able to rectify that failure in the system.

Resolving data collection issues, negotiating value for the taxpayer and making the NICE assessment process flexible for innovative new drugs and drugs designed to treat only a small number of patients are vital for the fund to work successfully when it re-launches in April. Will the Minister please look again at the delisted drugs and give hope to people such as Graham that they can spend longer with their loved ones? Failing to do so will not help those whom the fund is designed to help most: cancer patients and their families.

--- Later in debate ---

[George Freeman]

The hon. Gentleman makes an interesting point about the balance of responsibilities between NICE and NHS England. The system was set up so that NHS England is statutorily bound by NICE’s recommendations. Part of the problem in recent years has been that even treatments approved by NICE can take up to two, three and in some cases five years to be rolled out across NHS England. Much as we all love the NHS, we accept—even the NHS accepts—that there is a problem with patchy roll-out. That is also to do with data, which various colleagues have touched on.

[David Mowat]

The Minister used the words “world class” in respect of NICE, but said that its scoring system was such that drugs did not get authorised, and that many that the drugs fund includes were not authorised by NICE. Those two things do not seem to be consistent. Should we not look carefully at what NICE’s criteria are, as they have done in Scotland, and make them more appropriate?

[George Freeman]

The answer is yes. That is why I have set up the accelerated access review, which is doing precisely that. NICE is heavily involved in contributing to setting up the reforms, giving it new flexibilities and changing the way we adopt, assess and reimburse new medicines. I meant that NICE is recognised internationally. Indeed, other countries follow its health technology assessments, and its methodology and protocols. The challenge now is to update them for a world of genomics and informatics, with a much more targeted and precision medicine landscape. I accept that in that context we are not yet world class—we have more to do—but NICE is a world class organisation. Given the chance to update its systems, I believe it will lead the world in that field.

In the autumn statement we fully funded the NHS’s five-year forward view, including its cancer strategy, with a commitment to £10 billion extra per year by 2020. We frontloaded that with £6 billion, as was asked for, to allow it to make the investments necessary to modernise. That is a half-trillion pound commitment to spending on the NHS over this Parliament, so I gently point out to the shadow Minister, the hon. Member for Denton and Reddish (Andrew Gwynne), that to describe that as a cut is testing the admirable elasticity of the English language.

On the importance of NICE and independent, clinically led decision making, much as at times like this I yearn to reach for a big lever, pull it, make a decision and send hon. Members out dancing and cheering and send patients home happy, I think we all understand that it is right that such decisions are not taken by MPs or Ministers; they must be taken by clinicians, based on the very best evidence from the very best independent advice. That is how this system works: NICE makes an independent judgment using the very best systems available to it. I take the point made by my hon. Friend the Member for Warrington South (David Mowat) that that needs to be, and it is being, updated to give NICE more flexibility to reflect the challenges of precision medicine—treatments that have a very definable, predictable response in a very small number of patients. NICE’s advice goes to NHS England, which makes the clinical judgment about treatment protocols. It is right that the Cancer Drugs Fund is based on that clinical decision making.

Nevertheless, there is an anomaly. Although we expect NHS England to be guided by NICE, in one therapeutic area, with the best of intentions, we have created a fund that sits at the end of the process, so that NHS England has a fund to buy drugs that NICE has said no to. That is an anomaly in the system. The point of the review is to take the CDF commitment to fund earlier, so that NICE can use it as an assessment fund to enable it to look earlier in the process at new drugs that are coming on stream and then give NHS England advice. That is in keeping with our general policy of opening up a space between research and medical practice in which we use data from the front-line treatment of patients and from the system to inform our procurement and reimbursement system.

Rather than “finger in the air” theoretical models of health-economic benefits, we are within touching distance of a system that is able to use real data in realtime from real patients with real diseases to drive real models of cost-benefit and health economics, and we are trying to wire the system in order to deliver that exciting prize. Members will understand that, where funding is finite—£1.3 billion is a big commitment, but it is finite—the system must re-prioritise which drugs it purchases. That is difficult for those who are in the process of getting a diagnosis and expecting a treatment that is then withdrawn, but I stress that no patient who is in receipt of a treatment that is withdrawn has that treatment withdrawn from them specifically. If they are getting a drug, they continue to get it.

My hon. Friend the Member for Mid Derbyshire mentioned pomalidomide, a drug used to treat relapsed myeloma. The CDF clinical panel looked at it, reviewed it, and, based on its independent, best-in-class assessment, the score was too low so the panel recommended that it not be approved. As I understand it, NICE is currently looking at other treatments for multiple myeloma, including panobinostat. I checked with NICE before the debate, and can say that final guidance on that treatment for that condition is imminent.

I remind Members that any patients receiving drugs continue to be treated, and that no drug will be removed if it is the only proven therapy available on the NHS. Sometimes in debates such as this we give the impression that we are taking away a drug, patients will stop getting it, and patients who have no other treatment will be left without treatment. That is not what happens. We should remember that there is an individual funding request mechanism—the IFR—for patients with exceptional conditions that are not met by other drugs. That is there specifically so that if any constituents have a unique claim on clinical exceptionality, their clinicians can make that case.

I should highlight the fact that two new drugs were approved in the previous CDF round. We sometimes forget that new drugs are being approved. We do not get requests for debates in Westminster Hall to congratulate the system on their approval, but it is worth mentioning them. The system approved panitumumab for bowel cancer and ibrutinib for cell lymphoma. Those approvals have been widely welcomed by patients and charities in the relevant sectors. I am delighted that, through the early access to medicine scheme that we introduced last year, which, with patient consent and their clinician’s approval, enables unlicensed drugs to be fast-tracked, we have now got pembrolizumab through, tested, into patients and purchased by NHS England several years earlier than would have been the case. That is a precursor of what we want to do much more widely through the accelerated access review.

It is no coincidence that one reason for the delay that was referred to earlier is that I am very keen for the CDF review to be done at the same time as the accelerated access review. Had we not done that, colleagues would have been saying to me, “How ridiculous, Minister, that you have reviewed the Cancer Drugs Fund and closed it before you have received the recommendations of the accelerated access review this spring.” I wanted to ensure that we are building a landscape that is logical and fit.