Cancer Drugs

Oliver Heald Excerpts

Tuesday 19th January 2016 Westminster Hall

[Pauline Latham]

I accept what the hon. Member for Torfaen (Nick Thomas-Symonds) says. I have also campaigned for Abraxane to continue because, very sadly, a former Member of this House died from pancreatic cancer in the last Parliament. He had very few weeks to live once he was diagnosed, so it is a particularly unpleasant disease.

[Sir Oliver Heald (North East Hertfordshire) (Con)]

On Abraxane, does my hon. Friend agree that if a cancer is fast-acting and the gap between diagnosis and death can be as little as six months, getting an extra month or two means that a person can settle their affairs and get peace of mind? That is very important time.

[Pauline Latham]

It is incredibly important time. Any extra few weeks in such a situation is so valuable to those patients.

In answer to a written question submitted by my hon. Friend the Member for Crawley (Henry Smith) on 10 December 2015, the Minister said:

“NHS England has advised that a draft treatment pathway for patients with multiple myeloma, which takes into account the…impact of treatments removed from the Cancer Drugs Fund (CDF), is currently being finalised.”

I hope he is able to update us today on when those proposals might be published. My constituent and his family would like to know what options, if any, he has.

It is not only drugs for rarer cancers that have been hit. Drugs to treat breast cancer, bowel cancer, prostate cancer, leukaemia and other blood cancers, some gynaecological cancers and cancers that affect the central nervous system have all been removed, which probably amounts to thousands of patients who are now unable to receive treatment. That is absolutely devastating for patients and their families, as the chance to prolong life for a few more months or years has been diminished.

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[Marion Fellows (Motherwell and Wishaw) (SNP)]

It is a privilege to serve under your chairmanship, Mr Streeter. I thank the hon. Member for Mid Derbyshire (Pauline Latham) for securing this important debate. I will give the debate a more Scottish context.

For patients with a life-threatening or highly symptomatic illness, getting access to the best treatment is crucial. Living with a condition that has no cure or treatment is difficult, but knowing that you or your loved one is denied access to an available treatment is intolerable. Our biggest problem is accessing new drugs, which are often very expensive and above the limit set for NHS access by the National Institute for Health and Care Excellence—NICE—or its Scottish equivalent, the Scottish Medicines Consortium, the SMC. That results in delayed access to new treatments and, as has been mentioned, it appears to contribute to the UK’s poor cancer outcomes by comparison with other countries. The issue is even worse for those with rare diseases, because the commercial imperative to develop a drug in the first place is weaker, due to low patient numbers.

There is also frustration for clinical researchers who enter patients into trials that lead to a drug’s development in the first place. The UK, and particularly Scotland, punch above their weight in the active recruitment of patients into drug trials for diseases such as cancer. Patients may benefit from gaining access to the new treatment during the trial but, once the trial has been successfully completed, new patients do not get that opportunity, which is demoralising and could undermine research efforts in the future. Some of the drugs that have been researched over the years are now being removed from the list in England.

Once a new drug has gained a licence, NICE and the SMC carry out their assessments. In Scotland, however, the SMC utilises the evidence gathered to carry out just a brief review, with the emphasis being more on the drug’s effectiveness. Cost comes after that.

There are three major differences in the access systems north and south of the border. While both have drug access funds, in England the fund is only for cancer whereas in Scotland it is for any new drugs and rare diseases.

The Cancer Drugs Fund in England, which was meant to be temporary, has enabled patients to access new cancer drugs that would otherwise have been unobtainable. It has now been running for five years and some drugs are being excluded on cost grounds. In Scotland, after a review in 2014, the SMC established the patient and clinician evaluation, which allows reconsideration of a drug while taking into account the wider experience of it and capturing input from patients and clinicians. That gives patients a voice.

[Sir Oliver Heald]

Abraxane fails the test of three months’ effectiveness, but it is useful in producing two. Why is it that the Scottish system allows Abraxane? Will the hon. Lady give us a bit more of an understanding of that? I would like to see the drug back on the list, and if the Scottish system is a way of doing that, it might be worth looking at.

[Marion Fellows]

I thank the hon. and learned Gentleman for his intervention. He has asked me something that I cannot answer definitively at the moment, because I am not a clinician. I am, however, more than happy to come back to him on that. I know that PACE—the patient and clinician engagement group—has done some development on it, but I would like to give the hon. and learned Gentleman a fuller answer and I can do that later, if he agrees.

[Sir Oliver Heald]

indicated assent.

[Marion Fellows]

Where cost is a factor in prescribing drugs it is important that we consider ways of lowering it. The pharmaceutical price regulation scheme could be used. When a drug’s spending threshold is reached, a rebate is paid. In England, it goes back to the Treasury but in Scotland it goes on to further new drugs.

The delisting of cancer drugs because of cost causes untold heartbreak to patients and families—the very people we all represent—and the time has come to find a way of making new drugs accessible to, and affordable for, the NHS by considering arrangements such as multi-year budgeting, which would allow for a lower initial price. Pharmaceutical companies would hopefully be open to that in exchange for getting their drug into use at an earlier stage.

It is important to understand that drug companies fund drug development research for years before they even know if the drug is worth licensing. Many potential drugs fall by the wayside and, as the public purse would never be able to fund such a level of risk, it is necessary that pharmaceutical firms see a return on their investment, to secure ongoing research. That goes back to why some drugs are delisted because of their cost. However, there must also be recognition of the support provided by universities in Northern Ireland and Scotland, and in England, which get Government funding to help towards researching new drugs.

Off-patent drugs can also be used in cancer treatments, usually through repurposing. It is important that we consider that, as it could also lead to a cost—[Interruption.] I am sorry, I will just wind-up my speech. Some of the barriers to treatment can, however, be broken down through negotiation between all interested parties. The aim would be a system that worked equitably for all stakeholders, from patients, doctors and the NHS to Governments and the pharmaceutical industry.

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[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.

[Sir Oliver Heald]

Does my hon. Friend the Minister accept that it is worth while to look at the difference between a condition that goes from diagnosis to death over, say, 18 months, where an extra two months of life is proportionately quite small, and one of these very fast-acting cancers, such as pancreatic, where a person gets only six months and giving them an extra two would be very important in allowing them to settle their affairs and come to terms with the world?

[George Freeman]

My hon. and learned Friend makes an important point. I urge colleagues, as elected representatives, to make such points to NHS England through the CDF review, which closes on 11 February. We represent 70,000 or 80,000-odd people, so it is appropriate to make the point that for different diseases there is a big difference between the benefits of extra time for patients.

In the limited time I have left, I want to touch on some of the questions that came up. Colleagues asked about performance measures for data. It is important that we use the data from the CDF better. We are introducing measures to ensure that the contracts for 2016-17 specify that trusts that do not submit complete datasets will be penalised. One hundred per cent. of trusts are now submitting data, so we have closed that door. Some of the horses may have bolted, but we are getting properly on top of the data.

My hon. Friend the Member for Mid Derbyshire asked first about a draft treatment pathway for multiple myeloma. NHS England advises that that is currently in the process of being finalised. It has been the subject of public consultation and is being revised to take account of the comments received and the potential impact of treatments that have been removed from the CDF. The treatment pathway is due to be published in 2016. Secondly, on individual funding requests, NHS England does publish data on its website, including the number of individual funding requests for each drug on the national CDF list. Thirdly, on the issue of penalties for failing to produce data, we have built specific performance measures into the systemic anti-cancer therapy database.

My hon. Friend also mentioned multi-drug treatment cost reductions. It would not be appropriate for me to comment on NHS England’s individual commercial discussions with companies, but I can say that I am actively looking at ways to integrate better the Department of Health negotiators with NHS England commissioners through the accelerated access programme, so that we can get the benefit of time, cost and risk reductions in the pathway in more enterprising pricing mechanisms. I am confident that there is interesting progress to be made in that space.

I am aware that it is traditional for the Minister to leave a little time for the Member who secured the debate to wind up. I have around 15 questions that I have not had the chance to answer, so with your permission, Mr Streeter, I will write to the Members who contributed to the debate. I close by reiterating our commitment, as a Government, to get on top of the issues that have been raised. I hope that Members can see that, as the first Minister for Life Sciences, I am making progress in the direction that has been highlighted.