Cancer Drugs

Pauline Latham Excerpts

Tuesday 19th January 2016 Westminster Hall

[Pauline Latham (Mid Derbyshire) (Con)]

I beg to move,

That this House has considered the removal of drugs from the Cancer Drugs Fund list.

It is a pleasure to serve under your chairmanship, Mr Streeter. I secured this debate to raise the case of a constituent and to allow other Members to discuss the effects that removing drugs from the Cancer Drugs Fund will have and, I suspect, the current consultation on the fund. The latest delisting of some drugs from the fund has happened since the last debate on cancer drugs, and I am sure that many Members have heard from constituents who have been affected.

In November, I was contacted by a constituent, Tina Spencer-Keyse, about her husband Graham, who in 2010, at 51, was diagnosed with myeloma, which is a rarer cancer caused by abnormal cells in the bone marrow, where all blood cells are made. Myeloma is a relapsing and remitting cancer, meaning that there are periods when the myeloma causes symptoms and complications and needs to be treated, followed by periods of remission or plateau, when the myeloma does not cause symptoms and does not require treatment. Because myeloma is relapsing and remitting, it is crucial that clinicians are always one step ahead of the disease and that there is a treatment option for the patient to receive when it returns, especially when other treatment options have already been used.

Until August 2015, Tina and Graham had hoped to use one further drug treatment available for myeloma. Pomalidomide, also known as Imnovid, is used to treat relapsed multiple myeloma patients who have received prior treatment regimens but for whom the disease has continued to grow and spread. Imagine how devastated the Spencer-Keyse family were to find out then that the drug had been removed from the list of drugs available through the fund. Following the delisting, there are no other licensed treatments available for myeloma patients in England. Patients have no other options once the drug they are currently taking fails. They have nowhere else to go. Imagine the frustration, and probably anger, that they and thousands of others feel when a drug that was available just months before is no longer available to them but is still being used by other patients who were prescribed it before the delisting. The situation is such that a doctor might see one patient in the morning and be able to continue prescribing a treatment yet see another patient with the same disease afterwards and not be able to do so, even when they know it could help.

[Nick Thomas-Symonds (Torfaen) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Streeter. I congratulate the hon. Lady on securing this important debate. Another example of a drug that has been delisted, causing similar frustration, is Abraxane, which is used in the treatment of advanced pancreatic cancer and was removed from the Cancer Drugs Fund in November. First, does she share my concern that although the delisting applies only to England, it causes worries across the rest of the UK as to whether the drug will become unavailable there, too? Secondly, although of course a consistent set of rules must be applied, one of the issues with pancreatic cancer is that 80% of patients are diagnosed when the cancer has already spread. Although Abraxane may only give a few weeks more life, those weeks may double life expectancy.

[Mr Gary Streeter (in the Chair)]

Order. Interventions must be brief.

[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.

[Julian Knight (Solihull) (Con)]

I congratulate my hon. Friend on securing this important debate and on the passion she is showing in putting her case. What does she think about NHS England’s proposal that the Cancer Drugs Fund should become a managed access fund that pays for promising new drugs for a set period before the National Institute for Health and Care Excellence decides whether the drugs should be routinely available on the NHS? Does she think that is a good idea or not a good idea?

[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.

[Mr Gary Streeter (in the Chair)]

Colleagues, we have 40 minutes until the winding-up speeches begin at 3.30, so we are looking at six-minute speeches, by voluntary submission. I will call Jim Shannon first, as he has to go and chair an important all-party parliamentary group; I hope that colleagues will accept that. He has promised to speak for no more than five minutes.

--- Later in debate ---

[Pauline Latham]

I thank all Members who have taken part in this very important debate. Turning to my hon. friend the Minister, I would just like to say that imminent is great, but it might not be imminent enough for my constituent Graham. He needs help now. I accept that the Minister is doing all he can to accelerate things, but imminent might not be soon enough.

Question put and agreed to.

Resolved,

That this House has considered the removal of drugs from the Cancer Drugs Fund list.