The Cancer Drugs Fund

The Cancer Drugs Fund was set up by the Coalition Government in October 2010 and should continue until the end of March 2016 when it is hoped that a long term, fair and financially viable alternative will take its place. The NHS already spends £1.3 billion annually on cancer drugs, and the CDF is additional money - worth £340 million per year - specifically set aside to pay for cancer drugs that have not been approved for use by the National Institute for Health and Care Excellence (NICE) and therefore not routinely available on the NHS.

The often contentious CDF has offered access to newer drugs which seek to extend life rather than cure cancer, for patients who have exhausted the drugs available to them via the NHS. There is much controversy over the cost (often tens of thousands of pounds per patient) of such drugs which may, it is claimed, only extend life by a few months, and that making special arrangements for cancer patients comes at the expense of people with other diseases.

There is further debate over the unfairness of the fund which can only be accessed by people who live in England, whilst those in Scotland, Wales and Northern Ireland cannot apply and may be denied drugs which could prolong their lives. The governments of Scotland, Wales and Northern Ireland have chosen not to create a cancer drugs fund, but do have an applications process to their local health boards, which apparently are often not successful, prompting demands that access to cancer drugs needs reviewing urgently in these countries.

Drugs for advanced breast cancer only available via the CDF

The following drugs for treatment of advanced breast cancer have all recently been reviewed for access via the CDF:

Anyone who is already being treated with any of these drugs will continue to receive it.

To find out which drugs are currently available or delisted via the CDF (latest update September 2015), visit:

Latest news (Feb 2016)

The next stage in the future of the CDF, following the 12 week public consultation, was decided at the NHS England Board meeting last week. Now in the hands of NICE, the new CDF will start on 1 July 2016 to ‘allow for further work on the operational detail’. It will be a managed access fund with a fixed budget of £340 million. The CDF has been closed to new drugs since May 2015 and this will continue until July.

All new drugs will be evaluated by NICE, who will place the drug in one of three categories - ‘available’ on the NHS, ‘not available’ on the NHS nor via the CDF, or ‘maybe’. The ‘maybe’ drugs will be funded through the CDF for an agreed period, whilst their effectiveness is evaluated.

The approval process has been speeded up, which is good news. But it appears that NICE will be applying the same criteria as they were using in 2010, when the CDF was deemed necessary to ensure cancer patients had access to the drugs they needed - because those drugs did not meet the strict NICE criteria. So it would seem that we are taking a definite step backwards.

All the drugs currently on the CDF list will be re-assessed too, but will continue to be available in the meantime. NHS England have made it clear that these drugs will not be withdrawn from anyone currently being treated with them.

Latest news (Sept 2015)

Cancer Drugs Fund – delisted drugs

NHS England recently announced that sixteen drugs will be removed from the Cancer Drugs Fund. Two of these drugs, Trastuzumab (Kadcyla) and Bevacizumab (Avastin), used to treat advanced breast cancer, are amongst those which will no longer be available. The decision comes into effect from 4 November 2015.

Pharmaceutical companies are thought to be appealing these decisions whilst major cancer charities and patients have expressed their dismay. Currently discussions are underway for there to be a new style of Cancer Drugs Fund that will become operational in April 2016. It is understood that the National Institute for Clinical Excellence (NICE) will take control of the fund and will allow greater flexibility for the use of cancer drugs.

Investigation into the Cancer Drugs Fund

The Investigation conducted by the National Audit Office into the Cancer Drugs Fund was published on 17th September 2015. The investigation covered:

Read the full Investigation Into The Cancer Drugs Fund report on the National Audit Office site.

Sections 12 and 16 are perhaps of greatest interest to those who do not wish to read the full 40 page report so have been reproduced below:

Section 12 - What impact has the Fund had on patient outcomes?

“Data on patient outcomes to evaluate the impact of the Fund are not available. The Department of Health (the Department) recognised the importance of outcomes data when it set up the Fund. However, hospital trusts were not mandated to submit data to the national chemotherapy dataset until April 2014 and there are still significant gaps in the data.

"The dataset has not been able to distinguish treatments paid for by the Fund from those paid for through routine NHS commissioning but, in July 2015, NHS England and Public Health England established a data-sharing agreement, which should enable the outcomes of patients supported by the Fund to be tracked. In addition, the data submitted by trusts are not complete; for example, in 2014-15 only 7% of records had an outcome summary”

The report expands further on patient outcomes in Part Four (page 27).

Section 16 - What is the future of the Fund?

“All parties agree that the Fund is not sustainable in its current form and NHS England is developing proposals for reform. The Fund was intended as a temporary measure until the government put in place a new pricing system when the existing Pharmaceutical Price Regulation Scheme expired in 2013. However, no new pricing mechanism has been introduced.

In July 2015, NHS England proposed that the Fund should become a ‘managed access’ fund that would pay for promising new drugs for a set period before NICE decides whether the drugs should be recommended for routine commissioning. The implication of NHS England’s proposals is that the Fund would no longer support the provision of drugs that have been appraised but not recommended by NICE. NHS England plans to consult on its proposals in autumn 2015, with the aim of implementing the new arrangements from April 2016”.

The report expands further on the future of the Fund in Part Six (page 33).

Cost versus Benefit

Cancer drugs, particularly newer drugs, are known to be very expensive, hence decisions have to be made on a cost-benefit basis and some have been removed from the fund because they are not considered to be cost-effective or there is limited evidence to show that they work well enough. The Government keeps the CDF under review and makes changes to the drugs available. The CDF was only ever meant to be a stop-gap solution until a comprehensive medicines pricing deal was developed between pharmaceutical companies and the NHS to provide a long-term sustainable solution.

There is an argument that in the real world, the cumulative benefits of different drugs is not taken into account during the assessment of a drug’s value and clinical effectiveness. Evaluation of cancer drugs by NICE are based on clinical trial data that are short term so give no consideration to the management of advanced breast cancer where it is common for patients to try one drug for a few months, then another then another – some may work for a time then stop working, whilst others may not work at all. Specialists currently have no way of knowing if an individual patient will respond to any given drug, it is a trial and error situation which is highly stressful for the patient and unscientific but the best on offer at present.

The situation is not helped by some media articles suggesting that other patients may suffer because of the amount of money spent on cancer drugs, or that it is a futile waste of money just to give terminally ill patients a few months more of poor quality life.

Anecdotally, many patients with advanced breast cancer can tell of their experiences of living good quality lives as partners, mothers and employees and may be living substantially longer than a few months with some of the drugs now denied to others. It is most distressing to be told that your life is not worth extending because of cost. Individuals, patient groups and cancer support groups campaign relentlessly for a fairer system so that everyone who needs the drugs available can access them.

How to apply for drugs

Your Oncologist, supported by the clinical cancer lead for your hospital, must apply to the CDF to access drugs from the list of those available. You must meet certain criteria and show that all other options have been used or considered. Decisions are made by one of four regional CDF panels (North, Midlands, South and London, East ) made up of specialist cancer doctors, pharmacists, public health specialists and patient representatives, who will consider:

Decisions are usually made quickly – within a few days. If the application is rejected, your Oncologist can appeal if they believe the correct process was not followed or did not take into account all the evidence available.

What can you do if the drug you want is refused?

If a drug is refused by the CDF or becomes de-listed, this can be very difficult to cope with – often causing much distress to patients who might feel they have been denied their last option for treatment. Speak to your Oncologist who should be able to explain why a particular drug has been declined. It may be possible to self-fund a drug, but this would be very expensive. Ask about clinical trials or other options.

Northern Ireland

In Northern Ireland currently the only way to access those drugs listed on the CDF for England, is through an Individual Funding Request. There is no criteria for this, it’s not based on age or on first come first served, it’s purely pot luck and 95% of applications are denied. Mechanisms need to be found to allow greater access to these medicines in Northern Ireland.

In February 2015, The Northern Ireland Health Minister announced recommended changes to the current drug approval process. Four key recommendations have come out of the review and will be put out to public consultation:

Latest News - Northern Ireland

The health minister for Northern Ireland, announced in September 2015 that he has signed off £1.5 million for NICE - approved specialist drugs for several non-cancerous diseases and advanced renal cell cancer, to be made available for patients.

One major cancer charity in Northern Ireland welcomed the approval for increased funding but said it did not go far enough as there was no movement at all for non-NICE approved drugs.

You can read the full news bulletin here: http://www.bbc.co.uk/news/uk-northern-ireland-34277248

Scotland

Medicines in Scotland are assessed by the Scottish Medicines Consortium (SMC). The SMC advises the NHS Health Boards about medicines, and aims to make sure that people have the same access to treatment wherever they live in Scotland. The purpose of the SMC is to accept for use those newly licensed medicines that clearly represent good value for money to NHS Scotland.

The SMC analyses information supplied by the drug manufacturers on the health benefits of the medicine and justification of its price. As the NHS has limited resources, the SMC works to make sure that those medicines which represent good value for money are accepted for routine use as quickly as possible so that they can benefit patients. The Consortium is made up of lead clinicians, pharmacists and health economists together with representatives of health boards, the pharmaceutical industry and members of the public.

Applying to your health board

Under the current system, if you and your cancer specialist think you would benefit from a particular drug or treatment that has not been approved by the SMC, you can apply to your health board asking for it to be made available to you as an exception from its usual rules. In Scotland, these applications used to be called Individual Patient Treatment Requests (IPTR).

You need to ask your cancer specialist or GP to make the request on your behalf. An IPTR needs to be made by someone who knows your medical situation well and believes that the drug or treatment will help control your cancer. They must show why you are more likely to benefit from a medicine than would normally be expected. You can only apply for a drug that has been licensed for your particular condition.

The Scottish Government is currently reviewing its policy and developing a new system for access to new treatments. The new system was expected to be in place from early 2014. The aim is to make Scotland’s drug approval system more transparent and to improve access to medicines for end-of-life care and treating very rare conditions.

The Peer Approved Clinical System (PACS) will replace the Individual Patient Treatment Request (IPTR) for using medicines not approved for regular use in the NHS. This would give clinicians the freedom to prescribe the medicines they feel will best help their patients without the need to demonstrate exceptional clinical circumstances.

The SMC plan to transform their drug approval through the introduction of a new Patient and Clinician Engagement (PACE) meeting to give patient groups and clinicians a stronger voice in SMC decisions for life-limiting and rare conditions. Pharmaceutical companies will also have an additional opportunity in the new process to put forward a Patient Access System which should make their medicines more affordable.

For more information about the Scottish Medicines Consortium and PACE visit: https://www.scottishmedicines.org.uk/files/PACE/PACE_factsheet_FINAL_2.pdf

What you can do if you live in Scotland and treatment isn’t available?

If a request for a drug is denied, the reasons for this will be explained, and you will be told how you can appeal against the decision. Some people have been able to get original decisions changed through appeal. You can appeal if you think the panel’s decision was not justified or if the proper process was not followed. You can only appeal if your doctor supports your decision.

If your appeal is unsuccessful, you can’t appeal again, but you can use the NHS complaints procedure or write to the Scottish Public Service Ombudsman. You can also seek legal advice or contact the Patient Advice & Support Service at: www.patientadvicescotland.org.uk/

Wales

There is no Cancer Drugs Fund in Wales and no intention of one being set up despite public pressure and the opinion that this is an obvious injustice. Wales usually follows NICE decisions on access to medicines. Patients in Wales must apply for health board funding through an Individual Patient Funding Request (IPFR). Decisions are made by the All Wales Medicines Strategy Group (AWMSG).

Research by the Rarer Cancer Foundation in 2013 found that patients in Wales are four times less likely to receive newer treatments than those in England. Only 18% of all applications (across all medical specialities) get funding, so it is a low approval rate. All drugs approved by NICE are available in Wales, the slight deviation is that there are a few drugs which the local health boards won’t pay for as they are expensive.

However, this situation is changing very soon as breast cancer groups have been working with local politicians to ensure a fair and accessible system by the introduction of a Welsh Medicines and Treatments Fund for treatments not available on the NHS.

You may like to contact the Welsh Patient and Advisory Service at: www.wales.nhs.uk/sitesplus/862/page/65382

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