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Tighter controls for cancer drugs funding

Dramatic overspend on some cancer drugs prompts strict limit on spending

It will never be easy to explain to a well-informed patient with cancer why the NHS does not fund a drug that could be their last hope.

Picture credit: iStockphoto

In 2010, the cancer drugs fund (CDF) gave access to drugs not routinely available on the NHS, particularly for people with rarer cancers. It followed a pledge by prime minister David Cameron that the NHS should no longer deny patients with cancer the drugs they need on cost grounds.

Since then, 84,000 patients have benefited. Now, six years on, the model has been judged unaffordable and will be replaced to put funding on a sustainable footing.

For some time spiralling costs had put the fund’s future in doubt. The initial budget of £200 million had risen to £340 million for 2015/16, with a projected £100 million overspend. This led to the reassessing and delisting of some drugs, upsetting patients and cancer charities.

The fund was also criticised by the National Audit Office and Public Accounts Committee (PAC), not just for the overspend, but for a lack of outcome data which was branded unacceptable. The PAC also revealed that large numbers of patients who benefited had common rather than rarer cancers.

At the end of last year, fund manager NHS England and the National Institute for Health and Care Excellence launched a 12-week consultation on plans for a new operating model. Following 300 responses, the revamped fund was launched in April, going live on July 1 with a budget of £340 million.

Until now the fund has operated independently, providing funding and access to drugs that show promise for individuals, but which NICE hasn’t yet appraised or has rejected for widespread NHS use.

However, the changes mean NICE will now decide which drugs enter and exit the new ‘managed access fund’.

By the time a cancer drug comes to market, NICE will give it a ‘yes’, ‘no’ or ‘maybe’ rating. Where there is sound evidence of the drug’s effectiveness, it will be commissioned; clear evidence the other way means it won’t. If a drug shows promise, but cost-effectiveness is uncertain, it will enter the fund for a limited time to allow more detailed appraisal. This will usually be for up to two years, while the drug company gathers more evidence to show the medicine works and is fairly priced.

Fund management remains with NHS England. Stricter financial controls mean drug companies will also be required to pay into a contingency fund.

NICE will then conduct a shortened review to consider the drug for routine NHS commissioning. This will either result in the medicine moving on to routine budgets or, if the company has not demonstrated its case, being provided in ‘exceptional’ circumstances on application by a clinician.

In the transition, patients already on funded drugs will continue receiving them, but the fund will be closed to new drugs. Drugs on the list will be ‘rolled over’ and funded while the drug company co-operates promptly with appraisals. Cancer specialists can continue to apply on patients’ behalf with the support of their trust’s clinical cancer lead.

Meanwhile, NICE will apply new decision making to the drugs to decide if they stay on the list. The exception is off-label drugs, which will continue to be funded until a routine funding decision is made.

The CDF applies in England only, so the impact on the rest of the UK is unclear. Scotland’s is run by the Scottish Medicines Consortium, which is reviewing changes made in 2014 to increase transparency, patients’ role and access to new medicines, particularly for rare and end of life conditions. Wales and Northern Ireland follow NICE guidance. Where NICE has not ruled, Northern Ireland takes into account other advice, including that of the Scottish consortium.

The RCN in its consultation response welcomes a stronger role for NICE, but is concerned it is only a partial solution. The college wants to see a single, centralised system managed by NICE, where all approved drugs have been through a full appraisal, to avoid situations where ‘an initial decision could be made and then overturned later causing significant distress and confusion for patients and families’.

The college is also concerned that having a CDF means ‘nurses and other health professionals can be put under pressure from patients demanding treatment options that are not provided by the NHS or that may not be clinically effective in individual cases’.

It predicts that despite the new controls, spending on the fund ‘will inevitably be exceeded’ and questions whether it is a good use of NHS resources, pointing out that since its start, ‘the numbers of specialist nurses have declined dramatically’.

NICE’s involvement is welcomed by patients’ charity Myeloma UK, which petitioned the government last year after drugs Revlimid and Imnovid were removed from the fund. Kate Morgan from the charity says it will ensure ‘decision making is robust’ and that drugs aren’t suddenly withdrawn ‘arbitrarily’.

Drug Cancer No of patients
1. Enzalutamide Prostate cancer 1,341
2. Cetuximap Squamous cell carcinoma of head and neck and colorectal cancer 1,017
3. Bendamustine Chronic lymphocytic leukaemia, non-Hodgkin lymphoma, mantle cell lymphoma, multiple myeloma 939
4. Bevacizumap Breast cancer, cervical cancer, colorectal cancer, low grade gliomas of childhood, ovarian cancer 915
5. Radium-223 dichloride Prostate cancer 545
6. Eribulin Breast cancer 518
7. Ibrutinib Chronic lymphocytic leukaemia and mantle cell leukaemia 493
8. Abiraterone Prostate cancer 493
9. Pomalidomide Multiple myeloma 450
10. Pertuzumab Breast cancer 412
including drugs since delisted (NHS England)

Although the number of drugs on the CDF list will fall, in the long term the changes could lead to more cancer drugs being approved for routine use, she believes, because drug companies will have renewed incentive to improve their NICE submission.

Maria Noblet, past RCN cancer forum chair, believes that time will tell. ‘I share patients’ concerns that NICE’s track record of funding new treatments has been poor,’ she says.

See reflections page 28

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