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Providing support to anyone affected by blood cancer
The Cancer Drugs Fund (CDF), launched in 2011, was an extra pot of money to fund cancer drugs. It was a way to make sure patients had access to drugs that would not otherwise have been routinely available from the NHS because of their cost. The CDF could fund drugs that:
Since it began, the CDF has helped over 84,000 patients receive life-extending drugs, fulfilling its purpose to widen access to drugs.
A particular benefit of the CDF is that it enabled patients with rarer cancers access to effective treatment, where there may not have been sufficient data for it to be recommended by NICE under their standard approach.
Due to the way that drugs were appraised by NICE, numerous drugs entered and were funded by the CDF over the years and, as there was no “exit criteria”, they were funded indefinitely.
By 2015 the CDF had been severely overspent and it had become clear to the government and NHS England that it was unsustainable and something needed to change.
As a result, NHS England, in partnership with NICE, launched a review which was followed by a 12-week consultation that set out plans for a new operating model. This gave stakeholders, like Leukaemia CARE, the opportunity to review and comment on the new proposals.
The changes that are due to take effect from July 1st will see the joining of the NICE appraisal and the Cancer Drugs Fund process.
The proposals suggest that the CDF will move to the beginning of the appraisal process and will temporarily fund drugs (whilst more data is collected to rule out uncertainty) that show “plausible potential” to be recommended by NICE as cost effective.
Drugs that already have enough data and demonstrate their cost and clinical effectiveness will receive a “yes” decision and be routinely funded without needing to end the Cancer Drugs Fund.
Drugs that are seen to not be cost and clinically effective “enough” and do not show that they have “promise” will receive a “no” decision and will not be routinely available to NHS patients or enter the CDF.
All drugs that are currently on the existing version of the CDF will be reviewed under this model by the end of 2017.
We’re concerned that these policy changes will affect access to drugs for all rarer cancer patients but many of the drugs due to be reviewed are for blood cancers.
Although the proposed reforms may lead to a more financially sustainable process, the challenges in the methods (particularly for rarer cancers) used by NICE for the appraisal of cancer drugs have not been looked at. The way that NICE appraises drugs is not appropriate for indications with small population sizes. Although the drugs are clinically effective due to the lack of data, under NICE’s standard approach there is too much uncertainty to recommend them as a cost effective use of NHS resources.
This means that many drugs (particularly for rarer cancers, including blood cancers) will struggle to be successfully recommended for routine use. In the past, drugs such as these would be funded by the CDF – this will now not be an option in the future.
As a participant in the drug appraisal process, Leukaemia CARE is concerned that the proposed changes to the appraisal process could mean that access to rarer cancer (including many blood cancers) drugs could be reduced. Although patients who are already receiving treatments affected by these policy changes will continue to do so, the changes could affect future treatment options for existing patients (should their current one stop working and they need a new line of treatment) and new patients, yet to be diagnosed.
There is the added concern that the reform could mean inequalities in access to rarer cancer treatment throughout the UK as some drugs may be approved for use in Scotland or Wales but not in England, should NICE be unable to recommend them. This is already happening with some drugs, for example, ponatinib has reduced access in England (and certain patients therefore struggle to access it) but there is less restrictive criteria in Scotland and Wales which enables more patients to access it.
To illustrate how these policy changes will affect real patients we have captured a number of chronic myeloid leukaemia (CML) patient experiences.
A number of CML drugs that are currently available via the CDF are under review - dasatinib, bosutinib and ponatinib. Although we have used CML treatments as an example, these changes could affect all patients with a rarer cancer (including many blood cancers).
For more detail on the challenges of access to rarer cancer drugs in England and why access to these drugs should be retained, see our patient experiences.