In 2011, the Cancer Drugs Fund (CDF) was established to provide access to cancer treatments not routinely available on the NHS due to their failure to meet NICE’s clinical or cost-effective thresholds. Since then, it has helped nearly 100,000 people receive treatment they would otherwise have been unable to access. However, a lack of evidence on the results it yields and continual overspend of its £200 million annual budget led to the CDF becoming financially unsustainable.
A solution was needed, and it came in the form of a complete overhaul of processes, and bringing the control of the CDF under the jurisdiction of NICE. A number of important changes have been made to the previous model to help ensure that the fund remains solvent and sustainable in the long-term.
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Simply put, the CDF is now a ‘holding place’ for treatments where extra data is needed to enable NICE to make a better-informed yes or no decision in regard to long-term NHS funding.
So what’s changed?
Here’s a brief low-down on the key changes to the CDF The CDF now falls under the jurisdiction of NICE. For a product to gain admittance to the new CDF, the pharma company must sign up to a data collection agreement and a commercial agreement. These detail the clinical data that must be collected to enable NICE to make a better informed final decision, and an agreement on how the company will offer the drug to the NHS in a financially stable way.
A two-year time limit (with some wriggle room allowed for less common cancers) has been allotted for collecting data to address the areas of concern detailed by NICE, to enable them to make a more informed yes/no final decision. All eligible patients will have access to treatments in the CDF during this time. The fund’s annual budget has been increased from £200M to £340M. In the case of overspend, pharma companies with a product in the CDF will be required to rebate the extra costs back to the NHS.
An unknown impact
For pharma, the rebate of funds received from the CDF in case of overspend presents a big financial risk. A recent poll by Bright Talk, during their webinar ‘Cancer treatment access: Right strategy, right approach, right outcomes’ asked the audience ‘Will the changes to cancer drug access affect your decision to launch in the UK?’ A worrying 53% replied yes, with only 17% saying it would have no effect on their decision. The new proposal looks promising for the NHS, but if it is to be an effective long-term solution it has to work for pharma too.
A bright future?
So where does that leave us? The 90-day time period from market authorisation to NICE appraisal is faster than any other European country, meaning new treatments should be available to patients much earlier than before. This can only be seen as a positive step but, for this to be maintained, the fund must be financially viable. With an increased budget and a rebate scheme in place to ensure the NHS is not left crippled by overspend, the new CDF has the plans in place to enable a long-term future. But will the financial risks be too much for pharma who, at the end of the interim funded two-year data collection period, could still not receive a positive recommendation? That is something only time will tell.