Comment

Improving access to cancer drugs

Nina Pinwill, the newly appointed national Cancer Drugs Fund (CDF) operational lead at NHS England, reflects on her first couple of months in the role and explains what the new changes mean for the system and patients.

The National Institute for Health and Care Excellence (NICE) is the body that make decisions on what cancer treatments are funded in the NHS. This is based on an assessment of the clinical and cost-effectiveness of the treatment and ensures that all NHS patients have equitable access to the most clinically and cost-effective treatments that are available. 

The ‘old’ CDF, which operated between April 2011 and April this year, funded cancer drugs NICE had not considered or had not recommended for routine NHS commissioning because they did not meet NICE’s clinical and cost-effectiveness thresholds. 

The Fund helped nearly 100,000 people access treatments not routinely available on the NHS. However, there was a consensus that it was not working in its previous form and needed to evolve, so NHS England closed the doors on the ‘old’ CDF. 

In partnership with NICE, Public Health England, the DH and charities, new arrangements were developed to redesign the CDF and put it on a more sustainable footing. These changes were consulted on at the end of 2015. 

At the end of July this year, NHS England and NICE unveiled their new collaborative approach to the appraisal and funding of cancer drugs in England. This new approach links the decisions made by NICE to the CDF money and means patients are getting faster access to new cancer treatments than ever before in England. 

What’s changed? 

The new arrangements have fundamentally changed the idea behind the CDF, while maintaining the aim of speeding up access for patients to cancer treatment. 

New financial control mechanisms ensure that the £340m annual budget cannot overspend and does not, therefore, divert resources away from other important areas of care. 

At NICE the appraisal process now starts earlier, with the aim of publishing draft guidance before drugs receive their licence. Once licensed, and if the draft guidance published is positive (recommending routine commissioning or for use within the CDF), they are immediately funded, through interim arrangements, by the CDF. This means there is the potential for patients to be treated with new cancer drugs up to four months earlier than they would have been in the old system. 

NICE now appraises all cancer drugs – that’s around a 20% increase in its annual outputs, and it has increased its capacity to meet that demand. 

NICE and NHS England are also responding to the industry need for advice and assistance on topics such as the plausible assumptions they can use in economic models, for example, and how best to present their data to have a successful appraisal. The key message here is for pharmaceutical companies to price their products responsibly. 

Another difference with the new arrangements is that when a drug shows genuine promise, NICE – instead of having a binary decision to make about a drug on whether or not it will be available to patients – can now recommend a drug is funded through the CDF whilst data is collected to show its benefits. This means that patients can receive new treatments with genuine promise, while evidence is collected on how they work before NICE reassesses them. 

So the CDF is now a transitional fund for new cancer drugs, enabling patients to get drugs before they are routinely commissioned and be part of the real-world evidence collection, allowing the evidence to emerge to show how well the drugs work in practice. 

In early October, the first NICE draft recommendation for a drug to be funded by the CDF was issued for osimertinib, for treating locally advanced or metastatic EGFR T790M mutation-positive non-small-cell lung cancer. The company and NHS England have agreed the managed access arrangements and patients can now access the drug whilst further evidence is collected. 

Another major benefit of the new arrangements is the Fund is there to instantly pay for drugs that NICE has issued draft recommendations for the drug to be routinely commissioned. At the point NICE publishes its recommendation the Fund starts to pay for the drug, bridging the gap, whilst the work is done for the drug to move into baseline commissioning. Again, patients are getting new cancer drugs earlier than ever before.

The challenges 

So for this newbie, moving from a 16-year career at NICE, where I was influential in developing the processes used for technology appraisal, moving to NHS England, now with responsibility of actually making NICE recommendations happen in practice, on the ground, I can see the challenges for the service. 

Getting the information out to the right people in trusts that the drug is available, the CDF is paying for it and the process to follow to access the drug for prescribers isn’t perfect. There are requirements for prescribers around registering patients on a database and data to be entered about each patient, for example. 

I have regional teams who support me with all that – the information we get back from the trusts about what’s been prescribed in relation to the CDF is essential to prove it is working, is sustainable, and is bringing benefits to patients, the service and taxpayers. The key is that the arrangements in place to manage the CDF cannot overburden the service. 

The new CDF also has in-built systems to ensure the budget cannot be overspent – the expenditure control mechanism can come into play if the Fund is overcommitted at the end of a financial year. The mechanism requires companies that have had drugs funded by the CDF to pay a rebate to NHS England. This rebate is distributed between the companies as a pro-rata calculation of the spending on each company’s drugs as claimed by trusts. 

Measuring success 

How will we know the new CDF is a success? Firstly, it’s my job to ensure it stays within budget. Secondly, it is about ensuring that the managed access arrangements NHS England agree with companies are workable within the NHS system. 

Thirdly, maintaining stakeholder support for the Fund will be crucial – this includes patients and NHS staff, the government and industry. Lastly, being able to show patients have benefited from earlier access to new cancer treatments will be the acid test. 

Conclusion 

This new way of commissioning cancer drugs aims to benefit patients, taxpayers and those pharmaceutical companies that are willing to price their products responsibly. I look forward to the coming months and the evidence developing to prove the success of the new CDF.

FOR MORE INFORMATION

W: www.england.nhs.uk/cancer/cdf

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