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*Updated 26/02/2016*: The NHS England Board has now agreed to the take forward the proposals within the consultation. The new system is due to be fully operational from 1st July 2016. 

For just over five years, a temporary chunk of Government money has plugged a hole in how the NHS in England pays for cancer drugs.

In that time we’ve seen the costs of new drugs swell. And the NHS has struggled to balance these rising prices with cancer patients’ needs.

It’s fair to say that the system is not fit for purpose.

England’s recent cancer strategy confirmed this, and reports from the National Audit Office and the Public Accounts Committee have made it clear that change is needed.

But today, an opportunity to start sealing up the holes in our drug approval process begins.

Back in November, the Government’s health watchdog, NICE, and NHS England unveiled plans to reform how they pay for and approve new cancer drugs. And since then, they have been asking for responses on the plans as part of a consultation process.

That consultation has now closed, and speculation on any resulting changes to the Cancer Drugs Fund has begun.

We’ve submitted our thoughts – which you can read here – following discussions with patients and doctors to make sure those most closely affected by the Fund have their voices heard.

As things stand, we think the proposed changes are a positive step, and NICE and NHS England shouldn’t delay in acting on them. But it’s also important that discussions to find the best possible system for patients, as well as NHS budgets, don’t stop now – these changes should be seen as a starting point.

So what are the key proposed changes being put forward for the Fund?

‘An important step forward’

In the current system, costs have spiralled and some drugs have had to be removed from the Fund as budgets are squeezed – it’s clearly unsustainable. We’ve already laid out what we think the drug approval system should look like. And the new proposals go some way towards achieving this.

Central to the proposals are that NICE will be able to say ‘maybe’ to some drugs, making them available to patients on a conditional basis – supported by a new version of the Fund – where there is uncertainty about how effective the drug is. This is good news because in the past, NICE has only been able to say ‘yes’ or ‘no’ to drugs.

This so-called ‘managed access’ approach would allow time for doctors to prescribe those promising drugs to patients, while collecting more data on how effective the treatment is. These data will then be used to help make a final decision on whether the drug should be made routinely available across the NHS or not. And setting up clear criteria for assessing how and when a drug is made available, or removed, from the Fund gives greater certainty to patients about their treatment options.

We have heard from patients that they want a process that places an emphasis on the added benefit of new drugs, collects good data, and acts as quickly as possible. And these proposals do that

– Sir Harpal Kumar, Cancer Research UK

The emphasis on collecting data is a big one. And an approach of funding drugs while collecting more data on how effective they are will form a big part of making the whole system of approval more efficient and evidence-based. Put simply, it’s shocking that this has been lacking in the system for the last five years.

Another positive move is that NICE will be able to make recommendations on whether a drug should be routinely available, or available through the Fund on a conditional basis, much earlier. This means that patients can access these drugs much sooner after they have been licensed for use than the current system allows. Previously it has taken 6-18 months after a drug is licensed for NICE to make a recommendation. But the proposals commit to NICE making a draft recommendation before the drug is licensed, and a final decision within 90 days.

NICE will also look at all cancer drugs, where previously it didn’t assess drugs used to treat rarer cancers. It will be vital that they take a flexible approach to this, where collecting data through clinical trials is often a challenge due to smaller numbers of patients being affected by these cancers.

Crucially, all these changes help strike a balance between ensuring that a drug is truly better than what’s already available while also making sure ‘promising’ drugs are available to patients without delay.

It’s a good start, but there’s still more to be done.

Our chief executive, Sir Harpal Kumar, believes that the proposals from NICE and NHS England “represent an important step forward” and that NHS England and NICE “should now work to clarify some of the details of the proposals so the system can be transformed without delay.”

“We have heard from patients that they want a process that places an emphasis on the added benefit of new drugs, collects good data, and acts as quickly as possible. And these proposals do that,” he says.

So it’s vital that they don’t delay in making these reforms, and continue on what will be a much longer road towards truly transforming the system.

Wider reforms

An important part of ensuring a drug gets funding will lie in the opportunities given for drug companies to negotiate on pricing. The Public Accounts Committee heard from companies that they want better opportunities to discuss pricing with NHS England. We hope that these changes will provide a way for innovative solutions on drug pricing to be discussed. So that NHS money can go further in allowing patients to access to the best drugs.

As we consider ways to ensure the most promising new treatments are hitting hospital wards as soon as possible, it’s also important to look at how drugs are developed. And these proposals need to be viewed as part of the bigger picture of research in the UK.

Government investment in the way science is carried out in the UK makes it an attractive place to work. In some cases, drug companies couldn’t develop new treatments without Government and charitable investment – for example, the drugs abiraterone for prostate cancer and temozolomide for brain cancer wouldn’t exist without Cancer Research UK-funded research.

So we are also working on reducing the risk that comes with developing new drugs, and improving clinical trials to make the process cheaper and quicker.

On top of this, initiatives like the Early Access to Medicine Scheme can help make the most exciting new treatments available earlier in their development. This is particularly important for rarer cancers, where the number of patients that can take part in clinical trials is small, so we are keen to understand how this will work within the reformed system.

These are just a few examples of how the proposed changes to the Cancer Drugs Fund answer some questions while still raising others. But while some details still need to be worked through, it’s vital that we start making these changes now, with further work to do to address the rest of the system in the long run.

What happens next?

We’ve written before about how simply tweaking the Cancer Drugs Fund isn’t the answer to having a sustainable way of approving cancer drugs in England.

And the fact this is solely focussed on England raises further challenges. We think it’s crucial that drug approval processes across the UK, but particularly in Wales and Northern Ireland where they follow NICE guidance, Scotland has its own separate system – should consider these changes and understand any impact on patient access to the best evidence-based treatments.

More broadly, the Government needs to begin working with NICE to review whether its cost-effectiveness measures should be changed to help reach a more efficient and fair system.

For now, it would be easy to say ‘let’s wait until all the answers are in place’. But that would be short-sighted.

“While it is right to focus on all the elements of a broken system to identify where we need to apply remedies, we must not wait for all the solutions to be apparent before we begin to take action,” says Sir Harpal Kumar.

NICE and NHS England, with Government support, mustn’t delay in bringing these proposed changes into practice. Only with that hole sealed can we begin closing the others.

Nick

Update 26/02/2016:

The NHS England Board has now agreed to the take forward the proposals within the consultation. The new system is due to be fully operational from 1st July 2016. Any patients currently on drugs funded via the CDF will be able to continue with them until their doctors agree they should stop – and these drugs will continue to be funded until they are looked at by NICE sometime in the coming year. We will be monitoring the changes as they are rolled out.

Our Chief Executive, Sir Harpal Kumar, said: “Cancer Research UK welcomes today’s decision to move forward with reforms to how the NHS makes certain cancer drugs available to patients. We see this as a positive step in creating a more sustainable and flexible system.

“Importantly, we believe the proposals will bring more certainty to patients and doctors about the drugs that can be prescribed, and swifter access to promising drugs.”

Comments

Susan Davies June 16, 2016

I am truly thankful to cancer research for the work they do for us the ordinary people. I think and pray we find a cure sooner than later. I have a feeling we are not far off. Thank you. Keep up the good work and never give up.

Charles Purnell March 3, 2016

Hooray, it has been a disgrace that the FDA, for example, was straitjacketed against early
even if conditional, use of the new immunotherapy treatments, which will eventually cure without the debilitating effects of chemotherapy.

Andrew JClubb March 3, 2016

It has been a concern to me that huge sums of money are raised to fund Cancer Research, yet, when drugs are developed they are extremely expensive with Research costs being quoted as the reason.

Nick Peel February 29, 2016

Hi Ronny,
Thanks for your comment. For the drugs that were removed from the Fund last year, patients that were already receiving a drug before it was removed will continue to receive it for as long as necessary. For patients receiving treatment after last year’s removal of drugs, NICE would need to assess these drugs again under the updated regulations, following a submission from the drug company that makes the drug, before it would be made available to these patients.
Best wishes,
Nick, Cancer Research UK

Ronny February 26, 2016

What about drugs which were removed in last year’s cull please?

Robert February 15, 2016

So how will drug makers respond to this? A short article here with some theories: https://www.linkedin.com/pulse/cancer-drugs-fund-dead-so-why-replacement-another-philip-ford

R Butcher February 13, 2016

Serms to be some confusion about the roles. Whether new drugs are effective and safe compared to existing available standard of care treatment is determined by the European Medicines Agency (EMA -HQ in London) in a very vigarous process. Only after obtaining marketing authorisation (licensing) from the EMA is a drug available for sale in the EU. So NICE does not need to re-assess whether a drug has a positive benefit/risk profile (works or not), it just looks at costs compared to existing treatments. NICE performs a valuble role, and could probably do more to negotiate drug prices, but its time would be wasted if it concentrates on re-assesing the EMA’s assessment.