Responsible for deciding which drugs will be funded for the world’s largest single-payer healthcare system, the UK’s National Institute of Health and Care Excellence (NICE) appraisal process is world renowned.

Traditionally NICE determines whether a drug should be made routinely available to patients through the NHS – this decision was a yes or no and based on both cost and clinical effectiveness. However, this all changed in 2016 when NHS England created the managed access-focused Cancer Drugs Fund (CDF), the first of its kind in the world.

The CDF allows for the most promising and innovative oncology treatments to be approved even if there are uncertainties about the product’s clinical effectiveness.

Under a CDF managed access agreement, patients have immediate access to the drug and pharma companies are reimbursed for their product while further studies are carried out to resolve the remaining questions around efficacy. At the end of the agreed period, NICE will determine if, following further trials, the drug is now eligible for routine access through the NHS.

According to the NHS’s fourth quarter 2018 to 2019 CDF activity update, in the past three years, 31 managed access agreements have been made between companies and the CDF. So far only two drugs have been re-appraised following the CDF process and both have been recommended for NHS routine use.

NHS England head of commercial operations and CDF national operational lead Nina Pinwill explains the benefits and successes of the fund to date in terms of patient access to drugs and the NHS’s reimbursement model, as well as noting particularly revolutionary drugs that have been made available to UK patients as a result of this fund.

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Allie Nawrat: What were the motivations behind the founding of the CDF in 2016?

Nina Pinwill: A previous model of the CDF was set up by the UK Government in 2011 as a temporary solution to help patients gain access to cancer drugs not routinely available on the NHS. The fund was reformed by NHS England and NICE to improve patient access, speed up approvals and deliver better value for taxpayers’ money in July 2016.

AN: How has the CDF transformed funding processes in the UK?

NP: NHS England [which directly funds the CDF] now has more direct involvement with industry across different indications, working closely with NICE, to help to find deals that work for patients. Previous arrangements would be down to industry proposing a price which either resulted in NICE saying yes or no to the drug.

The new approach provides a mechanism for providing patient access to drugs that show real clinical promise, but where there remains uncertainty around clinical and cost-effectiveness. This uncertainty is then resolved through real-world data collection, often combined with innovative outcomes-based reimbursement schemes.

AN: How does the CDF help to bring innovative cancer drugs to patients quicker?

NP: The reforms to the CDF have led to the NICE appraisal process starting much earlier for newly referred drugs, with the opportunity to publish draft recommendations before drugs receive their licence, and then final guidance within 90 days of that.

Patients are able to benefit from treatment with new cancer drugs up to five months earlier than was previously the case. All cancer treatments recommended by NICE, whether for routine commissioning or the CDF are now available to patients as soon as positive recommendations are published by NICE.

The CDF has a fixed annual budget of £340 million. If this fixed budget is exceeded, the additional cost is paid back by companies who generate income from the CDF via a proportional rebate to NHS England and NHS Improvement.

AN: How successful has the CDF been in its first three years of existence?

NP: Since the reforms to the appraisal and funding of cancer drugs was introduced in July 2016 to date, two cancer treatments have been reviewed by NICE following a period of data collection. Both treatments have been recommended for routine commissioning in the patient population that was referred to the CDF. This demonstrates the benefit of allowing earlier access for patients to promising new drugs while further data is collected to evaluate their effectiveness. Two further topics are due to be reviewed by NICE before the end of 2019.

In terms of patient access, between July 2016 and August 2019, the CDF has funded 78 drugs treating 155 different cancer indications. Over 37,300 patients have been registered to receive a CDF funded treatment, of which 8,200 patients have been registered to receive treatment sooner than they previously would have through interim funding arrangements in the CDF and 16,100 patients have been registered to receive promising new treatments while further evidence is collected to address clinical uncertainty.

AN: Are there any particularly noteworthy examples of drugs that have been approved through the CDF?

NP: A string of ‘smart deals’ [have been] struck to. [As well as successfully] striking the first full access deal in Europe for CAR-T therapy via the CDF [Gilead’s Yescarta] which can potentially cure some children and adults with blood cancers where other treatments have failed, [a noteworthy success was] reaching a deal to make the life-extending lung cancer drug pembrolizumab (Keytruda) available for routine use on the NHS.

Investment in world-class, cutting edge technologies and treatments is at the heart of the NHS Long Term Plan, [meaning] a string of ‘smart deals’ struck to drive value for the taxpayer and benefits for patients [and these expand beyond oncology and into other indications covered by NICE.] [Examples include:] a deal to make ocrelizumab, an innovative multiple sclerosis drug available, a ground-breaking deal which could eliminate hepatitis C and a £300 million saving after negotiating deals with five manufacturers on low cost versions of the health service’s most costly drug, adalimumab (Humira). [As well as a] deal to make nusinersen available – the first treatment that targets the underlying cause of spinal muscular atrophy.