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A brighter future for the Cancer Drugs Fund?

Published on 14/01/16 at 10:05am
The future is uncertain for patients who need costly cancer treatments

In November 2015, NICE and NHS England announced proposed changes to the operation of the Cancer Drugs Fund. This is currently a £340 million a year scheme in England to fund cancer patients' access to innovative treatments not routinely available on the NHS – either because NICE has not recommended them, or because they are awaiting appraisal.

Why the need for reform? Well, the Fund was only ever meant to be an interim measure, and as the price of drugs continues to rise, the number of treatments which NICE is forced to reject for cost reasons – despite in most cases being clinically effective – rises. This has meant the Fund has become financially unsustainable; the budget has climbed from an initial £200 million to today’s figure in five years. Increasing numbers of treatments have been removed from the list as a result of these financial constraints, denying patients access to medicines that could extend or even save their lives.

According to the proposals, when the Fund in its current form comes to an end in April, the CDF is set to become a ‘managed access fund’ within NICE and NHS England, and a transitional one where drugs stay on the list for a limited period of time, as opposed to the indefinite time in the current system.  The CDF will also be more closely linked to NICE’s decision-making process.

Under the new system, when NICE gives its initial technology appraisal (or draft guidance), it will give ‘yes’, ‘maybe’, or ‘no’ decisions. While drugs rejected at this stage will definitely receive no funding, ‘yes’ or ‘maybe’ drugs will receive interim funding through the CDF and be immediately available to patients until final guidance is given. The ‘maybe’ category is a new option for the reformed CDF, where NICE will be able to approve a drug for use on the NHS conditionally, before making a final decision.

When it comes to final decisions on genuinely promising new cancer drugs, the drug will be either approved for the NHS; be CDF-funded for up to two years while real-world evidence is gathered; or be rejected and receive no CDF (or NHS) funding.

In the case of ‘maybe’ drugs, where the promising treatment is funded by the CDF but more evidence is required, at the end of the two years, NICE will conduct a short reassessment of the drug. If it decides not to recommend the treatment, it is hoped (but by no means guaranteed) that the pharma company behind it may continue to fund the cost for patients already receiving it.

NHS England and NICE think these changes would allow faster access to promising drugs, and make it easier for the Fund to remain in budget. The proposals are open to comment until February 11, and leading cancer charities have urged interested parties to have their say on the suggested changes.

Prostate Cancer UK, for one, has a mixed view. It agrees the reforms will lead to faster and earlier NICE appraisal, as the regulator will assess new drugs at the same time as they are being assessed for their license and make draft decisions about access within a shorter period of time.

It also welcomes the new ‘maybe’ outcome. This means some patients will have access to the drug on the NHS for up to two years while the manufacturer collects data that can better demonstrate the treatment’s benefits.

The charity, however, is concerned that drugs not recommended by NICE will not receive any funding from the CDF, as they currently do in the interim, while NICE completes its appraisal. This means if NICE rejects a drug on a cost basis in draft guidance, it will not reach patients at all, even if it’s clinically effective.

As an example, PCUK cites Janssen’s Zytiga (abiraterone), pointing out that under the proposed new system, men would not be able to access the drug before chemotherapy because NICE has rejected it for cost reasons.

Rising drug costs linked to increased R&D expenses and other circumstances means cases like this would occur more and more. In recent months, NICE has rejected BMS’ Opdivo (nivolumab) for non-small cell lung cancer on a cost basis, despite recognising it as a promising treatment. It also initially rejected Novartis’ Farydak (panobinostat), despite the drug having demonstrated its ability to extend progression-free survival rates for multiple myeloma by 7.8 months in clinical trials.

Prostate Cancer UK also fears the new system would rely too heavily on pharma companies offering cuts to drug prices, and predicts the CDF pot will reduce in real terms year-on-year- meaning there will be less money available to fund new treatments with draft 'yes' or ‘maybe’ approvals.

This fear may be well founded. In November, five drugs were reinstated to the CDF, having been earmarked for removal in September as NHS England sought cost efficiencies. Roche’s Kadcyla (trastuzumab emtansine) and Janssen’s Imbruvica (ibrutinib) were amongst the treatments reinstated. However, they were in the minority to reach a successful compromise with the regulator and pharma companies are of course reluctant to offer their drugs cut-price if they can possibly avoid it.

The pharma industry awaits the comments collected during the consultation period and what impact they may have on the proposals and the Fund’s future. This time next month, we will have a clearer idea on what the Cancer Drugs Fund will look like beyond 2016.

Joel Levy

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