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Leela Barham is a freelance health economist and policy expert. She has published in peer-reviewed journals and presented at national and international conferences. She has provided advice to the Department of Health and Social Care on policy on pricing of branded medicines to inform the negotiation of a successor to the UK’s Pharmaceutical Price Regulation Scheme (PPRS), the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), as well as worked with patient groups, the NHS, pharmaceutical companies and many others internationally on the economics of healthcare and pharmaceuticals. Contact Leela on email@example.com
July 29, 2016
A ‘new’ version of the English Cancer Drugs Fund (CDF) will come into force on July 29, 2016, later than the anticipated April 2016 start. This is the latest evolution of a fund that was first put forward in 2010.
The CDF pays for those cancer drugs that NICE says are not cost effective, or that NICE hasn’t looked at, or those that are in limbo, waiting for NICE’s recommendation. The original plan was that the fund would serve as a bridge to a new way of assessing new medicines, Value Based Pricing (VBP). Unlike VBP, the CDF has persisted (like a parasite?).
A new deal
Final details for the 2016 guise of the CDF were only published on the 8 July 2016. An earlier consultation, closing in February 2016, had trailed the headlines of what can best be summarised as managed access. Now the operational details are set out in ‘Appraisal and funding of cancer drugs from July 2016 (including the new cancer drugs fund)’.
The subheading, ‘a new deal for patients, taxpayers and industry’ is telling. Reading between the lines it’s clear that companies will need to discount – probably quite heavily – to achieve market access with the prospect of providing rebates too. In return, they’ll potentially get faster NICE appraisal and interim funding from the point of marketing authorisation.
Re-instating the primacy of the NICE recommendation
Funding for routine use, or in the CDF, now depends on the first NICE appraisal. If a company doesn’t participate in a NICE appraisal of their product then they will automatically be denied CDF funding too.
A no from NICE will ultimately mean the only option for patients is via Individual Funding Requests (IFRs) that clinicians need to do on their behalf.
This goes back to how things were before the CDF was introduced in 2010; the worry for some is that this is circular. The CDF was introduced to overcome real or perceived – depends who you ask - difficulties with NICE. NICE has evolved since 2009, but enough to overcome those difficulties?
Managed access when NICE says ‘maybe’
A maybe (formally referred to as a recommendation for use within the CDF) from NICE will see companies enter into discussion with NHS England – who actually pay for the drugs – on what NHSE will pay during the CDF funding period.
With no change to the threshold on cost effectiveness, £20,000 to £30,000 ($26,000-$40,000) cost per Quality Adjusted Life Years (QALYS) in most cases, or up to £50,000 ($66,000) for end of life drugs - the discount required could be significant. (And as an aside, NICE has accepted drugs at a higher cost effectiveness threshold and it seems to have been brought down to the maximum of £50,000 cost per QALY).
Re-appraisal will likely take place in two years, or perhaps longer, depending on how long data needs to be collected for. Reflecting the fragmented nature of the NHS these days, the discussion for those companies given a maybe NICE recommendation also needs to be with NICE on what evidence will be good enough to inform their re-appraisal in future and Public Health England (PHE) who have the responsibility for the key dataset that is expected to be used, the Systemic Anti-Cancer Therapy dataset (SACT).
There’s reference to input from patients and clinicians. Realistically that will be marginal, at best. Key will be the NICE Appraisal Committee for their recommendation. If they are minded for say ‘maybe’, the CDF Investment Group will be instrumental in setting the parameters for both evidence and commercial aspects. The CDF Investment group includes both NHSE and NICE.
The local NHS will hold the key to data for re-appraisal
The local NHS is key too should the maybe recommendation be made; restrictions could be placed on Trusts to access and be reimbursed for CDF drugs if they don’t meet requirements for e-prescribing. Quite simply, if you can’t collect the data, you can’t gather the evidence, and can’t meaningfully re-appraise whether the drug works and how well in real patients in real NHS settings. Companies will also be able to table any new evidence that they have collected.
Not yet ready?
It was more than a little embarrassing when it was pointed out by the National Audit Office (NAO) that data on patient outcomes to evaluate the CDF were not available in September 2015. That was compounded in the February 2016 Public Accounts Committee report and hearings that supported the report. They said, “it’s unacceptable that the Department and NHS England still no not have data to evaluate the impact of the fund on outcomes for patients five years after the Fund was set up.” (Incidentally some people had been saying where is the audit for some time….it took the powers at be years to notice).
When asked in a Freedom of Information request in January 2016 whether PHE had analysed drugs on the CDF with SACT data, they said “no, there have not yet been such analyses”. They went on to say, “we now have additional information on CDF patients from NHSE which we are linking with SACT. This work is underway, to be published this year”.
By May 2016 they published work which suggests that there remains gaps in SACT; the overall completeness of SACT reporting by Trusts - versus cancer waiting time data being used as a cross check – varied from 38% to 100% with an average of 88%. This is just a routine cross check; let’s hope they’re ready for the demands that will be placed on SACT under the new arrangements.
Trusts face a considerable burden to ‘claim’ their share from the CDF and will be subject to scrutiny to check that their claims are appropriate. NHSE can use 2% of the CDF to fund their admin and NICE are getting paid a further £2million to cover admin and the increase in their appraisal activity; Trusts don’t get the same allowance. Yet it is the Trusts who have to do the real leg-work; treating patients and managing their care.
No more busting the budget
Whatever NICE says, however much interim funding is given to one cancer drug or another, and whatever NHSE will be willing to pay whilst data is collected on drugs where NICE isn’t sure of their value, the CDF will not be permitted to over-spend as it has done in previous years. Its budget is £340million for 2016/17. There is the potential for rebates from companies to make sure NHSE can balance their books on the CDF.
Transition from ‘old’ CDF to ‘new’ CDF
There are also those drugs caught between the old and new system; they are going through a transition arrangement with funding continuing from the CDF. That means either being looked at by NICE for the first time for those products that didn’t get NICE’d before, or looked at again, if NICE said no before.
So far NICE has finished looking at just one of the products in the transition arrangements – Pfizer’s Bosutinib (Bosulif) - and this time it has gone into routine funding and out of the CDF. They said yes, but only because of discount from the company involved. Some drugs that fell between the time the old CDF closed and the new one coming in will be considered for NICE appraisal, but that might mean a first NICE appraisal will be years away.
How will success of the new CDF be measured?
Much like beauty, whether the new CDF works, is likely to be in the eye of the beholder. It’s clear that the CDF is no panacea; evaluation of the new arrangements is planned for 2017. The tricky part is deciding on what criteria should it be judged?
Leela Barham is an independent health economist and policy expert. You access her website here and contact her at firstname.lastname@example.org