Cancer Drugs Fund to change – but will the data revolution arrive in time?
NHS England has confirmed that it wants to overhaul the Cancer Drugs Fund (CDF), which, it says, will stop some pharma companies gaining market access with overpriced drugs.
The solution will see the CDF aligned much more closely with NICE, and will involve real-world data being collected to produce a final verdict on a cancer drug's clinical and cost effectiveness.
While the plans have already been welcomed by the UK industry's ABPI, there are doubts about the National Health Service's ability to collect the data needed to make these evaluations.
Rising costs and pharma's bypass
The CDF has seen its budget rise from £200 million a year when it was launched in 2010 to £340 million for the next financial year, a sharp rise which has become one of NHS England's biggest financial headaches.
News of the proposed changes emerged yesterday in papers for today's NHS England board meeting, where its medical director Sir Bruce Keogh said: "Basically, the Cancer Drugs Fund isn't working."
Echoing earlier comments made by the CDF's chair Peter Taylor, Keogh said the Fund had created 'perverse incentives' for pharma to bypass the established health technology assessment of NICE. He said by going through the less rigorous CDF system, companies could gain market access for the drugs with higher prices. This is because, while NICE often raises objections on price, the CDF has, until recently, rubberstamped drugs for funding.
But Keogh added that with a new generation of groundbreaking cancer drugs emerging (such as recently-approved immunotherapy drugs Opdivo and Keytruda) the system needed to be urgently updated.
Keogh formed a working group in December last year, bringing together his organisation with the Department of Health, cancer charities, and the ABPI to discuss how the Fund should be reformed.
He said this review had to take into account a lot of regulatory change in the UK and Europe: the European Medicines Agency introduced Adaptive Licensing and the MHRA launched the Early Access to Medicines Scheme last year.
These initiatives, along with UK government's ongoing Accelerated Access Review, are all aimed at cutting bureaucratic delay to drug approvals, and allow earlier access to drugs, with the aim of efficacy data being generated after launch.
The NHS England board papers say the proposed new CDF would be a 'managed access' fund; when NICE indicates a cancer drug doesn't have data to support NHS use, it would issue a 'conditional approval', and funding would be provided through the CDF for a period. During this period, real-world data will be collected to allow a value-based assessment of a drug's worth, resulting either in a NICE 'yes' or removal from the CDF.
The terminology to describe the process is clearly not yet set: Bruce Keogh described the new CDF as an 'evaluative incubator' which would allow the NHS to resolve uncertainty about a drug's value.
A seat at the table for charities?
Keogh conceded that, while the concept was agreed, there was much detail to be thrashed out: "There is some complex work to be done to get a working model for the CDF, and some complex issues to be resolved among lots of different organisations."
Cancer patient organisations have already formed an alliance around the issue of the CDF and access to drugs, and will play a pivotal role in finalising the plans, alongside pharma. The key for these charities will be if they are involved in the final 'technocratic' deliberations – they have complained that they have been excluded from crucial negotiations (e.g. on prices and access) between the government and the pharmaceutical industry.
£340m funding level to remain
Commenting on the plans, NHS England chief executive Simon Stevens said the changes would not affect the CDF budget, which rises significantly to £340 million for the next financial year 2015/16.
He also said that changes could not prevent the NHS having to make some "incredibly difficult choices and trade-offs."
Stevens added that this might mean different drugs would be funded – suggesting that further rounds of 'de-listing' drugs will take place in order to make room for others.
NHS England has now approved the plans, which means the proposals will go to public consultation in September, with the aim of launching the new CDF in April 2016.
Data concerns
Among the many outstanding questions and doubts about the proposals is whether the NHS can collect the data to support real world evidence assessment. The existing Systemic Anti-Cancer Therapy Dataset (SACT) database has been in operation for a number of years, and is intended to supply the real world data needed for the CDF, but not enough NHS trusts are currently supplying the complete datasets it needs.
It seems unlikely that the NHS will be able to up its game on data collection in time for April 2016, as variation across the country is considerable.
Bruce Keogh and Simon Stevens both expressed their frustration about the difficulty of getting simple data on cancer outcomes from the NHS, and said new efforts needed to be made across the health service.
Talking in the wider context of improving cancer outcomes in the NHS, Keogh said the NHS was still not able to provide him with complete one-year survival rates by different cancer types and regions.
"I am meeting all sorts of barriers," said Keogh, "but I will break them down."
If the NHS in England can break down these barriers, however, it has the chance of forging one of the most forward-looking cancer services in the world. Balancing the interests of the NHS and the pharma industry with the aim of improving patient care will also be a major challenge.
Read further details from NHS England's board papers – plans for the CDF are item 8.
Read my review of them here.
