This year’s NICE Annual Conference gave the very clear message that the NHS is entering probably the most difficult period in its history.
Discussions included commissioning for quality, challenges of multi-morbidity, delivering a fair system and how £22bn savings may be possible. The conference also saw the launch of the Office for Market Access, set up to provide expert advice and direction to help suppliers engage with NICE technology evaluation in order to speed up the adoption of innovative and cost-effective health technologies.
Although there were many discussions around assessing the value of new medicines, one topic noticeably missing in any great detail was the future delivery of the Cancer Drugs Fund (CDF) and access to cancer drugs.
What do we know so far?
- The current CDF is due to end in March 2016
- A proposal outlining the future delivery of the CDF was due for public consultation in September 2015 but is yet to be released
- The emerging proposal is that the CDF should become a ‘managed access’ fund for new cancer drugs, with clear entry and exit criteria
- This managed access fund would be used to resource those drugs which appear promising, but where NICE indicates that there is insufficient evidence to support a recommendation for routine commissioning, and where additional evidence would likely enable a more informed appraisal decision
- Instead of a simple failure to recommend, the drug would be given ‘conditional approval’ and would be provided through the managed access fund for a defined period, while further evidence from ‘real world’ use was collected
- At the end of this period, the drug would go through an abbreviated NICE appraisal process, using this additional evidence and the company’s offer price, and then either gain a NICE positive recommendation (at which point it would move out of the fund into mainstream commissioning) or a NICE negative recommendation (at which point it would move out of the fund and become available only on an individual patient referral basis)
There are still many unknowns; for example, what happens to those drugs on the existing CDF? Will those with existing negative NICE guidance be viewed differently to those who have not been through the NICE appraisal process? What level/strength of data will need to be collected and who will finance and conduct the collection of these data?
As the delay in publication of the proposal lengthens, is there sufficient time for responses to be analysed, an orderly transition from the existing scheme to be implemented, and time for the new CDF to be operational from 1 April 2016?
It is clear Pharma need to start thinking about scenario planning for their cancer medicines now. Ideally, ensuring plans are in place (well in advance) to have all the evidence required to achieve a positive recommendation at first appraisal.
At OPEN Health we can help you in developing your strategy, scenario planning, collecting the right kind of real-world data and supporting you throughout the entire appraisal process. Let us help you navigate the uncertainty.
For any further information please contact:
Cathy Wright Joint Managing Director, OPEN Access Consulting firstname.lastname@example.org
Cathy Jarrold Joint Managing Director, OPEN Access Consulting email@example.com
Sean McGrath Director of Oncology, OPEN Health firstname.lastname@example.org