The final piece of the puzzle?
NHS England has announced the budget for the innovative medicines fund (IMF) today.
Long-awaited fund launched
NHS England has announced the budget for the innovative medicines fund (IMF) today. The amount – £340 million – matches the current amount allocated to the cancer drugs fund (CDF). This means NHS England will have a total of £680 million of funds ring-fenced for patients to access medicines for which more data might be needed before a normal funding decision can be made by NICE.
This may be the final piece of the puzzle to improve access to rare disease medicines, depending on how well it fits with the NICE Methods and Process Review. The fund announcement has been eagerly awaited since it was a part of the Conservative Party manifesto. The amount awarded has exceeded many stakeholders’ expectations, although how much is enough is a challenging question for the IMF.
Like the CDF already does for cancer medicines, this will provide an alternative option for NICE when assessing non-cancer medicines to pay for access through the IMF rather than completing a technology appraisal. This should in theory speed up access to some treatments for genetic and rare conditions. These are the most obvious candidates for the fund as it is in rare conditions that there is most likely to be challenges in creating evidence around a medicine’s value to satisfy NICE.
How much is enough?
There will soon be a consultation on how to implement the IMF. When this is published, we will be looking closely at when the decision to select a medicine for the IMF is made. If the system follows the pattern of the CDF, where the CDF option is placed towards the end of the health technology appraisal process, then we may not see the full potential of this initiative.
We believe the trigger for a treatment to enter the IMF should be designed to be as early as possible so that there is no delay after marketing authorisation – when the medicine becomes available.
As to whether the fund will be a success, and how much investment is enough, that question depends on the other pieces of the puzzle. If the NICE Methods and Process Review delivers an ambitious programme of change, then we can be optimistic that the IMF will be a third piece of the puzzle to meaningfully improve the speed of access to treatments for genetic and rare conditions in the UK. If the process review fixes challenges around access to the Highly Specialised Technology pathway by improving its criteria, and fixing the current version’s unfairness. and if the Methods review can improve how NICE deal with uncertainty and implement good quality rare and/or severity disease modifiers … then the IMF will be a final boost to NICE’s ability to handle treatments for genetic and rare conditions. If NICE doesn’t deliver this level of ambition though, we will be expecting the IMF to do too much.
Role for the UK Rare Disease Framework?
Priority 4 of the UK Rare Diseases Framework is perhaps the most overcrowded of them all. There are many initiatives already underway, including the Accelerated Access Collaborative, the UK Research and Development Roadmap, as well as the initiatives already mentioned. So the question is how does the Framework add value?
Some of the answer might lie in the monitoring of the Framework – perhaps we can use this to provide some much needed visibility to what is being assessed by NICE, how long is it taking and are there any delays? What medicines are in the new IMF, and how long have they got left?
Many other aspects of the Framework’s underpinning themes are likely to support a good quality implementation of the IMF too. If we can build a proper foundation of data within the NHS, then the IMF can more easily generate the evidence that treatments were lacking.
For all these initiatives to succeed, they need to link together well. For now, we should be pleased the IMF has been awarded a sizeable budget and look forward to the consultation to ensure we can get the most out of this opportunity.