Could more medicines be recommended for routine commissioning rather than spending time in the Cancer Drugs Fund?
A new analysis commissioned by the ABPI suggests they could.
Victoria Jordan, Head of HTA and Market Access Policy at the ABPI.
The Cancer Drugs Fund (CDF) has successfully provided an early access mechanism for many cancer medicines. In 2016 it was brought under NICE’s remit and has since allowed more than 51 recommendations to be made whilst additional evidence is generated1. NICE applied new criteria for entering the fund and, perhaps more importantly, provided a clear process for medicines to exit the fund. There continues to be much debate about the use of managed access, its pros and cons, and how the approach should evolve. The recent launch of the Innovative Medicines Fund (IMF) has helped level the playing field for cancer and non-cancer medicines so that both can now routinely benefit from managed access. NICE’s proportionate approach to technology appraisals (PATT) work programme is currently exploring whether there is a more efficient way to make decisions about whether a medicine should enter into a period of managed access, ahead of undergoing a full NICE evaluation. It therefore seems like a good time to take stock of what we can learn from the CDF and how it has been operating for the past six years.
The ABPI commissioned Lumanity to explore how the CDF has been operating, including how well clinical outcomes are being predicted by manufacturers at the time of the initial appraisal. Reviewing the 18 appraisals that had entered and exited the CDF between June 2016 and April 2022, it was found that:
- Most medicines (78%) have been able to exit the CDF with a positive recommendation.
- Time spent in the CDF has ranged from 12 to 47 months, with an average of 31 months (just over 2.5 years).
- Predictions of survival estimates at the time of the initial appraisal turned out to be relatively accurate and usually underestimated (although more data was available to explore LY gains, incremental QALY gains followed the same directional trend).
- Additional evidence required for exit evaluation is primarily follow up clinical trial data from global clinical evidence generation programmes.
The findings of the report signal that managed access is not being used optimally and that the CDF has perhaps been overly relied upon by NICE’s committees to delay making routine recommendations. Therefore, there are opportunities to enable the CDF (and Innovative Medicines Fund) to be utilised in a more efficient way:
- The launch of NICE’s new manual for health technology evaluations sets out circumstances when committees may be able to accept a higher degree of uncertainty (rare diseases, paediatric conditions, innovative and complex technologies). This could support more routine commissioning decisions being made at the time of initial appraisal.
- Improvements in cancer outcomes have meant more medicines are being evaluated with no, or very immature, overall survival data. More confidence in the use of surrogate endpoints could avoid the need to route some medicines into the CDF.
- The development and piloting of a new approach for routing some medicines into managed access could provide a better and more efficient mechanism for making a large proportion of managed access decisions - when it is clear the gaps in the evidence base are too significant to do a full evaluation of the clinical and cost effectiveness of the medicine.
- More routine use of flexible pricing arrangements that allow the price of the medicine to reflect the value of the indication being evaluated could circumvent the need for managed access in some cases.
As well as being more efficient for all involved, evolving the approach to managed access can provide a sustainable way of enabling early patient access to the most promising treatments. This is good for patients, the NHS and the industry. We look forward to continuing to support NICE and NHS England with evolving a more optimal approach.
1 – NICE website. TA cancer recommendations. Downloaded 14 October 2022.
Last modified: 20 September 2023
Last reviewed: 20 September 2023