Objectives

The primary objective of this research was to assess outcomes in Scotland for CDF-approved drugs and to investigate whether there is differential access to oncology medicines in Scotland due to the absence of a CDF type fund. The secondary objective was to assess the reasons for entry into the CDF and reasons for negative or restricted use recommendations by the SMC.

Methods

34 drugs were identified via the NICE website as being in the CDF and eligible for analysis. The Managed Entry Access agreements were identified for each drug in the CDF and data collection requirements were tabulated. The reasons for uncertainty were quantified into 7 different categories. As a next step, the 34 drugs were identified on the SMC website and their assessment outcome recorded. For the drugs which were restricted or rejected, the submission paperwork was reviewed and categorised using the same 7 categories as the CDF drugs for comparison.

Results

Out of 34 drugs that are currently in the CDF, 55% (19/34) were approved, 29% (10/34) were approved for restricted use and 14% (5/34) were not approved by the SMC. The primary reasons for the SMC to restrict or reject the use of a drug were the survival analysis and the comparator presented by companies. Of the five not approved drugs, three were rejected due to a non-submission by the company and two of the drugs were rejected due to a single-arm trial design.

Conclusion

In conclusion, the majority of CDF-approved drugs were approved without restriction in Scotland. However, a small proportion were not approved by the SMC and a larger proportion were approved with restrictions. There may be scope for further policy changes (such as, but not limited to, an interim funding mechanism such as the CDF) to support access for these drugs.