OBJECTIVES:

The SMC advises NHS Scotland on the clinical and cost-effectiveness of all new medicines. Methods changes introduced in 2014 aimed to increase access to medicines used at the end of life and for very rare conditions. This research examines the impact of the changes on the acceptance rates for all full submissions.

METHODS:

A quantitative analysis was undertaken of assessments under the new process up to May 2017. A direct comparison of acceptance rates before and after the process changes is not possible as new criteria for end of life (EoL) and medicines for very rare conditions were introduced in 2014. The acceptance rate for decisions published from January 2011 to December 2013 for orphan and cancer medicines (as a proxy measure) was compared with those for medicines assessed as end of life and orphan under the new processes (decisions published October 2014 - May 2017). The acceptance rates for all medicines during these time periods were also compared.

RESULTS:

From January 2011 to December 2013 the acceptance rates were: for medicines assessed as a full submission 114/175 (65%); for cancer and orphan medicines 15/31 (48%). From October 2014 to May 2017 the acceptance rates were: for all medicines assessed 154/180 (86%); for medicines assessed under the new process 61/78 (78%). The acceptance rate for EoL medicines was 42/46 (91%) and for very rare conditions medicines it was 52/68 (76%). Note that medicines may be categorised as both EoL and for a very rare condition.

CONCLUSIONS:

These findings show that the changes have met the Scottish Government’s policy imperative of increasing access to new medicines used at the end of life and for very rare conditions that may not have been accepted under the previous assessment process. The analysis was limited by the inability to undertake a direct comparison.