NICE ‘Optimised’ Recommendations: What Do They Mean for Patient Access?

OHE publishes a report quantifying the level of patient access associated with NICE ‘optimised’ recommendations.

The ‘optimisation’ of NICE TA recommendations is becoming more common

The National Institute for Health and Care Excellence (NICE) makes recommendations for use of interventions including medicines in the National Health Service (NHS) in England based on their clinical and cost-effectiveness, through their Technology Appraisal (TA) programme. Following review, the main TA outcomes are to ‘recommend’ the medicine (in line with marketing authorisation), ‘not recommend’ the medicine, or something in between: ‘optimised’. Optimised recommendations support use of the medicine for a smaller group of patients than originally stated by the marketing authorisation, based on the findings of the appraisal relating to clinical or cost-effectiveness in different patient sub-groups.

In the ten years from 2010 to 2019 (inclusive), 31% of all ‘positive’ (recommended or optimised) decisions were optimised; considering just the five years between 2015 and 2019, this rose to 43%.

We quantify the level of patient access associated with NICE optimised decisions

The option for NICE to ‘optimise’ recommendations offers a route to treatment access for sub-groups of patients in whom a medicine offers a clinically- and cost-effective alternative to current practice, in cases where this was not the case for the full patient population (determined by the licensed use and the scope of NICE’s appraisal). However, the level of patient access associated optimised recommendations is not immediately clear. 

In a consulting report published today, funded by the Association of British Pharmaceutical Industry (APBI), we quantify the proportion of patients recommended for treatment in NICE optimised decisions over the five years between 2015 and 2019. In doing so, we update previous research in this area (O’Neill and Devlin, 2010).

In about two-thirds (65%) of optimised recommendations for which information was available, NICE recommended use for less than half of eligible patients

Of the 112 treatments that received an optimised recommendation between 2015 and 2019, 40 appraisals included sufficient information that allowed the estimation of patient access. Around two-thirds (65%) of optimised decisions recommended treatment in less than half of eligible patients, and around one-third (35%) recommended use in less than a quarter of patients within NICE’s appraisal scope. On average, 39% of the patient population that was potentially eligible for the treatment under review were recommended for treatment in NICE’s ‘optimised’ recommendation. 

NICE states that 82% of their recommendations have been positive (NICE, 2020). However, a significant proportion of these are optimised recommendations, and we have demonstrated that the recommended level of patient access associated with these can be low. While the justification for these restrictions may be well-founded, more granular reporting of recommendations would help paint a more accurate picture of recommended levels of patient access associated with NICE decision outcomes.