Are patient and commercial access agreements essential for NICE to recommend access

Are patient access schemes and commercial agreements essential for NICE to recommend access


A  comparison of oncology and non-oncology appraisals”


To gain a positive recommendation from the National Institute of Health and Care Excellence (NICE), pharmaceuticals must demonstrate cost-effectiveness. This can be aided by the implementation of financial agreements such as patient access schemes (PAS) or commercial access arrangements (CAA). PAS are the standard way for pharmaceutical manufacturers to make drugs cost-effective for NHS England, whilst CAAs are reserved for drugs entering the Cancer Drugs Fund (CDF) or transitioning from the old-CDF (pre-July 2016). This study aimed to compare the use of financial agreements for oncology and non-oncology appraisals conducted by NICE.


Single technology appraisals published by NICE between January 2017 to January 2019 were analysed. Outcomes and use of financial agreements were extracted for each appraisal. The data were analysed and compared for oncology and non-oncology appraisals.


Of the 98 appraisals identified, 89% received positive recommendations, of which only 11% did not have any financial arrangement in place. Financial arrangements in the form of either a simple discount PAS (62%) or a CAA (36%) was required for all but one positive oncology appraisal. In contrast, 31% of non-oncology appraisals received positive recommendations without any financial agreements in place. The remaining 69% of non-oncology appraisals were subject to either simple discount (95%) or complex (5%) PAS. Negative recommendations were received by 11% and 12% of oncology and non-oncology appraisals, respectively. Negative recommendations were primarily due to a lack of cost-effectiveness (86%) for oncology indications and due to high uncertainty on cost-effectiveness (75%)  for non-oncology indications.


To gain a positive NICE recommendation, pharmaceutical products must demonstrate cost-effectiveness with low uncertainty. Approximately one-third of non-oncology appraisals do not require a financial arrangement to demonstrate cost-effectiveness and gain a positive recommendation. In contrast, 98% of oncology products require the use of a PAS or CAA to enable cost-effectiveness to be achieved.

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