NICE appraisals process for oncology indications

Is the new NICE appraisal process for oncology indications too positive in its assessment of cancer drugs in England?


Objectives – Since 29 July 2016, the NICE appraisal process for oncology indications in England has been modified to allow one of three outcomes; recommended for routine use, not recommended, or recommended within the Cancer Drugs Fund (CDF) managed access scheme. This study investigates the outcomes of NICE appraisals for new cancer drugs assessed via the modified process.

Methods – Cancer drugs assessed via the new NICE process between 29 July 2016 and 24 April 2018 were identified from publicly available data sources. Draft and final NICE recommendations were extracted and analysed from Appraisal Consultation Documents (ACDs) and Final Appraisal Determinations (FADs), respectively. Drugs transitioning from the old CDF were excluded from analysis.

A total of 39 cancer drugs were identified. Of these, only 22% received positive FADs directly. The remaining 78% had ACDs published; in all cases, ACDs did not recommend the technology for use. However, in 93% of cases, guidance was changed to a positive recommendation with FAD publication. Overall, 95% of drugs received positive final recommendations. Of these, all were recommended with patient access schemes (PAS) involving simple discounts (62%) or within the CDF (38%). Drugs not recommended by NICE (5%) had a PAS agreed with the Department of Health, but still exceeded NICE’s incremental cost-effectiveness threshold.

The majority of new cancer drugs assessed by NICE are receiving positive recommendations. However, most of these are initially not recommended at the ACD stage, delaying funding until FAD. The high percentage of indications requiring ACDs before FADs suggests that pharmaceutical companies may have insufficient clinical trial data or unrealistic price expectations leading to uncertainty regarding the product’s cost effectiveness. It appears that to secure a positive NICE opinion, after the initial FAD, companies must enter into a PAS (requiring discounts) or the CDF (requiring further data collection).

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