What Are the Reasons for Receiving a Negative Decision from NICE? - A 5-Year Review (2019-2023) of NICE Decisions


Dhawan A1, Takyar J2, Bergemann R3, Pandey R4
1Parexel International, Ambala, India, 2Parexel International, Panchkula, India, 3Parexel Access Consulting, Loerrach, Germany, 4Parexel International, Bangalore, Karnataka, India

Presentation Documents

OBJECTIVES: After-market authorization, receiving positive recommendations from the respective Health Technology Assessment (HTA) bodies is necessary for achieving access to new drugs. Approximately, more than 40% of the new drugs approved by European Medicines Agency (EMA) are not recommended by National Institute for Health and Care Excellence (NICE). Understanding the factors influencing NICE's decisions is crucial for ensuring access to innovative and effective treatments. To understand the reasons for negative reimbursement decisions, we undertook a review of NICE decisions.

METHODS: Hand searching of NICE website was undertaken to retrieve the HTA submissions receiving negative recommendations in the last 5 years (2019-2023).

RESULTS: Search identified a total of 25 technology appraisals [24 Single Technology Appraisal (STA) and 1 Highly Specialized Technologies (HST)] that received negative recommendations from NICE. Among these, majority of the non-recommendations were in oncology (11/25) followed by blood and immune system conditions (4/25), (2/25) each in cardiovascular, respiratory, and neurological conditions and (1/25) each in infections, metabolic, neurodevelopmental, and digestive tract conditions. Reasons for negative recommendations were uncertain long-term benefits/efficacy measure (11/25), absence of direct comparison with relevant comparators (8/25), lack of meaningful improvement in health-related quality-of-life assessments (3/25), inadequate sample size (3/25), unclear method used for indirect comparisons (2/25), trial results not being generalizable to the National Health Service (NHS) (1/25) and failure to meet NICE's criteria for consideration as a life-extending treatment at the end of life (1/25). Additionally, all the 25 HTA reported that the cost-effectiveness estimates were uncertain and higher than what NICE normally considers an acceptable use of NHS resources.

CONCLUSIONS: Analysis of NICE's decisions indicated that unavailability of robust data establishing long-term efficacy, lack of direct comparisons, and high cost were the common reasons for receiving a negative decision. Addressing these factors is crucial for improving patient access to effective treatments and ensuring equitable healthcare outcomes.

Conference/Value in Health Info

2024-05, ISPOR 2024, Atlanta, GA, USA

Value in Health, Volume 27, Issue 6, S1 (June 2024)




Health Technology Assessment, Study Approaches

Topic Subcategory

Decision & Deliberative Processes, Literature Review & Synthesis


Cardiovascular Disorders (including MI, Stroke, Circulatory), Drugs, Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal), Oncology, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory

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