Assessment of Time to HTA Outcome for Novel Oncology Combinations and Decision Drivers Across UK and Europe

OBJECTIVES: Advances in cancer biology have led to combination therapies becoming the cornerstone of treatment. Patient access to combinations remains challenging in the UK and EU, as supported by a 2022 analysis of time to decision for oncology combinations versus the oncology EFPIA WAIT indicator and a more recent analysis by Investigate Europe into access to innovative medications.

METHODS: A review of 127 HTAs of oncology combinations was conducted. A search of an international HTA database (Market Access Insights) was conducted in October 2023, including HTAs with decision dates between July 2020 and September 2023. HTAs were restricted to double branded combinations for England, France, Germany, Ireland, Italy, Portugal, Scotland, Spain and Sweden. Data extractions included evidence under assessment, agency critique and outcome. Time to decision was calculated as time between regulatory approval and date of positive HTA outcome (+/- restrictions).

RESULTS: Oncology combinations showed delayed time to positive decision (mean: 450 days, range: 223-806) versus all oncology treatments (mean: 438, range: 102-713). Assessed combinations varied from 7 (Sweden) to 24 (France), with a mean of 10 across agencies. Time to positive decision improved for Italy, Spain and Ireland but increased for Portugal, England, Germany, Scotland and Sweden. Agency critique of combinations included sources of uncertainty commonly mentioned for monotherapies. 51 HTAs included real-world evidence (RWE), which was accepted for 40 with quicker positive decision at a mean of 443 days versus 462 days for 68 HTAs not including RWE.

CONCLUSIONS: European markets face varied delays in accessing oncology combinations, despite similarities in agency critique to monotherapies, suggesting other decision drivers are of influence for combinations. The observed variation suggests that combinations’ challenges with access are being addressed differently across markets. RWE remains an influential but less common source of evidence for HTA decision making, even for oncology combinations.