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Are we overcoming historical barriers to accessing innovation?
An assessment of “time to access” to novel oncology combinations across the UK and EU
Dec 17, 2024
This blog post summarises research presented at ISPOR EU 2024, which can be found here.
Oncology has been a leading force in drug development and new drug launches. Between 2014 and 2023, there were 201 global launches of novel active substances in the field of oncology (IQVIA Institute for Human Data Science, 2024). Specifically, advances in cancer biology have led to combination therapies becoming the cornerstone of treatment. However, patient access to combinations remains challenging in the UK and EU. A 2022 analysis by Wilsdon et al. highlights the delays in decision-making for oncology combinations compared to all oncology products, as shown in the 2022 EFPIA WAIT indicator.
Study Overview
Analysed data for this project came from a search of an international HTA database (IQVIA Market Access Insights) that was conducted in October 2023. All HTAs with decision dates between July 2020 and September 2023 were considered. This review included 127 HTAs that were restricted to double-branded oncology combinations for England, France, Germany, Ireland, Italy, Portugal, Scotland, Spain and Sweden.
Data extractions included evidence under assessment, agency critique and HTA recommendation. Time to decision was calculated as time between regulatory approval and date of positive HTA recommendation (with or without restrictions).
Key Findings
The number of assessed combinations ranged from 7 in Sweden to 24 in France, averaging 10 across agencies. Notably, most submissions leading to negative recommendations for oncology combinations came from Spain (N=6) and Ireland (N=5).
On the positive side, oncology combinations achieved faster positive decisions with a median of 235 days (ranging from 153 to 588 days), compared to all oncology treatments, which had a median of 366 days (ranging from 182 to 704 days), as illustrated in Figure 1. However, challenges remain, as delays for combinations continue to affect Germany, Spain, and England where the median for decision was between 212 and 588 days.
Compared to the 2022 analysis by Wilsdon et al., the median time to positive decision for combinations decreased in Italy, Portugal, Scotland, Spain and Ireland but increased in England, Germany, and Sweden. The greatest improvement in “time to decision” was noted in Italy, achieving quicker access by 348 days. Germany was found to have the largest increase in delays by 177 days; however, it is important to note that this analysis only looks at G-BA decisions and excludes IQWiG.
Agency critique of combinations included sources of uncertainty commonly mentioned for monotherapies. HTA agencies most often critiqued the choice of outcomes for the submitted clinical evidence, compared to other attributes of the evidence (Figure 2). Key insights from the negative recommendations indicate that the primary clinical factors that influence HTA bodies’ decisions are outcomes (mainly due to data immaturity) and comparators (mainly due to poor quality of indirect treatment comparisons [ITCs]). Regardless of recommendation, clinical negative critiques were most common for those submitting immature evidence and evidence for increased risk of (severe) adverse events.
Submissions lacking real world evidence (RWE) generally experienced longer decision times (N=68; median: 285 days; SD: 452.9); however, the dataset for submissions with RWE (N=51; median: 242.0 days) showed greater variability (SD: 508.1).
For France, the majority of RWE comes from safety data and is the sole country utilising this type of data. Most common accepted RWE areas for England and Sweden were effectiveness/survival data followed by epidemiological evidence. Additional information on accepted RWE areas by country is shown in Figure 3.
Takeaways
As is usually observed with the WAIT indicator, varied time to decision-making in the approval of oncology combinations was observed across the UK and EU markets, despite similarities in agency critique to monotherapies, suggesting that other drivers influence decision-making for branded combinations. This variation observed also suggests that the challenges with access to combinations are being addressed differently across markets.
Notably, compared to previous research, the time to decision has in fact improved for most markets within the scope of this research, likely reflecting the implementation of processes that impact access to innovation. We hypothesize that the challenges with market access of innovative treatment like oncology combinations are being addressed on a policy level in some countries: France has introduced the Early Access Programme; Ireland is utilising its Rapid Review process; and Italy has adopted the Innovativeness Appraisal. In England, improvement in timely access to oncology combinations remains the same despite recent progress, including a new government-level policy making it easier for pharmaceutical companies to work together to ensure market access. However, this has yet to translate into quicker access.
Agency critiques of the evidence submitted for HTA of combination therapies frequently reflected the uncertainties observed with monotherapies. Most commonly, these were in reference to immature data submitted to demonstrate clinical outcomes. This underscores the essential need for robust and mature clinical data to obtain positive decisions for combination therapies, similar to monotherapies. RWE remains an influential but less common source of evidence for HTA decision making, even for oncology combinations.
Abbreviations
AEMPS, Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency of Medicines and Medical Devices); EFPIA, European Federation of Pharmaceutical Industries and Associations; EU, European Union; G-BA, Gemeinsamer Bundesausschuss (Federal Joint Committee in Germany); HAS, Haute Autorité de Santé (French National Authority for Health); HTA, Health Technology Assessment; INFARMED, Autoridade Nacional do Medicamento e Produtos de Saúde (National Authority of Medicines and Health Products, Portugal); IQWIG, Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care, Germany); ITC, Indirect treatment comparison; NCPE, National Centre for Pharmacoeconomics (Ireland); NICE, National Institute for Health and Care Excellence (UK); QoL, Quality of Life; RWE, Real-World Evidence; SMC, Scottish Medicines Consortium; TLV, Tandvårds- och läkemedelsförmånsverket (Dental and Pharmaceutical Benefits Agency, Sweden); UK, United Kingdom; WAIT, Waiting Time for Access to Innovative Therapies.Related solutions
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