OBJECTIVES: Since entering the market immunotherapies have led to a paradigm shift in mortality rates for patients with melanoma resulting in an overall improvement in survival and quality of life. This review maps the shift by comparing changes in patient outcomes alongside the frequency of positive HTA decisions for immunotherapy treatments in the UK and Australia between 2019 and 2023.

METHODS: A targeted literature review was conducted using Embase, Clinicaltrials.gov and PubMed, for pivotal clinical trials, and the NICE and PBAC databases for technology appraisals (TA) for immunotherapies in melanoma including ipilimumab, nivolumab and pembrolizumab.

RESULTS: Thirty-five clinical trials were first published, or reported updated results, for ipilimumab, nivolumab and pembrolizumab. Of these studies, 7 (20%) were reported for ipilimumab, 7 (20%) for nivolumab and 4 (11.5%) for pembrolizumab, as monotherapy regimens. Results for nivolumab in combination with ipilimumab were reported across 17 (48.6%) studies. Overall survival (OS) was the most commonly reported outcome (n=30), followed by progression-free survival (PFS) (n=13) and recurrence-free survival (RFS) (n=6). A search of NICE’s TA database returned 9 single TA guidance documents for immunotherapies in melanoma, all of which (100%) received a positive NICE recommendation. A review of PBAC’s database returned 23 guidance documents for immunotherapy in melanoma, of which 52.2% (n=12) achieved a positive PBAC recommendation between 2019 and 2023.

CONCLUSIONS: Overall, it is evident that an increased availability of safe and effective immunotherapies has led to a shift in mortality rates for patients with melanoma when assessed for key outcomes. A growing trend in positive recommendations for immunotherapies in melanoma in the last 5-years is suggestive of an increased confidence in the clinical trial data and a clear upward trajectory in the benefit being demonstrated by pembrolizumab, nivolumab and ipilimumab.