Patients with regional spread of melanoma could soon have access to federal government subsidised neoadjuvant pembrolizumab in addition to complete surgical resection following a landmark recommendation by the PBAC.
The decision has described as the first such public funding recommendation globally and follows a successful application by the Melanoma Institute Australia (MIA).
Under the recommendation, the PBS pembrolizumab restrictions would be expanded to allow treatment in patients with resected Stage IIIB, Stage IIIC, and Stage IIID melanoma.
This was expected to result in “minimal financial impact” as there would be no change to total treatment duration and cost, the PBAC noted in an outcomes statement following its May 2023 intracycle meeting (link here).
“The PBAC advised that treatment in addition to complete surgical resection should be restricted to the three weekly regimen only.”
MIA medical directors Professor Georgina Long and Professor Richard Scolyer together co-authored the application and said its success was an important moment.
PBAC (Aus) has recommended to expand current #PBS listing for pembrolizumab for #neoadjuvant therapy in resected Stage IIIB-D melanoma (world’s 1st approval of neoadj therapy in melanoma). Led by @ProfRScolyerMIA & @ProfGLongMIA -1st time academics changed immunotherapy listing. pic.twitter.com/Re1ooiPD1U
— Melanoma Institute Australia (@MelanomaAus) June 16, 2023
Professor Long said the positive recommendation also made Australian authorities the first in the world to approve and fund the treatment, but this was just a first step.
With the evidence still far from complete, more neoadjuvant clinical trials were critical to achieve the institute’s aim of zero melanoma deaths, she added
So proud! BUT we have more work to do! Major pathological response only 30% with anti- PD-1 alone as used in SWOG1801 and >70% with #neoadjuvant anti-PD1 + CTLA as used in ongoing NADINA study #NCT04949113 in #melanoma (@MelanomaAus sponsor in Australian ) https://t.co/RkOyCT8VLQ https://t.co/aDfmEy4j6j
— Professor Georgina Long AO (@ProfGLongMIA) June 16, 2023