The PBAC has recommended the PBS listing of dabrafenib in combination with trametinib as adjuvant treatment for patients who have had completely resected BRAF V600 mutation positive Stage IIIB, IIIC or IIID malignant melanoma.
A summary document of outcomes from the July PBAC meeting released last week said the Committee was satisfied that the targeted drug combination provides, for some patients, “a significant improvement in efficacy over routine follow-up, in terms of recurrence free survival, and a likely benefit in terms of overall survival”.
However the leadership of the Melanoma Institute Australia is disappointed it was the only positive outcome from a meeting that was also tasked with considering submissions for nivolumab and pembrolizumab.
The PBAC deferred making a recommendation for nivolumab for the adjuvant treatment of patients who have had completely surgically resected Stage IIIB, IIIC, IIID or Stage IV malignant melanoma.
And the Committee did not recommend listing of pembrolizumab as an adjuvant treatment for completely surgically resected Stage IIIB, IIIC or IIID melanoma.
The co-medical directors of the Institute said dabrafenib plus trametinib was effective for less than half of melanoma patients and calling for a timely and efficient review of immunotherapy for melanoma.
Professor Georgina Long said Australia, with the highest melanoma rates in the world, risked falling behind the US and many European countries in terms of access to subsidised immunotherapy.
“Australian patients would like certainty that they will be able to access affordable immunotherapy treatment which has proven successful in clinical trials and which many hundreds of patients have been forced to access on compassionate grounds or face costs of tens of thousands of dollars,” she said.
Professor Richard Scolyer said it was frustrating for Australia to be leading the international melanoma research effort while the government lagged behind the rest of the world in ensuring high risk patients have subsidised access to this proven immunotherapy treatment.
“We urge the federal government to fast track further consideration of this immunotherapy and remain hopeful it will eventually be listed on the PBS,” he said.