Federal Health Minister Greg Hunt
A $100 million package of PBS listings has provided subsidised access to new treatments for melanoma, metastatic bowel cancer and neuroendocrine tumours.
Combination treatment with nivolumab (Opdivo) and ipilimumab (Yervoy) has been be listed on the PBS from December 1 for patients with unresectable, stage lll or stage IV malignant melanoma.
The July 2018 meeting of the Pharmaceutical Benefits Advisory Committee (PBAC) recommended concurrent use of the drugs as first-line immunotherapy in patients with BRAF V600 mutation negative melanoma.
It was also recommended in patients with BRAF V600 mutation positive melanoma whose disease has progressed following treatment with a BRAF inhibitor.
PBAC considered the combination therapy, targeting PD-1 and CTLA-4 immune checkpoint pathways at the same time, provided ‘a modest, yet meaningful, improvement in progression free survival’ compared to monotherapy.
Dr Rachel Roberts-Thomson, a medical oncologist from the Queen Elizabeth Hospital and Adelaide Oncology and Haematology who specialises in melanoma, told the limbic that the combination of immunotherapies was very useful.
“Oncologists who in particular treat melanoma have gained experience with this combination through having patients on clinical trials and through a special patient access scheme. It’s a very positive announcement I think, to have it available on the PBS.”
She said the regimen was typically four cycles of the combination followed by monotherapy.
“There will still be some patient selection that will need to go on, depending a little bit on the patients’ tumour characteristics, but it will be wonderful to have this option for a proportion of patients with unresectable advanced melanoma in the first line setting.”
“Patients may need to come off to due to side effects – and that is not an uncommon scenario – but the beauty of this combination is that for patients who do respond to it, the hope is they will have quite a durable response to treatment.”
She said durability for some responders could be measured in years.
The Federal Health Minister Greg Hunt announced the new listing as one of five changes to oncology and haematology drugs.
From 1 December, the PBS listing of lanreotide (Somatuline Autogel) to reduce hormone production and symptoms in functional gastroenteropancreatic neuroendocrine tumours (GEP-NETs) has also been extended to include patients with non-functional disease.
Associate Professor Michael Michael, from the Peter MacCallum Cancer Centre, told the limbic the extension recognised relatively recent evidence that lanreotide also had an anti-proliferative effect.
“It’s been shown by a very large study completed two to three years ago, that using lanreotide in patients with NET arising from the GI tract, in particular the pancreas and small bowel, also decreases the rate of tumour growth and therefore stabilises the disease for at least up to three years compared to placebo.”
He said it appeared to be effective in active and stable disease.
The PBS change was particularly important given the increasing prevalence of the disease.
“It brings us up to date with what is happening in the US and Europe. It makes this drug available for patients whose NET is non-functional and allows us to use this drug to actually control tumour growth and therefore prolong patients’ survival.”
Other PBS changes include trifluridine with tipiracil (Lonsurf) now being listed on the PBS as a new treatment option for patients with metastatic bowel cancer.
And the listing of olaparib (Lynparza) for high-grade serous ovarian, fallopian tube and primary peritoneal cancer has been amended so patients can take four tablets instead of 16 capsules per day.
Meanwhile, patients living with acute myeloid leukaemia (AML) and a FMS like tyrosine kinase-3 (FLT3) mutation will now be able to access the oral, targeted therapy midostaurin (Rydapt) at a subsidised price.