FIRST COMBINATION IMMUNO-ONCOLOGY TREATMENT AVAILABLE ON PHARMACEUTICAL BENEFITS SCHEME FROM 1st DECEMBER
Federal Government confirms PBS listing to give advanced melanoma patients affordable access to new treatment
OPDIVO® in combination with YERVOY® becomes first dual therapy immuno-oncology treatment to get PBS listed1,2
Melbourne, Australia. Friday 30 November 2018 – Bristol-Myers Squibb today announced that patients with unresectable Stage III or Stage IV malignant melanoma will have affordable treatment access to OPDIVO (nivolumab) in combination with YERVOY (ipilimumab) via the Pharmaceutical Benefits Scheme (PBS) from 1st December 2018.1,2
The PBS listing represents the first time a combination immuno-oncology treatment has been reimbursed by the Federal Government.1,2 The option of OPDIVO in combination with YERVOY will provide healthcare professionals and patients with a new and affordable treatment option for advanced melanoma.
Australia has one of the highest incidence rates of melanoma in the world3 with around 14,000 patients diagnosed each year.4 Melanoma is also the most commonly diagnosed cancer in younger Australians aged 15–24.5 While the majority of melanomas can be treated successfully with surgery if diagnosed early, the cancer is associated with 1,900 deaths every year in Australia.4
Immuno-oncology treatments, such as OPDIVO and YERVOY, use the body's immune system to fight cancers. These medicines, which can be used in combination to target two distinct and complementary pathways, enable the immune system to recognise and attack cancer cells.
Associate Professor Matteo Carlino, Medical Oncologist and lead investigator at Westmead Hospital and the Melanoma Institute Australia, welcomed the PBS listing and explained how the combination of two immuno-oncology treatments gives oncologists a new option in treating cancer.
"The use of immuno-oncology treatments in combination means we are able to tackle two distinct cancer pathways at the same time. The use of two complementary pathways generates more activity than either drug alone and is a new approach to treat melanoma and other cancers," said Associate Professor Carlino.
"Most advanced melanoma patients have limited time to access treatment as the cancer spreads to other parts of the body. PBS-reimbursed access to a combination immuno-oncology therapy is a welcomed development and an important new option for melanoma patients," said Associate Professor Carlino.
Dr Jonathan Anderson, Medical Director, Bristol-Myers Squibb Australia and New Zealand, said this Australian-first PBS listing was an important milestone in patient access to immune-based therapies for cancer.
"BMS is pleased that Australian patients with advanced melanoma are now able to access combination treatment on the PBS," said Dr Anderson.
"Immuno-oncology and the use of these treatments in combination is a rapidly evolving field. Our global clinical development program is exploring the potential role of OPDIVO combined with other immuno-oncology treatments in a wide range of cancers," said Dr Anderson.
Victoria Beedle, CEO of Melanoma Patients Australia, said the PBS listing of this new combination immuno-oncology treatment may give further hope to patients diagnosed with advanced melanoma.
"We want a world where no one affected by melanoma walks alone, whether people are newly diagnosed or have advanced melanoma with limited options. The introduction of the first combination immuno-oncology treatment that is affordable on the PBS could help Australians with advanced melanoma," said Victoria Beedle.
"Introducing new and affordable treatments for late stage melanoma patients is critical," said Victoria Beedle.
OPDIVO (nivolumab) in combination with YERVOY (ipilimumab) for treatment of unresectable Stage III or Stage IV malignant melanoma with be available on the PBS from 1st December.1,2
The combination therapy is also registered with the Therapeutic Goods Administration (TGA) for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma (RCC).1 OPDIVO as monotherapy is currently reimbursed on the PBS for four distinct tumour types in head and neck cancer, advanced melanoma, advanced lung and advanced kidney cancers.1,2 The monotherapy treatment is registered with the TGA for use in eleven indications across seven cancer types.1
YERVOY as monotherapy is currently reimbursed on the PBS for advanced melanoma.2
About Immuno-Oncology (I-O)
Immuno-oncology is based on the premise that the immune system could be a powerful and effective tool for recognising and fighting disease.Immuno-oncology treatments are designed to harness the patient's own immune system to combat cancer by targeting the same immune pathways that tumour cells use to evade recognition and destruction.
About OPDIVO and YERVOY combination safety
Both OPDIVO and YERVOY act on the immune system and may cause inflammation. Inflammation may cause serious damage to a patient's body and some inflammatory conditions may be life threatening.1The most frequent adverse events reported for OPDIVO during the clinical trials included fatigue (feeling tired or weak), diarrhoea (watery, loose or soft stools), skin rash and itching, nausea and vomiting, fever, underactive or overactive thyroid gland, arthralgia, decreased appetite, headache and laboratory test abnormalities.1
