News & Trends - Pharmaceuticals

Sanofi, Amgen, BMS and Novartis welcome new/amended PBS listings

Health Industry Hub | March 29, 2021 |
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Pharma News: The Honourable Greg Hunt, Minister for Health, announced new and amended Pharmaceutical Benefits Scheme (PBS) listings for medicines in breast cancer, lung cancer, osteoporosis and asthma effective 1 April, 2021.

Breast Cancer

Novartis’ Kisqali will become the first CDK 4/6 inhibitor to be listed on the PBS, together with Fulvestrant Sandoz, for women with HR+ HER2- metastatic breast cancer. This combination is reimbursed for those who are newly diagnosed with metastatic breast cancer, as well as for those previously treated with endocrine therapy.

Dr Jodi Lynch, Medical Oncologist, Specialising in Breast and Gynaecological malignancies said “This is the first reimbursed and more broadly available CDK4/6 inhibitor in combination with Fulvestrant, creating more options for eligible patients across Australia”.

Kirsten Pilatti, Chief Executive Officer, Breast Cancer Network Australia (BCNA) welcomed the news stating “This is an important day in ensuring we’re delivering the best possible treatments to all Australians living with metastatic breast cancer. The PBS listing is another step closer to making sure Australia doesn’t have a two-tiered system where only those who can afford it can access the best care. Being able to provide quality drugs that may help women or men living with metastatic breast cancer live longer, means the world, not only to the patient, but to their family and friends.”

Fulvestrant Sandoz (fulvestrant) is also being made available on the PBS for the first time as monotherapy for those women in need of this targeted treatment on its own, for the treatment of hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.


Around 2.7 million Australians live with asthma with many of them suffering from severe asthma.

The listing for Sanofi’s Dupixent (dupilumab) will be extended providing a new treatment option to around 1,700 Australians 12 years and older suffering from uncontrolled, severe eosinophilic or allergic asthma per year.

Dupixent is the first and only therapy that blocks the action of IL-4 and IL-13 to relieve disease symptoms in severe asthma. It is used in combination with other asthma medications.

Associate Professor David Langton, Peninsula Health Director of Thoracic Medicine said, said, “Despite treatment advances, the struggle to breathe impacts the daily life of Australians who live with uncontrolled severe asthma,” he said.

“Many of these patients are already on high-dose steroid therapies but continue to wheeze, cough and have difficulty breathing because the underlying cause of inflammation remains untreated. This puts some at risk of life-threatening asthma attacks. It’s a positive step forward to have another treatment option for some patients with uncontrolled disease.”

Asthma Australia CEO Michele Goldman said “For people with severe uncontrolled asthma, finding treatments that work can be an enduring and expensive exercise, including countless hospitalisations and serious
setbacks. We welcome the PBS listing of Dupixent. It puts an important treatment option within greater reach of many Australians.”

Novartis’ Atectura Breezhaler (indacaterol + glycopyronum + mometasone), will also provide a new treatment option for other severe forms of asthma.


Amgen’s Evenity (romosozumab) will be listed on the PBS for the first time, for the treatment of severe osteoporosis.

The PBS listing of Evenity means up to 9,000 Australians living with severe osteoporosis and who are at very high risk of another broken bone, will now have another treatment option available.

Professor John Eisman, Fellow Emeritus, previous Director of Clinical Translation and Advanced Education, Garvan Institute of Medical Research said “There are a number of people for whom existing treatments are not enough and they continue to experience fractures that can be severely debilitating, impacting their quality of life and even life-threatening. For these people, additional treatment options are needed.”

Lung Cancer

To support over 130 Australians with previously untreated stage IV squamous non-small cell lung cancer (NSCLC), the listings for Bristol-Myers Squibb’s Opdivo (nivolumab) and Yervoy (ipilimumab) plus chemotherapy is being extended. Patients could otherwise pay over $100,000 per course of treatment without subsidy.

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