register

News & Trends - Pharmaceuticals

PBAC nods for AstraZeneca, Lilly, Novartis and Bayer

Health Industry Hub | August 26, 2024 |

Pharma News: The July PBAC outcomes have delivered positive news in oncology, rare diseases, diabetes and women’s health, amongst others.

In a win for Eli Lilly, Retevmo (selpercatinib) has received a positive Pharmaceutical Benefits Advisory Committee (PBAC) recommendation for advanced or metastatic RET fusion-positive non-small cell lung cancer (NSCLC).

This decision was supported by new clinical evidence presented during the resubmission process, which demonstrated that oral Retevmo outperformed MSD’s Keytruda (pembrolizumab) combined with platinum-based doublet chemotherapy in terms of progression-free survival (PFS). However, the overall survival (OS) benefit remains uncertain.

Despite this, the LIBRETTO-431 trial stands out as the first randomised study comparing a targeted therapy directly against a PD-1 inhibitor plus chemotherapy in cancer patients with a specific biomarker.

“Retevmo is currently the only available treatment for Australians living with RET fusion-positive, advanced or metastatic NSCLC, irrespective of line of therapy. Its recommendation for reimbursement through the Pharmaceutical Benefits Scheme is a very important step for those who might benefit from access to this medicine,” said Tori Brown, President of North Asia-Pacific and General Manager of ANZ, Eli Lilly.

Book your tickets now! FINALISTS revealed! WINNERS to be crowned at the Awards ceremony on 16th October.

The PBAC concluded that Retevmo would be cost-effective, with an incremental cost-effectiveness ratio (ICER) of less than $75,000 per quality-adjusted life year (QALY) gained, aligning it with other targeted therapies for NSCLC. This decision necessitates adjustments to the Pharmaceutical Benefits Scheme (PBS) listing of Keytruda, allowing its use post-Retevmo treatment.

AstraZeneca also secured a PBAC recommendation for Lynparza (olaparib) in treating HER2-negative locally advanced or metastatic breast cancer with a confirmed germline BRCA1 or BRCA2 mutation.

Ben McDonald, Country President of AstraZeneca Australia and New Zealand, expressed gratitude to the patient advocacy groups and clinical community for their vital role in amplifying the patient voice.

“While the PBAC continues to review applications under the current guidelines, we believe the current HTA review is critical to continue to drive reform to the PBS to deliver earlier, faster and fairer access for Australians to diagnosis and therapies.

“AstraZeneca supports Medicines Australia’s advocacy for faster access to medicines, with reimbursed access achieved within approximately 60 days of TGA registration. Currently, the average time from registration to reimbursement in Australia is 466 days,” McDonald emphasised.

He further stated, “AstraZeneca continues to advocate for medicines bridging funding, as we believe this is the best way to provide faster and fairer access to new cancer medicines, bridging the gap between TGA approval and PBS reimbursement.”

In women’s health, Bayer welcomed the PBAC’s recommendation for Visanne (dienogest), an established off-patent product currently available privately in Australia. The company’s submission to the PBAC was in response to stakeholder interest in this alternative treatment for endometriosis.

“We are now reviewing PBAC’s advice to determine next steps. Bayer is committed to advancing women’s health by providing solutions for different reproductive needs and advocating for equitable access,” said Manoj Saxena, General Manager Pharmaceuticals ANZ at Bayer.

In rare diseases, Novartis is eyeing the paroxysmal nocturnal haemoglobinuria (PNH) market following the PBAC’s positive recommendation for its oral factor B inhibitor, Fabhalta (iptacopan). PNH, a rare and life-threatening condition, involves the destruction of red blood cells, blood clots, and impaired bone marrow function.

Novartis has ambitious plans for Fabhalta, positioning it as a rival to AstraZeneca’s C5 inhibitor and as a treatment for other renal and haematological conditions, including primary immunoglobulin A nephropathy (IgAN), also known as Berger’s disease.

Meanwhile, negotiations for broader listing of AstraZeneca and Boehringer Ingelheim’s SGLT2 inhibitors (Forxiga and Jardiance respectively) has hit a financial snag. These therapies are to be used as add-on to metformin in type 2 diabetes mellitus (T2DM) for patients with cardiovascular disease or high cardiovascular risk.

Despite the Australian Evidence-Based Clinical Guidelines for Diabetes endorsing the use of SGLT2 inhibitors in this way, the PBAC has now stipulated that a 15% price reduction must be agreed upon by the pharmaceutical companies before the expanded listing can be implemented without further price reductions or a financial cap.

In reimagining healthcare across the entire patient journey, Health Industry HubTM is the only one-stop-hub uniting the diversity of the Pharma, MedTech, Diagnostics & Biotech sectors to inspire meaningful change.

The Health Industry HubTM content is copyright protected. Access is available under individual user licenses. Please click here to subscribe and visit T&Cs here.


News & Trends - MedTech & Diagnostics

Government's claim of progress in genomics falls flat while it fails to uphold the fundamental rights of Aussies

Government’s claim of progress in genomics falls flat while it fails to uphold the fundamental rights of Aussies

Health Industry Hub | February 7, 2025 |

The government has unveiled Cancer Australia’s National Framework for Genomics in Cancer Control, a strategic plan designed to guide healthcare […]

More


News & Trends - Pharmaceuticals

Healthcare sector’s political donations: What to expect ahead of the federal election

Healthcare sector’s political donations: What to expect ahead of the federal election

Health Industry Hub | February 7, 2025 |

Ahead of the upcoming federal election, attention turns to the financial contributions to major political parties. The Australian Electoral Commission’s […]

More


News & Trends - Pharmaceuticals

'Underinvestment in gynae cancer has left critical gaps,' says ANZGOG Chair

‘Underinvestment in gynae cancer has left critical gaps,’ says ANZGOG Chair

Health Industry Hub | February 7, 2025 |

Ovarian cancer is the deadliest women’s cancer, with the latest statistics revealing a five-year survival rate of just 49%. Alarmingly, […]

More


News & Trends - MedTech & Diagnostics

Labor's one-off funding a band aid for public hospitals while private sector left in limbo

Labor’s one-off funding a band aid for public hospitals while private sector left in limbo

Health Industry Hub | February 6, 2025 |

The Federal Government has committed a one-off funding boost of $1.7 billion to public hospitals under a one-year extension to […]

More


This content is copyright protected. Please subscribe to gain access.