Lilly’s first-in-class therapy PBS listed for early breast cancer after 15-year gap

Pharma News: Australians diagnosed with early-stage breast cancer, particularly those at high risk of recurrence, will gain access to the first CDK4/6 inhibitor, ending a 15-year treatment gap.

From 1 May 2024, Eli Lilly’s oral Verzenio (abemaciclib) will be included on the Pharmaceutical Benefits Scheme (PBS) for approximately 1,800 Australians with HR+, HER2- early breast cancer at high risk of recurrence, alongside adjuvant endocrine therapy (ET).

Federal Health Minister, Mark Butler MP, said “Every year thousands of Australian women get a lifechanging breast cancer diagnosis.The Albanese Government is working hard to ensure each one gets the latest and the best treatment at a price they can afford.”

Around 90% of breast cancer cases are diagnosed early, with approximately 70% falling under the HR+, HER2- subtype. Despite undergoing surgery, chemotherapy, radiotherapy, and hormone therapy, patients with this subtype still face a 30% risk of cancer recurrence.

Professor Fran Boyle AM, Medical Oncologist at Mater Hospital North Sydney and an investigator in the Verzenio clinical trials, said “Nobody wants their cancer to return. Unfortunately, for around a third of all patients with early breast cancer, it will come back.

“One in eight patients with early breast cancer is classified as high risk and the more we can do early in the disease course, the better. Understandably, these women often live with a high degree of anxiety about their cancer potentially coming back and the reality of their prognosis if that were to happen.

“The good news is that we are now able to intensify treatment during the narrow window of opportunity after surgery when patients are treated with curative intent.”

In the phase 3 MonarchE trial, Verzenio in combination with ET significantly decreased the risk of breast cancer recurrence by 32% compared to standard adjuvant ET alone at five years (p<0.001). Nearly twice as many patients receiving ET alone developed metastatic disease compared to those receiving Verzenio.

Eli Lilly Australia and New Zealand General Manager, Tori Brown, stated “Lilly commends the Federal Government for recognising the value of providing subsidised access to Verzenio for eligible Australians living with high-risk early breast cancer and their families.”

“We are delighted to achieve reimbursement after working relentlessly through PBAC and PBS processes for over 650 days since registration by the TGA. We are eager to collaborate with Government and the medicines industry to ensure Australians have fast and equitable access to innovative medicines,” added Ms Brown.

Australia’s registration to reimbursement timeframe compares poorly with other countries, such as Japan (102 days), Germany (136 days) and the UK (156 days). The most recent analysis of Department of Health data indicates this timeframe has blown out to 25 months, meaning Australian patients are waiting months longer for new medicines to become available on the PBS.

Eli Lilly sought the views of 100 Australian medical specialists on issues relating to medicines access. The response was clear – not one of the specialists surveyed considered the current average timeframe between registration and reimbursement acceptable.

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