More than 1200 Australians diagnosed with chronic lymphocytic leukaemia each year will gain subsidised access to a targeted treatment shown to improve survival and reduce reliance on chemotherapy.
Australians with chronic lymphocytic leukaemia will gain affordable access to a frontline targeted therapy after acalabrutinib was listed on the Pharmaceutical Benefits Scheme.
The move will reduce costs from around $7000 per script to standard PBS prices and will apply to more than 1200 Australians with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
The listing covers acalabrutinib (Calquence) in combination with venetoclax (Venclexta) as a first-line treatment for eligible patients with CLL and SLL, the most common forms of adult leukaemia in Australia.
CLL is characterised by the progressive accumulation of abnormal B lymphocytes and primarily affects older adults, often requiring long-term management.
While outcomes have improved substantially over recent decades, blood cancers remain a significant cause of cancer mortality, second only to lung cancer in cancer-related deaths nationally.
Federal health minister Mark Butler announced the listing earlier this week at the Royal Adelaide Hospital.
“This will be an enormous life-changing benefit to as many as 1200 patients every single year with these types of blood cancer and will be available to them at affordable PBS prices,” said Mr Butler.
“This is another instalment in our ongoing commitment and mission to make available to Australians the world’s best medicines, which are often very expensive, at affordable prices for patients. And today’s listing is another example of that.”
The PBS decision follows evidence from international and Australian clinical trials evaluating fixed-duration treatment with acalabrutinib, a second-generation Bruton’s tyrosine kinase (BTK) inhibitor, alongside the BCL-2 inhibitor venetoclax.
The combination forms part of a growing movement towards targeted, time-limited therapies that avoid conventional chemotherapy while delivering deeper and more durable responses.
Royal Adelaide Hospital and King’s Hospital haematologist Dr Uwe Hahn, who served as principal investigator for the Australian arm of the study, said the treatment represented the latest advance in a decades-long transformation of CLL care.
“That has proved to be a very safe and effective treatment that we can now offer to all new patients with blood cancer types,” said Dr Hahn.
“That is the most recent advance in the development that has seen us move away from more traditional chemotherapy-based regimens to treatments that use targeted agents and that have been proved very effective.”
Dr Hahn noted that overall survival for patients with CLL had improved dramatically over recent decades as targeted therapies became available.
“There was decided improvement in the overall survival, and that has now reached 90% in 2020-23, as compared to just over 60% back in 1989,” he said.
Related
Data from the trial showed three-year overall survival of 94% among patients receiving acalabrutinib and venetoclax, compared with just over 80% among those treated with standard immunochemotherapy.
Dr Hahn said the oral regimen also offered practical advantages that can significantly improve patients’ quality of life.
“The treatment is so very effective, it is also safe, that can be administered to most of our patients and easily as it is in tablet base,” he said.
“That means that patients can spend more time at home and have fewer number of days than in hospital beds and in NHS which is, obviously, a very important improvement of their quality of life. And many can even work during the treatment.”
Unlike many cancer therapies that require ongoing treatment, the acalabrutinib-venetoclax combination is delivered over a fixed period of just over 12 months.
Dr Hahn said this allowed patients to complete therapy and return to normal daily activities without remaining on indefinite treatment.
For patient advocate Alona Robinson, the PBS listing marked the culmination of a journey that began seven years ago when she was diagnosed with CLL after experiencing fatigue and shortness of breath.
Initially overwhelmed by the diagnosis and concerned about the financial implications of treatment, Robinson enrolled in the clinical trial and has remained in remission for five years.
“It changed my life,” she said. “Back then, I felt like I didn’t know what was going to happen. You think the worst straight away.”
Robinson said affordability was one of her immediate concerns following diagnosis and welcomed the government’s decision to make the treatment widely accessible.
“That’s definitely a big thought. I was like, how am I going to pay for this? How much is it?” she said.
The government also used the announcement to confirm the PBS listing of blinatumomab (Blincyto), an immunotherapy for a form of leukaemia that would otherwise cost around $230,000 per course of treatment. The therapy is expected to benefit approximately 110 patients each year.
