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Decisions from the March PBAC meeting for CLL/SLL

Acalabrutinib (Calquence®) will be added to the therapy arsenal for CLL and SLL after receiving a positive recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC) at its March 2020 meeting.

Two treatments for SLL and/or CLL were considered at the meeting for listing on the Pharmaceutical Benefits Scheme (PBS). Venetoclax (Venclexta®) was given a first-time decision not to recommend in a particular indication and acalabrutinib received a positive recommendation.

Acalabrutinib was recommended for the treatment of patients with relapsed or refractory CLL/SLL who are not suitable for treatment or retreatment with a purine analogue (also known as second line treatment of CLL/SLL). The PBAC considered that acalabrutinib may provide a different toxicity profile compared to ibrutinib for some patients.

In its decision not to recommend venetoclax in combination with obinutuzumab for the first-line treatment of CLL patients with coexisting conditions and who are unsuitable for fludarabine-based chemoimmunotherapy, the PBAC accepted that venetoclax + obinutuzumab was clinically superior to current first-line therapy for CLL in delaying progression. However, the cost effectiveness ratio and financial estimates needed to be reviewed.

When the PBAC meets again, in July 2020, it will consider new submissions for acalabrutinib for CLL/SLL patients with a 17p deletion, and a resubmission for venetoclax in combination with obinutuzumab for patients with CLL.

In submissions to the PBAC in February 2020, in support of the availability of new treatment options for this blood cancer, the Leukaemia Foundation included consumer comments, sourced from our disease-specific community groups on Facebook. Australia’s patient population for these yet-to-be-listed therapies is small and we received two consumer responses in relation to acalabrutinib and venetoclax.

The Leukaemia Foundation also contacted the pharmaceutical sponsors who made the submissions, AstraZeneca (acalabrutinib) and AbbVie (venetoclax), for information to help inform our consumer comments. This included details about the target patient population/subgroup, current treatment pathways, how the medicine works, its efficacy relative to other medicines available to treat CLL/SLL, how the medicine is administered, side-effects and their management, and quality of life impacts.

In the Leukaemia Foundation’s submissions, CEO, Bill Petch, urged the PBAC to recommend the treatments be listed on the PBS for eligible patients, “given the high unmet needs of people living with CLL who are unable to tolerate the current standard of care”.

“People want choices,” he said.

“They want access to a range of treatments to help them fight the disease with fewer side-effects, to help them not only to survive but also to live well, and to provide them with greater options for remission and ultimately improved quality of life.

“Our priority is to ensure all Australians living with blood cancer have timely access to the best therapies and treatments available, to improve time spent in remission, survival and quality of life,” said Mr Petch.

Acalabrutinib for r/r CLL or SLL

AstraZeneca sought a listing of acalabrutinib for people with r/r CLL or SLL who were unsuitable for treatment with a purine analogue (e.g. fludarabine) and who have had a least one prior therapy for CLL/SLL.

Based on summary information on the ASCEND clinical trial, use of acalabrutinib versus current standard of care demonstrated a statistically significant reduction in the risk of death or disease progression for patients – including those with high risk features such as 17p deletion, 11q deletion, TP53 mutation, and unmutated IGHV. The usual dose (of acalabrutinib) is a capsule taken twice daily and which can be taken from home, which is convenient for patients and their families.

Bruce Wood, from South Australia, who is living with CLL provided the following input to the PBAC for its consideration of this submission:

I have been taking acalabrutinib for 6 weeks now via a clinical trial at Flinders Medical Centre for CLL. 

My white cell count is rapidly decreasing and my spleen has reduced from 21cm below my lower rib to a normal size. It is a very effective drug with minimal side effects. 

“If it was available to the general public as frontline treatment for CLL it would make a huge improvement to current treatment regimes,” said Bruce.

Venetoclax/obinutuzumab combination as a first-line treatment

AbbVie had requested a streamlined listing of venetoclax in combination with obinutuzumab as first-line treatment for people with CLL with coexisting conditions and who are unsuitable for fludarabine-based chemotherapy such as FCR (fludarabine, cyclophosphamide and rituximab). The venetoclax/obinutuzumab regimen is administered orally, on a daily basis, and can be taken at home after an initial five-week treatment phase where the patient is closely monitored.

Patients who aren’t eligible for intensive chemoimmunotherapy, such as FCR, are currently treated with obinutuzumab in combination with chlorambucil.

Based on summary clinical trial information, AbbVie believes venetoclax in combination with obinutuzumab to be superior to the current standard of care (obintuzumab combined with chlorambucil) for these patients.

A Victorian patient with CLL responded to our request for input on this submission, saying they would be prescribed venetoclax combined with obinutuzumab when they started treatment.