BCNA is pleased to advise that, after many discussions with relevant pharmaceutical companies, two new compassionate access schemes are now open for patients wishing to access a CDK4/6 inhibitor for second or later line treatment of hormone receptor positive, HER2-negative metastatic breast cancer. These are in addition to the program already offered by Pfizer.

To enquire about enrolling patients in any of these programs, please contact the relevant pharmaceutical company.

Ribociclib – first and second line treatment (Novartis)

The SPARK Plus access program, being offered by Novartis, allows eligible patients to access ribociclib (Kisqali) free of charge for first and second line treatment.

In this setting, ribociclib is given in combination with fulvestrant (Faslodex), which is not currently available through the PBS. Fulvestrant is not provided as part of SPARK Plus and must be accessed independently, which will incur a cost.

AstraZeneca currently has an access program for fulvestrant as a monotherapy. BCNA is not aware if the program is being extended to patients wishing to use fulvestrant with a CDK inhibitor, but you can enquire direct with AstraZeneca.

Abemaciclib – third and later line treatment (Lilly)

Lilly has opened a special access scheme to provide abemaciclib (Verzenio) for third and later line treatment. Patients will be assessed on a case by case basis but must meet the eligibility criteria for the MONARCH1 trial. These include:

• Prior endocrine therapy (but no prior CDK4/6 inhibitor)
• At least two prior chemotherapy regimens, with at least one but no more than two in the metastatic setting and one must have included a taxane
• Adequate organ function
• Measurable disease according to RECIST v1.1
• ECOG performance score of 0/1.

In this setting, abemaciclib can be given as a monotherapy or with fulvestrant.

Palbociclib – second and later line treatment

Pfizer has a capped access program for its CDK inhibitor palbociclib (Ibrance) but, unlike the other schemes, there is a patient-co-pay for this program. Patients are required to purchase the first eight packs of palbociclib, at a cost of $4,850 per pack (plus pharmacy dispensing fee) – total cost around $40,000. Pfizer will then provide palbociclib free of charge for as long as the patient is clinically benefiting from it. Patients having the palbociclib / fulvestrant combination will also be required to pay fulvestrant.

Any patient who has already spent more than $40,000 on palbociclib is also eligible.

PBS applications for ribociclib (second line) and fulvestrant (any line)

The July meeting of the Pharmaceutical Benefits Advisory Committee will consider applications for ribociclib for first and second line use, and fulvestrant in any line of treatment. BCNA has provided a submission to PBAC in support of both drugs. The outcomes of the applications are due by the end of August. For more information, see the agenda for the PBAC meeting.