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BCNA News 04 Jun 2020

New compassionate access schemes for metastatic breast cancer patients

BCNA is aware that many people living with hormone receptor positive, HER2-negative metastatic breast cancer would like the opportunity to be treated with a CDK4/6 inhibitor such as Kisqali (ribociclib), Ibrance (palbociclib) or Verzenio (abemaciclib).

There are now a number of ways to get affordable access to one of these drugs for first, second and later lines of treatment.

Kisqali – first and second line treatment

BCNA has welcomed a new access program for Kisqali. Through the program, called SPARK Plus, pharmaceutical company Novartis is providing eligible people with Kisqali free of charge, for first or second line treatment in combination with the drug Faslodex (fulvestrant).

The program is open to people newly diagnosed with hormone receptor positive, HER2-negative metastatic breast cancer and to people who have been treated with only an aromatase inhibitor for this type of breast cancer.

Clinical trials have shown that Kisqali can significantly extend the length of time before the cancer spreads (progresses) and has few serious side effects, allowing people to enjoy a good quality of life. The trials have also shown it can significantly extend overall survival.

BCNA CEO Kirsten Pilatti says that after many years of hard work and pressure applied to pharmaceutical companies to open up access to CDK inhibitors, BCNA is pleased Novartis has responded.

“This will mean so much to our members who are currently living with metastatic breast cancer or who are diagnosed with this type of metastatic breast cancer in the future. At a cost of around $5,000 per month, Kisqali is well out of the reach of many Australian families. This program will mean they won’t have to mortgage their house or take out a loan during what is already a difficult and stressful time for them.”

The SPARK Plus program provides Kisqali for use in combination with Faslodex. Faslodex is not listed on the PBS and is not provided as part of SPARK Plus. There will be a cost to patients to purchase it.

The Kisqali – Faslodex combination is currently not available through the PBS, however applications have been made to the Government’s independent assessment committee, the Pharmaceutical Benefits Advisory Committee (PBAC). The outcomes of applications should be known by the end of August.

Verzenio– third and later line treatment

Pharmaceutical company Lilly has opened a special access scheme to provide its CDK inhibitor Verzenio free of charge 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, Verzenio can be given as a monotherapy or with Faslodex. Faslodex is not included in the access program and there will be a cost to use it.

Ibrance – second and later line treatment

Pfizer also has an access program for its CDK inhibitor, Ibrance. Under this program, the patient purchases the first eight packs of Ibrance, at a cost of $4,850 per pack plus any script fees charged by the pharmacist. Once eight packs have been paid for, Pfizer will provide Ibrance free of charge for as long as the patient is clinically benefitting from it. Using Ibrance with Faslodex, will also incur a cost. The total out-of-pocket cost is around $60,000.

If you have any questions about any of these programs or about whether a CDK inhibitor would work for you, please speak to your medical oncologist.

For more information on CDK Inhibitors go to the My Journey online tool.