Kisqali on PBS, very few will get it.
those of us who were waiting to get Ibrance or Kisqali on PBS we will not get either. Only newly the diagnosed who have NOT had an Aromatose drug. ( there would be very few of them ) BCNA failed t...
Forum Discussion
From the PBS Website: http://www.pbs.gov.au/medicine/item/11385F
It looks like you need to be a lawyer to understand the 'conditions' attached to the access to this drug!
They appear to contradict themselves, saying: Patient must not have previously been treated with an aromatase inhibitor,
- then further down say: The treatment must be in combination with anastrozole or letrozole
Hmmm ... so you only qualify if you start AIs AFTER starting Ribociclib?
How many are given AIs BEFORE starting Ribociclib?
Personally, I don't understand all the terms ..... like 'grandfather patients'?? Please explain?
There appears to be different criteria for 3 different 'Met BC & Phases/' ....
1) Locally advanced or metastatic breast cancer
Treatment Phase: Initial Treatment
2) Locally advanced or metastatic breast cancer
Treatment Phase: Continuing treatment
3) Locally advanced or metastatic breast cancer
Treatment Phase: Initial treatment - Grandfather patients
Direct PBS QUOTE:
Locally advanced or metastatic breast cancer
Treatment Phase: Initial treatment
Clinical criteria:
Patient must not have previously been treated with an aromatase inhibitor,
AND
The condition must be hormone receptor positive,
AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative,
AND
The condition must be inoperable,
AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less,
AND
The treatment must be in combination with anastrozole or letrozole,
AND
Patient must require dosage reduction requiring a pack of 21 tablets.
Population criteria:
Patient must not be premenopausal.
Authority Required
Locally advanced or metastatic breast cancer
Treatment Phase: Continuing treatment
Clinical criteria:
Patient must have previously received PBS-subsidised treatment with this drug for this condition,
AND
Patient must not develop disease progression while receiving treatment with this drug for this condition,
AND
Patient must have stable or responding disease,
AND
The treatment must be in combination with anastrozole or letrozole,
AND
Patient must require dosage reduction requiring a pack of 21 tablets.
Population criteria:
Patient must not be premenopausal.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
Authority Required
Locally advanced or metastatic breast cancer
Treatment Phase: Initial treatment - Grandfather patients
Clinical criteria:
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 July 2018,
AND
Patient must not have previously been treated with an aromatase inhibitor prior to initiating treatment with this drug for this condition,
AND
The condition must be hormone receptor positive,
AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative,
AND
The condition must be inoperable,
AND
Patient must have had a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less prior to initiating treatment with this drug for this condition,
AND
The treatment must be in combination with anastrozole or letrozole,
AND
Patient must not develop disease progression while receiving treatment with this drug for this condition,
AND
Patient must have stable or responding disease,
AND
Patient must require dosage reduction requiring a pack of 21 tablets.
Population criteria:
Patient must not be premenopausal.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
UNQUOTE