Proposal to fund palbociclib (Ibrance) for advanced breast cancer
We are seeking feedback on a proposal to fund palbociclib (Ibrance) as a first-line and second-line treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer through a provisional agreement with Pfizer New Zealand.
If approved, this proposal would mean that all eligible patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer would have access to a line of funded treatment with palbociclib.
Further details of this proposal, including how to provide feedback, proposed eligibility criteria and background information, can be found below.
Consultation closes at 5 pm on Friday, 31 January 2020 and feedback can be emailed to consult@pharmac.govt.nz.
A decision has been made
Read the notification of PHARMAC's decision – published 5 March 2020
What would the effect be?
Palbociclib (Ibrance) would be funded in both the first-line and second-line treatment settings for patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer who meet certain clinical criteria.
Our clinical advice is that palbociclib improves progression-free survival with maintained quality of life for patients with HR-positive HER2-negative locally advanced or metastatic breast cancer.
We estimate that the number of patients with HR-positive, HER2-negative disease who would be eligible for treatment with palbociclib each year in New Zealand under the proposed criteria could be:
First year of funding
- up to 550 people in the first-line setting
- up to 1600 people in the second-line setting.
Subsequent years
- up to 950 patients across both first-line and second-line settings.
Who we think will be interested
- People who have or may develop breast cancer and their whānau
- Oncologists
- Community and hospital pharmacies
- DHBs and other organisations providing testing services
- Organisations with an interest in cancer treatment
About palbociclib and HR-positive, HER2-negative locally advanced or metastatic breast cancer
Approximately 3000 people are diagnosed with breast cancer each year in New Zealand. Māori and Pacific women experience higher incidence of breast cancer and mortality, compared with non-Māori, non-Pacific women, and are more likely to present at a later stage of breast cancer. Around 20% of people diagnosed with breast cancer will have locally advanced or metastatic disease. Up to two-thirds of patients with advanced breast cancer have hormone receptor (HR)-positive, HER2-negative disease.
Palbociclib is an oral treatment that blocks the development of cancer cells by inhibiting cyclin-dependent kinases (CDK) 4 and 6. The recommended dose of palbociclib is 125mg taken once daily for 21 days followed by 7 days off treatment to comprise a 28-day cycle.
Further information about palbociclib dosing and administration:
Palbociclib is Medsafe-approved for the treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer as a first line treatment in combination with an aromatase inhibitor and as a second line treatment in combination with fulvestrant.
It is PHARMAC’s intention that if the proposal for palbociclib is approved, funded fulvestrant would be available for eligible patients alongside palbociclib from 1 April 2020.
Why we’re proposing this
Funding applications for two CDK4/CDK6 inhibitors (palbociclib and ribociclib) for the treatment of HR-positive HER2-negative locally advanced or metastatic breast cancer have been considered by PHARMAC’s Pharmacology and Therapeutics Committee (PTAC) and Cancer Treatments Subcommittee of PTAC (CaTSoP).
Both clinical advisory committees have recommended that a CDK4/6 inhibitor be funded as a first-line or second-line treatment for HR-positive HER2-negative locally advanced or metastatic breast cancer, subject to certain clinical criteria.
As a result of the RFP and our analysis of proposals received, PHARMAC has entered into a provisional agreement with Pfizer for the supply of palbociclib (Ibrance) for use in the first-line and second-line treatment settings for HR-positive HER2-negative locally advanced or metastatic breast cancer.
Details about our proposal
Palbociclib would be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 April 2020 at the following price (ex-manufacturer, excluding GST):
|
Chemical |
Formulation |
Brand |
Pack size |
Proposed price and subsidy |
|---|---|---|---|---|
|
Palbociclib |
Cap 75 mg |
Ibrance |
21 |
$4,000.00 |
|
Palbociclib |
Cap 100 mg |
Ibrance |
21 |
$4,000.00 |
|
Palbociclib |
Cap 125 mg |
Ibrance |
21 |
$4,000.00 |
A confidential rebate would apply to Ibrance that would reduce the net price to the Funder. Ibrance would have protection from delisting and subsidy reduction until 30 June 2023.
Palbociclib would be listed in Section B of the Pharmaceutical Schedule subject to the following proposed Special Authority criteria:
Special Authority for Subsidy – Retail pharmacy-Specialist
Initial application - only from a medical oncologist or medical practitioner on the recommendation of a medical oncologist. Approvals valid for 6 months for applications meeting the following criteria:
All of the following:
1. Patient has unresectable locally advanced or metastatic breast cancer; and
2. There is documentation confirming disease is hormone-receptor positive and HER2-negative; and
3. Patient has an ECOG performance score of 0-2; and
4. Either:
4.1. Patient’s disease has relapsed or progressed during prior endocrine therapy; or
4.2. Both:
4.2.1. Patient has not received prior systemic treatment for metastatic disease; and
4.2.2. Patient has been amenorrhoeic for 12 months of greater, either naturally or induced, with endocrine levels consistent with a postmenopausal state; and
5. Palbociclib must be used in combination with an endocrine partner.
Renewal - only from a medical oncologist or medical practitioner on the recommendation of a medical oncologist. Approvals valid for 12 months for applications meeting the following criteria:
All of the following:
- Palbociclib must be used in combination with an endocrine agent; and
- No evidence of progressive disease; and
- The treatment remains appropriate and the patient is benefitting from treatment.
The same restrictions would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).
If this proposal is approved, from 1 April 2020 PHARMAC would make funded palbociclib available to patients who have received treatment with palbociclib prior to 1 April 2020, who would have met the eligibility criteria set out above when treatment was initiated, and who continue to meet any relevant eligibility criteria set out above at 1 April 2020. The mechanism for enabling this would be communicated prior to 1 April 2020.
To provide feedback
Send us an email: consult@pharmac.govt.nz by 5 pm on Friday, 31 January 2020.
All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.
Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.
We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.