Decision to fund palbociclib (Ibrance) for advanced breast cancer

5 March 2020

Medicines Decision

We are pleased to announce a decision to fund palbociclib (Ibrance) for the treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer through an agreement with Pfizer New Zealand.

This decision means that all eligible patients in the first-line, second-line and subsequent-line treatment settings with HR-positive, HER2-negative locally advanced or metastatic breast cancer will have access to a line of funded treatment with palbociclib from 1 April 2020.

Palbociclib is registered by Medsafe for use in the second and subsequent line settings in combination with fulvestrant.

We previously notified a decision to fund fulvestrant (Faslodex) as soon as possible following Medsafe registration, which is currently under assessment.

However, in light of the need for patients to use fulvestrant in combination with palbociclib in some settings, fulvestrant will be funded from 1 April 2020 and the criteria have been amended for a similar reason. Any prescribing, sale and supply of fulvestrant prior to Medsafe registration will need to meet the requirements in Section 25 and 29 of the Medicines Act 1981.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 15 January 2020

Following consideration of consultation feedback, the listing of palbociclib has been amended to:

remove the requirement for patients to have postmenopausal endocrine levels for 12 months or greater,
clarify that the intended pre-treated population includes those who have received prior chemotherapy,
ensure that funded access is available to eligible patients who started palbociclib treatment prior to 1 April 2020, and
apply the wastage rule.

We have also decided to remove the requirement for patients to have postmenopausal endocrine levels for 12 months or greater from the special authority criteria for accessing funded fulvestrant. This will ensure that the criteria for palbociclib and fulvestrant are aligned, which is particularly relevant for people taking palbociclib in combination with fulvestrant.

Who we think will be most interested

People who have or may develop breast cancer and their whānau
Oncologists
Community and hospital pharmacies
DHBs and other organisations providing testing and treatment services
Organisations with an interest in cancer treatment

Details about this decision

Palbociclib

Palbociclib will 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	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

The listing of palbociclib in Section B of the Pharmaceutcial Schedule will have the wastage rule applied.

A confidential rebate will apply to Ibrance that will reduce the net price to the Funder.

Ibrance will have protection from delisting and subsidy reduction until 30 June 2023.

Palbociclib (Ibrance) will be the only funded brand of CDK4/CDK6 inhibitor listed on the Pharmaceutical Schedule for the treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer from 1 April 2020 until 30 June 2023.

Palbociclib will be listed in Section B of the Pharmaceutical Schedule from 1 April 2020 subject to the following Special Authority criteria (differences from criteria consulted on shown by additions in bold and deletions in ~~strikethrough~~):

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

Either:

second or subsequent line setting
4.1. ~~Patient’s disease~~ Disease has relapsed or progressed during prior endocrine therapy; or
4.2. Both:

first line setting
~~4.2.1.~~ ~~Patient has not received prior systemic treatment for metastatic disease; and~~
4.2.1. Patient ~~has been~~ is amenorrhoeic ~~for 12 months of greater~~, either naturally or induced, with endocrine levels consistent with a postmenopausal state; and
4.2.2. Either:

4.2.2.1. Patient has not received prior systemic endocrine treatment for metastatic disease; or
4.2.2.2. All of the following:

4.2.2.2.1. Patient commenced treatment with palbociclib in combination with an endocrine agent prior to 1 April 2020; and
4.2.2.2.2. Patient had not received systemic endocrine treatment for metastatic disease prior to commencing treatment with palbociclib; and
4.2.2.2.3. There is no evidence of disease progression; and

5. Treatment 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:

1. Treatment must be used in combination with an endocrine partner; and
2. There is no evidence of progressive disease; and
3. The treatment remains appropriate and the patient is benefitting from treatment.

The same changes to the restrictions for palbociclib will apply in Part II of Section H of the Pharmaceutical Schedule.

Fulvestrant

Fulvestrant will be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 April 2020 as follows (ex-manufacturer, excluding GST):

Chemical	Formulation	Brand	Pack size	Price and subsidy
Fulvestrant	Inj 50 mg per ml, 5 ml prefilled syringe	Faslodex	2	$1,068.00

The listing of fulvestrant in Section B of the Pharmaceutcial Schedule will have the wastage rule applied.

Fulvestrant will be listed in Section B of the Pharmaceutical Schedule from 1 April 2020 subject to the following Special Authority criteria (differences from criteria previously approved and notified shown as deletions using ~~strikethrough~~):

Special Authority for Subsidy – Retail Pharmacy - Specialist

All of the following:

Patient has oestrogen-receptor positive locally advanced or metastatic breast cancer; and
Patient has disease progression following prior treatment with an aromatase inhibitor or tamoxifen for their locally advanced or metastatic disease; and
~~Patient is amenorrhoeic for 12 months or greater, either naturally or induced, with endocrine levels consistent with a postmenopausal state; and~~
Treatment to be given at a dose of 500 mg monthly following loading doses; and
Treatment to be discontinued at disease progression.

Renewal – 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:

Treatment remains appropriate and patient is benefitting from treatment; and
Treatment to be given at a dose of 500 mg monthly; and
There is no evidence of disease progression.

The same changes to the restrictions for fulvestrant will apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).

Faslodex will be listed as an unapproved medicine (Section 29 of the Medicines Act 1981) until the Medsafe registration process is completed. Until then, any prescribing, sale and supply of fulvestrant will need to meet the requirements in sections 25 and 29 of the Medicines Act 1981.

Our response to what you told us

We’re grateful for the time people took to respond to this consultation. Responses were generally supportive of the proposal. A summary of the main themes raised in feedback, our responses to the feedback received and changes we have made after listening to you, are set out below:

Theme	Comment
Definition of ‘second line’
Requests for clarification of whether the use of the term “second-line” referred to in PHARMAC’s consultation dated 15 January 2020 is intended to mean patients who have received only one line of prior endocrine therapy or whether patients who have received multiple lines of therapy for their metastatic disease would also be eligible.	References to “second-line” in this context refer to both second-line and any subsequent lines of treatment. The criteria are intended to include patients who have had one or more previous lines of treatment for their metastatic disease.
Requests for access criteria amendments
Requests for removal of the requirement for first-line patients to be amenorrhoeic for a period of 12 months or greater whether naturally or induced.	We have amended the criteria for palbociclib to remove the requirement for first-line patients to be amenorrhoeic for a period of 12 months or greater whether naturally or induced. Amendments to the fulvestrant criteria have also been made to align with this.
Request for patients who have received chemotherapy for metastatic disease to be eligible by amending the criteria to specify that the patient has not received prior systemic ‘endocrine’ therapy for their metastatic disease.	The criteria for palbociclib have been amended to reflect this. We note that clinical trials supporting the use of palbociclib included patients who had received prior chemotherapy in the context of advanced disease.
Eligibility of different patient groups
Requests for clarification regarding the eligibility of patients who have already commenced first-line or second-line treatment with currently funded endocrine agents as monotherapy.	Patients who have recently begun a first-line endocrine agent only treatment (ie. that does not include palbociclib) and have not experienced relapse or progression would be eligible under criterion 4.1 if their disease progresses. Patients who are receiving a second or later-line of endocrine treatment, having experienced disease relapse or progression following the first agent, will be eligible for treatment with palbociclib under criterion 4.1. It would be a clinical decision regarding whether and when such patients commence a palbociclib regimen.
Requests for clarification regarding the eligibility of patients who have already commenced first-line or second-line treatment with a palbociclib regimen.	Patients who met the approved criteria when they started palbociclib will be eligible for funded treatment. To facilitate access to funded treatment for these patients, the Special Authority criteria have been amended to include a category for ‘grandparenting’ any first-line patients who commenced palbociclib prior to the listing date (provided all other criteria are met). As noted above, patients in the second-line or subsequent-line settings are eligible at any point under criterion 4.1 regardless of whether or not they had already commenced palbociclib, so no amendments to the criteria were needed for this scenario.
System Impacts
Requests that the Original Pack (OP) rule be applied to all strengths of palbociclib, because there could be dose adjustments due to adverse effects such that community pharmacy could be left with a part pack and at risk of financial burden.	The wastage rule has been added to all strengths of palbociclib. Given the capsule presentation of palbociclib, we consider that the wastage rule is more appropriate than OP in this instance.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.