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IBRANCE® (palbociclib) to be funded

Pfizer New Zealand today welcomed the provisional decision by PHARMAC to fund IBRANCE (palbociclib) for women with hormone-receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2–) advanced or metastatic breast cancer in combination with an aromatase inhibitor, or with fulvestrant in women after prior endocrine therapy.[1],[2]

Pfizer Australia & New Zealand Managing Director Melissa McGregor said: “Access to targeted treatments like IBRANCE, which enable New Zealand patients to live well and for longer without their disease progressing, is crucial for people with advanced cancer.[3],[4],[5] More than 600 New Zealand women are diagnosed with advanced breast cancer every year[6] and the majority of these patients will have HR-positive, HER2-negative (HR+/HER2-) disease.[7]

“We estimate at least 1,100 New Zealand patients will benefit from IBRANCE this year alone.[8] Pfizer New Zealand is very pleased that, after a long wait, patients in New Zealand will soon be able to access IBRANCE”, Ms McGregor said.

IBRANCE represents an important advancement in the treatment of HR+/HER2- advanced or metastatic breast cancer3,4,5,[9] and has been registered by MEDSAFE in New Zealand since 2017.[10] IBRANCE works by inhibiting cyclin-dependent kinases 4 and 6 (CDK4/6), thereby delaying cancer cell division and growth.[11] It is anticipated that IBRANCE will be funded from 1 April 2020 once approved by the PHARMAC board at the end of February 2020.

IBRANCE is an oral therapy approved for use in women with HR positive/HER2 negative (HR+/HER2-) advanced or metastatic breast cancer, in combination with an aromatase inhibitor, or with fulvestrant after prior endocrine therapy.2

When used in combination with endocrine (hormone) therapy, IBRANCE significantly prolongs the duration of tumour control compared to hormone therapy alone.2,3,4,5 The addition of a CDK 4/6 inhibitor, such as IBRANCE, to endocrine therapy is now considered a standard treatment approach for postmenopausal women with advanced or metastatic HR positive/HER2 negative (HR+/HER2-) breast cancer, and is supported by major international guidelines.[12],[13],[14]

In the Phase 3 PALOMA-2 trial of 666 postmenopausal women with HR positive/HER2 negative (HR+/HER2-) metastatic breast cancer in the first-line treatment setting, the combination of IBRANCE plus letrozole resulted in a statistically significant improvement in progression-free survival (PFS) (HR=0.563 [95% CI: 0.46–0.69], P<0.0001), with a median PFS of 27.6 months compared to 14.5 months for those treated with letrozole plus placebo.2,4

The Phase 3 PALOMA-3 trial of 521 women with HR positive/HER2 negative (HR+/HER2-) metastatic breast cancer, regardless of menopausal status, whose disease had progressed on or after prior endocrine therapy, found that the combination of IBRANCE plus fulvestrant substantially improved PFS compared to fulvestrant plus placebo (HR=0.497 [95% CI: 0.398–0.620), P<0.000001), with a median PFS of 11.2 months (95% CI: 9.5–12.9) in the IBRANCE plus fulvestrant arm compared to 4.6 months (95% CI: 3.5–5.6) in women who received placebo plus fulvestrant.2,5

To support New Zealand patients with HR positive/HER2 negative (HR+/HER2-) advanced or metastatic breast cancer whilst they are awaiting funding, until 1 April 2020, Pfizer New Zealand will provide IBRANCE at no charge* to patients for whom the treating clinician determines that IBRANCE is appropriate, and who meet the PHARMAC clinical criteria for funded access. After 1 April 2020, we anticipate that these patients will be eligible for funded IBRANCE‡.

Some New Zealand patients currently enrolled in the IBRANCE Assistance Program and receiving IBRANCE at no charge*, may not meet the PHARMAC clinical criteria for funded access. These patients will continue to receive IBRANCE at no charge*.

It is important that all patients speak with their healthcare professional to understand what treatment options are right for them.

Healthcare professionals who wish to obtain IBRANCE for their patients are to contact Pfizer for further details.

* Pfizer New Zealand provides IBRANCE medicine at no charge, pharmacy dispensing fees may apply.

‡ Assumes PHARMAC funding from 1 April 2020, based on approval of PHARMAC board at the end of February 2020. From 1 April 2020 PHARMAC intends to make funded IBRANCE available, in a manner to be determined by PHARMAC, to patients who have received treatment with IBRANCE prior to 1 April 2020, who met the eligibility criteria when treatment was initiated, and who continue to meet any relevant eligibility criteria above at the time that funding is made available.1

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