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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
DIRECT TO CONSUMER MANDATORY
IBRANCE® (palbociclib 75 mg, 100 mg and 125 mg) Capsules
IBRANCE (palbociclib) is an unfunded prescription medicine used to treat HR+, HER2- advanced breast cancer taken in combination with an aromatase inhibitor or fulvestrant.
IBRANCE has risks and benefits. Do not take IBRANCE if you are allergic to palbociclib or any of the other ingredients in IBRANCE capsules. Caution is needed if you are premenopausal or perimenopausal, have or have had abnormal blood test results, problems with your liver or kidneys, are lactose intolerant, are pregnant or planning to become pregnant or are breastfeeding. Tell your doctor if you are taking any other medicines.
Common side effects include infection, abnormal blood test results, tiredness, feeling sick or vomiting, diarrhoea, sore mouth, lips or tongue, hair loss, loss of appetite, nose bleed, skin rash, change in sense of taste, blurred vision, increased tearing or dry eyes, shortness of breath, bleeding or bruising more easily than usual. If symptoms continue or you have side effects, see your doctor, pharmacist or healthcare professional.
Ask your doctor if IBRANCE is right for you. Use strictly as directed. Contains 75 mg, 100 mg or 125 mg of palbociclib. You will need to pay for this medicine and normal doctor’s fees apply.
Further information on IBRANCE is available from Medsafe www.medsafe.govt.nz or Pfizer New Zealand Limited, Auckland, www.pfizer.co.nz Ph. 0800 736 363. V10817 IBRANCE® is a registered trademark. ©Pfizer 2020.
Date prepared by January 2020. PP-IBR-NZL-0064. TAPS NA11623. DA2015MA.
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[1] PHARMAC Consultation 15 Jan 2020
[2] IBRANCE Data sheet
[3] Rugo HS et al. Annals of Oncology 29: 888–894, 2018
[4] Rugo HS et al. Breast Cancer Research and Treatment (2019) 174:719–729
[5] Turner NC et al. N Engl J Med 2018; 379:1926-36
[6] https://www.pharmac.govt.nz/assets/ptac-cancer-treatment-subcommittee-record-2019-04.pdf
[7] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6001771/
[8] Pfizer data on file
[9] https://www.icr.ac.uk/news-archive/icr-responds-to-nice-approval-of-palbociclib-for-treating-advanced-breast-cancer-after-hormone-therapy
[10] Medsafe Gazette notice
[11] Rocca A, et al. Expert Opin Pharmacother. 2014;15(3):407-420.
[12] NCCN Guidelines. Breast Cancer V4.2018
[13] Cardoso F, et al. Ann Oncol. 2018:29: 1634-1657
[14] American Society for Clinical Oncology. Treatment of Advanced HER2-Negative Breast Cancer. Available at: www.cancer.net/research-and-advocacy/asco-care-and-treatment-recommendations-patients/treatment-advanced-her2-negative-breast-cancer
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