IBRANCE (palbociclib)
SELF ADMINISTRATION - ORAL
Indication for Prior Authorization:
Treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or fulvestrant in patients with disease progression following endocrine therapy.
Coverage Criteria:
- Prescribed by or in consultation with an oncologist; AND
- Patient is at least 18 years of age; AND
- Medical record documentation confirms a diagnosis of advanced, recurrent, or metastatic breast cancer that is HR-positive and HER2-negative; AND
- Medical record documentation confirms the patient will use Ibrance in combination with:
- an aromatase inhibitor (e.g. anastrozole, exemestane, letrozole) as initial endocrine-based therapy; OR
- fulvestrant (Faslodex) with disease progression following endocrine therapy.
Dosing:
125 mg once daily taken with or without food for 21 days followed by 7 days off treatment.
Coverage Duration:
Initial: 6 months.
Reauthorization: 1 year.
Authorization is Not Covered for the Following:
The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.
Additional Information:
- Avoid concurrent use of Ibrance with strong CYP3A inhibitors. If the strong inhibitor cannot be avoided, reduce the Ibrance dose.
- Avoid concurrent use of Ibrance with strong CYP3A inducers.
- Ibrance is available as tablets or capsules in strengths of 125mg, 100mg, and 75mg.
- Per NCCN guidelines (v 6.2020), either an aromatase inhibitor or fulvestrant in combination with a CD4/6 inhibitor (i.e., abemaciclib, palbociclib, ribociclib) are preferred regimens (category 1 recommendation) for first line systemic therapy in patients with ER and/or PR positive recurrent or stage IV breast cancer.
Review History:
- 03/31/2017 – Approved by FDA
- 05/29/2018 - Annual review
- 12/31/2020 – Annual review; Format updated; Added statement from NCCN treatment recommendations.
References:
- Ibrance - palbociclib capsule [package insert]. New York, NY: Pfizer Inc; September 2019.
- Ibrance - palbociclib tablet, film coated [package insert]. New York, NY: Pfizer Inc; November 2019.
- National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – Breast Cancer, version 6.2020 – September 8, 2020. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed December 31, 2020.
Last review date: January 4, 2021