Ibrance

Palbociclib

• Brand(s): Ibrance
• Dosage Form/Strength: 75 mg, 100 mg, 125 mg tablet or capsules
• Updated December 4, 2020

Initial Criteria

For the treatment of patients with estrogen receptor(ER)-positive, human epidermal growth factor receptor 2 (HER 2)-negative; unresectable locally advanced breast cancer or metastatic breast cancer in patients who meet the following criteria:

1. Palbociclib is being used as combination therapy in one of the following treatment regimens¹:
   i) As first line therapy in combination with an aromatase inhibitor (i.e., letrozole, anastrozole, or exemestane) or fulvestrant in a patient who has not progressed on a prior systemic treatment (i.e., chemotherapy, immunotherapy, or endocrine therapy) for their unresectable locally advanced or metastatic disease;
   OR
   ii) As second line therapy in combination with an aromatase inhibitor (i.e., letrozole, anastrozole, or exemestane) or fulvestrant after progression on a chemotherapy for unresectable locally advanced or metastatic disease;
   OR
   iii) As a second or subsequent line therapy in combination with fulvestrant after progression on any number of endocrine monotherapies with the exception of progression during prior fulvestrant therapy.

   ¹Note: EAP funding will be considered for only one CDK 4/6 inhibitor regimen (i.e. Palbociclib or Ribociclib) OR Everolimus based regimen for the treatment of unresectable locally advanced or metastatic disease. No funding for sequential treatment regimens involving palbociclib or ribociclib or everolimus will be considered.

   AND

2. Patients who received anastrozole or letrozole in the neo-adjuvant or adjuvant setting, must demonstrate a minimum disease-free interval of twelve (12) months after stopping therapy to qualify for funding of palbociclib in combination with anastrozole or letrozole. (Note: This does not apply to patients receiving tamoxifen or exemestane in the neoadjuvant or adjuvant setting who progress or relapse early on those treatments.)

3. Patient has good performance status defined as an Eastern Cooperative Oncology Group (ECOG) score of 0 to 2; AND

4. Patient does not have active or uncontrolled metastases to the central nervous system; AND

5. In the case of a Patient who is pre-menopausal or peri-menopausal, the Patient is receiving a luteinizing hormone-releasing hormone (LHRH) agonist to achieve chemically-induced menopause (Note: Women who have had an oophorectomy are considered to be post-menopausal); AND

6. The Patient has not experienced disease progression on any of the following regimens for locally advanced or metastatic breast cancer:
   i) a palbociclib or ribociclib regimen;
   ii) an everolimus regimen; OR
   iii) another CDK 4/6 regimen that has been publicly funded.

Renewal Criteria:
Renewals will be considered in patients who have not demonstrated evidence of disease progression or development of unacceptable toxicity requiring discontinuation while on palbociclib.

Exclusion Criteria: (Note that exclusion criteria apply to both Initial eligibility criteria and renewal criteria.) Patients meeting the following criteria will not be funded.

1. Patient is using palbociclib as retreatment after disease progression on a prior palbociclib-based regimen in advanced breast cancer.
2. Patient is using palbociclib with other drugs or in combinations other than those situations mentioned in 1 i), ii), iii) of the eligibility criteria.
3. Patient is using palbociclib in combination with letrozole or anastrozole in the metastatic setting but has experienced progression in the neoadjuvant or adjuvant setting occurring during treatment or within 12 months of stopping treatment with letrozole or anastrozole;
4. Patient is pre- or peri-menopausal who is not being treated with a luteinizing hormone-releasing hormone (LHRH) agonist.
5. Patient who is intending to use palbociclib with fulvestrant who has progressed on prior fulvestrant used as monotherapy or as part of another regimen.
6. Patient whose disease has progressed during treatment with a ribociclib regimen, an everolimus regimen, or another CDK 4/6 inhibitor regimen used for advanced, metastatic breast cancer, unless that use was through a clinical trial.
7. Patient who has active or uncontrolled central nervous system (CNS) metastases.
8. The Patient is requesting Ibrance for use with fulvestrant and has extensive, symptomatic, potentially life-threatening visceral metastases.

On a time-limited basis, funding will be considered for the following on a case-by-case basis:

1. Patients who missed the opportunity to use palbociclib in the advanced setting in patients started on first-line, monotherapy with an aromatase inhibitor (AI) (e.g. letrozole, anastrozole, exemestane) AND who have not have not experienced disease progression with current AI therapy AND who meet the disease-free time requirement if anastrozole or letrozole was used previously in the adjuvant or neoadjuvant setting and the EAP request is submitted between the dates of December 4, 2020 to March 4, 2021.
2. Addition of palbociclib for patients already on fulvestrant in first, second or subsequent line who has not experienced disease progression on fulvestrant and who are CDK 4/6 inhibitor naïve and otherwise eligible for this therapy if the EAP request is submitted between the dates of December 4, 2020 to March 4, 2021.
3. A switch to palbociclib + fulvestrant at progression for patients already on endocrine/hormonal therapy other than fulvestrant and who are CDK4/6 naïve and otherwise meet the eligibility requirements for this therapy.
4. A switch to palbociclib + fulvestrant at progression for patients already on and benefitting from everolimus + exemestane, provided that the start of everolimus + exemestane was prior to December 4, 2020. Patients must be CDK 4/6 inhibitor naïve and otherwise eligible for this therapy.

Dosing:
Palbociclib (Ibrance) 125mg orally once a day for 21 consecutive days, followed by 7 days off treatment, in a combination regimen with one of the following:
• A continuous daily aromatase inhibitor
OR
• Fulvestrant 500mg administered intramuscularly on days 1 and 15 of cycle 1 and then on day 1 of each subsequent 28-day cycle.

EAP Drug Request Form:

Standard Form for EAP Drug Requests