| Oncology Drugs |
Ribociclib
- Brand(s): Kisqali
- Dosage Form/Strength: 200 mg tablets
- Updated: November 18, 2020
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:
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Ribociclib 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., Ribociclib or Palbociclib) OR Everolimus based regimen for the treatment of unresectable locally advanced or metastatic disease. No funding for sequential treatment regimens involving ribociclib or palbociclib or everolimus will be considered.
AND
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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 ribociclib 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.)
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Patient has good performance status defined as an Eastern Cooperative Oncology Group (ECOG) score of 0 to 2; AND
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Patient does not have active or uncontrolled metastases to the central nervous system; AND
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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
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The Patient has not experienced disease progression on any of the following regimens for locally advanced or metastatic breast cancer:
i) a ribociclib or palbociclib regimen;
OR
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 ribociclib
Exclusion Criteria: (Note that exclusion criteria apply to both Initial eligibility criteria and renewal criteria.)
Patients meeting the following criteria will not be funded:
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Patient is using ribociclib as retreatment after disease progression on a prior ribociclib-based regimen in advanced breast cancer.
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Patient is using ribociclib with other drugs or in combinations other than those situations mentioned in 1 i), ii), iii) of the eligibility criteria.
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Patient is using ribociclib 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;
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Patient is pre- or peri-menopausal who is not being treated with a luteinizing hormone-releasing hormone (LHRH) agonist.
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Patient who is intending to use ribociclib with fulvestrant who has progressed on prior fulvestrant used as monotherapy or as part of another regimen.
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Patient whose disease has progressed during treatment with a palbociclib 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.
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Patient who has active or uncontrolled central nervous system (CNS) metastases.
On a time-limited basis, funding will be considered for the following on a case-by-case basis:
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Patients who missed the opportunity to use ribociclib 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 November 18, 2020 to February 18, 2021.
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Addition of ribociclib 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 November 18, 2020 to February 18, 2021.
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A switch to ribociclib + 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.
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A switch to ribociclib + fulvestrant at progression for patients already on and benefitting from everolimus + exemestane, provided that the start of everolimus + exemestane was prior to November 18, 2020. Patients must be CDK 4/6 inhibitor naïve and otherwise eligible for this therapy.
Dosing:
Ribociclib (Kisqali) 600mg orally once daily for 21 consecutive days, followed by 7 days off treatment in combination with one of the following:
- A continuous daily aromatase inhibitor
OR
- Fulvestrant 500mg administered intramuscularly on days 1 and 15 of cycle 1 and tehn on day 1 of each subsequent 28-day cycle.
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