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Exceptional Access criteria on record are for Brand(s): Ibrance; DOSAGE FORM/ STRENGTH: 75 mg, 100 mg, 125 mg tablet or capsules — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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 348 Palbociclib Brand(s): Ibrance DOSAGE FORM/ STRENGTH: 75 mg, 100 mg, 125 mg tablets or capsules 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. i) Patient is using palbociclib as retreatment after disease progression on a prior palbociclib-based regimen in advanced breast cancer. ii) Patient is using palbociclib with other drugs or in combinations other than those situations mentioned in 1 i), ii), iii) of the eligibility criteria. iii) 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; iv) Patient is pre- or peri-menopausal who is not being treated with a luteinizing hormone- releasing hormone (LHRH) agonist. v) Patient who is intending to use palbociclib with fulvestrant who has progressed on prior fulvestrant used as monotherapy or as part of another regimen. vi) 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. vii) Patient who has active or uncontrolled central nervous system (CNS) metastases. viii) The Patient is requesting Ibrance for use with fulvestrant and has extensive, symptomatic, potentially life-threatening visceral metastases. 349 Palbociclib Brand(s): Ibrance DOSAGE FORM/ STRENGTH: 75 mg, 100 mg, 125 mg tablets or capsules 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 tehn on day 1 of each subsequent 28-day cycle. 350  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 348, record 202, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Taro-Palbociclib · DIN 02547651 Manufacturer: Taro Pharmaceuticals Inc.; listing date 2024-11-29 Health Canada: Marketed since 2024-09-17 · brand TARO-PALBOCICLIB · ATC L01EF01 PALBOCICLIB · form Tablet · route Oral · ingredients PALBOCICLIB 125 MG · company Taro pharmaceuticals inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02547651). DIN 02547651: Taro-Palbociclib Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 100000319; group id 178; item number 0323; lccId None; manufacturer id TAR Source form: Tab; strength: 125mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $126.9562; ministry $126.9562 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02547651 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103659

Interchangeable products

Ibrance · DIN 02493551 · $126.9562 PMS-Palbociclib · DIN 02552140 · $126.9562

Shortage status: not checked (no credentials)