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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 Everolimus Brand(s): Afinitor and generics see formulary for a funded list of generics DOSAGE FORM/ STRENGTH: 2.5 mg, 5 mg, 10 mg tablet Noting that provincial funding algorithms for treatment of mRCC no longer list the use of everolimus within the funding sequence. EAP will apply the criteria as was originally intended case-by-case for received requests. You may wish to review the provincial mRCC algorithm when requesting an anticancer treatment for mRCC. For the treatment of metastatic renal cell carcinoma (mRCC) as second or third line1 therapy in patients previously treated for mRCC with a funded tyrosine kinase inhibitor (TKI). Exclusion criteria: Use in the 4th line setting or later in the treatment course of their disease Dosage: 10 mg daily Renewal will be considered for those who have demonstrated benefit from Afinitor therapy (i.e. no disease progression) and is expected to continue to do so. 1Funded TKIs include sunitinib (Sutent), sorafenib (Nexavar), and pazopanib (Votrient). The criteria are derived from the review of everolimus for provincial funding for the treatment of MRCC at the time of the original review. Drugs that may have been used as standard treatment in first line may have included interferon and temserolimus. Everolimus is currently not funded after progression on axitinib (Inlyta) or nivolumab. For the treatment of patients who have progressive, unresectable, well or moderately differentiated, locally advanced or metastatic pancreatic neuroendocrine tumors (pNET). Patient must have an ECOG* ≤ 2 (prior to the start of Afinitor therapy). *ECOG = Eastern Cooperative Oncology Group Status Exclusion criteria: the patient’s disease progressed while taking sunitinib (Sutent) to treat pNET. Dosage: 10 mg daily Duration of Approval: 1 year Renewal will be considered for those who have benefited from Afinitor therapy (i.e. no disease progression) and is expected to continue to do so. Reimbursement of Afinitor will be considered until disease progression occurs on Afinitor. Duration of Approval: 1 year 312 Everolimus Brand(s): Afinitor and generics (see formulary for a funded list of generics) DOSAGE FORM/ STRENGTH: 2.5 mg, 5 mg, 10 mg tablet For the treatment of unresectable, locally advanced or metastatic, well-differentiated non-functional neuroendocrine tumours (NETs) of gastrointestinal or lung origin (GIL) in adult patients meeting the following criteria: • Documented radiological disease progression within six months; AND • Good performance status (ECOG 0-2). Treatment should continue until confirmed disease progression or unacceptable toxicity. Renewals will be considered where the patient’s physician has confirmed that the Patient has benefited or continues to benefit from therapy with Afinitor as evidenced by no disease progression, and that they are expected to continue to do so. For the treatment of postmenopausal women with hormone-receptor positive, HER2 negative advanced breast cancer meeting the following criteria: • Afinitor is to be used in combination with exemestane; AND • Patient must have an ECOG* ≤ 2 after recurrence or progression following a non- steroidal aromatase inhibitor (NSAI). *ECOG = Eastern Cooperative Oncology Group Status Dosage: 10 mg daily (dose titration is allowed). Duration of Approval: 1 year Renewals will be considered for patients who have benefited or continues to benefit from therapy with Afinitor and is expected to continue to do so. Duration of Approval: 1 year 313 Everolimus Brand(s): Afinitor and generics (see formulary for a funded list of generics) DOSAGE FORM/ STRENGTH: 2.5 mg, 5 mg, 10 mg tablet For the treatment of renal angiomyolipoma (AML) associated with tuberous sclerosis complex (TSC) in patients who meet all the following conditions: (i) Presence of coalescent or multifocal AMLs in either one or both kidneys; AND (ii) AML progression despite previous embolization and/or surgery; AND (iii) Further embolization and/or surgery is not recommended due to a documented clinical reason (Note: The physician must submit a clinical note with the request outlining/detailing why invasive therapy cannot be considered); The approved dosage: 10 mg orally once daily. Duration of Approval: 1 year Case-by-Case consideration will be considered in patients who have never been treated with invasive procedures such as embolization and/or surgery. The physician must provide detailed clinical rationale (e.g., from clinical consultation notes) as to why embolization and/or nephrectomy would be medically contraindicated for the patient. Renewals will be considered in patients with the following documented benefits from therapy; No AML progression (i.e. no significant new lesions and increase in kidney volume, as well as no significant AML related bleeding); AND There is a reduction in volume of AMLs identified prior to treatment with the everolimus. Duration of Approval: 2 years 314 Everolimus Brand(s): Afinitor and generics (see formulary for a funded list of generics) DOSAGE FORM/ STRENGTH: 2.5 mg, 5 mg, 10 mg tablet For the treatment of Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) for whom surgical resection cannot be considered* for reasons such as: • Location, size, and/or distribution of tumour(s); OR • SEGA progression despite previous surgical interventions; OR • Neurocognitive problems/ other complications secondary to previous surgical interventions. • *Requests must provide details/ consultation notes outlining why the patient cannot be considered for surgical treatment. Duration of Approval: 1 year Renewals will be considered in patients with the following documented benefits from therapy: • Stabilization of SEGA progression (based on assessment of SEGA volume and/or appearance of new lesions); AND • Improvement of symptoms (e.g., reduced seizure frequency and decreased need for neurosurgical intervention). Duration of Approval: 2 years 315  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 312, record 185, 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 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Reddy-Everolimus · DIN 02532433 Manufacturer: Dr. Reddy's Laboratories Inc.; listing date 2024-09-27 Health Canada: Marketed since 2024-08-27 · brand REDDY-EVEROLIMUS · ATC L04AH02 EVEROLIMUS · form Tablet · route Oral · ingredients EVEROLIMUS 10 MG · company Dr reddy's laboratories ltd · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02532433). DIN 02532433: Reddy-Everolimus Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 100000200; group id 159; item number 0274; lccId None; manufacturer id DRR Source form: Tab; strength: 10mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $172.2559; ministry $172.2559 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02532433 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102147

Interchangeable products

Afinitor · DIN 02339528 · $172.2559 Nat-Everolimus · DIN 02530120 · $172.2559 PMS-Everolimus · DIN 02504693 · $172.2559 Sandoz Everolimus · DIN 02492946 · $172.2559 Teva-Everolimus · DIN 02463253 · $172.2559

Shortage status: not checked (no credentials)