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Reason for Use code 505 Confirmed chronic Hepatitis B infection in persons with - HBV DNA greater than or equal to 1000 IU/mL AND - ALT levels greater than ULN OR - Evidence of fibrosis or - Documented evidence of cirrhosis Coverage limit: LU Authorization Period: 1 year Reason for Use code 506 For patients with chronic Hepatitis B infection who have a contraindication, intolerance or inadequate response to one or more of the following: lamivudine, tenofovir, adefovir or telbivudine. Coverage limit: LU Authorization Period: 1 year Reason for Use code 507 Patients with chronic Hepatitis B infection currently receiving treatment with entecavir and requires treatment continuation. Coverage limit: LU Authorization Period: 1 year Reason for Use code 508 Patients with chronic Hepatitis B infection who are scheduled to undergo chemotherapy or significant immunosuppressive treatment. Coverage limit: LU Authorization Period: 1 year

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 ↗)

Apo-Entecavir · DIN 02396955 Manufacturer: Apotex Inc.; listing date 2013-01-29 Health Canada: Marketed since 2013-01-18 · brand APO-ENTECAVIR · ATC J05AF10 ENTECAVIR · form Tablet · route Oral · ingredients ENTECAVIR 0.5 MG · company Apotex inc · schedule Prescription

DIN 02396955: Apo-Entecavir Raw flags: sec12=Y, sec3=Y Item: 081800106; group id 85; item number 0153; lccId 00295; manufacturer id APX Source form: Tab; strength: 0.5mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $5.5000; ministry $4.4000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02396955 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=88196

Interchangeable products

Accel-Entecavir · DIN 02479907 · $4.4000 Auro-Entecavir · DIN 02448777 · $4.4000 Baraclude · DIN 02282224 · $4.4000 Entecavir · DIN 02527154 · $4.4000 Jamp-Entecavir · DIN 02467232 · $4.4000 Mint-Entecavir · DIN 02485907 · $4.4000 PMS-Entecavir · DIN 02430576 · $4.4000

Shortage status: not checked (no credentials)